IDSC offers fully integrated drug discovery and development services to biotech, pharma, academic, and VC clients. They have expertise in discovery, preclinical development, clinical development, and project leadership. Their services include medicinal chemistry, pharmacology, ADME/toxicology, API management, clinical development, and regulatory compliance. IDSC has therapeutic area experience in CNS, cardiovascular, oncology, and more. They provide individual experts or fully integrated project teams along with outsourcing management to guide clients' programs from hit identification through clinical development.

1. Mark Creswell
President and CEO
markcreswell@idscbiotechnetwork.com
Phone: 734.433.9670
Cell: 734.476.4097
Capabilities ● Expertise ● Services
IDSC
10/29/2013
WWW.IDSCBIOTECHNETWORK.COM
©2013 IDSC, LLC
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2. IDSC May Be A Fit For YOU…
If you are a…
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FROM HIT TO THE CLINIC…
Biotech
YOUR DRUG DISCOVERY AND DEVELOPMENT
Pharma
PARTNER
Academic
VC
In need of…
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Drug discovery…
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Preclinical development…
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Clinical development…
…High Impact Consulting
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WWW.IDSCBIOTECHNETWORK.COM
©2013 IDSC, LLC
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3. Who is IDSC?
IDSC: Integrated Team of
Specialists
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Interdisciplinary group
40 Ex-Pharma Leaders
25 yrs Pharma Experience
Sr. VPs, VPs, Exec. Directors
Careers in:
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Big Pharma
Biotech
Academia
Consulting
©2013 IDSC, LLC
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4. Stages of Drug Discovery & Development
IDSC’s Services Span:
Discovery
Lead
Optimization
Hit to Lead
Evaluate HTS
Hits or SBDD
Results
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Development
Select lead
compounds
Identify
Clinical
Candidate
Preclinical
Development
to IND Filing
FDA
Pre-IND
Meeting
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Clinical
Development
Draft &
Submit
IND
FDA
Phase 2
Meeting
Draft &
Submit
NDA
©2013 IDSC, LLC
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5. Why Clients Come to IDSC
Interim Leadership
Fully Integrated
Collaborations
• Filling the gaps
• Most major therapeutic
areas
• All line disciplines
• Small molecules, biologics,
stem cells, diagnostics,
devices, nutraceuticals
• IDSC supplies a full project
team to our client.
• All discovery, preclinical
development, or clinical
development line
discipline experts.
Due Diligence
Molecular Modeling
• Investment opportunities
• Program reviews
• SWOT analyses
• Venture capitalists
• Pharma companies
• Academics
• Structure based design
• Pharmocaphore modeling
• Homology models
• Docking, etc
• Small molecules or
biologicals
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Consulting
• Most major therapeutic
areas
• All line disciplines
• Small molecules,
biologics, stem cells,
diagnostics, devices,
nutraceuticals
Outsourcing
Management
• Medchem, API/ biological,
pharmacology, toxicology,
ADME, etc.
• Identify CROs & CMOs
• Manage CROs & CMOs
©2013 IDSC, LLC
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6. Examples of What Our Leaders Do
Medicinal Chemists
ADME, Toxicologists,
Pharmacologists
• Therapeutic area expert
• Evaluates SAR & decides what
compounds to make
• Know ADME & design targets
to improve ADME, potency, &
efficacy
• Designs synthesis and manages
outsourcing
• Design in vitro and in vivo studies
• Identify vendors and manage
outsourcing
• Evaluate study data and write IND
submission study reports
• Make decisions based on study
results
API & CMC Managers
Clinicians
• Manage CMOs
• Chemistry, biologicals, cell
lines…
• Optimize chemistry process
• Troubleshoot biologicals
• Submit regulatory registrations
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• 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
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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
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
©2013 IDSC, LLC
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7. Discovery Expertise
Line Discipline Experience
Therapeutic Area Experience
• Medicinal Chemistry
• Molecular Modeling
• Pharmacology
– in vitro
– in vivo
• ADME
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CNS
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Cardiovascular •
Dermatology
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Infectious
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Diseases
• Inflammation
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Immunology
Metabolic
Diseases
Oncology
Pain
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8. Development Expertise
Preclinical & Clinical
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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
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Biologics
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Stem Cells
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Devices
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Nutraceuticals
©2013 IDSC, LLC
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9. Discovery
Preclinical Development
Clinical Development
Teams
Client
IDSC
ClinPharm
Team Members
Contracted as:
IDSC
ADME
Director
Fully Integrated Collaborations
Individuals
Small Teams
ADME
CRO
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IDSC
Regulatory
Director
IDSC
Clinician
IDSC
In-vitro
Pharm
Director
In Vitro
Pharmacology
CRO
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IDSC
API & CMC
Director
IDSC
TA Expert &
PM, POC
IDSC
IDSC
Directors
Management:
Information & Data
Management:
Sample logistics
Information tree
Decision & Data
Sample logistics
CRO management
Decision tree
CRO management
In Vivo
Pharmacology
CRO
IDSC
Toxicology
Director
IDSC
In-vivo
Pharm
Director
Toxicology
CRO
©2013 IDSC, LLC
API Scale Up
CRO
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10. Summary
Expertise
Discovery
Clinical
Development
Preclinical
Development
Project
Leadership
Regulatory
Compliance
Commercial
Assessment
IDSC
Client
CROs
Therapeutic Area Expertise
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CNS
Cardiovascular
Dermatology
Infectious Diseases
Inflammation
Immunology
Metabolic diseases
Oncology
Pain
Discovery Expertise
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Development Expertise
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Medicinal Chemistry
Molecular Modeling
Pharmacology
Outsourcing Management
ADME
Small Molecules ● Biologics ● Stem Cells
IDSC offers the academic, biotech,
pharma, and VC community a fully
integrated drug discovery and
development partner
Discovery
Hit to Lead
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
Development
Lead
Optimization
Preclinical
Development
To IND Filing
Clinical
Development
Interim Leadership ● Consulting ● Fully Integrated Collaborations ● Outsourcing Management
Therapeutics . Stem Cells . Nutraceuticals . Devices . Diagnostics
IDSC’s clients come to us for Discovery, Preclinical Development, Clinical
Development, and Project Management expertise
10/29/2013
WWW.IDSCBIOTECHNETWORK.COM
©2013 IDSC, LLC
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