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

2. 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. Program Descriptions 2.5% 0.3%

3. Congress designated 4 major goals Small Business Innovation Development Act of 1982 (SBIR) Reauthorized in 2000—extended to 9/2008 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 PROGRAMS CRITICAL DIFFERENCES Research Partner SBIR: Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Requires research 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. 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] SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES

7. 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 SBIR/STTR PROGRAM Eligibility Requirements

8. SBIR/STTR: 3-Phase Program PHASE I Ü Feasibility Study Ü $100K and 6-month (SBIR) or 12-month (STTR) Award PHASE II Ü Full Research/R&D Ü $750K and 2-year Award (SBIR/STTR) PHASE III Ü Commercialization Stage Ü 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. SBIR “FAST-TRACK” Standard application, review, award process Fast-Track review option Satisfactory Phase I Final Report Phase I 7-9 months Simultaneous submission/review Phase I + Phase II 7-9 months Phase II 6 months 24 months 6 months Phase II 7-9 months

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

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

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

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

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

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

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

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