IDSC Expertise Capabilities Services Short 10 slides V5 Modified for PDF 2014-09-24

©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 1

Mark CreswellPresident and [email protected]

Phone: 734.433.9670Cell: 734.476.4097

Capabilities ● Expertise ● Servicesand IDSC’s

Discovery & Development Teams

IDSCFrom Hit to the Clinic…Your Drug Discovery

& Development Partner

©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC

• Biotech• Pharma• Academic• VC

If you are a…

IDSC May Be A Fit For YOU…

11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 2

FROM HIT TO THE CLINIC…

YOUR DRUG DISCOVERY AND DEVELOPMENT

PARTNER

• Drug discovery…

• Preclinical development…

• Clinical development…

In need of…

…High Impact Consulting


Who is IDSC?Integrated Team of Specialists

→ Interdisciplinary group

→ 55 Ex-Pharma Leaders

→ 25 yrs Pharma Experience

→ Sr. VPs, VPs, Exec. Directors

→ Careers in:

→ Big Pharma

→ Biotech Companies

→ Academia

→ Post Career Consulting


IDSC Supports All Stages of Drug Discovery & Development


Hit to LeadLead

Optimization

Preclinical Development to IND Filing

Clinical Development

DevelopmentDiscovery

IDSC’s Services Span:

Identify Clinical

Candidate

Draft & Submit

IND

Draft & Submit

NDA

FDAPre-IND Meeting

FDAPhase 2 Meeting

Evaluate HTS Hits or SBDD

Results

Select lead Series

Optimize Properties, Synthesis,

SAR

Medicinal ChemistryPharmacology

Molecular ModelingADME

Early Safety

ADME & PK/PD ModelingToxicology & PathologyProcess Development

API ManagementFormulation

Analytical Development

Drug Product Fill & FinishCMC Regulatory

Regulatory ComplianceClinical Study DesignClinical Operations

Commercial Assessment & Valuation


Molecular Modeling

• Structure-based design

• Ligand-based design

• Structural Bioinformatics

• Cheminformatics

• Small molecules and biologicals

Interim Leadership• Filling the gaps

•Most major therapeutic areas

•All line disciplines

• Small molecules., biologics, stem cells, diagnostics, devices, nutraceuticals

Why Clients Come to IDSC


Due Diligence

• Investment opportunities

• Program reviews

• SWOT analyses

• For venture capitalists

• For pharma companies

• For academics

Outsourcing Management

•Medchem, API/ biological, pharmacology, toxicology, ADME, etc.

• Parts of clinical that IDSC does not run ourselves

• Identify CROs & CMOs

•Manage CROs & CMOs

Consulting

•Most major therapeutic areas

•All line disciplines

• Small molecules., biologics, stem cells, diagnostics, devices, nutraceuticals

Fully Integrated Collaborations

• IDSC supplies a full or partial project team to our client.

• All discovery, preclinical development, or clinical development line discipline experts.

Commercial Assessment

• Commercial assessment & valuation

•Market Research–Quant & Qual

– KOsL, Payers, etc

• Forecasting

•Net Present Values

http://www.idscbiotechnetwork.com/services/drug-discovery/molecular-modeling/

http://www.idscbiotechnetwork.com/services/drug-discovery/interim-management-leadership/

http://www.idscbiotechnetwork.com/services/drug-discovery/strategic-technical-consulting/?logout=1

http://www.idscbiotechnetwork.com/services/outsourcing-management/

http://www.idscbiotechnetwork.com/services/drug-discovery/strategic-technical-consulting/?logout=1

http://www.idscbiotechnetwork.com/services/drug-discovery/fully-integrated-discovery-collaborations/

http://www.idscbiotechnetwork.com/services/outsourcing-management/


IDSC does not have laboratories and does not provide lab services... IDSC is a team of 55 consultants providing leadership to our

clients. We do, however manage our clients’ outsourcing efforts.

A Point of Clarity…

A Rhetorical Question…


Clinical Development and Operations Leader

• Point of Accountability and POC

• Develop corporate clinical strategy

• Develop & manage clinical operations

• Oversee clinical trials

• Manage timeline & budget

Examples of What Our Leaders Do


Clinical Operations• Clinical leadership & Project

management

• Biostatistics

• Study management

• Site monitoring

• Data capture & management

• Medical writing

• Recruitment & Retention

Regulatory Experts

• Guide client and IDSC team on and assure guidelines for the appropriate FDA division are met

• Assist client with preparation for and accompany client to regulatory agency meetings

• Assist client with preparation of and submission of regulatory documents

API & CMC Managers

• Identify CMOs and manage outsourcing

– Chemistry, biologicals, cell lines…

• Optimize chemistry process

• Troubleshoot biologicals

• Submit regulatory registrations

• API, CMC, cell lines, formulation, analytical, and, fill & finish, etc

IDSC is a team of 55 consultants providing leadership to ur clients… We do not have laboratories and do not provide lab services. We do, however manage our clients’ outsourcing efforts.

Clinicians• Support the indication preclinical

development plan

• Draft clinical protocols & plan

• Participate in and/or lead clinical advisory boards & identify KOLs

• Oversee clinical trials

• Advise client, preclinical, and clinical project teams

ADME, Toxicologists, Pharmacologists

• Design in vitro and in vivo studies

• Identify ADME & Toxicology CROs

• Identify in vitro & in vivo indication specific CROs & manage outsourcing

• Evaluate study data and write INDsubmission study reports

• Make decisions based on study results & program goals

Medicinal Chemists• Therapeutic area expert

• Evaluates SAR & decides what compounds to make

• Knows TA & ADME requirements & designs compounds to optimize ADME, potency, & efficacy

• Designs synthesis and manages outsourcing

TA Experts and Project Leaders

• Advise client on therapeutic area and disease indication

• Prepare program reviews

• Lead teams in preparation of gap analyses and development plans

• Serve as project leader for project teams


Therapeutic Area Expertise

11/14/2014 8WWW.IDSCBIOTECHNETWORK.COM

→ Inflammation

→ Infectious Diseaseas

→ Antivirals

→ Antifungals

→ Antibacterials

→ Immunology

→ Immuno-inflammatory diseases

→ Metabolic Diseases

→ Oncology

→ Blood disorders

→ Most tumor types

→ Pain

→ CNS

→ psychotherapeutics

→ Neuro-degenerative diseases

→ Dermatology

→ Including wound healing

→ Cardiovascular

→ Including cardio-devices

→ Ophthalmology


Line Discipline Expertise


Drug Discovery

Preclinical & Clinical Development

• Medicinal Chemistry

• Molecular Modeling

• Pharmacology

– in vitro

– in vivo

• ADME

• ADME & PK/PD/TK modeling• Toxicology & pathology• Process chemistry/ API mgmt / CMC• Formulation, analytical, fill & finish• Clinical study design, MD, CMO• Regulatory support, including:

– Regulatory agency meetings– Document preparation & submission

• Clinical operations• Commercialization strategy• Product assessment & valuation• Market research

Small Molecules

●

Biologics

●

Stem Cells

●

Devices

●

Diagnostics

●

Nutraceuticals

http://www.idscbiotechnetwork.com/services/drug-discovery/

http://www.idscbiotechnetwork.com/services/drug-discovery/

http://www.idscbiotechnetwork.com/services/preclinical-development/

http://www.idscbiotechnetwork.com/services/preclinical-development/


Medical Devices


Regulatory Compliance•Determine the correct regulatory strategy

• Ensure actives and goals are aligned with the regulatory strategy

•Write regulatory documentation

•Make regulatory submissions

• Prepare client for meeting with regulatory agencies

Strategic Planning•Guide company strategy

•We help our client:

–Establish a business plan

–Set company goals, timelines, budgets, and milestones

–Generate an exit strategy

• Identify and oversee external vendors

Clinical Development• Establish and run clinical advisory board

• Identify and utilize KOLs

•Determine clinical pathway

•Write clinical protocols

• Ensure nonclinical studies & other development activities align with clinical plan & regulatory requirements

• Clinical operations

Market Assessment•Asset valuation

•Determine market size and potential market penetration

• Competitive intelligence

• Position client to manage negotiations with investors and partners by receiving the highest value for their asset

• Performing product valuations are not just in the domain of “big-pharma”

Disease Diagnostics Nutraceuticals


Directors

Management:

Information & Data Sample logisticsDecision funnel

CRO management

IDSC

Client

Toxicology

TA SpecificClinician

(MD)

API, CMC, Analytical,

Formulation

Regulatory

ADME PK/PD/TK Modeling

Clinical Pharmacology

Med-Chem & Pharmacology

Clinical Operations

Analytical labs, Clinics, &/or Clinical

CROs

Chemistry & API Scale Up

CROs

ToxicologyCROs

ADMECROs

PharmacologyCROs

TA Expert, PM, & POC

FDA

KOLs

CROs & CMOs:

Abbreviations:• POC: point of contact• CMO: chief medical officer• CROs & CMOs: contract research organizations

& contract manufacturing organizations

Team Members Contracted as:

Individuals

Small Teams

Fully Integrated Collaborations

Discovery Preclinical Development Clinical Development Team Study

Sites

The team grows and contracts as needed as the asset moves down the development continuum.


IDSCDirectors

& Staff


Client

Medical Writers

Clinician (CMO)

Biostats

Regulatory & Document Submission

Site Monitors

Clinical Pharma-cologist

API, Analytical, Formulation, CMC, Fill &

Finish

Study Managers

API, Final Dosage Form, Fill & Finish, Analytical

IVRS, Electronic Data Capture

Software

Clinical CROs(if needed)

Clinical PKAnalysis

Clinical Dev/Ops Leader &

POC

Study Sites

E-Data Capture &

Management

CROs & CMOs:

FDA

KOLsClinical Development& Clinical Operations

IDSC Clinical Ops Team Will Provide:

Program leadership

Project management

Site assessment & selection

Patient recruitment & retention

Tool kits, Dear Dr. referral letters

Timeline & budget management

Site management

Site monitoring

Budget development

Contract & budget approval facilitation

Data management

Real time data monitoring & capture

Keys To Success:

→ Team makes key decisions

→ Excellent project leadership

→ Excellent communication

→ Excellent project management

→ Significant operations expertise

→ Goal oriented team

→ Manage streamlined logistics process

Abbreviations:• POC: point of contact• KOL: Key Opinion Leader• CMO: chief medical officer

• CROs & CMOs: contract research organizations & contract manufacturing organizations


Program ReviewGap Analysis

Development Plan

Program Review•Often early in preclinical (Discovery)•Often performed by 1 director (consultant)•Review of client’s early data, issued patents, patent applications, &

relevant literature• Provide client with a SWOT (strengths, weaknesses, opportunities,

threats) analysis.• Provide brief scientific next steps needed, generally to move the

project to the next stage such as a funding spinout, out-licensing, VC funding, etc.• Provide a brief written report or teleconference or both•Often 10-20 hours of consulting work

Gap Analysis•Often performed late in preclinical development•Often performed by multiple directors (consultants)•Review client’s in vitro, in vivo efficacy, ADME, & tox data, issued

patents, patent applications, and relevant literature, clinical plan, & IND ready study reports• Provide client with key studies and protocols that are missing from the

technical package & and regulatory information needed to get to INDsubmission.• Provide a detailed written report and a teleconference call•Depending on # of directors and therapeutic area, it can take 25-115

hours of consulting work (1-8 directors)

Development Plan•Often performed when clinical candidate is identified• Performed by 1-8 directors (client’s budget dependent)•Review client’s in vitro, in vivo efficacy, & ADME data, issued patents,

patent applications, and relevant literature• Provide client with needed efficacy, ADME, & tox studies, protocols,

timeline, budget, regulatory needs, and cohesion with a PhI clinical plan to get to an IND submission • Provide a detailed written report and a teleconference call•Depending on # of directors and therapeutic area, can take 25-230

hours of consulting work (1-8 directors)


IDSC is an Interdisciplinary Group of Over 55 Ex-Pharma Leaders Averaging 25-Years of Big-Pharma and Biotech Experience

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Small Molecule & Biologic Therapeutics ● Stem Cells Therapies ● Nutraceuticals ● Medical Devices ● Diagnostics

Hit to Lead Lead OptimizationPreclin Developto IND Filing

Clinical Development

DevelopmentDiscovery

Therapeutic Area Expertise•CNS (Most Indications)•Cardiovascular•Dermatology• Infectious Diseases (AB, AV, AF)• Inflammation• Immunology•Metabolic diseases•Oncology (Most tumors & Blood)•Ophthalmology•Pain

Discovery Expertise•Medicinal Chemistry•Molecular Modeling•Pharmacology•Outsourcing Management•ADME

Development Expertise•ADME & PK/PD/TK Modeling•Toxicology & Pathology•API management & CMC•Formulation, Fill & Finish•Regulatory Compliance•FDA meetings, IND/NDA prep & submission•Clinical Study Design•Clinical Operations•Commercial Assessment & Valuation

IDSC’s clients come to us for Discovery, Preclinical Development, Clinical Development, and Project Management Expertise

Interim Leadership ● Consulting ● Fully Integrated Collaborations ● Due Diligence ● Molecular Modeling ● Outsourcing Management

IDSC Brings the Academic, Biotech, Pharma, and VC Community a Fully

Integrated Discovery and Development Partner


310 N. Main St. Suite 204Chelsea, MI 48118 USA

Phone: 734.433.9670Fax: 734.433.9671Cell: 734.476.4097

[email protected]

THANK YOUMark Creswell

President & CEO

For More Information, Visit:www.idscbiotechnetwork.com

http://www.idscbiotechnetwork.com/

IDSC Expertise Capabilities Services Short 10 slides V5 Modified for PDF 2014-09-24

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Transcript of IDSC Expertise Capabilities Services Short 10 slides V5 Modified for PDF 2014-09-24