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Crossing Boundaries The Do's and Don'ts of a Med School Professor Starting a Business Traditional Academic World – Goal: Understand and Communicate Something.

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Presentation on theme: "Crossing Boundaries The Do's and Don'ts of a Med School Professor Starting a Business Traditional Academic World – Goal: Understand and Communicate Something."— Presentation transcript:

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

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

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

5 35,000 Arrays Printed 25,000 Sera Probed Category Total # proteins# cloned%proteome RetrovirusesHIV 1&2 (5 clades) 83 100% PapillomaHPV viruses (11 types) 88 100% Orthopoxviruses3 types 260 100% Herpes Viruses HSV 1&2, VZV, EBV 300 100% Flaviviruses WNV, Dengue, YF, SLE, JE A 50 100% Alphaviruses Chikungunya C 10 100% BacteriaBrucella melitensisB 3,1943,190 100% Chlamydia trachomatis 911900 99% Chlamydia muridarum 911900 99% Mycobacterium tuberculosisC 3,9903,899 98% Francisella tularensisA 1,9331,874 97% Coxiella burnetiiB 2,0652,000 97% Borrelia burgdorferi 1,6001,540 97% Burkholderia pseudomalleiB 5,7281,400 24% Leptospira interrogans 3,658 100% Salmonella enterica thyphiB 4,3184,300 99% Orientia tsutsugamushiC 1,400 100% Rickettsia ricketsiiB 900 100% Bartonella henselae B 1,400 100% Clostridium difficile 3,747 100% Staphylococcus aureus (MRSA ) 2,6282,509 95% Streptococcus pneumoniae 2,200 100% Enteric toxogenic E. coli 9,000 100% ParasitesPlasmodium falciparum 5,6435,400 97% Plasmodium vivax 5,3003,200 60% Schistosoma mansoni 9,000900 10% Toxoplasma gondii 12,0004,000 30% Cytauxzoon felis 4,300850 20% Necator americanus 12,000600 5% Trypanosoma cruzi 15,099240 2% Trypanosoma brucei 8,529214 3% Human Autoimmune array 21,0001,800 9% Ovarian, Breast & Pancreas Cancer "" Total # of 62,812 Inventory of Cloned Genes, Proteins & Microarrays

6 $>18 MM STTR/SBIR Awards STTR 1. Vaccinia Proteome Affinity Reagents From Phage Display (NIH-NIAID, $1 million / 2y) 2.Scanning Chlamydia Proteome for Vaccine Antigens (NICHD-NIAID, $600K / 2y) 3.Scanning Chlamydia Proteome for Vaccine Antigens (NICHD-NIAID, $1.8 million/ 2y) SBIR 1.Phage Display for antigen discovery (NIH-NIAID, $1 million / 2yr) 2.Scanning the P. falciparum Proteome for Vaccine Antigens (NIH-NIAID, $600K / 2y) 3.Adjuvants for Agile Vaccine Development (NIH-NIAID, $1 million / 2y) 4.Multiplex Serodiagnostic Test for Lyme Disease (NIH-NIAID, $534K / 1y) 5.Antibody profiles in single and mixed-species malaria infections (NIH-NIAID, $600K / 2y) 6.Serodiagnostics Chips for Biodefense and Emerging Inf. Dis. (NIAID-NCRR, $3Million/3y) 7.Protective Biomarkers for the development of vaccines against malaria (NIAID, $2.3 Million/3y)

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 & Scope Between 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 Grants The SBIR Funding Opportunity http://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 Grants The 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 Development New 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 UCI Lab Technology, Staff & Resources New Products & Services Commercial Distribution & Licensing Agreements Research and Development Supported by Small Grants (SBIR & STTR) and by Government and Commercial Contracts

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

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 Systems Discovery of Lipofection: A highly efficient, lipid-mediated DNA- transfection procedure. (Felgner et al. PNAS 1987) Nonviral Strategies for Gene Therapy. (Felgner, Scientific American, 1997)

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

18 1985 Discovery Draft Patent application 1987 Publish in PNAS 1988 Patent issued BRL license Start Vical 1991-2000 Life Tech. buys BRL In vitrogen buys Life Tech. 2005 Patent expires 2013 From Invention to Innovation Lipofectin & Lipofectamne Invitrogen $250 Million Annual Sales of Lipofectin & Lipofectamine Invitrogen is supporting 2,000 families with income on sales of these reagents Innovation Invention

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

20 1988 Discovery Draft Patent application 1990 - 91 Published in Nature Merck License 1993 Initial Public Offering IPO $350 million 1996 Patent issued 1998 - 2002 Move to UCI 2013 From Invention to Innovation Vical – The Naked DNA Company 200 employees Numerous clinical trials underway Innovation Invention


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