Welcome to IDBS i3 · Management Instrument Data ... Instrument Checks & Calibration Certificate of...
158
Welcome to IDBS i3 Seattle 2017 Laurence Painell
Transcript of Welcome to IDBS i3 · Management Instrument Data ... Instrument Checks & Calibration Certificate of...
Welcome to IDBS i3Seattle 2017
Laurence Painell
Welcome to Seattle
The Theme
IDEAS
INSIGHT
INSPIRATION
Agenda
E-WorkBook CloudCurrent Strategy amp Future Direction
Scott Weiss VP Product Strategy
66
ELN
Challenge
Can we simplify the RampD Informatics landscapehellip
while delivering key functionalityhellip
in a cost effective simpler to maintain user friendly package
In study Data Analysis
Study Reporting
File Sweeping
Test Requesting
Sample Management
Instrument Data Capture
Raw Data amp Large filearchiving
Recipe Management
Instrument Checks amp Calibration
Certificate of Analysis
Process Execution
IP capture
Lab Inventory
Chemistry Registration
Biologics Registration
Stability Testing
StructuredResults
Management
Method Management
Resource Scheduling
Experiment Write-up
BatchRecords
InstrumentTracking
Chemistry
Corp Inventory amp Logistics
Biology
Cross DomainAnalysis
DataExploration
Knowledge Extraction
Analytical Automation
Project Reporting
Formulation Management
Big DataAnalytics
Data Marts
Test Automation
SemanticsOmics file
mngt
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Welcome to Seattle
The Theme
IDEAS
INSIGHT
INSPIRATION
Agenda
E-WorkBook CloudCurrent Strategy amp Future Direction
Scott Weiss VP Product Strategy
66
ELN
Challenge
Can we simplify the RampD Informatics landscapehellip
while delivering key functionalityhellip
in a cost effective simpler to maintain user friendly package
In study Data Analysis
Study Reporting
File Sweeping
Test Requesting
Sample Management
Instrument Data Capture
Raw Data amp Large filearchiving
Recipe Management
Instrument Checks amp Calibration
Certificate of Analysis
Process Execution
IP capture
Lab Inventory
Chemistry Registration
Biologics Registration
Stability Testing
StructuredResults
Management
Method Management
Resource Scheduling
Experiment Write-up
BatchRecords
InstrumentTracking
Chemistry
Corp Inventory amp Logistics
Biology
Cross DomainAnalysis
DataExploration
Knowledge Extraction
Analytical Automation
Project Reporting
Formulation Management
Big DataAnalytics
Data Marts
Test Automation
SemanticsOmics file
mngt
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
The Theme
IDEAS
INSIGHT
INSPIRATION
Agenda
E-WorkBook CloudCurrent Strategy amp Future Direction
Scott Weiss VP Product Strategy
66
ELN
Challenge
Can we simplify the RampD Informatics landscapehellip
while delivering key functionalityhellip
in a cost effective simpler to maintain user friendly package
In study Data Analysis
Study Reporting
File Sweeping
Test Requesting
Sample Management
Instrument Data Capture
Raw Data amp Large filearchiving
Recipe Management
Instrument Checks amp Calibration
Certificate of Analysis
Process Execution
IP capture
Lab Inventory
Chemistry Registration
Biologics Registration
Stability Testing
StructuredResults
Management
Method Management
Resource Scheduling
Experiment Write-up
BatchRecords
InstrumentTracking
Chemistry
Corp Inventory amp Logistics
Biology
Cross DomainAnalysis
DataExploration
Knowledge Extraction
Analytical Automation
Project Reporting
Formulation Management
Big DataAnalytics
Data Marts
Test Automation
SemanticsOmics file
mngt
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Agenda
E-WorkBook CloudCurrent Strategy amp Future Direction
Scott Weiss VP Product Strategy
66
ELN
Challenge
Can we simplify the RampD Informatics landscapehellip
while delivering key functionalityhellip
in a cost effective simpler to maintain user friendly package
In study Data Analysis
Study Reporting
File Sweeping
Test Requesting
Sample Management
Instrument Data Capture
Raw Data amp Large filearchiving
Recipe Management
Instrument Checks amp Calibration
Certificate of Analysis
Process Execution
IP capture
Lab Inventory
Chemistry Registration
Biologics Registration
Stability Testing
StructuredResults
Management
Method Management
Resource Scheduling
Experiment Write-up
BatchRecords
InstrumentTracking
Chemistry
Corp Inventory amp Logistics
Biology
Cross DomainAnalysis
DataExploration
Knowledge Extraction
Analytical Automation
Project Reporting
Formulation Management
Big DataAnalytics
Data Marts
Test Automation
SemanticsOmics file
mngt
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
E-WorkBook CloudCurrent Strategy amp Future Direction
Scott Weiss VP Product Strategy
66
ELN
Challenge
Can we simplify the RampD Informatics landscapehellip
while delivering key functionalityhellip
in a cost effective simpler to maintain user friendly package
In study Data Analysis
Study Reporting
File Sweeping
Test Requesting
Sample Management
Instrument Data Capture
Raw Data amp Large filearchiving
Recipe Management
Instrument Checks amp Calibration
Certificate of Analysis
Process Execution
IP capture
Lab Inventory
Chemistry Registration
Biologics Registration
Stability Testing
StructuredResults
Management
Method Management
Resource Scheduling
Experiment Write-up
BatchRecords
InstrumentTracking
Chemistry
Corp Inventory amp Logistics
Biology
Cross DomainAnalysis
DataExploration
Knowledge Extraction
Analytical Automation
Project Reporting
Formulation Management
Big DataAnalytics
Data Marts
Test Automation
SemanticsOmics file
mngt
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
66
ELN
Challenge
Can we simplify the RampD Informatics landscapehellip
while delivering key functionalityhellip
in a cost effective simpler to maintain user friendly package
In study Data Analysis
Study Reporting
File Sweeping
Test Requesting
Sample Management
Instrument Data Capture
Raw Data amp Large filearchiving
Recipe Management
Instrument Checks amp Calibration
Certificate of Analysis
Process Execution
IP capture
Lab Inventory
Chemistry Registration
Biologics Registration
Stability Testing
StructuredResults
Management
Method Management
Resource Scheduling
Experiment Write-up
BatchRecords
InstrumentTracking
Chemistry
Corp Inventory amp Logistics
Biology
Cross DomainAnalysis
DataExploration
Knowledge Extraction
Analytical Automation
Project Reporting
Formulation Management
Big DataAnalytics
Data Marts
Test Automation
SemanticsOmics file
mngt
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
In study Data Analysis
Study Reporting
File Sweeping
Test Requesting
Sample Management
Instrument Data Capture
Raw Data amp Large filearchiving
Recipe Management
Instrument Checks amp Calibration
Certificate of Analysis
Process Execution
IP capture
Lab Inventory
Chemistry Registration
Biologics Registration
Stability Testing
StructuredResults
Management
Method Management
Resource Scheduling
Experiment Write-up
BatchRecords
InstrumentTracking
Chemistry
Corp Inventory amp Logistics
Biology
Cross DomainAnalysis
DataExploration
Knowledge Extraction
Analytical Automation
Project Reporting
Formulation Management
Big DataAnalytics
Data Marts
Test Automation
SemanticsOmics file
mngt
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
ELNLIMS
LES
SDMS
PLMMES
REGBI
LIMS
ERPEDW
ELNELN ELN
ERP
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
purchase only the capabilities you require
modules can be designed for specific needs = less configuration overhead amp better user experience
out-of-box integration = lower costs to maintain and upgrade
IDBSrsquo Modular Approach
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Assay management test execution and decision support
New for 2017 Plan and coordinate work
Manage samples materials amp equipment
Accelerate B2B collaboration
Support chemical workflows
New for 2017 Support biomolecule workflows
Integrate systems and instruments
Capture content and manage data
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Chemist or Biologist
in your own notebook
One system for seamless workflow
Plan and execute a chemical or biosynthesis experiment
External Partner
or through an outsourcing partner
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
One system for seamless workflow
Request analytical tests directly from notebook
Register new chemical or biologic samples for subsequent tracking
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Analytical Tester
Analytical team receives and schedules tests uses predefined method template
One system for seamless workflow
Fetch details of samples common reagents or equipment status
From notebook create a worklist and integrate with CDS
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Analytical Tester
One system for seamless workflow
Analyst fulfills request to notify originator and returns links to
test results
Chemist or Biologist
Originating chemist or biologist has direct access to data shared by analyst
and can mine that data to create subsequent reports and analyses
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
interoperate modules
modern architecture amp interface design
or to add capabilities that augment existing infrastructure
can be deployed as a standalone platform
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
faster onboarding with reduced internal support costs
quicker access to the latest technology amp upgrades
reliable and performant service with a more direct level of support
Built for the Cloud
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
CORE ADD-ON CAPABILITIES
SaaS or On Premise
COLLABORATION TOOLS
SaaS OnlyIntegrates with On-premise ELN amp Advance
FOUNDATIONS
SaaS or On Premise
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
EWB 100 (2015)
New Architecture
Web UI amp Spreadsheets
EWB 103 (2018)
EWB 101 (2016)
ChemistrySearching
Instrument Integration
EWB 102(2017)
Curve FittingEmpower
Launch of Cloud
Launch of Request
Launch of Connect
Launch of Biology
Launch of Inventory
Desktop Migration Tool
Launch of GxP Cloud
Evolution of E-WorkBook
EWB 1023 amp INV 211
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
2018 ROADMAP
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Data Accessibility IDBS Data Service
Operational Data Services
IDBS Data
eln advance biology chemistry inventory
spreadsheets
Normalisation ndash tagging amp inference
Indexing ndash fast access amp aggregation
Availability ndash search amp export
Ingestion
Cat
alo
g ndash
dat
a m
od
el c
on
tro
lled
voca
bula
ry m
eta
dat
a m
aste
r d
ata
Secu
rity
ndash b
oun
dar
y t
enan
t is
ola
tio
n e
ncr
ypti
on a
uth
enti
cati
on
RB
AC
Other consumers ndash standalone search browsing analytics visualisation warehouses reporting
data marts
public data
data sets search events
upload events etl
fee
d
dat
a av
aila
bili
ty t
o s
ou
rce
ap
plic
atio
ns
Cloud based
Consolidated view of IDBS data
Highly scalable amp performant
Interfaces for simplified 3rd
party data consumption (vizanalytics tools)
Support for semantic enrichment
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Focus on Biomolecule RampD
Bioregistration amp Bioinventory
BioAssay Support amp Data Visualization
Integration with 3rd Party Tools
Blending of Biologics and Traditional Chemistry
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Compliance
Tools to make it easier to enforce business rules amp
enhance traceability
features to support chemical health amp safety reporting
Improved reporting on operational metrics
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Connecting the dots between the moduleshellip
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
to deliver Common Workflows
Method Validation amp Execution
Analytical Testing Workflows
Formulation and Recipe Management
Sample Lifecycle Management amp Reporting
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
QampA
E-WorkBook CloudAn end-to-end enterprise cloud-based platform designed to meet demanding scientific data and RampD workflow management challenges across the globe
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
E-WorkBook CloudDetailed Roadmaps
Scott Weiss VP Product Strategy
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
ELN Roadmap
Q3
E-WORKBOOK 1023
bull Experiment Save API
bull Notebook Action API
bull Multi select insert templates
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Updated Text Editor
bull Prism 7 support (display pagesediting)
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull NuGenesis integration
bull Additional Public APIs
bull Office 365 Genesis integration
Q4
Candidates
2018
E-WORKBOOK 103x
bull Administration Configuration functions
bull Audit log enhancements
bull PKI signing
Areas of Focus
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfillenhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
Areas of Focus
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
CHEMISTRY Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Areas of Focus
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull SDF import amp batch registration
bull Expose user preferences
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 1030
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
BIOLOGY Roadmap
Q3
E-WORKBOOK 1023
bull Basic Rendering (Genbank FASTA)
bull HELM-based Editing standard
bull Registration to 3rd
party systems (BMT)
Commitments
Q2
E-WORKBOOK 1022
bull Rendering and registering biomolecules
bull PoC of Biosynthesis in Stoichiometry
Pre-release
E-WORKBOOK 103
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
Q4
Candidates
2018
E-WORKBOOK 103x
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
INVENTORY Roadmap
Q3
INVENTORY 21x
bull Performance enhancements
bull Defect fixes
Commitments
Q2
INVENTORY 21
bull Genealogy Reporting
Delivered
INVENTORY 22
bull Data model upgrade Inventory records and items
bull Support 3rd party unique ID
bull Genealogy enhancements
bull Public API release
bull Basic user permissions
Q4
Candidates
2018
INVENTORY 2x
bull Health amp safety
bull Search from spreadsheet
bull Storage enhancements
bull Bulk uploaddownload enhancements
bull Biologics domain
bull Item check incheck out
bull Label printing configuration
bull Advanced user permissions
Areas of Focus
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
CONNECT Roadmap
Early Spring lsquo17Defects and selected improvements
Early SummerImproved IP CaptureExperiment IDExperiment Audit TrailExperiment PDFTemplate supportAccessory file uploadCross experiment references
Late SummerDefects and selected improvements
AutumnExternalized Chemistry Support for E-WorkBook Stochiometric itemsChemAxon license management
WinterPublish XE docs to ActivityBaseBiology RendererUser saved Filters
Early Spring lsquo18Test RequestingSupport for E-WorkBook Request
Connect operates under a bi-weekly semi-automated release process New features and defects are continually being prioritized and pushed into the main code branch This roadmap is therefore just an indication by when
features would be available Note there is no version
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
REQUEST Roadmap
UX
Scheduling
AutumnSample Logistics
Sample receipt status
Link to genericIDBS Inventory system
WinterServices
Group services into a single offering
lsquoFavoritersquo frequently used services
Samples
Browse + add inventory
Metadata presented inline in requests and jobs
Spring lsquo18Scheduling
Fine grain scheduling
Team working days
Job view inline with calendar
Filters for assigned amp unassigned work
Overlay teams on calendar
A ldquomyrdquo view of workload
Samples
Import samples to SS from linked jobs
Update jobs from spreadsheet panels
Public APIs
Tailored for LIMs
Service Team ndash Additional TasksAdmin can create a set of tasks that each job will need to perform
A service team member can add tasks assign and complete them
Hierarchy
Summer lsquo18Permissions
Requests visible to Group that a requester belongs
Projects
Associate requests amp jobs to a Project
Filter requests by Project
Filter jobs by project
Filter scheduler by project
Fall lsquo18Connect Support
Ability to use Connect Experiments to complete work
Winter lsquo18Spreadsheet
Ability for a SS designer to map dimensions of the SS to fields in Connect
2018 Wishlist
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
MODULE OVERVIEW
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Center of the platform
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Focus on ease of use
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Key features and benefits
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Functionality videos
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
ELN Roadmap
Q4
E-WORKBOOK 1030
bull UI Update
bull Experiment Creation API
bull Bug fixes
Commitments
Q3
E-WORKBOOK 1023
bull Notebook Action API
bull Multi select insert templates
Delivered
2018
E-WORKBOOK 103x
bull Usability enhancements
bull Administration Configuration functions
bull Audit log enhancements
bull Performance enhancements
bull PKI signing
Candidates
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
The E-WorkBook Cloud ADVANCE
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull BioBook
bull Didnrsquot apply to the other industries
bull E-WorkBook with Spreadsheet
bull So much more than just a spreadsheet
bull E-WorkBook Enterprise
bull Didnrsquot quite fit the true definition of enterprise
ADVANCEverb to move forward in a purposeful way
The Never-Ending Marketing Struggle
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull AssayTest Execution Modulebull Create flexible templates for scientific protocolsbull Capture instrument data and direct observationsbull Calculate and store test results visualize databull Design queries amp reports
bull Benefitsbull Increase laboratory efficiency through automationbull Improve data qualitybull Provide data amp process insight via reporting
E-WorkBook ADVANCE
ANALYZE
CAPTURE
REPORT
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Current Situation
bull Not just fulfilling technical debt for the web spreadsheet
bull Wersquore listening to our customers and enhancing spreadsheet capabilities making them more intuitive and easier to use for end users
bull Ensuring customer spreadsheets can migrate to the web
bull Letrsquos talk about your use cases to see how they fit into the spreadsheet or the general platform
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Tracking Feature Migration
EWB Web Feature Support Matrixxlsx
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
End User Experience
Perspectives Interactive Instructions
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
End User Experience The Canvas
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bullKey component to managing your results data
bullKey underpinning for BioAnalytical Solution and BioProcess Solutions
bullWorks together with other modules to create cohesive work environment
bullRight DataProcess occurring in right module
Supporting the overall platform
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Lets get to the techy details
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
ADVANCE Roadmap
Q3
E-WORKBOOK 1023
bull Spreadsheet API enhancements
bull Blinding
Commitments
Q2
E-WORKBOOK 1022
bull Request integration
bull Run BRD Transforms on draft save
bull Auto run queries on open
bull Dynamic constrained lists
bull Display pages for Canvases
bull Randomization
bull Safari 10 support
bull Performance improvements
Delivered
E-WORKBOOK 103
bull Comment on changes
bull Chromeleon integration
bull Smartfill enhancements
Q4
Candidates
2018
E-WORKBOOK 103x
bull Additional public APIs
bull Migration Tool enhancements (ongoing)
bull Import definition tagged areas
bull Further GxP Enhancements
Areas of Focus
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
1023 Spreadsheet APIs
bull New webhook for creating custom actions from spreadsheet
bull Capabilities for bi-directional integration
bull Can launch an external browser window for additional interaction
Your Custom Integration
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
1023 Blinding
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Spreadsheet MIGRATION TOOL
Accelerate Desktop Conversions
Converts legacy desktop spreadsheets to new web format
Automatically converts tables formula catalog mapping formats etc
Delivered as a Secure Web Portal
Maintained and updated by IDBS
URL currently available to IDBS Consultants and Partners
IP white listing will be used to control access
Direct customer beta access targeted by end of 2017
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Get your hands on Advance and attend the Advance Workshop tomorrow
bull Discuss your migration strategy with your IDBS team
bull Start thinking about the data you are currently NOT managing today
bull What other groups or departments could benefit from properly storing their data
For your consideration
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
eWorkBook Inventory Management
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Canrsquot find it
bull Lost time
bull Wasted materials
bull Duplicate ordering
bull Unnecessary use of storage
IrsquoM OUT OF REFERENCE STANDARD
IrsquoM OUT OF FREEZER SPACE
THIS PIPETTE IS NOT
CALIBRATED
I NEED THAT ROTOR BACK
WHERE ARE THE NEW SPEC
BULBS
WE ALREADY HAD THIS BUFFER
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Need to route out an error source
bull Contaminated stocks
bull Out-of-calibration equipment
bull Incorrectly prepared reagents
The result is blank Zero
What just happened to me
Who prepared thisWas ithellipsabotage Was the temperature
off
How old was that buffer
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Principles and sample objectives
Easy to use
Comprehensive seamless platform integration
Facilitate data-informed RampD activities
Streamlining
bull Expand and improve bulk Excel updownload
bull Build commonly used EWB spreadsheets directly into the platform
Reporting amp analytics
bull Provide more detailed quantity tracking
bull Expand access to inventory usage log information
bull Expand equipment use data
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Find it - Detailed search
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
and quick status updates
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Components
Tracking components and next steps
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
EWB Data amp workflow integration
bull Plan use of items
bull Check compliance
Prepare
bull Calculations
bull Status
Processbull Register new
items
bull Usage log amp Genealogy
Results
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Components
Traceability ndash what happened
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Identifying the next generationshellip
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
and use in EWB experiments
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Road map 2018 Priorities
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Manage user access
bull By location or item typebull Full access read-only or blocked
User Management
USER
MANAGEMENT
Blocked
Read-only
Edit
GROUPS ROLES amp PERMISSIONSLOCATIONS
Next release Authorization
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Next release Public API
We will continue to evolve this API toenable integrated management of inventory data including
bull Inventory itemsbull Locationsbull Related itemsbull History and usagebull Some configurations
External inventory
Equipmentmaintenance
Chemical nutrition etc data
Financial system
RFIDlocation
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Save time relabeling use your existing bar code labels
bull Use pre-labeled items from vendors clients etc
Use external IDs as system IDs for inventory items
The external ID must be unique
2018 3rd Party ID Support
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Planned improvements
bull Search for locations and storage
bull Bulk Excel options for rooms and sites
bull Layout view of structured storage
bull Find available space in storage
Manage your storage more easily via additional options to find and view storage contents and capacity
2018 Storage enhancements
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
First approach
bull Leverage high-performance search facet feature
bull Enhance with summary visualizations with drill-down
bull Prioritiesbull Due expiry maintenance
calibrationbull Type-specific propertiesbull Status and quantitybull Usage
2018 Reporting
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
DETAILS ITEMS SAFETY
GHS Pictograms
Hazard Summary
Full MSDS
Download MSDS
Flammable liquids
Serious Eye DamageEye Irritation
Specific target organ toxicity (single exposure)
Target Organs - Central nervous system (CNS)
ITEMS
C₃H₆OChemical formula and structure
Storage Ambient ventilation
bull Key properties and health and safety information are automatically populated
bull Uses CAS number other options planned
2018 Auto-populate safety info
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Naptha
100
Franklin Lab
Exp 2019-10-11
Ace BioTech
MySample123
Laura Rueda
Exp 2019-10-11
Choose to add
bull Safety informationbull Contact name or ownerbull Expiration datebull Custom fields
2018 Label printing enhancements
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Download bull A search resultbull Contents of a location Process improvements
bull Easy choose import templatebull View import resultsbull Download list of failed imports
2018 Expand amp improve bulk updownload
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Scott Weiss
Advantages
bull See who has itemsbull Prevent conflicts in use
2018 Item check incheck out
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Who is it forMolecular biologist
biochemists
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
LARGE MOLECULES
SMALL MOLECULES
DNA
RNA Proteins
ADCs
Small Peptides
Oligos
Antibodies
Cell Therapies Fine Chemicals
Agrochemicals
SM Pharmaceuticals
Petrochemicals
Unnatural Monomers
Polymers
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
BIOLOGY Roadmap
Q4
E-WORKBOOK 1030
bull ELN enhancements
bull Biology search capabilities
Commitments
Q3
E-WORKBOOK 1023
bull Production Biology module
bull Render edit and register biomolecules
RELEASE
2018
E-WORKBOOK 103x
bull Integration with E-WorkBook Inventory
bull New tailored Inventory functionality
bull Advanced search capabilities
bull Support for external molecular biology tools
bull Support for additional file types
bull Production of Biosynthesis in Stoichiometry
Areas of Focus
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
E-Workbook Chemistry Module Overview
Scott C Mayer PhD
Confidential IDBS copy 2017
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
The Average Synthetic Lab
Confidential IDBS copy 2017
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
What do Chemists actually do
bull Synthesize novel chemical molecules
bull Record structures amp procedures of the chemical transformation
bull Purification amp analytical analysis
bull Registration amp biological testing (assay)
Confidential IDBS copy 2017
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Industry Challenges
bull Need to produce more novel compounds with high level of externalized research
bull Easy data entry and access to data from anywhere
bull IP protection with evolving patent landscape
bull Growing interest in synthetic biologicals
bull Integrations to existing systems and applications
bull IT consolidation of legacy systems into modern web-based architecture
Confidential IDBS copy 2017
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
hellipto enable scientists to work collaboratively efficiently and reliably
IDBSrsquo vision is to provide a single platformhellip
Confidential IDBS copy 2017
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
E-Workbook is specificallydesigned to provide a singleplatform with modules thatseamlessly work together
Confidential IDBS copy 2017
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Making the Chemistry Vision A Reality
bull Chemical Journey - Listening to the customer
bull Strategic Partnership ndash ChemAxon
bull User Experience ndash intuitive quick to search amp eliminate transcription concerns
bull Dynamic Platform ndash leveraging legacy information to accelerate research (turning negatives into positives)
bull Harmonized system that can communicate across all scientific disciplines ndash allows for consistency as well as complete analysis
Confidential IDBS copy 2017
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
E-WorkBook for Chemistry
Confidential IDBS copy 2017
E-WorkBook Chemistry is an enterprise Cloud platform designed specifically to empower chemists in their novel research
It smooths the path of discovery by moving your lab away from paper and ordinary ELNs towards an intuitive integrated system Supported by the data management expertise of IDBS combined
with ChemAxonrsquos cutting-edge technology you will have the worldrsquos most powerful solution for chemical research
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Chemistry module designed by Chemists
bull Molecule rendering amp searchingbull Reaction planning amp execution (fully flexible stoichiometry engine)bull Reagent lookup sources ndash internal databases or ChemSpiderbull Rapid data entry ndash procedure textbull Chemical health amp safetybull Compliance checking for restricted chemicalsbull Integration with chemical registration systems
bull Benefits
bull Modern scalable performant Web-based applicationbull Fully integrated with E-WorkBook Platform (Request amp Connect)
E-WorkBook CHEMISTRY
Confidential IDBS copy 2017
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
IDBS amp ChemAxon Strategic Partnership
bull Market-leader in enterprise cheminformatics
bull Technology is web-enabled with feature rich APIrsquos for direct integrations
bull Collaborative software development
Confidential IDBS copy 2017
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Chemistry User Forums
bull Direct stakeholder engagement is critical in agile development
bull Ratify our understanding and approach to solving key issues
bull Users are able to contribute ideas and actively shape the development of the product
Confidential IDBS copy 2017
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Customer Use Cases
bull Achillion ndash 360 degree integrationbull Reagent sources amp Registration
bull Moderna ndash transformation onto web via hosted instancebull Quick adoption to Web Chem ndash customer preference
bull Chemistry Forums ndash key customer feedbackbull Small molecule synthesis opening door to process world
Confidential IDBS copy 2017
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Collaboration and Integration
Confidential IDBS copy 2017
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Providing a secure neutrally hosted environment outside of the corporate firewall where two or more entities can jointly conduct RampD activities in real time
bull E-Workbook Connect provides the tools required to securely plan track and execute complex RampD work
bull External work can be captured directly into E-WorkBook to fully describe all experimental detail and thus add to the corporate knowledgebase and IP
Chemistry amp E-WorkBook Connect
Confidential IDBS copy 2017
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Designed to schedule tests amp manage multi-step workflows across both internalexternal service teams in intelligent stage-gated manner
bull Users can raise work requests for molecule synthesis analytical tests or biological assays
bull Obtain on-demand update of progress whilst allowing service teams to perform the task as part of a templated process
Chemistry amp E-WorkBook Request
Confidential IDBS copy 2017
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull The influence of biological entities like synthetic peptides siRNA and antibody-drug conjugates (ADCrsquos) are influencing traditional organic chemistry
bull Being able to accurately represent biological entities using HELM notation is a key advantage
bull Users are able to register biomolecules and use them in a synthetic reaction
Chemistry amp E-WorkBook Biology
Confidential IDBS copy 2017
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
E-WorkBook Chemistry Roadmap
Q3
E-WORKBOOK 1022
bull BioviaDraw Hotlinking
bull Promote product to new reaction
bull Parallel synthesis (v1)
bull Registration workflows amp duplicate handling
bull Analytical workflows for new structure proposal
Candidates Commitments
Q2
Delivered
E-WORKBOOK 1023
bull Stoich UX enhancements
bull Radiochemistry
bull Rxn conditions (timepoints)
bull IPC sampling table
bull Public API lookup
bull Proxy Registration Service (asynchronous)
bull Stoichiometry in EWB Connect
Q4 2018
Candidates
E-WorkBook 1030
bull Chemistry data model
bull Boolean Search
bull Polymer chemistry
bull Parallel Synthesis (v2)
bull Editable i-button
bull Print preview of stoich
E-WorkBook 103x
bull Advanced searching amp reporting
bull 3rd party HampS lookup
bull Design of experiment (manual amp stats package)
bull SDF import amp batch registration
bull Expose user preferences
bull Process chemistry
bull Flow chemistry
bull Reaxys Integration
bull Molecule design amp SAR
bull EWB Inventory integration
bull Public API (Reg Inv)Confidential IDBS copy 2017
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
E-WorkBook Chemistry Technical Session
bull Experience the future of electronic chemical data management
bull Hands-on workshop to explore dynamic power of capturing and managing chemical data in ldquoA Day in the Liferdquo of the synthetic chemist
bull Chemically enabled tool to capture all aspects of your reaction stoichiometry reagent sources automated procedure write-up health amp safety management of analytical samples and compound registration
bull Day 2 ndash Thurs Oct 5th ndash 200 PM
Confidential IDBS copy 2017
E-WorkBook for Bioprocess
BIOPROCESS
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
What is it
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Transfection
Cloning
Clone Screening
Thaw and Passage
Cell Expansion
Bioreactor
Harvest
Column Packing
Chromatography and Filtration
UV-VIS
Plate Based Assays
Gel Based Assays
HPLC
Solution Preparation
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Who is it for
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
We start with the existing workflow
Modify calculations as necessary
Adapt instructions to be specific to
customer scenario
Configure data import
Integrate laboratory
instruments
Set up required reports
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
BIOPROCESS Roadmap
Q4
bull New analytical workflows
bull Additional reports
bull Additional validation and auditing capabilities
bull Further training material
Commitments
Q3
bull Core spreadsheets
bull Core catalog
bull Inventory configuration
bull Workflow ocumentation
Delivered
bull Leverage E-WorkBook Request
bull Additional integration support
bull Additional workflows
bull Leverage new Advance and Inventory capabilities
2018
Candidates
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Upgrade amp Migration PlanningDesktop-to-Web
Presented by
Sermed Naaman Principal Consultant
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Why Develop a Plan
bull Needs for a Planbull Estimate effortbull Estimate costsbull Estimate duration
bull Leads Tobull Minimize riskbull Understand and change requiredbull Manage corrective actionsbull Ensure success
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Pre-requisites for a Plan
bull Clear scope of the taskbull Not always defined
bull Not decided
bull Not enough information
bull Understanding what is possiblebull Education
bull Do you know the new product(s) and features
bull Trial and Practicebull Lessons learned through doing (mistakes in a safe environment)
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Stepwise Approach
bull Ordered task list to ensure successbull Not always defined
bull Not decidedbull Not enough information
bull Analysis Tasksbull Provide quantitative databull How many how much
bull Evaluation Tasksbull Provide qualitative databull How whobull Is this the approach we want to take
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
IDBS Model for Migration
Existing System
Plan
Sandbox (update of
Production)
Whatrsquos my database
size
How many Workflows
How many Latest
Versions
What features are used in Workflows
What can be migrated
programmatically
Timings and Duration
Upgrade Plan
Education (Web builder
End User)
Evaluation of System
Features
Rollout and Training Plan
Migration Event
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Analyze
Analysis Tasks
118
The database has the answers we just have to ask
SQL Statements
bull To be run on database
Spreadsheet Analysis Tool
bull Desktop tool to be run against Hierarchy
Migration Tool
bull To be run against Workflows to be migrated
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Journey to the Cloud Pivoting to SaaS - BenefitsOctober 5 2017
Biology
Inventory
Chemistry
Connect
ELN
Integrations
Assay
Request
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Agenda
bull SaaSbull Introduction to SaaS
bull Drivers to go SaaS
bull The E-WorkBook Cloud bull Frequently asked questions
bull Business benefits
bull Financial impact
bull System delivery impact
bull Technical details
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
What is SaaS
Software as a service (SaaS pronounced saeligs) is a software licensing and delivery model in which
software is licensed on a subscription basis and is centrally hosted It is sometimes referred to as ldquothe
cloudrdquo SaaS is typically accessed by users using a thin client via a web browser
121
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Why SaaS
bull Improve the user experience
bull Higher adoption rates
bull Lower cost of entry
bull Reduce the cost of IT systems
bull Reduce time to benefit
bull Spend time implementing IT solutions instead of maintaining systems
bull Vendor is responsible for upgrades uptime and security
bull Be operationally agile
bull Work anywhere
bull Pay as you go
122
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Reasons to Deploy SaaS (Top Drivers)
InnovationCloud is a modern
approach
Operational Agility
Cost Reduction
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
The E-WorkBook Cloud
bull Provided as SaaS
bull Hosted by a market-leading public cloud provider
bull Installed managed by SRE team
bull Removes the need to install monitor upgrade
bull Access through a URL usernamepassword
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Who owns my data
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Who owns my data You Do
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Who has access to my data
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Who has access to my data
IDBS follows the philosophy of least privilege
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Is my data co-mingled with
other companiesrsquo data
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Is my data co-mingled with
other companiesrsquo data
No each company has its own separate instance of
the E-WorkBook Cloud
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Are you complaint
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Yes E-WorkBook is 21 CFR 11 compliant
Information security quality management system are ISO9001
ISO27001 TickITplus certified Data center is ISO9001 ISO27001
SOC1 SOC2 SOC3 certified
Are you complaint
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Is my data safe
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
IDBS deploys a variety of security layers including
intrusion detection systems vulnerability scanning
software and penetration testing We also monitor
the network for anomalous activity
Is my data safe
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Did I miss anything
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Ensure Return on Investment (ROI)
Better performance
Easy diagnosis of problems
Reduced risk of data loss
New features implemented bugs squashed faster
IT staff reassigned to innovative projects
Benefits of the E-WorkBook Cloud
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Ensure Return on Investment
performance ease-of-use high-levels of user adoption
ROI
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Align to best practice
bull Continually reconfigure Oracle
bull Address deviations before they disrupt the user
bull Active monitoringbull On-call management
bull Incident notification
bull Infrastructure timeline
bull Real time alerts
bull Increase server capacity
Better performance
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Simplifies troubleshooting
bull Access to server Oracle application log files
bull Address issues wo asking you to replicate the issue
bull Limits the impact to users IT
Easy diagnosis of problems
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Strong disaster recovery
bull Fast mean time to repair (MTTR)
bull Backed up continuously ensuring that once data is entered it is backed up
bull Seven-day transaction window in which data lost within a seven-day period can be restored without restoring the entire backup
Reduced risk of data loss
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Upgrades services included in subscriptionbull New features
bull Resolution of bugs defects
bull Improved system performance stability
bull Upgrades scheduled with youbull Non GxP quarterly upgrades
bull GxP yearly upgrades
bull Better end-user experience bull Problems resolved
bull New capabilities deployed
New features implemented bugs squashed faster
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
bull Eliminate application support troubleshooting
bull Deploy to innovative value-added projectsbull Improve market position
bull Advance science
bull Improve the lives of patients
IT staff reassigned to innovative projects
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Questions
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
License Costs On Premise vs SaaS Deployment
0
50
100
150
200
Year 1 Year 2 Year 3 Total ThreeYear Costs
On-Prem License Costs Compared to SaaS License Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Comparing License Cost A False Equivalency
lt65 gt90
Modified from ldquoSaaS VS On-Premise HR Systems Pros Cons amp Hidden Costsrdquo httpswwwpeoplehrcomrdquo
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Total Costs On Premise Costs vs SaaS Costs
0
50
100
150
200
250
Year 1 Year 2 Year 3 Total ThreeYear Costs
Total On-Prem Costs Compared to Total SaaS Costs (reflected as of SaaS)
Annual Costs (On-Premise) Annual Costs (SaaS)
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
E-WorkBook Cloud Delivery
Fast
bull Production instance within 4-6 weeks
bull Hierarchy and security in days instead of weeks
Efficient
bull IT team needed only to help configure the network
bull IT time can be spend supporting the business
Consultative
bull Benefit from IDBS best practice
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Service Delivery Effort
156
0
2
4
6
8
10
12
14
16
5-10 users 10-20 users 50-75 user Example on-premise
Day
s
Comparison of Deployment Effort
Configuration Services Post Go-Live Support
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Benefits of the E-WorkBook Cloud
Eliminates
Cost of servers (eg new servers to support Web)
Cost of Oracle licenses
Cost of off-site disaster recovery
Effort to upgrade bi-yearly upgrades
Effort to troubleshoot
Effort to maintain Oracle servers
Effort to install support
Adds
Performance
Improved user experience
Speed to issue resolution
System health dashboard
Active monitoring amp response
Quarterly upgrades
Operational flexibility
EWB platform functionality
Cost transparency
157
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Acknowledgements
bull Images provided by freepixcom peoplehrcom
bull Data provided by Accenture Linford amp Company LLP IDBS staff and IDBS customers
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Single-tenancy EWB instance
bull Amazon Web Service public cloud
bull Single tenancy environment which separates customer data from another customers environment
bull Accessible via VPC Peering VPN or SSL connection from customer network (whitelist IP)
159
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Backups and disaster recovery
bull E-WorkBook infrastructure is n+1 resulting in a high level of redundancy
bull If a primary database fails our MTTR (mean time to repair) is less than 30 minutes
bull 7 day transactional windowbull If any data deleted within 7 days IDBS can restore the data (without
restoring the complete backup)
160
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Data loss prevention
bull IDBS deploy an IDS (Intrusion detection system) across production networks monitoring network traffic to monitor for unusual network activity
bull In addition we use a VSS (vulnerability scanning software) to ensure our servers and AWS account are managed securely and fully patched
bull All web access is over HTTPS allowing for encrypted transmissions All data is encrypted at rest
bull 3rd party experts run the IDS and VSS
161
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Information security auditing and responsebull IDBS operates an information security management system in
accordance with and certified to ISO 27001
bull IDBS operates internal audits under ISO 9001 and ISO 27001
bull Events are escalatedprioritized on a five band scale Top level (4 and 5) are treated as incidents
bull ISO 90012008 ISO 270012013 both certified by the accredited certification body (DNV) Certificates are provided
162
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Infrastructure security
bull SRE perform annual penetration tests or tests when major network changes are made
bull SRE follow the AWS CIS guidelines to manage our AWS account and infrastructure
bull In addition we deploy an intrusion detection system and vulnerability scanning software to all production AWS VPCs
bull SRE follow the ubuntu RedHat and Amazon security mailing lists to monitor for security issues
163
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Logging and monitoring
bull All failed login events are logged and sent to a centralized log management tool
bull Server login attempts and escalated privilege requests (sudo) are managed reported in our IDS and VSS systems
bull All server and application logs are aggregated in Logentries Logentries will alert for system warnings and errors
bull Logs are aggregated in our IDS and VSS tools for security monitoring
bull Any critical and high warnings are escalated within a 15 minute window
bull AWS follow 522022-M (ldquoNational Industrial Security Program Operating Manualrdquo) or NIST SP 800-88 guidelines to destroy data as part of decommissioning
164
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Network security
bull Firewalls are managed using AWS security groups
bull IDBS use a third party to perform intrusion detection vulnerability scanning and malware detection of the hosted EWB setup
bull Access is IP whitelisted
165
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
Single sign-on (SSO)
bull Support SAML2 protocols
bull Implemented Ockta and Azure AD for SSO
166
