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BIO-CT What we are What we are not What we are expected to do Gabriel Mergui Manuel Vega

This workshop explores the maturation process of biotech projects, discussing the tools and challenges faced by industry and public research. It focuses on the need for further maturation, market validation, financing options, and regulatory frameworks. The objective is to identify appropriate tools for project maturation and deliver an implementation roadmap at the European level.

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BIO-CT What we are What we are not What we are expected to do Gabriel Mergui Manuel Vega

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  1. BIO-CTWhat we areWhat we are notWhat we are expected to doGabriel Mergui Manuel Vega Bio-C.T. Workshop Turin Feb 2010 1

  2. The Innovation process: where are we? Market Industry Research Bio-C.T. Workshop Turin Feb 2010 2

  3. Bio-C.T. Workshop Turin Feb 2010

  4. Very scarcely, the PoC is mature enough: the industry may in-licence directly… Scenario 0 Industry Risk : controlled Financing: private (and public) Public Research Risk: the notion is absent or recent Financing : public scientific PoC Bio-C.T. Workshop Turin Feb 2010

  5. … but in most cases there is a need for further maturation to obtain ‘industrial’ PoC Industry or Venture Capital Take over Risk : controlled Financing: private (and public) Public Research Risk: the notion is absent or recent Financing : public Maturation industrial PoC scientific PoC Bio-C.T. Workshop Turin Feb 2010

  6. Maturation is plenty of uncertainties and risks… Business sense ? Market ? Clients ? Competitors ? Intellectual property ? Validation of scientific POC ?.. …In animals ? …In humans ? Prototype ? Manufacturing ? Up-scaling ? Regulatory frame ? Industry or Venture Capital Take over Public Research industrial PoC scientific PoC Bio-C.T. Workshop Turin Feb 2010

  7. …it is the so-called Death Valley Industry or Venture Capital Take over Public Research « Death Valley » Maturation Risk: very high The maturation process is not ‘spontaneous’ (Each side says: “It’s not our Job”) industrial POC scientific POC Bio-C.T. Workshop Turin Feb 2010

  8. The objectives of BIO-CT • Phase 1 : To identify appropriate Tools (human, technical and financial) available in the partnering Bio-Regions and likely to be shared in support to the maturation of innovative biotechnology projects • Method: Performing a SWOT analysis for each Bio-Region to identify the human, technical and financial Tools available or lacking in each Bio-Region and their suitability for sharing between Bio-Regions. Bio-C.T. Workshop Turin Feb 2010 8

  9. The objectives of BIO-CT • Year 2 : To deliver an implementation roadmap (Joint Action Plan and Business Plan) for the maturation of innovative biotechnology projects at the European level: • While maximizing the sharing of existing tools available in the Bio-Regions; • For selected projects within or without a Company; • Up to the industrial PoC (Industry take over or VC investment). Bio-C.T. Workshop Turin Feb 2010

  10. The classic model is not perfect… • Scenario 1 • …in the presence of a founder entrepreneur • Relies on the founding endeavor of an entrepreneur.. • Is the technology / product validated enough? / Is company creation too early? • Why is it so difficult for certain companies to raise VC investment? Bio-C.T. Workshop Turin Feb 2010

  11. Tools : Scenario 1 vs Scenario 2 Scenario 1 Board of Directors Founder entrepreneur Company Private investors Scenario 2 Surveillance Committee Project leader Project (contract) “Public” financing Shared Tools Human Human Human + Technical (platforms, facilities, maturation instruments) Financial Bio-C.T. Workshop Turin Feb 2010

  12. Basic criteria for the selection of appropriate Tools to be shared in the Project Maturation Process (Scenarios 1 & 2) • Candidate Tools for sharing between Bio-Regions to be selected according to specific criteria: • Consistency with Maturation process • - Excellence • (Qualified, Labeled, ) • - Accessibility • (Technical, Legal, Financial, ……) Bio-C.T. Workshop Turin Feb 2010

  13. Thanks Bio-C.T. Workshop Turin Feb 2010 13

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