IDSC Drug Discovery Development Partner
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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.
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IDSC Drug Discovery Development Partner
- 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