Mark Creswell
President and CEO
markcreswell@idscbiotechnetwork.com
Phone: 734.433.9670
Cell: 734.476.4097

Capabilities ●...
Mission
IDSC's mission is to add significant value to our client's
organization by providing drug discovery, development,
...
Stages of Drug Discovery & Development

IDSC’s Services Span:
Discovery
Lead
Optimization

Hit to Lead

Evaluate HTS
Hits ...
Why Clients Come to IDSC
Interim Leadership

Fully Integrated
Collaborations

• Filling the gaps
• Most major therapeutic
...
Interim Leadership
 Filling gaps in our client’s scientific leadership and project teams
 Leadership, program & project ...
Examples of What Our Leaders Do
Medicinal Chemists

ADME, Toxicologists,
Pharmacologists

• Therapeutic area expert
• Eval...
Strategic & Technical Consulting
• Small molecules, biologics, nutraceuticals, devices, diagnostics
• Medchem, pharmacolog...
Fully Integrated Collaborations
• Drug discovery, pre-clinical development & clinical development
collaborations
• For vir...
Rhetorical Question…
Could an interdisciplinary group of 40 pharma
experts with a combined >1,000 years of drug
discovery,...
Therapeutic Area Focus
•
•
•
•
•

Cardiovascular
CNS
Dermatology
Immunology
Infectious diseases

• Inflammation
• Metaboli...
Discovery Expertise
• Medicinal Chemistry
• Molecular Modeling
• Pharmacology

Small
Molecules
&
Biologics

–in vitro
–in ...
Development Expertise
Preclinical & Clinical

• ADME / Toxicology / Pathology
• PK/PD/TK Modeling
• Process Chemistry/ API...
Broad Outsourcing Expertise:
• Med-Chem, Custom Synthesis
• API Supply & Raw Materials
– Small Molecules, Biologics

• Pha...
MEDICAL DEVICES

10/25/2013

CONFIDENTIAL

©2013 IDSC, LLC

14
IDSC Medical Device Services
Regulatory Compliance

Market Assessment

• Determine the correct regulatory strategy
• Ensur...
DIAGNOSTICS
10/25/2013

CONFIDENTIAL

©2013 IDSC, LLC

16
IDSC Diagnostics Services
Regulatory Compliance

Market Assessment

• Determine the correct regulatory strategy
• Ensure a...
NUTRACEUTICALS

10/25/2013

WWW.IDSCBIOTECHNETWORK.COM

©2013 IDSC, LLC

18
IDSC Nutraceutical Services
Regulatory Compliance

Market Assessment

• Determine the correct regulatory strategy
• Ensure...
IDSC Nutraceutical Services

Training
•Ensure Pharmaceutical companies
moving into nutraceuticals gain the
needed knowledg...
STEM CELL THERAPIES

10/25/2013

CONFIDENTIAL

©2013 IDSC, LLC

21
Rapidly Evolving Science
• Somatic (adult), embryonic, pluri-/multi-potent cells
• Non-embryonic sources: Peripheral blood...
Stem Cells: Clinical Development
Regulatory Compliance
• Optimize regulatory strategy
• Ensure activities and goals are al...
Summary
Expertise

Discovery
Clinical
Development

Preclinical
Development
Project
Leadership

Regulatory
Compliance

Comm...
IDSC

CASE STUDIES

10/25/2013

WWW.IDSCBIOTECHNETWORK.COM

©2013 IDSC, LLC

25
To The Rescue (Receptor Antagonist For Oncology)
• Client was downsizing
– Came to IDSC to contract head of med-chem and m...
From Target to Pre-Candidates
•
•
•
•
•

•
•
•
•
•

Client had a biological target based platform
IDSC helped client estab...
Relationships Grow: Oncology
Development (International Client)
• Web Inquiry led to a gap analysis
• Gap analysis led to ...
Molecular Modeling
• In-House full service molecular modeling supports all
appropriate med chem projects (We use the MOE
i...
Program Reviews
• University
– Started with 6 programs for relevance of
biological target and quality of lead
chemical mat...
40 Consultants – One Roof
• IDSC received a phone call – Client
needed a preclinical & phase I
development plan & budget t...
IDSC

DISCOVERY & DEVELOPMENT
TEAMS
10/25/2013

WWW.IDSCBIOTECHNETWORK.COM

©2013 IDSC, LLC

32
DISCOVERY
Client
Keys To Success
 Team can make key decisions
 Good communication
 Good project management
 Significan...
PRECLINICAL
DEVELOPMENT

Client

FDA
IDSC

IDSC

Regulatory
Director

Clinician

Keys To Success

 Team can make key
deci...
CLINICAL
DEVELOPMENT

Client
IDSC

IDSC

Regulatory
Director

Clinicians/MDs

Study
Sites

IDSC

Clinical-Ops

FDA

IDSC

...
Partial Client List
 Pfizer
 Cubist
 Profectus
 Lycera
 Deciphera
 AKI
 Altiris
 ShaunaRx
 Nymirum
10/25/2013

 ...
IDSC
10/25/2013

WWW.IDSCBIOTECHNETWORK.COM

©2013 IDSC, LLC

37
Leadership
• IDSC’s 40 discovery and development directors have a career
averaging 25 years each with high level managemen...
Science & Consulting
• IDSC brings its clients an interdisciplinary leadership team
with career expertise in all of the ma...
Outsourcing
• IDSC was founded by leaders who built a $35M
global discovery outsourcing program within big
Pharma
• We bri...
Brief BIOs (Partial List)
•
•
•
•

•
•
•
•
•
•
•
•
•
•

Alex Bridges, PhD: 25 years big pharma, 6 years Academics, 5 yrs b...
Brief BIOs (Partial List)
•
•
•
•

•
•
•

•
•
•
•
•

Ron Shebuski, PhD: 20+ year academia, & pharma, cardiovascular, pharm...
THANK YOU
Mark Creswell
President & CEO
310 N. Main St.
204
Chelsea, MI 48118 USA

Phone: 734.433.9670
Fax: 734.433.9671
C...
IDSC

SUPPLEMENTAL SLIDES
10/25/2013

WWW.IDSCBIOTECHNETWORK.COM

©2013 IDSC, LLC

44
Gene Family Expertise
• GPCRs
• Kinases
• Cytokines
• Ion channels

10/25/2013

• Proteases
• Nuclear
receptors
• Transpor...
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IDSC Expertise Capabilities Services

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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.

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IDSC Expertise Capabilities Services

  1. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 1
  2. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 2
  3. 3. Stages of Drug Discovery & Development IDSC’s Services Span: Discovery Lead Optimization Hit to Lead Evaluate HTS Hits or SBDD Results 10/25/2013 Development Select lead compounds Identify Clinical Candidate Preclinical Development to IND Filing FDA Pre-IND Meeting WWW.IDSCBIOTECHNETWORK.COM Draft & Submit IND Clinical Development FDA Phase 2 Meeting ©2013 IDSC, LLC Draft & Submit NDA 3
  4. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM 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 4
  5. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 5
  6. 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 10/25/2013 • 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 WWW.IDSCBIOTECHNETWORK.COM 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 6
  7. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 7
  8. 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. 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 8
  9. 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? 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 9
  10. 10. Therapeutic Area Focus • • • • • Cardiovascular CNS Dermatology Immunology Infectious diseases • Inflammation • Metabolic diseases • Oncology • Pain Back to Slide 7 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 10
  11. 11. Discovery Expertise • Medicinal Chemistry • Molecular Modeling • Pharmacology Small Molecules & Biologics –in vitro –in vivo • ADME 10/25/2013 Back to Slide 8 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 11
  12. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM Small Molecules ● Biologics ● Stem Cells ● Devices ● Nutraceuticals ©2013 IDSC, LLC 12
  13. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 13
  14. 14. MEDICAL DEVICES 10/25/2013 CONFIDENTIAL ©2013 IDSC, LLC 14
  15. 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 10/25/2013 • 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 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 15
  16. 16. DIAGNOSTICS 10/25/2013 CONFIDENTIAL ©2013 IDSC, LLC 16
  17. 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 10/25/2013 • 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 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 17
  18. 18. NUTRACEUTICALS 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 18
  19. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 19
  20. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 20
  21. 21. STEM CELL THERAPIES 10/25/2013 CONFIDENTIAL ©2013 IDSC, LLC 21
  22. 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. ~ 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 22
  23. 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 10/25/2013 • 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 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 23
  24. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 24
  25. 25. IDSC CASE STUDIES 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 25
  26. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 26
  27. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 27
  28. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 28
  29. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 29
  30. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 30
  31. 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. 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 31
  32. 32. IDSC DISCOVERY & DEVELOPMENT TEAMS 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 32
  33. 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 10/25/2013 Sample (Bulk to client) Chemistry CRO Sample In Vitro Screening CRO WWW.IDSCBIOTECHNETWORK.COM In Vivo Pharmacology CRO ©2013 IDSC, LLC 33
  34. 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) 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 34
  35. 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 10/25/2013 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 WWW.IDSCBIOTECHNETWORK.COM API GMP Manufacture CRO ©2013 IDSC, LLC 35
  36. 36. Partial Client List  Pfizer  Cubist  Profectus  Lycera  Deciphera  AKI  Altiris  ShaunaRx  Nymirum 10/25/2013  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 ©2013 IDSC, LLC 36
  37. 37. IDSC 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 37
  38. 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. 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 38
  39. 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. 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 39
  40. 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 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 40
  41. 41. Brief BIOs (Partial List) • • • • • • • • • • • • • • 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. 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 41
  42. 42. Brief BIOs (Partial List) • • • • • • • • • • • • 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 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 42
  43. 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 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 43
  44. 44. IDSC SUPPLEMENTAL SLIDES 10/25/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 44
  45. 45. Gene Family Expertise • GPCRs • Kinases • Cytokines • Ion channels 10/25/2013 • Proteases • Nuclear receptors • Transporters WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 45
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