Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH 301.435.2688 jg128w@nih

1. Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH 301.435.2688 jg128w@nih.gov AdvaMed2008Entering the North American MarketNIH Funding Opportu”NIH”ties National Institutes of Health

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

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

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

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

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 NIGMS NIDDK

9. BRIDGING THE DISCOVERY TO DEVELOPMENT GAP SBIR/STTR Programs Are Fully Integrated Within NIH Research Agenda • 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

11. PHASE I • Feasibility Study- idea with commercial potential • $100K and 6-month (SBIR) or 12-month (STTR) Award • 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 SBIR/STTR: COMPETITIVE 3-PHASE PROGRAM NIH permits deviations where scientifically justified

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 controlledby 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. SOLICITATIONS AND DUE DATES

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

15. NIH SBIR/STTR RESEARCH TOPICS (cont) 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 Keyword search the Solicitation Ctrl - F

16. NUMBER OF COMPETING SBIR APPLICATIONS BY PHASE INFORMATION

17. SUCCESS RATES OF COMPETING SBIR APPLICATIONS INFORMATION

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

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

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

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

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

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

25. SUMMARY 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.

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: Subscribe SBIR-STTR your name • Contact NIH Program Staff: Listed in Solicitations under each IC

27. THANK YOU! www.nih.gov 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