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Shortcuts to Commercialization

Shortcuts to Commercialization. Laurie Owen, Ph.D. Associate Director USA Mitchell Cancer Institute. What is Commercialization?.

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Shortcuts to Commercialization

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  1. Shortcuts to Commercialization Laurie Owen, Ph.D. Associate Director USA Mitchell Cancer Institute

  2. What is Commercialization? “The process of developing markets and producing and delivering products or services for sale (whether by the originating party or by others)….. commercialization includes both government and non-government markets.” – National Science Foundation SBIR Solicitation

  3. Commercialization of University-Based Research Patent and Licensing Activities Patents are costly with long time horizon to issue ($12,000+ associated costs, with roughly half applications approved) In some cases, research reagent sale (such as antibodies) can generate substantial revenue stream in the absence of patent protection Spin-out Companies

  4. What is the Fundamental Challenge in Commercialization Of University Research? • University Research is Curiosity-Driven Research is early-stage with long market horizon • The Marketplace is Product-Driven Timeline and cost of product development factor heavily into investment decision for new technology Valuation of early stage inventions are difficult

  5. Classic Model for Commercialization of University-Based Research Research Expenditures Invention Disclosure Patent Application Royalty Revenues Licenses Executed Start-up Companies Jobs WealthFame

  6. 2010 Model of Commercialization of University-Based Research Research Expenditures Prior Art Assessment Invention Disclosure Patent Landscape Analysis License Executed Option Agreement Years Commercialization Assessment Product Development Patent Application Royalties Validation Research Provisional Patent

  7. Early Stage University-Based Research=Increased Risk for Companies “Successful licensees are visionaries who recognize that early stage university innovations can add value to their company’s mission and bottom line—bringing important products to the marketplace, contributing to the economy, and public well-being.”

  8. High Cost and Early Stage of University-Based Research Creates Higher Risk for Industry Partners Source: Ferguson, Federal Register, Vol 75 (52)

  9. Universities Can Create Additional Value and Interest for Commercializable Technologies ● Patent Protection (in most cases) ● Commercial Assessment ● Creating Prototypes ● Performing Validation Studies and Early Development In-House ● Creating interest through industry interactions and networking Downside: $$$$

  10. Stanford University ExperienceBy the Numbers 2983 Active Inventions 517 Royalty producing inventions totaling $65.1M 39 Inventions generating $100,000 or more 3 Inventions generating $1M or more $6.83M Legal fees 400 New Invention disclosures 77 New licenses Source: Stanford Office of Technology and Licensing 2008

  11. Stanford University Commercialization “98% of the income came from licenses signed many years ago” Source: Stanford OTL 2008 Brochure Stanford OTL was established in 1970

  12. Stanford Model Promotes Commercialization ● Established networks and relationships Industry Investors (Angels and VC) Business Community Legal Community ● Financial Commitment of University Patent and Legal expenses Commercial Assessments Net inventory of $15.3M representing patent expenses of unlicensed inventions ● Birdseed Fund –funds prototypes and modest reduction-to-practice experiments for unlicensed technologies

  13. Factors Underlying Commercialization Success in University Settings •University R&D Base •Core Competency and Strategic Focus •Research Infrastructure •Entrepreneurial Incentives and Culture •University-Industry Enablers “Total Links Matter” •Leadership—Political, Academic, and Corporate •Availability of Early Stage Capital

  14. Strong, Focused University Research Feeds Commercialization Pipeline ●Develop Critical Federal R&D Funding Base ● Assess Core Competencies and Develop Strategic Plans Around Them Hire research “stars” in targeted fields Increase corporate sponsored research Promote state initiatives that leverage federal and corporate funds

  15. Entrepreneurial Culture is Key ●Top Down and Bottom Up Leadership --Incentives and rewards for tech transfer and commercialization activities --Hiring and promotion practices that favor entrepreneurial culture --Acting as a champion ●Tech transfer offices that facilitate interactions with VC, angels, law firms, and corporations ●Research parks and incubator space

  16. Relative Factor Importance in Choosing Where to Locate Commercial R&D Facilities FactorRank University Collaboration 1 Faculty Expertise 2 Cost 3 Growth 3 Supporting Sales 5 Quality of R&D personnel Not important Source: Thursby and Thursby 2006

  17. SBIR Grants As An Indicator of Potential Commercialization SBIR funds are one indicator of commercializable technologies and cluster around University campuses with active research programs Source: Total Links Matter, Lee and Walshok UCSD, 2003 SBIR Phase I Awards and Proposals 2008 •Alabama 73/447 (16.3%) NIH 7/38 (18.4%) DOD 56/336 (16.7%) •California 688/4197 (16.4%) NIH 140/625 (22.4%) DOD 384/2527 (15.2%) Mississippi 5/49 (10.2%) Louisiana 8/52 (15.3%) Florida 102/754 (13.5%) Source: http://www.ssti.org

  18. Commercialization “Proof of Concept” Centers MIT—Deshpande Center at School of Engineering (2002), $17.5M seed UCSD-von Liebig Center at Jacobs School of Engineering (2001), $10M seed ●Centers provide: “Bridge” grants(UCSD: $15K-$75K; MIT: $50K-$250K) Advisory services, and educational programs ●Centers work with University TTO to: Promote IP and secure licensees ●Centers work with community for: Business guidance, coaching, and identification of investment capital Source: “Proof of Concept Centers—Accelerating the Commercialization of University Innovation” Kauffman Foundation (January 2008)

  19. In the Absence of Large Amounts of Seed Money How Might Universities Build Centers That Accelerate Commercialization?

  20. Green-Field Opportunity for Research Commercialization at the Mitchell Cancer Institute ● Basic research: cancer metabolism, underlying mechanisms of cancer progression, response to chemotherapy and radiation ● Translational component: therapeutic approaches, early diagnostic testing, and biomarkers of cancer progression and resistance

  21. Green-Field Opportunity for Research Commercialization at the Mitchell Cancer Institute ● 8 PI-led research teams (6 basic scientists,2 physician scientists) ● Research team interaction with physicians Clinical trial development and research sample collection Pharma/biotech--identifying unmet medical needs and pipelines Day-to-day functions (mixed office/interaction space)

  22. Creating an Entrepreneurial Research Culture at the MCI  ●Faculty, postdocs and students attend presentations on intellectual property, tech transfer, start-up businesses, business plans, collaborations/interactions with industry, etc.  ●MCI faculty handbook specifically identifies “entrepreneurial activities” as a component of tenure and promotion portfolio.  ●Faculty actively involved with tech transfer office for invention disclosures, commercialization assessment, patentability search ●Faculty have established working relationships with IP attorneys and interact on patent strategy, claims drafting, and review of patent documents

  23. Collaboration With Start-Up Company (Swift Biotechnology) ●President and CEO have expertise and experience in Life Science start-ups ●Work on-site at MCI (two days weekly) ● Have executed blanket NDA for emerging IP ●Blanket royalty agreements that include milestone payments that will fund future “bridge” research ●Interact with MCI faculty on a near daily basis ●Optioned technology in November that placed 2nd in Alabama Launchpad competition Driven by relationships and common interests

  24. Collaboration Brings Benefits for MCI ●Shared Cost of Regulatory Consultants ●Shared Costs for Lab Readiness for FDA Validation ●Shared Patent Costs ●Close Access to Investigators for STTR and SBIR Grant Submissions ●Increased Access to Local Business Community ●Increased Access to Investor Community ●MCI Faculty “Ownership” of Entrepreneurial Culture ●Faculty Development ●Enhancement of MCI “Total Links”

  25. Commercialization of University-Based Research Requires: ●Collaboration ●Relationships ●Networks (Legal, Industry, Investors, Business) ●Access to Investment Capital The most vulnerable place in University-based commercialization today is the “valley of death” between concept and validation. “Valley of death” $125-150,000

  26. Enhancing University-Based Commercialization What steps can be taken to increase commercialization rates? Inventor Forums?? Regional Alliances to Maximize Licensing Income?? Internet-Based marketing?? Free agent model (Wisconsin)?? Identifying funding source to bridge “valley of death” and create value and access to market??

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