Overview of the NIH SBIR/STTR Program NCET2 March 2014 Matthew - PowerPoint PPT Presentation

National Institutes of Health Office of Extramural Research Overview of the NIH SBIR/STTR Program NCET2 March 2014 Matthew Portnoy, Ph.D. SBIR/STTR Program Coordinator Office of Extramural Research, NIH 1

SBIR/STTR ¡Budgets ¡ National Institutes of Health ¡by ¡Agency, ¡FY2012 ¡ Office of Extramural Research DOE NSF All Agencies with SBIR and STTR Programs NASA Others Department of Defense (DOD) $ 1.1 B Department of Health and Human Services: $717.0 M NIH National Institutes of Health (NIH) National Aeronautics and Space $161.8 M Administration (NASA) Department of Energy (DOE) $188.3 M National Science Foundation (NSF) $ 150.6 M Agencies with SBIR Programs U.S. Department of Agriculture (USDA) $19.3 M DOD Department of Homeland Security (DHS) $12.6 M Department of Education (ED) $13.4 M Department of Transportation (DOT) $8.6 M ~ $2.4B in FY12 across all agencies Department of Commerce: National Oceanic $4.7 M and Atmospheric Administration (NOAA) and National Institute of Standards and Technology (NIST) Environmental Protection Agency (EPA) $4.8 M

HHS/NIH Program Funding National Institutes of Health Office of Extramural Research 2013 Budget SBIR STTR NIH $617M $80M CDC $8.4M FDA $1.4M N/A ACF $233K Phase I $150K* $150K* 6 months* 1 year* Phase II $1M* $1M* 2 years* 2 years*

NIH Mission National Institutes of Health Office of Extramural Research To seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability .

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

SBIR/STTR Program Overview National Institutes of Health Office of Extramural Research SMALL BUSINESS INNOVATION 2.8% RESEARCH (SBIR) PROGRAM Set-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization. SMALL BUSINESS TECHNOLOGY 0.4% TRANSFER (STTR) PROGRAM Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization.

SBIR Eligibility Criteria National Institutes of Health From 1/28/2013 FOAs going forward Office of Extramural Research ü Organized as for-profit U.S. business ü Small: 500 or fewer employees, including affiliates ü PD/PI’s primary employment must be with small business concern at time of award and for duration of project period ü Greater than 50% U.S.- owned by individuals and independently operated or Greater than 50% owned and controlled by other business concern/s that is/are greater than 50% owned and controlled by one or more individuals OR ü Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these

NIH SBIR/STTR Budget Allocations FY2013 2.7% SBIR $617M NIMHD ¡ NIAAA ¡ NINR ¡ 0.35% STTR $80M NCCAM ¡ NLM ¡ NIDCR ¡ NIAMS ¡ ORIP ¡ NHGRI ¡ NIBIB ¡ Total FY2013 $697M NIDCD ¡ NIEHS ¡ NCI ¡ NCATS ¡ NEI ¡ NIDA ¡ NIA ¡ NIAID ¡ NIMH ¡ NICHD ¡ NHLBI ¡ NINDS ¡ NIDDK ¡ NIGMS ¡

Success Rate of SBIR/STTR National Institutes of Health 2012 and 2013 by Phase Office of Extramural Research STTR 39.9% ¡ 39.4% ¡ 34.4% ¡ 32.8% ¡ 28.6% ¡ 26.4% ¡ 2012 ¡ 20.3% ¡ 18.7% ¡ 2013 ¡ 15.9% ¡ 15.6% ¡ 15.7% ¡ 13.2% ¡ Fast ¡Track ¡ Phase ¡I ¡ Phase ¡II ¡ Fast ¡Track ¡ Phase ¡I ¡ Phase ¡II ¡ 9

NIH-wide SBIR/STTR National Institutes of Health Success Rates Office of Extramural Research Number ¡of ¡ Number ¡of ¡ Success ¡ Fiscal ¡Year ¡ SBIR/STTR ¡ Phase ¡ ApplicaMons ¡ ApplicaMons ¡ Total ¡Funding ¡ Rate ¡ Reviewed ¡ Awarded ¡ 2012 ¡ SBIR ¡ Fast ¡Track ¡ 358 ¡ 57 ¡ 15.9% ¡ $13,985,802 ¡ 2012 ¡ SBIR ¡ Phase ¡1 ¡ 4,287 ¡ 667 ¡ 15.6% ¡ $154,237,890 ¡ 2012 ¡ SBIR ¡ Phase ¡2 ¡ 557 ¡ 222 ¡ 39.9% ¡ $153,650,162 ¡ 2012 ¡ STTR ¡ Fast ¡Track ¡ 32 ¡ 11 ¡ 34.4% ¡ $2,840,632 ¡ 2012 ¡ STTR ¡ Phase ¡1 ¡ 542 ¡ 110 ¡ 20.3% ¡ $23,857,700 ¡ 2012 ¡ STTR ¡ Phase ¡2 ¡ 71 ¡ 28 ¡ 39.4% ¡ $18,240,418 ¡ 2012 ¡ FY ¡TOTAL ¡ ¡ ¡ 5,847 ¡ 1,095 ¡ 18.7% ¡ $366,812,604 ¡ 2013 ¡ SBIR ¡ Fast ¡Track ¡ 313 ¡ 49 ¡ 15.7% ¡ $13,981,386 ¡ 2013 ¡ SBIR ¡ Phase ¡I ¡ 3,738 ¡ 495 ¡ 13.2% ¡ $114,040,157 ¡ 2013 ¡ SBIR ¡ Phase ¡II ¡ 542 ¡ 178 ¡ 32.8% ¡ $136,348,846 ¡ 2013 ¡ STTR ¡ Fast ¡Track ¡ 42 ¡ 12 ¡ 28.6% ¡ $2,542,128 ¡ 2013 ¡ STTR ¡ Phase ¡I ¡ 583 ¡ 109 ¡ 18.7% ¡ $24,138,629 ¡ 2013 ¡ STTR ¡ Phase ¡II ¡ 72 ¡ 19 ¡ 26.4% ¡ $10,985,373 ¡ 2013 ¡ FY ¡TOTAL ¡ ¡ ¡ 5,290 ¡ 862 ¡ 16.3% ¡ $302,036,519 ¡

NIH Website National Institutes of Health Reauthorization pages Office of Extramural Research http://sbir.nih.gov Standard Due Dates: Apr 5; Aug 5; Dec 5

Solicitations and Due Dates National Institutes of Health Office of Extramural Research • NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation ** Omnibus FOAs: SBIR: PA-14-071 STTR: PA-14-072 New SBIR Direct to Phase II FOA PAR-14-088 Release: January Standard Due Dates: April 5, Aug 5, Dec 5 (AIDS/AIDS-related: May 7, Sept 7, Jan 7) • SBIR Contract Solicitation (NIH, CDC) Release: August November close date • NIH Guide for Grants and Contracts Release: Weekly Receipt dates specified in each FOA (http://grants.nih.gov/grants/guide/index.html) Solicitations and Funding Opportunities

Important changes in this year’s National Institutes of Health Omnibus Grant Solicitations Office of Extramural Research See http://grants.nih.gov/grants/guide/notice-files/NOT- OD-14-048.html for details. 1. NIH SBIR and STTR applicants may now switch programs at Phase II or Phase IIB. a) Phase I STTR Awardees may apply for NIH SBIR or STTR Phase II. b) Phase I SBIR Awardees may apply for NIH SBIR or STTR Phase II. c) Phase II STTR Awardees may apply for NIH SBIR or STTR Phase IIB. d) Phase II SBIR Awardees may apply for NIH SBIR or STTR Phase IIB.

Important changes in this year’s National Institutes of Health Omnibus Grant Solicitations Office of Extramural Research 2. NIH has issued a Pilot SBIR Direct to Phase II solicitation, PAR-14-088. 3. VC-backed companies (VCOC, Hedge fund, private equity firm) CAN apply to NIH SBIR FOAs (since May 2013). 4. SBA Company registry at SBIR.gov required for all submissions.

Stay Informed … National Institutes of Health Office of Extramural Research Ø NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm Ø NIH SBIR/STTR Notification Send email to LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name.

For More Information National Institutes of Health Office of Extramural Research Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Email: mportnoy@mail.nih.gov Lenka Fedorkova, PhD Robert Vinson SBIR/STTR Program Manager SBIR/STTR Program Manager Phone: 301-435-0921 Phone: 301-435-2713 Email: lenka@nih.gov Email: vinsonr@mail.nih.gov Julie Beaver Betty Royster SBIR/STTR Statistician SBIR/STTR Communications Specialist Phone: 301-496-8807 Phone: 301-402-1632 Email: julie.beaver@nih.gov Email: roysterbr@mail.nih.gov