1. National Institutes of Health Office of Extramural Research 1 Overview of the NIH SBIR/STTR Program Texas SBIR/STTR Summit June 12, 2013 Matthew Portnoy, Ph.D. SBIR/STTR Program Coordinator Office of Extramural Research, NIH

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

3. National Institutes of Health Office of Extramural Research NIH Mission 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.

4. National Institutes of Health Office of Extramural Research Office of the Director National Institute on Minority Health and Health Disparities National Institutes of Health 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 Advancing Translational Sciences National Institute of Biomedical Imaging and Bioengineering No funding authority Center for Information Technology Center for Scientific Review NIH Clinical Center Office of Research Infrastructure Programs

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

6. NIH SBIR/STTR Budget Allocations FY2013 2.7% SBIR $617M 0.35% STTR $80M Total FY2013 $697M

7. National Institutes of Health Office of Extramural Research NIH-wide SBIR/STTR Success Rates Fiscal YearSBIR/STTRPhase Number of Applications Reviewed Number of Applications Awarded Success Rate Total Funding 2011SBIRFast Track4094210.3%$10,059,904 2011SBIRPhase 14,67253611.5%$123,802,074 2011SBIRPhase 268120329.8%$137,152,687 2011STTRFast Track4249.5%$813,900 2011STTRPhase 15088015.7%$18,321,516 2011STTRPhase 21033735.9%$20,977,584 2011FY TOTAL 6,41590214.1%$311,127,665 2012SBIRFast Track3585715.9%$13,985,802 2012SBIRPhase 14,28766715.6%$154,237,890 2012SBIRPhase 255722239.9%$153,650,162 2012STTRFast Track321134.4%$2,840,632 2012STTRPhase 154211020.3%$23,857,700 2012STTRPhase 2712839.4%$18,240,418 2012FY TOTAL 5,8471,09518.7%$366,812,604

8. National Institutes of Health Office of Extramural Research Texas Success Rates FY2010-12 Fiscal Year SBIR or State All SBIR/STTR Phases STTR Number of Applications Reviewed Number of Applications Awarded Success RateTotal Funding 2010SBIRTEXAS2643513.3%$9,542,456 2010STTRTEXAS471225.5%$3,411,215 2011SBIRTEXAS2382811.8%$8,592,046 2011STTRTEXAS30413.3%$1,584,769 2012 SBIRTEXAS2274118.1%$13,919,585 2012 STTRTEXAS40717.5%$1,610,460

9. National Institutes of Health Office of Extramural Research HHS/NIH Program Funding 2013 BudgetSBIR STTR NIH (2013)$617M$80M CDC FDA ACF $8.3M $1.382 M ~350K N/A Phase I$150K* 6 months* $150K* 1 year* Phase II$1M* 2 years* $1M* 2 years*

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

11. National Institutes of Health Office of Extramural Research http://grants.nih.gov/grants/funding/sbir/reauthorization.h tmhttp://grants.nih.gov/grants/funding/sbir/reauthorization.h tm NIH Website Reauthorization pages

12. National Institutes of Health Office of Extramural Research Key Re-Authorization Provision FYSet-aside SBIRSet-aside STTR 20112.5%0.30% 20122.6%0.35% 2013 (current)2.7%0.35% 20142.8%0.40% 20152.9%0.40% 20163.0%0.45% 20173.2%0.45% Set aside requirements for Agencies will increase

13. National Institutes of Health Office of Extramural Research NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation ** 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: AugustNovember 2013 close date NIH Guide for Grants and Contracts Release: WeeklyReceipt dates specified in each FOA (http://grants.nih.gov/grants/guide/index.html) Solicitations and Due Dates “Parent” FOAs: SBIR: PA-13-234 STTR: PA-13-235PA-13-234PA-13-235

14. National Institutes of Health Office of Extramural Research Important changes in this year’s Omnibus Grant Solicitations See http://grants.nih.gov/grants/guide/notice-files/NOT- OD-13-071.html for details.http://grants.nih.gov/grants/guide/notice-files/NOT- OD-13-071.html New SBIR/STTR award budget HARD caps in place ProgramPhase IPhase II SBIR$150,000$1,000,000 STTR$150,000$1,000,000 Award Guidelines Award Hard Caps – cannot exceed

15. National Institutes of Health Office of Extramural Research Important changes in this year’s Omnibus Grant Solicitations Technical Assistance option NIH offers distinct technical assistance programs to SBIR Phase I and Phase II awardees (Niche & CAP)technical assistance programs Applicants wishing to utilize their own technical assistance vendor are required to include this in your budget and provide a detailed budget justification. Please note, if funds are requested to utilize your own technical assistance vendor and an award is made, the awardee is not eligible to apply for the NIH- provided technical assistance program for the phase of their award.

16. National Institutes of Health Office of Extramural Research New provisions implemented in this year’s Omnibus Grant Solicitations VC-backed companies (VCOC, Hedge fund, private equity firm) CAN NOW apply at this time (NIH SBIR only). SBIR/STTR applicants must register at the SBA Company registry at SBIR.gov.

17. National Institutes of Health Office of Extramural Research New provisions NOT implemented in this year’s Omnibus Grant Solicitations at this time 1. No Switching mechanisms at Phase II Applicants cannot apply for Phase II SBIR funding based on a Phase I STTR award or conversely a Phase II STTR based on a Phase I SBIR award. Similarly, applicants cannot apply for a Phase IIB SBIR or STTR based on a Phase II STTR or SBIR award, respectively. 2.No Direct Phase II applications (pilot FOAs when implemented) Why not? NIH is currently updating its electronic systems and forms for these provisions.

18. National Institutes of Health Office of Extramural Research 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… Our Ideas: Suggested topic areas* SBIR/STTR Program Descriptions and Research Topics

19. National Institutes of Health Office of Extramural Research 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… Our Ideas: Suggested topic areas* SBIR/STTR Program Descriptions and Research Topics Your Ideas: Investigator-initiated R&D l Research projects related to the NIH mission l “Other” areas of research within the mission of an awarding component Keyword search the Solicitation Ctrl - F

20. National Institutes of Health Office of Extramural Research Targeted SBIR/STTR Funding Opportunity Announcements NIH Guide for Grants and Contracts –High priority areas for ICs –Various IC participation –Nuances: Various due dates Additional review criteria Limited funds Varying project periods Etc. http://grants.nih.gov/grants/funding/sbir_announcements.htm

21. 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!!!  System for Award Management (SAM)  Grants.gov (company)  eRA Commons (company and all PD/PIs)  SBA company registry at SBIR.gov http://era.nih.gov/ElectronicReceipt/index.htm

22. National Institutes of Health Office of Extramural Research Small Business Concern Applicant Initiates Research Idea Grantee Conducts Research IC Staff Prepare funding Plan for IC Director NIH Center for Scientific ReviewAssign to IC and IRG Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds Submits SBIR/STTR Grant Application to NIH Electronically ~2-3 months after submission ~2-3 months after review NIH Application and Review Process

23. National Institutes of Health Office of Extramural Research Review Criteria Overall Impact Score Scored Review Criteria (score 1-9)  Significance (Real Problem/Commercial Potential)  Investigators (PI and team)  Innovation (New or Improved?)  Approach (Research Design, Feasible)  Environment (Facilities/Resources) Additional Review Criteria (not scored individually)  Protection of Human Subjects  Inclusion of Women, Minorities & Children  Vertebrate Animals  Biohazards

24. National Institutes of Health Office of Extramural Research Timeline: New Applications DueDate April 5 August 5 December 5 Scientific Review July November March Council Review October January May Award Date (earliest) December April July 2 2 4 4 5 5

25. National Institutes of Health Office of Extramural Research Common Application Problems No Significance  Unimportant problem, unconvincing case for commercial potential or societal impact Inadequately defined test of feasibility Lack of innovation Diffuse, superficial, or unfocused research plan Questionable reasoning in experimental approach  Failure to consider potential pitfalls and alternatives Lack of experience with essential methodologies Unfamiliar with relevant published work Unrealistically large amount of work proposed

26. National Institutes of Health Office of Extramural Research 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. Competing Successfully for SBIR/STTR Funding

27. National Institutes of Health Office of Extramural Research Phase III NIH SBIR/STTR: 3-Phase Program Plus Gap Funding (Phase I-Phase II Fast-Track) Phase I Feasibility Phase II Full R/D $3M/3 years Mt. “FDA” Phase II Competing Renewal Award

28. National Institutes of Health Office of Extramural Research (Simultaneous Submission and Concurrent Review) SBIR/STTR Phase I + Phase II Phase I Award 7-9 months Completion of Phase I Phase I Final ReportProgram Staff assess completion of specific aims and milestones Phase II award Aims/Milestones Met Phase II award Aims/Milestones NOT Met Go? No Go? NIH Phase I/Phase II Fast-Track NIH SBIR/STTR Program Specifics

29. National Institutes of Health Office of Extramural Research SBIR/STTR Phase II awardee Promising pharmacologic compound identified in original Phase II Device prototype developed in original Phase II Instrumentation/Interventional technologies not subject to FDA regulatory approval but require extraordinary time/effort to develop Awards up to $1M/year for up to 3 years IC must accept Competing Renewal applications ( NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NEI, NIGMS NHLBI, NIMH, NINDS, NCATS, ORIP, NCI, NHLBI, NINDS ) Contact NIH Program Staff to discuss Parameters Phase IIB Competing Renewal Award NIH SBIR/STTR Program Specifics

30. National Institutes of Health Office of Extramural Research Phase IPhase IIPhase III NIH Technical Assistance Program Mt. “FDA” ??? Commercialization Assistance Program Niche Assessment Program Helping Companies cross the “Valley of Death” “In-NIH-vative” Approaches

31. National Institutes of Health Office of Extramural Research NIH Technical Assistance Programs Commercialization Assistance Program (CAP) (Humanitas Inc and Larta Inc) 75 Phase II SBIR/STTR companies per year Business & strategic planning (9 month hands-on program) Help build strategic alliances and investor partnerships 125 recent Phase I SBIR/STTR companies per year Vendor prepares Technology Niche Analyses TM Identifies alternative uses for technology, competitive advantage, market entry strategy Niche Assessment Program (Foresight S&T)

32. National Institutes of Health Office of Extramural Research NIH SBIR/STTR Program Summary of Key Features SBIR and STTR Program  Single SBIR/STTR grant solicitation  Investigator-initiated research ideas  Special Funding Opportunities (NIH Guide for Grants and Contracts)  Electronic Submission (grants only)  Awards: Grants, Contracts, Cooperative Agreements Multiple Receipt Dates (Grants)  April 5, August 5, December 5  May 7, September 7, January 7 (AIDS)  Contracts: Early November Budget and Project Period  $150K/6 -12months (Ph I)  $1M/2 yrs (Ph II) External Peer Review  Option to request review group  Experts from Academia/Industry  5 Criteria: Significance, Approach, PI(s), Innovation, Environment  Summary Statement for all applicants  Revise & resubmit Gap Funding Programs  Phase IIB Competing Renewals  Ph I/Ph II Fast Track  Administrative Supplements Technical Assistance Programs  Technology Niche Assessment  Commercialization Assistance Summary

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

34. National Institutes of Health Office of Extramural Research Save the Date! 15 th Annual NIH SBIR/STTR Conference October 28-30, 2013 Sioux Falls, South Dakota Hosted by University of South Dakota Research Park, Inc. Stay tuned to NIH SBIR website and listserv for details!NIH SBIR website listserv

35. 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 Lenka Fedorkova, PhD SBIR/STTR Program Analyst Phone: 301-435-0921 Email: lenka@nih.gov Subscribe to the SBIR/STTR List Serv: Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name Robert Vinson SBIR/STTR Program Analyst Phone: 301-435-2713 Email: vinsonr@mail.nih.gov sbir@od.nih.gov Follow us @NIHsbir@NIHsbir