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Research Opportunities Reserved for Small Business NACDA May 2008 PowerPoint Presentation
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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