Idsc Expertise Capabilities Services Short 10 Slides 2013 10-09
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IDSC provides drug discovery,preclinical development, clinical development, and outsourcing expertise to assist clients in delivering innovative medicines to the clinic & market faster, while minimizing attrition. We are an interdisciplinary group of 40 ex-pharma leaders averaging 25 years of big pharma experience. Our clients come to us for six main reasons: Drug discovery and 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 Short 10 Slides 2013 10-09
- 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 1
- 2. IDSC May Be A Fit For YOU… If you are a… • • • • FROM HIT TO THE CLINIC… Biotech YOUR DRUG DISCOVERY AND DEVELOPMENT Pharma PARTNER Academic VC In need of… • Drug discovery… • Preclinical development… • Clinical development… …High Impact Consulting 10/29/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 2
- 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: • • • • 10/29/2013 WWW.IDSCBIOTECHNETWORK.COM Big Pharma Biotech Academia Consulting ©2013 IDSC, LLC 3
- 4. Stages of Drug Discovery & Development IDSC’s Services Span: Discovery Lead Optimization Hit to Lead Evaluate HTS Hits or SBDD Results 10/29/2013 Development Select lead compounds Identify Clinical Candidate Preclinical Development to IND Filing FDA Pre-IND Meeting WWW.IDSCBIOTECHNETWORK.COM Clinical Development Draft & Submit IND FDA Phase 2 Meeting Draft & Submit NDA ©2013 IDSC, LLC 4
- 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 10/29/2013 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 5
- 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 10/29/2013 • 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. Discovery Expertise Line Discipline Experience Therapeutic Area Experience • Medicinal Chemistry • Molecular Modeling • Pharmacology – in vitro – in vivo • ADME 10/29/2013 • • • • CNS • Cardiovascular • Dermatology • Infectious • Diseases • Inflammation WWW.IDSCBIOTECHNETWORK.COM Immunology Metabolic Diseases Oncology Pain ©2013 IDSC, LLC 7
- 8. Development Expertise Preclinical & 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 10/29/2013 WWW.IDSCBIOTECHNETWORK.COM Small Molecules ● Biologics ● Stem Cells ● Devices ● Nutraceuticals ©2013 IDSC, LLC 8
- 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 10/29/2013 IDSC Regulatory Director IDSC Clinician IDSC In-vitro Pharm Director In Vitro Pharmacology CRO WWW.IDSCBIOTECHNETWORK.COM 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 9
- 10. 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 10/29/2013 WWW.IDSCBIOTECHNETWORK.COM ©2013 IDSC, LLC 10