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Case Study Update on Structured Content Approaches at Genzyme
Monica Mehta
Director, Regulatory Operations
The views and opinions expressed in the following PowerPoint slides arethose of the individual presenter and should not be attributed to Drug
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Agenda
Background Background Plans for 2009 SCM Business Case Development Plans and next steps
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Agenda
Background Background Plans for 2009 SCM Business Case Development Plans and next steps
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Background
Recognized the value of SCM Recognized the value of SCM approaches in submission development and compilation for global submissions
Conducted a Proof of Concept in 2008
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Co duc ed a oo o Co cep 008
Content will be:
SCM Perceived Benefits
Authored once in a manner that is independent of formatting, publishing or viewing considerations and then reused and repurposed for use in a variety of submission documents;
Tagged for inclusion/exclusion in submission documents
Stored in a content library from where it can be linked
Dynamically assembled into global submission documents
Delivered to a variety of channels or media
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Easily searched for reuse and maintenance
Reviewed at a granular content level or at a composite document level based on reviewer or organizational preferences
Rendered or presented based on the regional agency requirements including different formats and languages (translations)
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Objective
SCM Proof of Concept Objective
Analyze the potential for utilizing structured content concepts and techniques to the content authoring processes in providing efficiencies in the compilation of global submissions.
Focused on the quality related content for submissions in CTD (Proprietary), Redacted (Non Proprietary) and ASEAN
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Redacted (Non-Proprietary) and ASEAN presentations.
The Proof of Concept utilized Virtifys Structured Content Management (SCM) solution as the technology platform.
Successfully demonstrated
SCM POC Resultsy
the following for a document Editing Structure and Content Map Linking Content Redacting Proprietary Content Tagging/Replacing Content Viewing/Rendering the same document in
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g gdifferent formats ICH or ASEAN CTD
Export to Word, PDF or HTML
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Agenda
Background Background Plans for 2009 SCM Business Case Development Plans and next steps
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Develop a roadmap Identify Submissions, Geography or Therapeutic
Transition to SCMIdentify Submissions, Geography or Therapeutic area for a pilot
Collect metrics Demonstrate the Benefits Identify Best Practices and Lessons Learned
Organizational Change Management Process Roles and Responsibilities Supporting Tools and technologies
Ed ti i ti
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Education, awareness, communication and training
Technology choices are critical Solutions should support global, long-term needs Must be open, scalable and extensible
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Build on the success of the POC
Plans for 2009
Identify business processes which could benefit from SCM approaches
Develop strong business case Qualitative and Quantitative
Align with Structured Protocol initiative
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Develop RFI for vendors
Develop Transition Plan
Agenda
BackgroundBackground Plans for 2009 SCM Business Case Development
Communications Process Scope SIPOC Analyses Examples Alignment with Structured Protocol Initiative
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Alignment with Structured Protocol Initiative Quantitative Business Case Model Lessons Learned and Best Practices
Plans and next steps
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Now I can find all of the documents ever created!
Communication: Why SCM
SCMSCM
documents ever created!
But what I need is to know which documents
have the correct information for my
purpose!
-- and where are the supporting documents
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Research Preclinical Quality Clinical Regulatory MarketingManufacturing
Search Search SearchSearch Search SearchSearch
pp gand data!
Companiesspendtoomuchtimecreatingnewdocuments,rewritingexistingdocuments,repairingformatandapplyingmetadatatodocumentsthatprovidethesameproductinformationfor
TooMuchRework
SCMSCM
Communication: Why SCM
differentaudiences.
Intodaysbusinessmodels,contentiscreatedinmultiplelocations,sometimesbymultipleauthorsandfrequentlymovedfromonerepositorytoanothermakingitdifficulttofindandtrack.
Assignmentofsufficientandmeaningfulmetadatatoenableworkflow automation, security, findability and interoperability of
LackofDiscoverability
Ineffective Automation,
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workflowautomation,security,findabilityandinteroperabilityofdocumentsacrosssystemsislaborintensiveandtimeconsuming.
Authoringandcontentsearchsystemsareisolatedinfunctionalareasiloswhichmakesitdifficultforauthorstoavoidrewritingandcontentconsumerstodiscovercrossfunctionalinformation.
IneffectiveAutomation,SecurityandFindability
StovePipeSystems
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Createdocumentsfromreusablecontent(i.e.,buildingblocks)oftextanddata,thesystemautomatically
Reuse&RepurposeContent
SCMSCM
Communication: SCM User Benefits
appliesformattingandmetadataratherthanauthors.
Statusistrackedatboththetopicanddocumentlevelmakingiteasiertounderstandwhatpartsofadocument,(i.e.,topics),arereadyforreview,andwhichremain.
Metadataisatboththetopicanddocumentlevel
EnhanceTransparency
ImproveWorkflow,
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penablingthesystemtoautomaticallyandselectivelynotifyusersoftheirwritingand/orreviewtasks.Withtopics,userssearchandnavigatetofindcontenteitherbysubjectmatter(i.e.,thetopic)ordocument.
p ,SecurityandFindability
WriteitOnceinamannerthatisindependentofformatting,publishing or viewing considerations and then reuse and repurpose for
SCMSCM
Communication: SCM User Benefits
publishingorviewingconsiderationsandthenreuseandrepurposeforuseinmultiplesubmissiondocuments
Applyeffectivemetadatatoimprovesearchanddynamicallyassembleglobalsubmissiondocuments
Storeallcontentinasinglesourcelibraryfromwhereitcanbediscovered,linkedandreusedformultiplepurposes
bl h d f l ll l b
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Publishdocumentsforinternaluseaswellasregulatorysubmissions
Reducerereviewbyreusingcontentatagranularleveloratacompositedocumentlevelbasedonreviewerororganizationalpreferences
Republish,dontrewritecontentbasedonregionalagencyrequirementsincludingdifferentformatsandlanguages(translations)
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On the surface, structured content takes unnecessary re-work out of the business process i e copy & paste
Communication: SCM and Business Process Maturation
SCMSCM
the business process, i.e., copy & paste
Structured content also opens the door to enable maturation of business processes
Content is created in more standardized business processes Carried out with predictable results by internal or external resources Based on accepted standards for data, terminology and readability
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Automatically evolving over time and aligned to business purpose With measurable work effort and tracking of improvements
Bottom line, more time is dedicated to quality of the result and achievement of business objectives
Content ReusedUse of a text fragment, without modification, in multiple documents
SCMSCM
SCM: Real World Example
For example: Reuse in:Clinical Protocol: ICH E6(R1) Clinical Study Report: ICH E36.2 Background and Rationale 7. IntroductionProtocol Synopsis-Objectives 8. Study Objectives6.3 Study Objectives and Purpose 8. Study Objectives
Content Re-purposedProvision of text to users in multiple roles to provide context and supporting
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Provision of text to users in multiple roles to provide context and supporting information for multiple business uses
For example: Re-purpose information for:Clinical Protocol: ICH E6(R1) Clinical Study Report: ICH E36.9 Statistical Methods-Efficacy Analysis 9.5.1 Efficacy Evaluation6.9 Statistical Methods-Safety Analysis 9.5.2 Safety Evaluation6.13 Data Management and Monitoring 9.6 Data Quality Assurance
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Clinical: Process: Phase III Clinical Trial
SCMSCM
SCM: Genzyme Process Scope
Process steps to design, conduct, collect data, analyze and report
Nonclinical: Process steps to design, conduct, collect data, analyze and report
CMC Analytical Testing: Process steps to prepare, execute, collect data, analyze and report
Labeling: Develop Target Product Profile
Process: Repeat Dose Toxicology Study
Process: Stability Testing
Process: Label Development
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Develop Core Data Sheet Develop Package Inserts SPL; PIM etc
Administrative: Process steps for submissions to comply with local regulations for drug development
and marketing Process steps for submissions and regulatory communications to implement a products
global regulatory strategy
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Process: Comply With Local Regulations Implement Global Regulatory Strategy
Designing the Protocol
Protocol Reusable text is
Writing the Protocol Using the Protocol
So rce Output
SCMSCM
Design, Develop and Use a Clinical Protocol
Medical Writer selects clinical protocol template based on study design,
experience and standardsMedical Writers & Clinical Scientists
write study specific text using MS Word
document is published and
delivered to clinical sites
Reusable text is mapped to future
clinical documents
Clinical Trial Management
Study Hypothesis
XML
Study configuration information is
delivered to clinical systems
Source
Process
p
Consumer
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Text is collaboratively reviewed and
updated
Management Systems
Clinical Data Management
SystemsXML
Templates apply previously created
reusable text to reduce re-writing
e-Data Collection Systems
XML
Input
Process
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Target Product Profile
CCDS documentReusable text is
Core Data Sheet Labeling
So rce Output
SCMSCM
Design, Develop and Use a CCDS
Research, Development and Marketing provides input to define the target
product
Labeling creates and maintains the CCDS
CCDS document is published and made available from LiveLink
mapped to future pre-clinical and
clinical documents
Local markets refer to the CCDS for
labeling submissions
Source
Process
p
Consumer
Medical Affairs
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Text is collaboratively reviewed and
updated, continuously
Templates apply previously created
reusable text to reduce re-writing
Input
Process
Medical Affairs refers to the CCDS in responding to
customer questions
Internal decision making bodies refer
to the CCDS as a product profile
Consumer
Drug R&D Timeline
Years -3 -2 -1 C 1 2 3 4 5 6 7 8 9 10
A Document is an information snap-shot but product information continuously evolves
SCMSCM
MarketedPre-market
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Drug R&D Timeline
Years -3 -2 -1 C 1 2 3 4 5 6 7 8
Target Product Profile
Global Development Plan: A Series of Snapshots over time
Indications and Usage Target
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Drug Abuse and Dependence
Overdosage
Launch
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Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
Patient Counseling Information
Research Preclinical Quality Clinical Regulatory MarketingManufacturing
Posting Trial Results Determination to post results of a trial
Process: Phase III Clinical Trial
SCMSCM
Process Scope of Trial Registration & Results Posting
Where the trial results should be posted When (e.g., post-study, interim, )
After product approval (posting is in context of all studies as submitted) After completion of study (one study at a time) Delay in posting for incomplete study or new indication (file request to delay, requires IND Information)
Gather existing trial information Tables, lists and figures (TLFs) CSR (interim, final, errata) Clinical Trial Management information IND/IB/IMPD Registration posting List of publications (peer reviewed if results are presented)
Create posting content
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p g Author additional topics
Character length summaries of:- Patient Disposition (Patient Flow)- Outcome Measures (e.g., PK)
- Efficacy or Safety or Both (tabular, no narrative)- Adverse Event Information (SAE, Non-serious AE)
Posting trial results to Regulatory Authority Data elements required by Regulatory Authority
Maintaining trial results posting Interim to Final Links to new publications with results
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BackgroundAuthorization to conduct a Phase 3 clinical study usually requires the study be registered and approved in advance for countries where clinical sites are located. Posting of results may also be required
Goal
SCM Business Case: Clinical Trial Registration and Result Posting
SCMSCM
Description
The data elements and content components required for trial registration are standardized as elements of the protocol and other documents or data elements required in design of the study
Metadata is standardized and templates are defined to enable automatic assembly of trial registration elements by country
The data elements and content components required for results posting are standardized as elements of the study report and otherdocuments or data elements provided with the study report
Metadata is standardized and templates are defined to enable automatic assembly of trial results elements for posting by country
Integrate data and content for Phase 3 clinical study trial registration documents to minimize the time required for authoring, review and approval of new content
Benefits
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Elimination of manual transcription errors and time to transfer data and content elements to registration/results package
Reduce time and resource required for initial and updated registration or results posting
Improve consistency and quality of data and content elements for registration or results posting
Opportunity Cost
Inability to reduce time for transfer of data or content to registration or results postings
Inability to reduce time to review and ensure data and content qualityProcess Maturity Perform Manage Define Quantify Optimize
Objective
Current State
Gather Summarize andDraft Review
ProjectSubmit
Start Process End Process
Update
Clinical Trial Registration and Result Posting Current State SIPOC Business Process Model
SCMSCM
GatherInformation
SummarizeandIntegrate
RegistrationPackage
RegistrationPackage
ProjectManagement
RegistrationPackage
Supplier/Source Input Process Output Consumer
[i] Clinical Trial Management System
Clinical trial sites Access CTMS to determine location of trial sites
List of countries for trial registration
[r] BMRAC Program Dev. & Ops.
[r] BMRAC Program Dev. & Ops.
List of data elements required for registration
Work with Regulatory Affairs
Clinical Trial Registration Package for each country
[i] Regulatory Authority
[r] Biomedical Data Sciences
Tables lists and figures from Access tables, lists and figures to
[r] Clinical Research Protocol Synopsis Access Protocol Synopsis
[r] Regulatory Affairs Access IRiS information
UpdateRegistration
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[r] Regulatory Affairs Access IRiS information
[r] Regulatory Affairs Access IND information
Legend [r] Role involved in conduct of a business process
[i] Information source or application
Relies upon labor intensive manual processes to copy and paste information from source to trial registration documents
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GatherInformation
SummarizeandIntegrate
DraftRegistrationPackage
ReviewRegistrationP k
ProjectManagement
SubmitRegistrationP k
Start Process End Process
SIPOC Business Process Model
UpdateRegistration
Clinical Trial Registration and Result Posting Future State
SCMSCM
g gPackage
gPackage
Supplier/Source Input Process Output Consumer
[r] Regulatory Affairs List of countries and data elements required for registration
Work with Regulatory Affairs Clinical Trial Registration Package
[i] Regulatory Authority
[r] Biomedical Data Sciences
Tables lists and figures from Access tables, lists and figures
[r] Clinical Research Protocol Synopsis Access Protocol Synopsis
[i] Clinical Trial Management System
List of clinical sites and countries Access Clinical Trial Management information
g
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[r] Regulatory Affairs Access IRiS
[r] Regulatory Affairs Access IND
Legend [r] Role involved in conduct of a business process
[i] Information source or application
Labor intensive content transfer steps are removed, reducing level of effort and potential for error
Structured Protocol Template Development
Structured Protocol in the scope of the Clinical Data Standards program at Genzyme
SCMSCM
Standards program at Genzyme
Process for structuring the global protocol template: Identify content in the protocol which could potentially be structured Identify content as data vs text vs free (ie, unique)
Define rules and exceptions for structuring
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Structured protocol templates will be based on industry standards and variability will be based on Genzyme-defined implementation of these standards (ie, preferences)
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Quantitative Business Case: Structured Protocol
Develop a quantitative business case model for Structured Protocol Timebox the effort
F 2 3 l t d t b t t th &
SCMSCM
Focus on 2 3 programs selected to best represent the pros & cons Gather only the data needed on cycle times and resources from the selected
programs, find the balance of enough data to be credible while not overburdening resources
Create a model (based on the data) to project the future state with SCM for each program
Candidate Programs A recent program representing Genzymes evolving business strategy, A legacy program representative of the norm in how Genzyme conducts clinical
t di
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studies A Phase I focus, one program where we look at a small set of representative
Phase I studies A Phase III focus, one program where we look at a pivotal Phase III study Etc.
Lessons Learned and Best Practices
Focus on the business process and information content involved
SCMSCM
involved Do not discuss final document output or format Do not discuss tools and technologies
Talk in business terms
Clearly articulate business case for the organization
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Clearly articulate business case for the organization
Develop models and simulations to articulate the best practices
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Agenda
Background Background Plans for 2009 SCM Business Case Development Plans and next steps
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Identified business processes
Summary 2009 Accomplishments
p
Business case development in progress
Identified ways of having SCM conversations
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y gwith stakeholders
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Plans and Next Steps
Complete Business Case DevelopmentComplete Business Case Development
Decide on Prioritized SCM Initiatives
Gather detailed Business Requirements
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Issue RFI to Vendors RFI Development Vendor Assessment
SCM Candidate Future Development Projects
SCMSCM
Structured Content Management
Clinical Protocol Template(s)
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Informed Consent (IFC)
Non Clinical Study Report
Stability Testing Results
Batch Analyses
Drug Product Specifications
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Core Data Sheet Investigators Brochure (IB)
Integrations with Systems: IVRS, EDC, CTMS, CDMS, Registries
Package Insert
Clinical Trial Registration and Results Disclosure
Data Management Plan (DMP)
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Q&A
SCMSCM
Monica MehtaMonica MehtaDirector, Regulatory Operations
Genzyme [email protected]
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