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Research Opportunities Reserved for Small Business NACDA May 2008

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM. Research Opportunities Reserved for Small Business NACDA May 2008. Program Descriptions. Small Business Innovation Research (SBIR) Set-aside program for small business

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Research Opportunities Reserved for Small Business NACDA May 2008

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  1. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Research Opportunities Reserved for Small Business NACDA May 2008

  2. Program Descriptions Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization. Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization. 2.5% 0.3%

  3. Small Business Innovation Development Act of 1982 (SBIR) Reauthorized in 2000—extended to 9/2008 Congress designated 4 major goals • Stimulate technological innovation • Use small business to meet federal R&D needs • Foster and encourage participation by minorities and disadvantaged persons in technological innovation • Increase private-sector commercialization innovations derived from federal R&D

  4. Small Business Research and Development Enhancement Act of 1992 (STTR) Reauthorized in 2001—extended to 2009 • Stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions • Foster technology transfer between small business concerns and research institutions

  5. SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES • Research Partner SBIR:Permitsresearch institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR:Requiresresearch institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)] AWARD ALWAYS MADE TO SMALL BUSINESS

  6. SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES • Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated [PI can be from research institution and/or from small business concern]

  7. SBIR/STTR PROGRAM Eligibility Requirements • Applicant is a for-profit U.S. business • At least 51% U.S. (or permanent resident alien) owned • Located in the U.S. • 500 or fewer employees SBIR:P.I.’s primary employment with small business during project STTR:Cooperative effort, PI from either small business or research organization

  8. SBIR/STTR: 3-Phase Program PHASE I • Feasibility Study • $100K and 6-month (SBIR) or 12-month (STTR) Award PHASE II • Full Research/R&D • $750K and 2-year Award (SBIR/STTR) PHASE III • Commercialization Stage • Use of non-SBIR/STTR Funds

  9. Phase II Competing Continuations • Goal: Provide additional research funds to move already identified drugs or devices requiring regulatory approval into clinical trials • Stipulations: • Available only to Phase II SBIR grantees preparing for clinical trials • Focus -- Diagnostics, devices, tissue engineering, drug development • Funding level: $750K to $1M per year for maximum of 3 years • IC must have announced the opportunity • NIDA PA-06-036

  10. 7-9 months 7-9 months Phase I Phase II 6 months 6 months 24 months Satisfactory Phase I Final Report 7-9 months Phase I + Phase II Simultaneous submission/review Phase II SBIR “FAST-TRACK” Standard application, review, award process Fast-Track review option

  11. No! NIH SBIR “FAST-TRACK”Best Option For Everyone? • Convincing preliminary data? • Clear, measurable, achievable milestones? • Well-conceivedCommercialization Plan? • Letters of Phase III support/interest? • Track record for commercializing?

  12. NIDA FY08 Budget Estimate • SBIR Grants - $15,500,000 • STTR Grants - $2,590,000 • SBIR Contracts - $6,000,000

  13. NIDA SBIR Contract Mechanism • ~ 30% of SBIR budget • Program submits short contract solicitations in April • After NIDA review, approximately 10 solicitations are sent to NIH for inclusion in their SBIR Contract Solicitation • NIH generally releases the Contract Solicitation by 8/1 • Program can’t discuss the small business proposal with the applicant • Contracts are reviewed winter and early spring • At most, NIDA awards 1 contract/solicitation • NIDA DOES NOT retain ownership of the product

  14. Contract Concepts • Science Literacy Materials • Metabolomics Technologies • Marketing Prevention Interventions • Epidemiological Tools • Electronic Data Capture for Clinical Trials • Real Time fMRI Feedback System • New Treatments; New Drug Delivery

  15. What are the Success Rates for NIDA’s SBIR/STTR Program?

  16. NIDASBIR Grants Received vs. Funded (FY 2002-2007) 62% funded were Phase I Number of SBIR Applications

  17. NIDA STTR Grants Received vs. Funded (FY 2002-2007) 100% funded were Phase I Number of STTR Applications

  18. How Does NIDA’s Success Rate Compare with Other ICs?

  19. NIH FY 2007 SBIR Success Rates:Phase I % Funded NIH Average

  20. NIH FY 2007 SBIR Success Rates:Phase II % Funded NIH Average

  21. What Types of SBIR/STTR Projects Does NIDA Fund? • Prevention • HeadOn: Grades 3-5; 6-8, • Parent Power: Raising Drug –free Kids • Ripple Effects: Adolescents • Smart Rx: Preventing Rx Drug Abuse • HIV/AIDS Prevention for Women • Multimedia Safe Driving Program for Adolescents

  22. Screening and Assessment • Addiction Severity Index: Multimedia Interactive Version • Screening Addiction Risk in Chronic Opioid Treatment Therapy • Multi Problem Youth Screening Science Education • Neuroscience TV—Euphoria • Science Club Kit—Elementary School • Body Simulation for Drug Abuse Education

  23. Treatment Development • Immunotherapy for Cocaine Abuse • 5-HT Treatments for Methamphetamine • Smoking Cessation Intervention for Youth • Internet Delivered Therapeutic Education System (Community Reinforcement Approach) • Virtual Reality for Burn Pain • Nanoformulations for Drug Delivery

  24. HIGHLIGHTS

  25. N • Gold Award for Documentary: Houston Intl. Film Festival • Official Selection: • Santa Fe Film Festival • Maryland Film Festival • Greenfest, Washington DC Lee Boot(PI) Neuroscience TV to Steer Teens from Substance Abuse

  26. Stephen Butler (PI) ASI: A multimedia interactive version

  27. cocaine antibody Norman and Ball (PIs): A human antibody as immunotherapy for cocaine abuse

  28. http://grants.nih.gov/grants/funding/sbir.htm • Alerts • Solicitations • Targeted Research Opportunities • Sample Application • Award Information • Collaborative Opportunities • Success Stories

  29. Cathrine Sasek, Ph.D. SBIR Coordinator csasek@nih.gov 301-443-6071

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