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The University of Pittsburgh

The University of Pittsburgh. Office of Enterprise Development, Health Sciences. Creating the Best Investments. Carolyn Green, Director Office of Enterprise Development, Health Sciences University of Pittsburgh Schools of Health Sciences.

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The University of Pittsburgh

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  1. The University of Pittsburgh Office of Enterprise Development, Health Sciences Creating the Best Investments Carolyn Green, Director Office of Enterprise Development, Health Sciences University of Pittsburgh Schools of Health Sciences

  2. “One way to have a good idea is to have a lot of ideas, and throw the bad ones away.” ~Dr. Linus Pauling American theoretical chemist and biologist 1901-1994

  3. The Evolution of Biomedical Research 1940 1943 – DNA is shown to be the basic genetic material 1950 1953 – Watson and Crick identify DNAs double helix 1960 1966 – DNA’s complete genetic code deciphered 1970 • 1972 - Paul Berg makes first rDNA • 1977 - First human protein (somatostatin) manufactured in bacteria • 1978 - Herb Boyer uses e-coli to make recombinant human insulin 1980 • 1980 – Kary Mullis invents PCR; The patent is sold in 1991 for $300M • 1981 – Ohio University scientists produce first transgenic animals • 1982 – Genentech markets recombinant human insulin • 1986 – Chiron granted a license for recombinant hepatitis B vaccine; Genentech markets rt-PA 1990 • 1990 – First gene therapy on 4 year old with ADA • 1996 – Genetic maps of humans and mice complete; Avonex approved for treatment of MS • 1997 – FDA approves Rituxan for non-Hodgkin’s lymphoma; Dolly is cloned in the UK • 1998 – Embryonic stem cells grown for the first time; an inexpensive E. coli biosensor sold 2000 2000 – Pharmacogenomics produce Herceptin with accompanying diagnostic test

  4. “Intellectual Property Protection” becomes part of the biomedical research lexicon…

  5. UNIVERSITY INDUSTRY Knowledge for Knowledge’s Sake Management ofKnowledge for Profit Teaching Profits Research Commercializationof New and UsefulTechnologies Service Product R&D EconomicDevelopment Academic FreedomOpen Discourse ConfidentialityLimited Public Disclosure Conflicting Values - Common Interest

  6. Overcoming barriers to success… • Cultural barriers • Legal barriers • Financial barriers • High risks associated with all embryonic technologies

  7. Cultural Barriers Entrepreneurship is…. • Not part of the cultural norm in academic medicine • May restrict ability to publish • Hampered by restrictive policies and procedures • Rarely a factor in performance evaluation • Considered to be a distraction from primary research and teaching focus, impedes career advancement Legal and Financial Barriers • Compliance with Bayh Dole Act, NIH guidelines, other laws • Private Inurement / Private Benefit (FMV) • Unrelated Business Income Tax (UBIT) • Tax Exempt Bond Financing restrictions • Resources to support growing patenting and business development activities

  8. Embryonic technologies require a plan to reduce risk, build value • Academic discovery ≠ Commercial validation • A risk assessment should encompass three key areas • Scientific • IP • Market • Prioritization and execution of risk reduction activities -eg • Animal experimentation • Freedom to operate analysis • Application selection and competitive review • Inventor may not have skills needed to validate or enough knowledge to select most appropriate use Faculty nearly always under estimate time and effort required to overcome the commercialization hurdles that lie ahead.

  9. “Genius is 1% inspiration and 99% perspiration.” ~Thomas A. Edison

  10. Intellectual Property Timeline (OTM): Preliminary Research Invention Disclosure Provisional Patent Patent Application PCT/Intl Filing     Concept Development Timeline (OED): Preliminary Research Viability Assessment Opportunity Incubation Preparing for Partnership    Patent Analysis Application Development Licensing or Start-Up Options Market Analysis Funding Assistance Product Development Competitive Analysis Business Model Development Pitching to Investors

  11. One page opportunity summary; identification of OED lead Concept Development Timeline (OED): Viability Assessment Patent Analysis Market Analysis Competitive Analysis • market size & growth • problem/product • definition • customer demand • feasibility/regulatory • issues • prior disclosures • novelty, usefulness • competing patents • “freedom to operate” • platform technology? • barriers to competitors • differentiation • sustainable advantage

  12. Concept Development Timeline (OED): Opportunity Incubation Funding Assistance Application Development Business Plan Development • defined customer need • proof of concept data • clinical development • plan with milestones • that reduce risk & • increase value • execute plan • federal • state/local gov • corporate • HNW Individuals • foundations • internal sources • monetization strategy • product/service pricing • reimbursement • market entry strategy • rough timeline • rough financials Two page executive summary; two minute “elevator pitch”, two PowerPoint slides

  13. Concept Development Timeline (OED): Preparing for Partnership Licensing Options Start up Options Closing the Deal • valuation • extraction of FMV • projected financial needs • projected exit strategy • COI, COC, EOC • identifying potential partners • making contacts • getting a face to face meeting • contract facilitation • role of the inventor • finding management • incubator resources • scaling up the science • funding • role of the inventor Helping the inventor to understand what lies ahead; facilitating communication and progress toward clinical development

  14. Six nationally ranked schools of health sciences + top ranked bioengineering Over $600M research funding Ranked 8th in NIH funding Exceptional history of fostering multi-disciplinary bioengineering-clinician research teams Developing sophisticated intramural and extramural entrepreneurial support Two Organizations – Working Together University of Pittsburgh • $5.4B revenues • 19 hospitals + a network of care facilities • 40,000+ employees • (Largest employer in Commonwealth of PA) • One of the country’s fastest growing health insurance plans • Financially healthy • Recruitment growth of 10%/year • Biotechnology venture fund • Diversified, entrepreneurial and willing to invest in the future. …to create a nationally and internationally renowned center of medical excellence. Source: 2004 NIH Awards to Domestic Institutions of Higher Education

  15. UPMC Strategic Business Initiatives and Health Ventures Investments

  16. While we have had successes, they have been largely serendipitous Road to commercialization is long and difficult Most faculty lack the experience and skills to drive commercialization Internal funding for “the last mile” is often difficult to find Resource partners exist, but are difficult for a novice to navigate • Make the process nimble • Make access to experts part of the process • Provide funding to reduce commercial risk factors • Provide an experienced navigator from start to finish Overcoming Translational Research Challenges • Create a Program that drives commercialization

  17. “Life is short, science is long; opportunity is elusive.” ~Hippocrates

  18. Contact Information Carolyn Green, Director Office of Enterprise Development, Health Sciences University of Pittsburgh 412-623-3204 greence@upmc.edu www.oed.pitt.edu

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