National Center for Research Resources NATIONAL INSTITUTES OF HEALTH A c c e l e r a t i n g a n d e n h a n c i n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t I e n t c a r e SBIR/STTR and Tech Transfer Update Lili M. Portilla, MPA Senior Advisor for Technology Transfer National Center for Research Resources, National Institutes of Health Email: Lilip@nih.gov 8 th CM Resource Directors Meeting May 10-11, 2010 Bethesda, MD
Congressional Goals 1. Stimulate technological innovation 2. Use small business to meet Federal R&D needs 3. Increase private-sector commercialization innovations derived from Federal R&D 4. Foster participation by minority and disadvantaged persons in technological innovation Small Business Innovation Development Act of 1982 Small Business Technology Transfer Act of 1992 Currently extended through 4/30/2010
Percent of NIH Budget SBIR: Set-aside program for small business concerns to engage in Federal R&D with the potential for commercialization Set Aside 2.5% STTR: Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with potential for commercialization 0.3% ~ 30 Million annually at the ~650 Million annually at the NIH
Reasons to Seek SBIR/STTR Funding Provides seed funding for innovative technology development Provides recognition, verification and visibility Helps provide leverage in attracting additional funding or support (e.g., venture capital, strategic partner) Not a Loan No repayment is required Doesn t impact stock or shares in any way (i.e. nondilutive) Intellectual property rights retained by the small business Bayh-Dole Act (1980)
Three-Phase Programs PHASE I R41, R43 Feasibility Study $150K and 6-month (SBIR) * or 12-month (STTR) Award PHASE II R42, R44 Full Research/R&D $1 Million and 2-year Award (SBIR & STTR) * Commercialization plan required PHASE III Commercialization Stage Use of non-sbir/sttr Funds *Note Actual Funding levels may differ by topic
SBIR Eligibility Applicant must be a Small Business Concern (SBC) Organized for-profit U.S. business 500 or fewer employees, including affiliates PD/PI s primary employment (i.e., >50%) must be with SBC at the time of award and for duration of the project period At least 51% U.S.- owned by individuals and independently operated OR At least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals
STTR Eligibility Applicant is a Small Business Concern Formal Cooperative R&D Effort Minimum 40% by small business Minimum 30% by U.S. research institution U.S. Research Institution: College or University; Non-profit research organization; Federally- Funded R&D Center (FFRDC) Intellectual Property Agreement Allocation SBC of IP rights (to SBC) and rights to carry out follow-on R&D and commercialization Principal Investigator s primary employment may be with either the Small Business Concern or the research institution
Multiple Principal Investigators on SBIR Grants More than one Principal Investigator is allowed on SBIR research projects This policy offers new approaches to maximize the potential of team science efforts Only the contact PI need be employed primarily by the small business concern
Multiple Funding Solicitations NIH SBIR/STTR Omnibus Solicitations for Grant Applications Release: January Receipt Dates: April 5, August 5, and December 5 Solicitation of the NIH & CDC for SBIR Contract Proposals Release: August Receipt Date: Early November See NIH Guide for various other Program Announcements (PAs) and Requests for Application (RFAs), i.e. other grants Release: Weekly Receipt Dates: Various
Competing Continuation Phase II Award SBIR Phase II awardee Promising pharmacologic agents or devices have already been identified (or developed) and some preclinical pharmacology has been conducted, or development of complex instrumentation and tools for basic, translational or clinical research where extraordinary time and effort is needed Response to an NIH Announcement Generally, $750k-$1M/year for up to 3 years
Technical Assistance Programs http://grants.nih.gov/grants/funding/tap.htm Commercialization Assistance Program for phase II awardees Business & strategic planning Builds alliances and investor partnerships Niche Assessment Program for phase I awardees Identify other uses of the technology Determine competitive advantages Develop market entry strategy
http://grants.nih.gov/grants/funding/sbir.htm
Small Business Funding Opportunities http://ncrr.nih.gov/research_funding/small_business_opportunities
http://projectreporter.nih.gov/reporter.cfm
CTSA Pharmaceutical Assets Portal: Goals To improve information exchange between pharmaceutical companies and the CTSA Consortium regarding investigational drugs that were discontinued at clinical stage Tremendous value because of their previous clinical exposure Information on these assets has never been made public Via the Portal, these unique and previously inaccessible assets will be made available to the academic community enabling new translational research and a considerably accelerated path to the bedside
Two ways to create a match between Academia and Pharma CTSA Requests for shelved drugs from Portal participants based on desired mechanism of action Researchersponsored Pharma Make a match with academic researchers interested in a particular gene/protein ( Foci-of-Expertise (FoX)) Company-sponsored
How to use the Portal
Overview Stimulate to collaboration and partnering with and between CTSA member institutions. Site to attract complementary efforts allow some level of free access provide search of CTSA-specific content Develop next generation software that meshes with CTSA efforts to aggregate research & education resources
Site Overview URL http://www.rochesterctsa.org/ip/ Fifteen institutions participating so far 4,200+ technologies indexed
CTSA Industry Forum February 17 th and 18 th Purpose was serve as the catalyst in finding ways to leverage the CTSA consortium to accelerate and streamline the discovery and development of commercially viable therapies, devices and diagnostics to improve the public health of the nation. Engaged stakeholders (government agencies, industry and and non-profit sector) to opportunities and challenges for partnership and collaboration with CTSA institutions. Work groups have spun out of the Forum to stay engaged and tackle identified barriers and challenges. Visit www.palladianpartners.com/ctsaindustryforum
Highlights from the Forum: How to do we cross the Valley of Death? Misaligned IP polices continue to be an issue Implement successful precompetitive partnering models; Look at EU models, NIH Biomarker Consortium Training of translational investigators in realities of drug discovery; Develop shared curriculum in translational medicine and mentored training programs More funding opportunities and resources in pre- proof of concept studies
Highlights from the Forum: Small Business Issues Extremely challenging to finance a biotech start-up today; VCs are funding later stage deals Phase 1 studies Use Angel investors and SBIR funds to show initial proof of principle Intellectual property licensing is critical to the small business concern University and Government subcontracting challenges
Highlights from the Forum: Other Burning Issues Under appreciated and underfunded FDA; Acceptance of FDA as a science based agency; Funding commensurate with its mission; Close collaboration with stakeholders Conflict of Interest; Proper implementation and oversight of the of COI for all involved stakeholders Social networking tools for collaboration Don t forget the patient and disease organizations/groups, Fourth Leg of Stool ; Use of Venture Philanthropy