1. National Institutes of Health Office of Extramural Research The HHS SBIR/STTR Program: Strategies for Success Robert Vinson SBIR/STTR Program Manager; Office of Extramural Research, NIH 2015 National SBIR/STTR Conference Gaylord National Resort & Convention Center June 15-18, 2015

2. National Institutes of Health Office of Extramural Research SBIR/STTR Program Overview SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM Set-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization. 2 2.9% 0.4%

3. National Institutes of Health Office of Extramural Research Agencies with SBIR and STTR Programs Department of Defense (DOD)$ 1.0 B Department of Health and Human Services: National Institutes of Health (NIH) $697.0 M Department of Energy (DOE), including ARPA-E $183.9M National Science Foundation (NSF)$153.0 M National Aeronautics and Space Administration (NASA) $ 148.8 M Agencies with SBIR Programs U.S. Department of Agriculture (USDA)$18.4M Department of Homeland Security (DHS): Science and Technology Directorate (S&T) and Domestic Nuclear Detection Office (DNDO) $15.7 M Department of Education (ED)$13.4 M Department of Transportation (DOT)$7.6 M Department of Commerce: National Oceanic and Atmospheric Administration (NOAA) and National Institute of Standards and Technology (NIST) $7.4 M Environmental Protection Agency (EPA)$3.8 M SBIR/STTR Budgets by Agency FY13 ~ $2.3B in FY13 across all agencies

4. National Institutes of Health Office of Extramural Research NIH SBIR/STTR3-Phase Program Discovery Phase I Feasibility Study Budget Guide: $150K for SBIR and STTR Project Period: 6 months (SBIR); 1 year (STTR) Phase I Development Phase II Full Research/R&D $1M for SBIR and STTR, over two years Phase IIB Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many, but not all, IC’s participate Varies~$1M per year; up to 3 years Phase II Commercial- ization Phase III Commercialization Stage NIH, generally, not the “customer” Consider partnering and exit strategy early Phase III Phase IIB

5. 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. NIH Mission

6. National Institutes of Health Office of Extramural Research No funding authority Office of Research Infrastructure Programs 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 on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research 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 Institute on Minority Health and Health Disparities National Center for Complementary and Integrative Health Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine National Institute of Biomedical Imaging and Bioengineering Office of the Director NIH Clinical Center Center for Information Technology Center for Scientific Review National Institutes of Health http://www.nih.gov/icd

7. 2.9% SBIR $691M 0.40% STTR $95M Total FY15 $786M NIH SBIR/STTR Budget Allocations FY2015

8. National Institutes of Health Office of Extramural Research Success Rate of SBIR/STTR 2013 and 2014 by Phase 8 SBIRSTTR

9. National Institutes of Health Office of Extramural Research NIH-wide SBIR/STTR Success Rates 2013-2014 9 Fiscal YearSBIR 1 /STTR 2 Phase 3 Number of Applications Reviewed Number of Applications Awarded Success Rate 4 Total Funding 5 2013SBIRFast Track3134915.7%$13,981,386 2013SBIRPhase I3,73849513.2%$114,040,157 2013SBIRPhase II54217832.8%$136,348,846 2013STTRFast Track421228.6%$2,542,128 2013STTRPhase I58310918.7%$24,138,629 2013STTRPhase II721926.4%$10,985,373 2013FY TOTAL 5,29086216.3%$302,036,519 2014SBIRFast Track3287121.6%$17,054,967 2014SBIRPhase I362265218.0%$144,793,079 2014SBIRPhase II56622940.5%$170,387,226 2014STTRFast Track6058.3%$1,082,086 2014STTRPhase I78816020.3%$35,828,877 2014STTRPhase II873742.5%$22,182,184 2014FY TOTAL 5,4511,15421.2%$391,328,419 Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx

10. National Institutes of Health Office of Extramural Research HHS Program Funding 2015 BudgetSBIRSTTR NIH$691M$95M CDC$7MN/A ACL (NIDILRR)$2.7MN/A FDA$1.45MN/A ACF$88KN/A

11. National Institutes of Health Office of Extramural Research NIH SBIR/STTR FOAs http://sbir.nih.gov/funding

12. National Institutes of Health Office of Extramural Research Solicitations and Due Dates NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation “Parent” FOAs: SBIR: PA-15-269 STTR: PA-15-270PA-15-269PA-15-270 Release: June Standard Due Dates: September 5, January 5, April 5 SBIR Contract Solicitation (NIH, CDC) Release: JulyClose Date: October NIH Guide for Grants and Contracts Release: Weekly Receipt dates specified in each FOA (http://grants.nih.gov/grants/guide/index.html) 12

13. National Institutes of Health Office of Extramural Research SBIR/STTR Program Descriptions and Research Topics Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Proteomics / Genomics Biosilicon devices Biocompatible materials Acousto-optics / opto- electronics Health IT Imaging devices Genetically engineered proteins … 13 Our Ideas: Suggested topic areas*

14. National Institutes of Health Office of Extramural Research SBIR/STTR Program Descriptions and Research Topics YOUR Ideas: Investigator-initiated R&D Research projects related to the NIH mission “Other” areas of research within the mission of an awarding component Keyword Search the Solicitation Ctrl + F

15. National Institutes of Health Office of Extramural Research Omnibus vs Targeted FOAs OmnibusTargeted Due DatesStandard Due Dates Standard or Customized Due Dates Review SBIR/STTR panels at CSR OR SBIR/STTR panel at Institute/Center Application Instructions Follow SF424 R&R SBIR/STTR Application Guide & Annotated Form Set AND any additional instructions in FOA Read FOA very carefully!

16. National Institutes of Health Office of Extramural Research New SBIR/STTR Standard Due Dates See NOT-OD-15-038NOT-OD-15-038 Current SBIR/STTR Standard Due Dates 16 Cycle I Due DateCycle II Due DateCycle III Due Date April 5August 5December 5 New SBIR/STTR Standard Due Dates (no AIDS standard due dates) * Effective September 5, 2015 Cycle I Due DateCycle II Due DateCycle III Due Date September 5January 5April 5 No August 5, 2015 due date

17. National Institutes of Health Office of Extramural Research New SBIR/STTR award budget HARD caps in place Pre-approved topics list can be found on funding page: https://sbir.nih.gov/funding https://sbir.nih.gov/funding ProgramPhase IPhase II SBIR$150,000$1,000,000 STTR$150,000$1,000,000 Award Guidelines Award Hard Caps – cannot exceed Budget Hard Caps ProgramPhase IPhase II SBIR$225,000$1,500,000 STTR$225,000$1,500,000

18. National Institutes of Health Office of Extramural Research Electronic Submission SBIR/STTR grant applications must be submitted electronically. SBIR contract proposals still in paper form. Registrations are required!!! o DUNS Number (Company) o System for Award Management (SAM) o Grants.gov (Company) o eRA Commons (Company and all PD/PIs) o SBA Company Registry at SBIR.gov 18 http://era.nih.gov/applicants/index.cfm

19. National Institutes of Health Office of Extramural Research Venture Capital Companies Small business concerns that are majority-owned by multiple venture capital operating companies (VCOCs), hedge funds and/or private equity firms ARE NOW ELIGIBLE to apply (NIH SBIR only, CDC SBIR as of 7/10/14 for new solicitations) SBIR and STTR VCOC forms available at: http://grants.nih.gov/grants/forms.htm#sbir http://grants.nih.gov/grants/forms.htm#sbir *Note: SBIR VCOC form also used for SBIR contracts 19

20. National Institutes of Health Office of Extramural Research Switching between SBIR and STTR NIH SBIR/STTR applicants may now ‘switch’ programs at Phase II or Phase IIB to any active NIH SBIR/STTR solicitation. Which means: Phase I STTR Awardees may apply for NIH SBIR or STTR Phase II Phase I SBIR Awardees may apply for NIH SBIR or STTR Phase II Phase II STTR Awardees may apply for NIH SBIR or STTR Phase IIB Phase II SBIR Awardees may apply for NIH SBIR or STTR Phase IIB Note that not all NIH Institutes and Centers accept Phase IIB applications. 20

21. National Institutes of Health Office of Extramural Research For a full list of changes: http://sbir.nih.gov/reauthorization NIH Reauthorization Changes

22. National Institutes of Health Office of Extramural Research NIH Application and Review Process Applicant Initiates Research Idea Small Business Concern Submits SBIR/STTR Grant Application to NIH Electronically NIH Center for Scientific Review/ Assign to IC and IRG Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Staff Prepare funding Plan For IC Director IC Allocates Funds Grantee Conducts Research

23. National Institutes of Health Office of Extramural Research Timeline: New Applications Sept 5 Jan 5 April 5 Oct/Nov Feb/Mar June/July Jan/Feb May/June Aug March July Sept or Dec Due Date Scientific Review Council Review Award Date (earliest)

24. National Institutes of Health Office of Extramural Research Most Important Piece of Advice Talk to an NIH Program Officer about your application and SUBMIT EARLY (days not hours and minutes)! o Program Officer contact information found in the NIH SBIR/STTR Solicitation on http://sbir.nih.govhttp://sbir.nih.gov o Questions about who to contact? Email sbir@od.nih.govsbir@od.nih.gov 24

25. National Institutes of Health Office of Extramural Research NIH Technical Assistance Program Helping Companies cross the “Valley of Death” Phase I Phase II Phase III Commercialization Assistance Program Niche Assessment Program Valley of Death Phase IIB Market- Ready Technology Early-Stage Technology ?

26. National Institutes of Health Office of Extramural Research NIH Technical Assistance Programs Niche Assessment Program Foresight S&T (Phase I awardees) Commercialization Assistance Program Larta, Inc. (Phase II awardees) Identifies other uses of technology Determines competitive advantages Develops market entry strategy “Menu” of technical assistance/training programs in: o Strategic/business planning o FDA requirements o Technology valuation o Manufacturing issues o Patent and licensing issues Helps build strategic alliances Facilitates investor partnerships Individualized mentoring/consulting 26

27. National Institutes of Health Office of Extramural Research For More Information Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Email: mportnoy@mail.nih.gov Robert Vinson SBIR/STTR Program Manager Phone: 301-435-2713 Email: vinsonr@mail.nih.gov 27 Lenka Fedorkova, PhD SBIR/STTR Program Manager Phone: 301-435-0921 Email: lenka@nih.gov Betty Royster SBIR/STTR Communications Specialist Phone: 301-402-1632 Email: roysterbr@mail.nih.gov Julie Beaver SBIR/STTR Statistician Phone: 301-496-8807 Email: julie.beaver@nih.gov JP Kim, JD, MBA SBIR/STTR Program Manager Phone: 301-435-0189 Email: jpkim@nih.gov

28. National Institutes of Health Office of Extramural Research More Information Get Connected! Subscribe to the SBIR/STTR Listserv: o Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your nameLISTSERV@LIST.NIH.GOV NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm Follow us on Twitter: @NIHsbir Submit your SBIR/STTR Success Story at: http://sbir.nih.govhttp://sbir.nih.gov Email: sbir@od.nih.govsbir@od.nih.gov 28

29. National Institutes of Health Office of Extramural Research NIH SBIR/STTR Website http://sbir.nih.gov

30. National Institutes of Health Office of Extramural Research NIH SBIR/STTR Conference 17th Annual NIH SBIR/STTR Conference October 27 – 29, 2015 Seattle, Washington Stay tuned for details! 30 Conference Hashtag #SBIRConf