©2013 IDSC, LLC10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 1

IDSC

Capabilities ● Expertise ● Services

Mark CreswellPresident and CEOmarkcreswell@idscbiotechnetwork.comPhone: 734.433.9670Cell: 734.476.4097

©2013 IDSC, LLC

IDSC May Be A Fit For YOU…

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FROM HIT TO THE CLINIC…

YOUR DRUG DISCOVERY AND DEVELOPMENT

PARTNER

• Biotech

• Pharma

• Academic

• VC

If you are a…

• Drug discovery…

• Preclinical development…

• Clinical development…

In need of…

…High Impact Consulting

©2013 IDSC, LLC10/29/2013 WWW.IDSCBIOTECHNETWORK.COM 3

Who is IDSC?

IDSC: Integrated Team of Specialists• Interdisciplinary group

• 40 Ex-Pharma Leaders

• 25 yrs Pharma Experience

• Sr. VPs, VPs, Exec. Directors

• Careers in:• Big Pharma

• Biotech

• Academia

• Consulting

©2013 IDSC, LLC

Stages of Drug Discovery & Development

Hit to LeadLead

Optimization

Preclinical Development to IND Filing

Clinical Development

DevelopmentDiscovery

IDSC’s Services Span:

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Identify Clinical

Candidate

Draft & Submit

IND

Draft & Submit

NDA

FDAPre-IND Meeting

FDAPhase 2 Meeting

Evaluate HTS Hits or SBDD

Results

Select lead compounds

©2013 IDSC, LLC

Why Clients Come to IDSC

Interim Leadership

• Filling the gaps

• Most major therapeutic areas

• All line disciplines

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

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Due Diligence

• Investment opportunities

• Program reviews

• SWOT analyses

•Venture capitalists

• Pharma companies

•Academics

Molecular Modeling

• Structure based design

• Pharmocaphore modeling

•Homology models

•Docking, etc

• Small molecules or biologicals

Outsourcing Management

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

• 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 project team to our client.

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

©2013 IDSC, LLC

Examples of What Our Leaders Do

Medicinal Chemists• Therapeutic area expert

• Evaluates SAR & decides what compounds to make

• Know ADME & design targets to improve ADME, potency, & efficacy

•Designs synthesis and manages outsourcing

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API & CMC Managers•Manage CMOs

• Chemistry, biologicals, cell lines…

•Optimize chemistry process

• Troubleshoot biologicals

• Submit regulatory registrations

Clinicians• Support preclinical

development plan

•Draft clinical protocols

• Participate in and/or lead clinical advisory boards

•Oversee clinical trials

•Advise client, preclinical, and clinical project teams

TA Experts and Project Leaders

• Advise client on therapeutic area

• Prepare program reviews

• Lead teams in preparation of gap analyses and development plans

• Serve as project leader for project teams

Regulatory Experts• Guide client and IDSC team on

and assure regulatory guidelines are met

• Assist client with preparation for and accompany client to FDA meetings

• Assist client with preparation of and submission of regulatory documents

ADME, Toxicologists, Pharmacologists

• Design in vitro and in vivo studies

• Identify vendors and manage outsourcing

• Evaluate study data and write INDsubmission study reports

• Make decisions based on study results

©2013 IDSC, LLC

Discovery Expertise

• Medicinal Chemistry

• Molecular Modeling

• Pharmacology

– in vitro

– in vivo

• ADME

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Line Discipline ExperienceTherapeutic Area Experience

• CNS

• Cardiovascular

• Dermatology

• Infectious Diseases

• Inflammation

• Immunology

• Metabolic Diseases

• Oncology

• Pain

©2013 IDSC, LLC

Development ExpertisePreclinical & Clinical

• ADME / Toxicology / Pathology

• PK/PD/TK Modeling

• Process Chemistry/ API Mgmt / CMC

• Formulation/ Fill/ Finish…IV/ Solid

• Regulatory Compliance

• Clinical Study Design

• FDA Meetings

• IND/NDA Preparation & Submission

• Commercialization Strategy

• Product Assessment & Valuation

• Competitive Intelligence

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Small

Molecules

●

Biologics

●

Stem Cells

●

Devices

●

Nutraceuticals

©2013 IDSC, LLC

Fully Integrated Collaborations

Individuals

Small Teams

Team MembersContracted as:

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DiscoveryPreclinical DevelopmentClinical DevelopmentTeams

Management:

Information & Data Sample logistics

Decision treeCRO management

IDSCDirectors

Client

IDSCTA Expert &

PM, POC

Management:

Information & Data Sample logistics

Decision treeCRO management

IDSC Toxicology

Director

IDSC Clinician

IDSCAPI & CMC

Director

IDSC Regulatory

Director

IDSC ADME

Director

IDSCClin-

Pharm

IDSCIn-vivo Pharm

Director

IDSCIn-vitro Pharm

Director

IDSC

In Vivo Pharmacology

CRO

API Scale UpCRO

ToxicologyCRO

ADMECRO

In Vitro Pharmacology

CRO

©2013 IDSC, LLC

Summary

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

Expertise

IDSC offers the academic, biotech,

pharma, and VC community a fully

integrated drug discovery and

development partner

Discovery Development

Interim Leadership ● Consulting ● Fully Integrated Collaborations ● Outsourcing Management

Discovery

CommercialAssessment

ClinicalDevelopment

ProjectLeadership

RegulatoryCompliance

PreclinicalDevelopment

CROsClient

Small Molecules ● Biologics ● Stem Cells

Therapeutic Area Expertise• CNS• Cardiovascular• Dermatology• Infectious Diseases• Inflammation• Immunology• Metabolic diseases• Oncology• 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• Commercial Assessment &

Valuation

Hit to LeadLead

Optimization

PreclinicalDevelopmentTo IND Filing

ClinicalDevelopment

Therapeutics . Stem Cells . Nutraceuticals . Devices . Diagnostics

IDSC