IDSC is an interdisciplinary group of over 55 former pharmaceutical leaders with expertise in drug discovery and development from small molecules and biologics to medical devices. They provide consulting, project management, and integrated collaboration services across therapeutic areas from hit identification to clinical trials. IDSC's clients include biotech, pharma, academia, and venture capital seeking expertise in discovery, preclinical and clinical development to advance their programs.

1. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 1
Mark Creswell
President and CEO
markcreswell@idscbiotechnetwork.com
Phone: 734.433.9670
Cell: 734.476.4097
Capabilities ● Expertise ● Services
and IDSC’s
Discovery & Development Teams
IDSC
From Hit to the Clinic…Your Drug Discovery
& Development Partner

2. ©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…
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FROM HIT TO THE CLINIC…
YOUR DRUG DISCOVERY AND DEVELOPMENT
PARTNER
• Drug discovery…
• Preclinical development…
• Clinical development…
In need of…
…High Impact Consulting

3. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 3
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

4. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
IDSC Supports All Stages of Drug Discovery & Development
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Hit to Lead
Lead
Optimization
Preclinical
Development
to IND Filing
Clinical Development
DevelopmentDiscovery
IDSC’s Services Span:
Identify
Clinical
Candidate
Draft &
Submit
IND
Draft &
Submit
NDA
FDA
Pre-IND
Meeting
FDA
Phase 2
Meeting
Evaluate HTS
Hits or SBDD
Results
Select lead
Series
Optimize
Properties,
Synthesis,
SAR
Medicinal Chemistry
Pharmacology
Molecular Modeling
ADME
Early Safety
ADME & PK/PD Modeling
Toxicology & Pathology
Process Development
API Management
Formulation
Analytical Development
Drug Product Fill & Finish
CMC Regulatory
Regulatory Compliance
Clinical Study Design
Clinical Operations
Commercial Assessment & Valuation

5. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
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
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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

6. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 6
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…

7. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
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
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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 IND
submission 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

8. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
Therapeutic Area Expertise
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→ 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

9. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
Line Discipline Expertise
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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

10. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
Medical Devices
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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

11. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 11
Directors
Management:
Information & Data
Sample logistics
Decision funnel
CRO management
IDSC
Client
Toxicology
TA Specific
Clinician
(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
Toxicology
CROs
ADME
CROs
Pharmacology
CROs
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.

12. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC
IDSC
Directors
& Staff
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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 PK
Analysis
Clinical
Dev/Ops
Leader &
POC
Study
Sites
E-Data
Capture &
Management
CROs & CMOs:
FDA
KOLs
Clinical 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

13. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 13
Program Review
Gap 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 IND
submission.
• 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)

14. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 14
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 Optimization
Preclin Develop
to 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

15. ©2007-2014 IDSC, LLC©2007-2014 IDSC, LLC©2013 IDSC, LLC11/14/2014 WWW.IDSCBIOTECHNETWORK.COM 15
310 N. Main St. Suite 204
Chelsea, MI 48118 USA
Phone: 734.433.9670
Fax: 734.433.9671
Cell: 734.476.4097
markcreswell@idscbiotechnetwork.com
THANK YOU
Mark Creswell
President & CEO
For More Information, Visit:
www.idscbiotechnetwork.com