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Crossing Boundaries The Do's and Don'ts of a Med School Professor Starting a Business

Crossing Boundaries The Do's and Don'ts of a Med School Professor Starting a Business. Traditional Academic World Goal: Understand and Communicate Something That Other People Can Learn Propose and Prove Hypotheses; Publications ( Scientists )

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Crossing Boundaries The Do's and Don'ts of a Med School Professor Starting a Business

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  1. Crossing Boundaries The Do's and Don'ts of a Med School Professor Starting a Business • Traditional Academic World • Goal: Understand and Communicate Something That Other People Can Learn • Propose and Prove Hypotheses; Publications (Scientists) • Inventions seem to appear “out of the blue” in this setting • The Corporate World • Goal: Make Something That Other People Can Use • Deliverables and Applications Oriented; Products (Entrepreneurs) • Innovations occur by collaboration and networking in this setting • The New Translational Science • Teach and Encourage Innovation • Promote an Entrepreneurial Spirit

  2. Innovation Invention (Patent) Henry Ford was an Innovator Innovator Steve Jobs “Stay hungry. Stay foolish.”

  3. Antigen Discovery Inc. Peter Crompton, NIAID Joe Vinetz, UCSD Denise Doolan, QIMR Angela Trieu Robert Sauerwein, Nijmegen Rob Hermsen Carlota Dobano, Barcelona Joe Campo Pierre Baldi, UCI Matt Kayala Michael Zeller Arlo Randall Antigen Discovery Xiaowu Liang Angela Yee Doug Molina Gary Hemanson Andy Teng Vu Huynh Scott Weiss JiinFelgner Abe Lee, UCI Armando Tovar Arlene Doria Maulik Patel

  4. P. falciparum protein microarray containing 4,528 proteins USA Malaria Naïve Adult Naturally Exposed Resident of Mali West Africa

  5. Inventory of Cloned Genes, Proteins & Microarrays 35,000 Arrays Printed 25,000 Sera Probed

  6. STTR • Vaccinia Proteome Affinity Reagents From Phage Display (NIH-NIAID, $1 million / 2y) • Scanning Chlamydia Proteome for Vaccine Antigens (NICHD-NIAID, $600K / 2y) • Scanning Chlamydia Proteome for Vaccine Antigens (NICHD-NIAID, $1.8 million/ 2y) • SBIR • Phage Display for antigen discovery (NIH-NIAID, $1 million / 2yr) • Scanning the P. falciparum Proteome for Vaccine Antigens(NIH-NIAID, $600K / 2y) • Adjuvants for Agile Vaccine Development (NIH-NIAID, $1 million / 2y) • Multiplex Serodiagnostic Test for Lyme Disease (NIH-NIAID, $534K / 1y) • Antibody profiles in single and mixed-species malaria infections (NIH-NIAID, $600K / 2y) • Serodiagnostics Chips for Biodefense and Emerging Inf. Dis. (NIAID-NCRR, $3Million/3y) • Protective Biomarkers for the development of vaccines against malaria (NIAID, $2.3 Million/3y) $>18 MM STTR/SBIR Awards

  7. What are the tools of successful Entrepreneurship? (Wollaeger) • Technology • Sustaining vs. Disruptive • Patents – a vocation, not inspiration • don’t have to appear out of the blue • Scientists and engineers can learn to invent • Capitol • Grants – SBIR/STTR • Contracts – NIH, Industry • Angels – ~$1M; 10X return in 10 yrs • Venture – ~$10M; 5X return in 5 yrs • People • Teamwork

  8. Difference in Orientation & ScopeBetween R01 and SBIR Grants • R01 Grant • Understand and Communicate Something That Other People Can Learn • Small Business (SBIR) Grant • Make Something That Other People Can Use

  9. SBIR Advanced Technology GrantsThe SBIR Funding Opportunityhttp://grants1.nih.gov/grants/funding/sbir.htm Standard Funding Distribution • Phase I - $100,000 for 6 months • Proof of Concept • Phase II - $750,000 for 2 years • Commercial/Preclinical Development

  10. Advanced Technology SBIR/STTR GrantsThe SBIR Funding Opportunity (Expired Jan 8, 2014)http://grants2.nih.gov/grants/guide/notice-files/NOT-AI-03-049.html Vaccine and Diagnostic Discovery and Development • Phase I - $600,000 for 2 years • Phase II - $3,000,000 for 3 years

  11. Replaced with: Direct Phase II SBIR Grants to Support Biomedical Technology DevelopmentNew SBIR Funding Opportunity Must use a Small Business with prior SBIR experience Vaccine and Diagnostic Discovery and Development • Phase I - $600,000 for 2 years • Phase II - $3,000,000 for 3 years

  12. Requirments to Qualify for SBIR/STTR Funding • Small business <500 people • <50% Venture Capital Equity Support • SBIR: PI retains >50% employment in the small business • 60% $$ to small business / 40% $$ to UCI • STTR: PI can be 100% with UCI • 60% $$ to UCI / 40% $$ to small business

  13. Accessing Small Business Grants & Contracts at UCI Commercial Distribution & Licensing Agreements New Products & Services UCI Lab Small Business Technology, Staff & Resources Reagents & Staff Research and Development Supported by Small Grants (SBIR & STTR) and by Government and Commercial Contracts

  14. ImmPORT An Active Example:Davies/Guan/ImmPORT SBIRAdjuvants for improved vaccines Commercial Distribution Contracts & Licensing New Products & Services $550,000 / 2 yr $450,000 / 2 yr UCI Novel chemistry Animal studies Vaccinia Proteome 200 Proteins

  15. Does & Don’ts • Talk with the Office of Technology Alliances • File a provisional patent application • Start a small business • Come up with a name and an aim • Apply for SBIR grants • Partner with an established small business • Disclose everything on your Conflict of Interest Forms • Don’t try to keep secrets from the COI committee

  16. Synthetic Gene Delivery SystemsDiscovery of Lipofection: A highly efficient, lipid-mediated DNA-transfection procedure. (Felgneret al. PNAS 1987) Nonviral Strategies for Gene Therapy. (Felgner, Scientific American, 1997)

  17. Synthetic Gene Delivery SystemsDiscovery of Lipofection: A highly efficient, lipid-mediated DNA-transfection procedure. (Felgneret al. PNAS 1987) Nonviral Strategies for Gene Therapy. (Felgner, Scientific American, 1997)

  18. From Invention to Innovation Lipofectin & Lipofectamne Innovation Invention Invitrogen $250 Million Annual Sales of Lipofectin & Lipofectamine Invitrogen is supporting 2,000 families with income on sales of these reagents

  19. Naked DNA Gene Delivery(Wolff et al. Science 1990) Influenza Naked DNA VaccineProtection against influenza by injection of DNA encoding a viral protein (Ulmer et. al. Science 1993)

  20. From Invention to Innovation Vical – The Naked DNA Company Innovation Invention 200 employees Numerous clinical trials underway

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