IDSC is an interdisciplinary group of 40 ex-pharma leaders averaging 25-years of big-pharma, biotech, and academic experience. Our clients come to us for drug discovery and drug development interim leadership, consulting, fully integrated collaborations, due diligence, molecular modeling, and outsourcing management. Because we are a fully integrated drug discovery, preclinical development, and clinical development partner, we help our biotech, VC, academic, and pharma clients get from early discovery to IND filing and through phase I clinical trials in all major therapeutic areas and on to NDA in antibacterials, CNS, and oncology.

1. Mark Creswell
President and CEO
markcreswell@idscbiotechnetwork.com
Phone: 734.433.9670
Cell: 734.476.4097
Capabilities ● Expertise ● Services
IDSC
From Hit to the Clinic…Your Drug
Discovery & Development Partner
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©2013 IDSC, LLC
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2. Mission
IDSC's mission is to add significant value to our client's
organization by providing drug discovery, development,
and outsourcing leadership and expertise to assist our
clients in delivering innovative medicines to the clinic
and on to the market faster, while minimizing attrition.
IDSC’s scientists have delivered many drugs to the clinic & to the market
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3. 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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Draft &
Submit
IND
Clinical
Development
FDA
Phase 2
Meeting
©2013 IDSC, LLC
Draft &
Submit
NDA
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4. 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
• Pharmacophore 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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5. Interim Leadership
 Filling gaps in our client’s scientific leadership and project teams
 Leadership, program & project management

Med-chem, pharmacology, molecular modeling, chemical
development, API management, CMC, formulation, ADME,
toxicology, regulatory, clinical study design, clinical operations,
clinical pharmacology, outsourcing management (chemistry, API,
pharmacology, ADME, toxicology, some pieces of clinical)
 Small molecules, biologicals, stem cells, devices, diagnostics,
nutraceuticals
• CNS, CV, dermatology, infectious diseases, inflammation,
immunology, metabolic diseases, oncology, pain
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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
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7. Strategic & Technical Consulting
• Small molecules, biologics, nutraceuticals, devices, diagnostics
• Medchem, pharmacology, ADME, toxicology, regulatory, CMC,
Process development, clinical, formulation, fill/finish, commercial
assessment
• Most major therapeutic areas (slide 10)
• Due diligence - Evaluation of investment and in-licensing
opportunities
• SWOT analyses: Strengths, Weaknesses, Opportunities, Threats
• Program reviews, gap analyses, & development plans
– Discovery, preclinical development, and clinical development
• Writing & evaluating patents & IP space
• How: Ad hoc consulting, retainers, to partial FTEs
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8. Fully Integrated Collaborations
• Drug discovery, pre-clinical development & clinical development
collaborations
• For virtual biotechs; universities; foundations; small, medium, & large
Pharmas expanding bandwidth…
• IDSC supplies most of or the entire project team (all of the line
discipline experts; slides 11 & 12)
• Progress our client’s program from its current state to the next
desired milestone: spinout, funding, partnering, licensing…
• IDSC provides the leadership, therapeutic area expertise, line
discipline expertise, outsourcing expertise, outsourcing management
• Chemistry, biologics production, cell line production, assays, studies,
API manufacturing, and depending on size, pieces of clinical trials are
outsourced.
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9. Rhetorical Question…
Could an interdisciplinary group of 40 pharma
experts with a combined >1,000 years of drug
discovery, preclinical, & clinical development
experience make a difference in YOUR drug
discovery & development program?
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10. Therapeutic Area Focus
•
•
•
•
•
Cardiovascular
CNS
Dermatology
Immunology
Infectious diseases
• Inflammation
• Metabolic
diseases
• Oncology
• Pain
Back to Slide 7
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11. Discovery Expertise
• Medicinal Chemistry
• Molecular Modeling
• Pharmacology
Small
Molecules
&
Biologics
–in vitro
–in vivo
• ADME
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12. Development Expertise
Preclinical & Clinical
• ADME / Toxicology / Pathology
• PK/PD/TK Modeling
• Process Chemistry/ API Mgmt / CMC
• Regulatory Compliance
• Clinical Study Design
• FDA Meetings
• BLA/IND/NDA Prep & Submission
• Commercialization Strategy
• Product Assessment & Valuation
• Competitive Intelligence
Back to Slide 8
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Small
Molecules
●
Biologics
●
Stem Cells
●
Devices
●
Nutraceuticals
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13. Broad Outsourcing Expertise:
• Med-Chem, Custom Synthesis
• API Supply & Raw Materials
– Small Molecules, Biologics
• Pharmacology (In Vitro/In Vivo)
• ADME (In Vitro/In Vivo)
• Toxicology/Safety
• IDSC manages clinical trials internally
while outsourcing non core activities
as well as large trials
Database of Vendors
…………..
Vendor Management
& Project Management
– PhI, II, III Clinical Trials
– US & International
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14. MEDICAL DEVICES
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CONFIDENTIAL
©2013 IDSC, LLC
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15. IDSC Medical Device Services
Regulatory Compliance
Market Assessment
• 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
• 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”
Strategic Planning
Clinical Development
• 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
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• 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
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16. DIAGNOSTICS
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CONFIDENTIAL
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17. IDSC Diagnostics Services
Regulatory Compliance
Market Assessment
• 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.
• 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”
Strategic Planning
Clinical Development
• 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
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• Establish and run clinical advisory board
• Identify and utilize KOL
• Determine clinical pathway
• Write clinical protocols
• Ensure nonclinical studies & other
development activities align with clinical plan
& regulatory requirements
• Clinical operations
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18. NUTRACEUTICALS
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19. IDSC Nutraceutical Services
Regulatory Compliance
Market Assessment
• 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.
.
• 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”
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
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©2013 IDSC, LLC
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20. IDSC Nutraceutical Services
Training
•Ensure Pharmaceutical companies
moving into nutraceuticals gain the
needed knowledge to be successful
•Ensure an appropriate understanding
of the risks, benefits, and regulations
around nutraceuticals
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21. STEM CELL THERAPIES
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CONFIDENTIAL
©2013 IDSC, LLC
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22. Rapidly Evolving Science
• Somatic (adult), embryonic, pluri-/multi-potent cells
• Non-embryonic sources: Peripheral blood, marrow, adipose
tissue, organ tissue, cord blood, amniotic fluid…
• General types: Hematopoietic, mesenchymal, endothelial,
neural, cardiac, ….
• Autologous, allogeneic
• Differing regulatory environments worldwide
• At least 17 companies active in heart disease alone
~ Many combinations currently in R&D
and even more to come, with time. ~
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23. Stem Cells: Clinical Development
Regulatory Compliance
• Optimize regulatory strategy
• Ensure activities and goals are aligned with
regulatory strategy
• Prepare regulatory documentation
• Create and deliver regulatory submissions
• Prepare client for meeting with regulatory
agencies
Market Assessment
• Evaluate client asset
• Determine market size and potential market
penetration
• Gather competitive intelligence
• Position client to manage negotiations with
investors/ partners in order to receive highest
value for their asset
• Performing product valuations are not just in
the domain of “big-pharma”
Strategic Planning
Clinical Development
• Guide development of company strategy
–Establish a business plan integrated across
R&D, manufacturing and clinical lines
–Set and track company goals, timelines,
budgets, and milestones
–Generate an exit strategy
• Identify and oversee external vendors
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• Establish and manage clinical advisory board
• Identify and utilize KOLs
• Determine clinical pathway to registration
• Design clinical protocols
• Ensure nonclinical studies & other activities
align with clinical plan & regulatory
requirements
• Manage clinical program and trial execution
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24. Summary
Expertise
Discovery
Clinical
Development
Preclinical
Development
Project
Leadership
Regulatory
Compliance
Commercial
Assessment
IDSC
Client
CROs
Therapeutic Area Expertise
•
•
•
•
•
•
•
•
•
CNS
Cardiovascular
Dermatology
Infectious Diseases
Inflammation
Immunology
Metabolic diseases
Oncology
Pain
Discovery Expertise
•
•
•
•
•
Development Expertise
•
•
•
•
•
•
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
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25. IDSC
CASE STUDIES
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26. To The Rescue (Receptor Antagonist For Oncology)
• Client was downsizing
– Came to IDSC to contract head of med-chem and manage chemistry CROs
• IDSC performed a program & budget review
– Performed by IDSC’s experienced oncology med-chemist and pharmacologist
• Based on data and remaining budget - IDSC recommended the client stop med
chem activity and focus in vivo efforts on select compounds already in the
portfolio.
• The implementation of this recommendation saved the company
– They now have a clinical candidate and have scaled material & have begun an IND enabling Tox
Study.
– Had they continued with med-chem, IDSC would have profited, and the client would have burned
their budget without getting a candidate.
– IDSC continues in a multi-disciplinary consulting role with this client
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27. From Target to Pre-Candidates
•
•
•
•
•
•
•
•
•
•
Client had a biological target based platform
IDSC helped client establish its goals
IDSC trained client in drug discovery strategy & budget
IDSC serves in an overarching discovery role that includes heads of
medicinal chemistry and molecular modeling
Began with mass screen of commercial compounds and analogs of
literature compounds
Lead to multiple novel series & rapid SAR expansion and lead
optimization in best series
IDSC manages 5 CRO chemistry FTEs
IDSC manages in vivo biology, PK/PD, tox, formulation, etc…
Several potential clinical candidates have been identified
Timeline – 9 months
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28. Relationships Grow: Oncology
Development (International Client)
• Web Inquiry led to a gap analysis
• Gap analysis led to ad hoc consulting
• Ad hoc consulting led to CAB (clinical advisory
board)
• CAB: Clinical advisory board preparation,
attendance, management, summary
• CAB led to a fully integrated 8-member IDSC
development team engaged to develop the asset
• Client is virtual
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29. Molecular Modeling
• In-House full service molecular modeling supports all
appropriate med chem projects (We use the MOE
integrated suite)
• IDSC currently serves as the molecular modeling
department for several pharmaceutical and biotech
companies
• IDSC modeling directors conducted computational
fragment-based design studies that led directly to two
clinical candidates and three additional chemical leads for a
nuclear hormone receptor program
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30. Program Reviews
• University
– Started with 6 programs for relevance of
biological target and quality of lead
chemical matter
– Based on results this relationship continues
to grow
– Six different IDSC Directors have written
program reviews for client
– Trained client on IND process
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31. 40 Consultants – One Roof
• IDSC received a phone call – Client
needed a preclinical & phase I
development plan & budget to be
delivered within 35 days.
• A team of 7 IDSC directors (toxicology,
clinical pharmacology, ADME, CMC, API,
regulatory, project management) met the
ambitious deadline.
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32. IDSC
DISCOVERY & DEVELOPMENT
TEAMS
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33. DISCOVERY
Client
Keys To Success
 Team can make key decisions
 Good communication
 Good project management
 Significant TA expertise
 Goal oriented team
 Manage streamlined logistics process
IDSC
Med Chemist &
PM, POC
IDSC
IDSC
DMPK Director
Pharmacologist
PM – Project Manager
POC – Point of Contact
Management:
Information & Data
Sample logistics
Decision tree
CROs
DMPK /ADME
CRO
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Sample
(Bulk to client)
Chemistry
CRO
Sample
In Vitro
Screening
CRO
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In Vivo
Pharmacology
CRO
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34. PRECLINICAL
DEVELOPMENT
Client
FDA
IDSC
IDSC
Regulatory
Director
Clinician
Keys To Success
 Team can make key
decisions
 Good communication
 Good project management
 Significant TA expertise
 Goal oriented team
 Manage streamlined
logistics process
IDSC
IDSC
Clinical
Pharmacologist
API & CMC
Director
IDSC
TA Expert &
PM, POC
IDSC
IDSC
Toxicology
Director
DMPK/ADME
Director
IDSC In-vitro
pharmacology
Director
Management:
IDSC In-vivo
pharmacology
Director
PM – Project Manager
POC – Point of Contact
Information & Data
Sample logistics
Decision tree
CROs
DMPK /ADME
CRO
In Vitro
Pharmacology
CRO
In Vivo
Pharmacology
CRO
Toxicology
Studies
CRO
API Scale up
and Synthesis
CRO
Sample
(Bulk to client)
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35. CLINICAL
DEVELOPMENT
Client
IDSC
IDSC
Regulatory
Director
Clinicians/MDs
Study
Sites
IDSC
Clinical-Ops
FDA
IDSC
IDSC
PM, POC
API & CMC
Director
(CRAs/monitors)
IDSC
Clinical
Pharmacologist
Clinical PK
Analysis CRO
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Statistics, IVRS,
Med Writing
CRO
Keys To Success
IDSC
 Team can make key
decisions
 Good communication
 Good project management
 Significant TA expertise
 Goal oriented team
 Manage streamlined
logistics process
preclinical
Directors
Data mgmt,
CRFs,
programming
PM – Project Manager
POC – Point of Contact
Supporting
Preclinical Studies
CRO
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API GMP
Manufacture
CRO
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36. Partial Client List
 Pfizer
 Cubist
 Profectus
 Lycera
 Deciphera
 AKI
 Altiris
 ShaunaRx
 Nymirum
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 Biolytx
 Biota
 Glenmark
 Maxthera
 Mazorx
 MBI
 NAEJA
 ReGenX
 ApiGenesis
WWW.IDSCBIOTECHNETWORK.COM









U of Iowa
U of Michigan
WARF
NVF
Nektar
CRL
Arsenal Cap
U of Louisville
KFSYSCC
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37. IDSC
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38. Leadership
• IDSC’s 40 discovery and development directors have a career
averaging 25 years each with high level management expertise.
• Our directors have taken programs from discovery to the clinic
and from phase I to market.
• IDSC’s leaders have proven discovery and development track
records within big pharma and consultancy having developed
their careers and skills at large pharma organizations like
Abbott, J&J, Novartis, and Pfizer among others & having led or
participated in teams responsible for the development or
commercialization of products like Zoloft®, Lyrica®, Nexterone®,
Cerebyx®, Linezolid®, and Plazomicin® just to name a few.
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39. Science & Consulting
• IDSC brings its clients an interdisciplinary leadership team
with career expertise in all of the major therapeutic areas
(We are especially strong in antibacterials, CNS, CV, oncology,
and inflammation).
• The team remains at the cutting edge of their fields by:
–
–
–
–
Progressing state of the art programs
Reviewing current market reports and review articles
Attending key therapeutic area conferences
Reading the current literature
• As respected leaders in their field our directors provide
insight to the industry by giving conference presentations.
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40. Outsourcing
• IDSC was founded by leaders who built a $35M
global discovery outsourcing program within big
Pharma
• We bring the highest value vendors to our fully
integrated collaborations
• Fully integrated collaborations bring new insights
into our client’s organization in addition to more
shots on goal through a very flexible & cost
effective business model
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41. Brief BIOs (Partial List)
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•
•
•
•
Alex Bridges, PhD: 25 years big pharma, 6 years Academics, 5 yrs biotech; oncology, metabolic disease; medicinal chemistry.
Brent Blumenstein, PhD: 30+ years academia, industry; FDA advisory committees; biostatistics; clinical trials; oncology, urology,
epidemiology.
Mukund Chorghade, PhD: 26 big pharma; regulatory filings; tech transfer; CMC, and API management.
Lauren Costantini, PhD: 20+ yrs biotech & academia; multiple vice president roles; nutraceuticals, medical foods, devices;
neurodegenerative diseases, research, clinical, regulatory, commercialization strategy.
John Domagala, PhD: 30 years big pharma, global head, infectious diseases, med-chem, 30 clinical candidates, 8 compounds to
the clinic.
Joe Fix, PhD, MBA: 30+ years big pharma, biotech; formulation, fill & finish, product development; CRO management; drug
delivery technologies.
Shelly Glase, PhD: 17 years big pharma; CNS; med-chem; outsourcing management, project management; 5 clinical candidates.
Richard Kavoussi, MD: 28 years of academia, pharma, consulting expertise. Board certified psychiatrist. Extensive experience
in the design, execution, and analysis of clinical psychopharmacology trials.
Joan Keiser, PhD: 30 years big pharma; cardiovascular, metabolic diseases; pharmacology; global therapeutic area head;
portfolio management; idea to POC.
Francie Kivel: 26 years big pharma & small biotech, clinical development & corporate strategy, program management, clinical
operations, stem cell therapies, CV, CNS, oncology, women’s health, inflammation.
Bill Kenney, PhD: 24 years big pharma; CNS, oncology, antiviral; medicinal chemistry.
Brad Martin, PhD: 15 years big pharma, CV physiology and regenerative medicine, stem cell therapies, translational research.
David Moreland, PhD: 24 years big pharma; molecular modeling; CNS, cardiovascular, infectious diseases; 3 clinical candidates.
Anne Norment, MD, PhD: 20 years biotech; immunology, inflammation; pharmacology; translational research.
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42. Brief BIOs (Partial List)
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•
•
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•
•
Ron Shebuski, PhD: 20+ year academia, & pharma, cardiovascular, pharmacology, therapeutics, devices, diagnostics.
Bob Sigler, DVM, PhD: 21 years big pharma; toxicology, pathology; study design; IND support.
Jeff Simpson, BS: 28 years big pharma, consulting; commercial strategy, product assessment, valuation, lifecycle
planning, advisory boards.
Richard Stead, MD: 24 years experience, clinical and regulatory strategy for development of biotechnology products,
including oncology and hematology products; academic experience in hematology & coagulation.
Ken Tack, MD: 26 years big pharma, Internal medicine, clinical trial design, 3 marketed drugs in infectious disease.
Charlie Taylor, PhD: 27 years big pharma; CNS; pharmacology; neurological disorders, psychiatric disorders, pain;
gabapentin, pregabalin.
Jim Thomson, PhD: 30 years biotech; biologics; process development, formulation, analytical development, CMC,
lyophilization, and stability.
Howard Welgus, MD: 30 years academia & pharma, global head, dermatology, inflammation, clinician, CMO, medical
affairs.
Lloyd Whitfield, PhD: 30 years big pharma, population PK and PK/PD, dose selection, allometric scaling, and modeling
and simulation support.
Jim Zeller, PhD: 22 years big pharma, 6 years API consultant, chemical development of API processes, API cost
analysis, CMO identification and management.
Bob Zimmerman, PhD: 25 years big-pharma, biotech; oncology pharmacology; large and small species; recombinant
proteins, monoclonal antibodies, vaccines, and engineered proteins.
Mary Zimmerman, MS: 25 years biotech; SVP; regulatory affairs & strategy; IND, CTA, INPD, CTD submissions.
10/25/2013
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43. THANK YOU
Mark Creswell
President & CEO
310 N. Main St.
204
Chelsea, MI 48118 USA
Phone: 734.433.9670
Fax: 734.433.9671
Cell: 734.476.4097
markcreswell@idscbiotechnetwork.com
From hit to the clinic:
Your drug discovery & development partner
10/25/2013
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43

44. IDSC
SUPPLEMENTAL SLIDES
10/25/2013
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45. Gene Family Expertise
• GPCRs
• Kinases
• Cytokines
• Ion channels
10/25/2013
• Proteases
• Nuclear
receptors
• Transporters
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45