1. 1 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH 301.435.2688 jg128w@nih.gov AdvaMed2008 Entering the North American Market NIH Funding Opportu”NIH”ties National Institutes of Health

2. 2 COMMON SOURCES CAPITAL TO JUMP-START YOUR START-UP Personal savings Credit cards Selling assets (boats & other toys) Second mortgages Loans & investments from family, friends and ….. Suppliers, vendors, other businesses Commercial bank loans Private investors, Angels Government Grants Venture Capital

3. 3 Topics to Discuss Today: Government Grants SBIR Small Business Innovation Research STTR Small Business Technology Transfer

4. 4 The largest, most accessible source of SEED CAPITAL for the nation’s innovative small businesses $2.3 Billion in 2008 SBIR/STTR PROGRAMS

5. 5 …and This capital is in the form of grants and contracts no repayment no debt service no equity forfeiture no IP forfeiture

6. 6 SBIR/STTR PROGRAM HIGHLIGHTS National competition sponsored by 23 NIH Institutes and Centers (11 Federal agencies total) R&D funding set-aside for small businesses to develop innovative products and services (2.5% SBIR / 0.3% STTR) Supports R&D aligned with our agency mission and technology needs Stimulates innovation and job creation in the Nation’s small business sector

7. 7 Office of the Director National Center on Minority Health and Health Disparities ORGANIZATIONAL STRUCTURE OF NIH http://www.nih.gov/icd National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of Nursing Research National Library of Medicine National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Institute of Biomedical Imaging and Bioengineering No funding authority

8. 8 NIH INSTITUTE/CENTER SBIR/STTR BUDGET ALLOCATIONS (FY2008) Extramural R&D Set-Asides: SBIR = 2.5% STTR = 0.3% FY 2008 SBIR/STTR Budget Allocations to NIH ICs: $580 M (SBIR) $ 70 M (STTR) Total: $650 M NIDDK NIGMS

9. 9 Improve human health through prevention, detection, diagnosis and treatment of disease or disability Speed process of discovery Reduce cost of medical care Improve research tools/ reduce cost of research Increase health knowledge base SBIR/STTR Programs Are Fully Integrated Within NIH Research Agenda BRIDGING THE DISCOVERY TO DEVELOPMENT GAP

10. 10

11. 11 PHASE II Full Research/R&D $750K and 2-year Award (SBIR & STTR) Pre-requisite: Phase I award PHASE III Commercialization Stage Use of non-SBIR/STTR Funds PHASE I Feasibility Study- idea with commercial potential $100K and 6-month (SBIR) or 12-month (STTR) Award SBIR/STTR: COMPETITIVE 3-PHASE PROGRAM NIH permits deviations where scientifically justified

12. 12 SBIR/STTR ELIGIBILITY CRITERIA U.S. small business organized for-profit 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 PD/PI primarily employed with small business STTR: Formal collaboration between small business and research institution

13. 13 AND DUE DATES SOLICITATIONS AND DUE DATES

14. 14 Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Biosilicon devices Biocompatible materials Acousto-optics / opto- electronics Imaging devices Proteomics / Genomics *Examples from 200+ pages of topics! Parent Solicitations SBIR: PA-08-050 and STTR: PA-08-051PA-08-050PA-08-051 Our Research Topic Ideas* NIH SBIR/STTR RESEARCH TOPICS

15. 15 Investigator-initiated Ideas Investigator-initiated Ideas (a.k.a. “I can’t find a topic match”) Research projects related to NIH mission “Other” areas of research within mission of an awarding component NIH SBIR/STTR RESEARCH TOPICS (cont) Keyword search the Solicitation Ctrl - F

16. 16 NUMBER OF COMPETING SBIR APPLICATIONS BY PHASE INFORMATION

17. 17 SUCCESS RATES OF COMPETING SBIR APPLICATIONS INFORMATION

18. 18 Phase IPhase IIPhase III CHALLENGES FOR BIOTECH FIRMS: NAVIGATING THE PEAKS AND VALLEYS Unusually long development times (5-12 yrs) High & intense capital needs (>$1B) Exceptionally high burn rate for investment funds Multiple rounds of financing required

19. 19 TECHNICAL ASSISTANCE PROGRAMS Commercialization Assistance Business & strategic planning Build alliances and investor partnerships (Phase II awardees) Niche Assessment Identify other uses of technology Determine competitive advantages Develop market entry strategy (Phase I awardees) Manufacturing Assistance (Phase II awardees) Partnership with NIST MEP Centers Help make better manufacturing and operational decisions

20. 20 TRANSITIONING TO THE MARKETPLACE NIH Pipeline to Partnerships Technology Showcase Potential partners search for technologies of interest Facilitates matchmaking between NIH SBIR/STTR awardees and potential strategic partners and investors (Ph I and Ph II awardees)

21. 21 PIPELINE TO PARTNERSHIPS (P2P) http://www.ott.nih.gov/p2p/index.asp

22. 22 PIPELINE TO PARTNERSHIPS (P2P) http://www.ott.nih.gov/p2p/index.asp Potential partner identifies technology of interest and contacts company's Web site.

23. 23 PIPELINE TO PARTNERSHIPS (P2P) http://www.ott.nih.gov/p2p/index. asp

24. 24 SBIR/STTR SUCCESS ABOUNDS! PediSedate TM Design Continuum, Inc. Percutaneous Ventricular Assist Device Cardiac Assist, Inc. Intralase Corporation Xilas Medical, Inc. HIT System TM Simbex, LLC. Next Generation Biotherapeutics GlycoFi, Inc. (Sold to Merck) Sonicare TM Toothbrush Optiva Corp. Cyberkinetics Neurotechnology Systems, Inc. -- BrainGate TM

25. 25 How Can You How Can You Qualify for and Compete Successfully for NIH Funding? Understand our mission. Review Funding Opportunity Announcements (FOAs). Propose innovative ideas with significance as well as scientific and technical merit. Give yourself ample time to prepare application. Communication. Communication. Communication. Contact NIH Staff to discuss your research idea. outcome of your review. challenges and opportunities. SUMMARY

26. 26 STAY INFORMED… NIH SBIR/STTR Web site http://grants.nih.gov/grants/funding/sbir.htm NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm NIH SBIR/STTR Notification LISTSERV@LIST.NIH.GOV: S ubscribe SBIR-STTR your nameLISTSERV@LIST.NIH.GOV Contact NIH Program Staff: Listed in Solicitations under each IC

27. 27 http://grants.nih.gov/grants/oer.htm Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Fax: 301-480-0146 Email: jg128w@nih.gov THANK YOU!