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UCSF Life Sciences: Week 6 Diagnostics Partners

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  • 1. UCSF Life Science The Lean LaunchPad Partners Who are your Partners and Suppliers? Version 6/13/12
  • 2. Key Partners Who are your Partners and Suppliers?
  • 3. © 2012 Steve Blank
  • 4. Partners – who are they? • Manufacturing / build / component suppliers • Technology partners • Channel (S&M) partners • Strategic partners • Co-everything (development, branding, etc.) Keep asking yourself: Why do I need this partner? How can we keep it valuable to both sides? How is this going to change with time? 4
  • 5. Partners – Key Suppliers • Outsource suppliers • Backoffice, supply chain, manufacturing • Direct suppliers • Components, raw materials, etc. Example: Apple builds the iPhone from multiple suppliers 5
  • 6. Partnering with (Big) Companies
  • 7. Leverage …is the only way to make it work
  • 8. Protectable Leverage 1. S&M support 2. IP (FTO) 3. Complementary products 1. Technology / Products 2. New customers 3. IP
  • 9. Molecular Diagnostics Partner Examples 9
  • 10. Partners Front End Back End Sample Prep (not for RUO) Dx Test Company Hospitals Chip Manufacturers Packaging LiquiLume Reagents (IDT, Fisher) OEMs Shippers (UPS, FedEx) Clinical Labs Doctors Distributors (Fisher) Research Labs
  • 11. Back-End Partners Type Examples Benefit Risk / Need Chip manufacturer HTE Labs Make optofluidic chips (key element of technology) High / Critical ? Keep device costs low Low / Essential Laser or detector manufacturers Parts needed to build complete instrument Low, Med / Essential IDT, Fisher Provide custom probes and control targets. Med / Essential Qiagen Partner for validation of input target samples Low / Nice Packaging OEMs Reagents Supplier Sample Prep. Instrument
  • 12. Front-End Partners Type Distributor Research labs Dx test company Clinical labs Examples Benefit Risk / Need Fisher Sell chips, reagents Low / Not critical for RUO UCSF oncologists, Stanford MDx Lab, UCSF Micro. Lab Will validate technology; publish; develop assays Low / Critical during phase I Genentech; Companion Dx w pharma and biotechs; Specialty Dx test cos. Possibly unique test on unique platform, partner develops assay Strategic alliance Low / Synergistic Quest, LabCorp Help develop CLIA-waived application; 510(k); clinical trials Med / Crucial during phase II
  • 13. Medical Device Partner Examples 13
  • 14. IP REGULATION REIMBURSEMENT CLINICAL TRIALS 17
  • 15. ONLY TWO WEEKS LEFT! REIMBURSEMENT CLINICAL TRIALS 18
  • 16. Next week’s lecture CLINICAL TRIALS IP REIMBURSEMENT REGULATION 19
  • 17. Next week’s slides As per the syllabus, plus: 1. Your final (validated?) hypotheses: regulation 2. Your final (validated?) hypotheses:reimbursement 3. Preliminary hypotheses: IP needs and clinical trial structure, size, etc.