1. National Institutes of Health Office of Extramural Research 1 Do Your Research – What you need to know about the business of Small Business Innovation Research (SBIR) June 30, 2014 NIH Industry Day Matthew Portnoy, Ph.D. SBIR/STTR Program Coordinator Office of Extramural Research, NIH

2. National Institutes of Health Office of Extramural Research 2.8% 0.40% SBIR/STTR Programs 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

3. National Institutes of Health Office of Extramural Research SBIR Purpose and Goals Stimulate technological innovation Use small business to meet Federal R&D needs Foster and encourage participation by minorities and disadvantaged persons in technological innovation Increase private-sector commercialization innovations derived from Federal R&D Small Business Innovation Development Act of 1982 P.L. 112-81 Re-Authorizes program through FY2017 3

4. National Institutes of Health Office of Extramural Research STTR Purpose and Goals (cont.) Stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions Foster technology transfer between small business concerns and research institutions Small Business Research and Development Enhancement Act of 1992 P.L. 112-81 Re-Authorizes program through FY2017 4

5. National Institutes of Health Office of Extramural Research SBIR/STTR in Your Portfolio Capital is in the form of grants and contracts Strategic Investment in Innovation Non-diluted funding: –No repayment –No debt service –No equity forfeiture –No IP forfeiture 5

6. National Institutes of Health Office of Extramural Research SBIR/STTR Budgets by Agency FY2013 Agencies with SBIR & STTR Programs: Department of Defense (DOD) = $1.0 B Department of Health & Human Services: National Institutes of Health (NIH) = $697.0 M Department of Energy (DOE),including ARPA-E = $183.9 M National Science Foundation (NSF) = $153.0 M National Aeronautics & Space Administration (NASA) = $148.8 M 6

7. National Institutes of Health Office of Extramural Research SBIR/STTR Budgets by Agency FY2013 (continued) Agencies with SBIR Programs: U.S. Department of Agriculture (USDA) = $18.4 M Department of Homeland Security (DHS): Science and Technology Directorate (S&T) and Domestic Nuclear Detection Office (DNDO) = $15.7M Department of Education (ED) = $13.4 M Department of Transportation (DOT) = $7.6 M Department of Commerce: National Oceanic & Atmospheric Administration (NOAA) and National Institute of Standards & Technology (NIST) = $7.4 M Environmental Protection Agency (EPA) = $3.8 M ~ $2.3B in FY13 across all agencies 7

8. 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. 8

9. National Institutes of Health Office of Extramural Research National Institutes of Health NIH Institutes, Centers and Offices

10. National Institutes of Health Office of Extramural Research NIH SBIR/STTR 3-Phase Program PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR) 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 10

11. National Institutes of Health Office of Extramural Research SBIR Eligibility Criteria Organized as for-profit U.S. business Small: 500 or fewer employees, including affiliates PD/PI’s primary employment must be with small business concern at time of award and for duration of project period 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 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 11

12. National Institutes of Health Office of Extramural Research STTR Eligibility Criteria Applicant is Small Business Concern Formal Cooperative R&D Effort Minimum 40% by small business Minimum 30% by U.S. research institution U.S. Research Institution College or university; other non-profit research organization; Federal R&D center Intellectual Property Agreement Allocation of rights in IP and rights to carry out follow-on R&D and commercialization 12

13. National Institutes of Health Office of Extramural Research PD/PI Eligibility on STTR PD/PI is not required to be employed by SBC PD/PI at RI must establish contract between RI and SBC describing PD/PI’s involvement PD/PI must commit a minimum of 10% effort PD/PI’s “signature” on application is agreement to conforming to Solicitation requirements 13

14. National Institutes of Health Office of Extramural Research SBIR and STTR Critical Differences Research Partner  SBIR: Permits partnering 33% Phase I and 50% Phase II  STTR: Requires partnering with research institution. Small business (40%) and U.S. research institution (30%) Principal Investigator  SBIR: Primary (>50%) employment must be with small business concern  STTR: PI may be employed by either research institution or small business concern Award is always made to Small Business Concern 14

15. National Institutes of Health Office of Extramural Research NIH SBIR/STTR Budget Allocations FY2014 2.8% SBIR $663M 0.4% STTR $95M Total FY2014 $758M 15

16. National Institutes of Health Office of Extramural Research HHS/NIH Program Funding 2014 Budget NIH  SBIR = $663M; STTR = $95M CDC  SBIR = $8.97M; STTR = n/a FDA  SBIR = $1.29M; STTR = n/a ACF  SBIR = $81K; STTR = n/a Phase I  SBIR = $150K*, 6 months*; STTR = $150K*, 1 year* Phase II  SBIR = $1M*, 2 years*; STTR = $1M*, 2 years*

17. National Institutes of Health Office of Extramural Research Success Rate of SBIR/STTR 2012 and 2013 by Phase SBIR Fast Track:2012 = 15.9% 2013 = 15.7% Phase 1:2012 = 15.6% 2013 = 13.2% Phase II: 2012 = 39.9% 2013 = 32.8% STTR Fast Track:2012 = 34.4% 2013 = 28.6% Phase 1:2012 = 20.3% 2013 = 18.7% Phase II: 2012 = 39.4% 2013 = 26.4% 17

18. National Institutes of Health Office of Extramural Research NIH-wide SBIR/STTR Success Rates Success Rates Success Rates are Posted Online: Fiscal YearSBIR/STTRPhase Number of Applications Reviewed Number of Applications Awarded Success Rate Total Funding 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 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

19. National Institutes of Health Office of Extramural Research NIH SBIR/STTR Webpage SBIR/STTR Webpage Standard Due Dates: Apr. 5; Aug. 5; Dec. 5

20. National Institutes of Health Office of Extramural Research New sbir.nih.gov! 20

21. National Institutes of Health Office of Extramural Research Solicitations and Due Date NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation “Parent” 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, August 5, December 5 (AIDS/AIDS-related: May 7, September 7, January 7) SBIR Contract Solicitation (NIH, CDC) Release: AugustNovember 2014 close date NIH Guide for Grants and Contracts Release: WeeklyReceipt dates specified in each FOA 21

22. National Institutes of Health Office of Extramural Research Reauthorization Changes – Budget Hard Caps Reauthorization required that budgets over the hard cap ($225,000 for Phase I and $1,500,000 for Phase II) Agencies (not applicants) apply for waiver from SBA SBA has recently approved a topics list, which allows budgets to exceed the hard caps as long as the project topics are on the list Pre-approved topics list is Appendix A in regular topics documentAppendix A The approval is good for the 2014 SBIR/STTR Omnibus, and any FOA that falls on the topic list, including the Direct Phase II FOA 22

23. National Institutes of Health Office of Extramural Research Other Reauthorization Changes Majority-owned venture capital provision Switching between SBIR and STTR SBIR Direct Phase II Full list of changes located at the Grants & Funding website.Grants & Funding Questions? – Talk to your NIH IC Program Officer! 23

24. 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). See NOT-OD-13-071NOT-OD-13-071 SBIR and STTR VCOC forms are availableSBIR and STTR VCOC forms *Note: SBIR VCOC form also used for SBIR contracts 24

25. 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 or 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. Check the Omnibus Topics document for listing.Omnibus Topics document 25

26. National Institutes of Health Office of Extramural Research Helpful Tips: Must follow program rules (PI, % effort, sub-contracting, etc.) No special instructions or requirements from applicants NOT-OD-14-048 Applicants are strongly advised to discuss this option with their program officer well in advance of any due date. 26 Switching between SBIR and STTR (cont.)

27. National Institutes of Health Office of Extramural Research Direct to Phase II SBIR FOA Allows small businesses that are ready for the Phase II stage of development to bypass applying for a Phase I grant. The SBC must already have a technology prototype, and must have tested its feasibility (i.e. completed Phase-I-type R&D) to move directly into a Phase-II-type R&D. Pilot SBIR Direct to Phase II Solicitation – it’s own SEPARATE FOA: PAR-14-088.PAR-14-088 Note: Not all ICs will accept Direct Phase IIs – only the ones listed on the solicitation. SBCs cannot apply for a Phase II and Direct Phase II for the same research project. 27

28. National Institutes of Health Office of Extramural Research All ICs on the Direct Phase II FOA will accept technology on anything within their mission. Note: NINDS has a few exceptions listed within the FOA. Applicants are strongly advised to talk to their SBIR Program Officer before applying. Some ICs may issue their own separate Direct Phase II FOA/s in the future. 28 Direct to Phase II SBIR FOA (2)

29. National Institutes of Health Office of Extramural Research A Direct Phase II is not a Phase IIB! No due dates past 12/5/2016 standard date. The Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACF SBIR programs. 29 Direct to Phase II SBIR FOA (3)

30. National Institutes of Health Office of Extramural Research Direct to Phase II SBIR FOA (4) How is a Direct Phase II different than a fast-track? A FT incorporates a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together as one application Intended to reduce or eliminate the funding gap between phases Which one is right for you? Talk to your SBIR Program Officer! 30

31. National Institutes of Health Office of Extramural Research Direct to Phase II SBIR FOA (5) What is the review process? Application goes to NIH Center for Scientific Review. Application is assigned a small business study section.study section Review staff have guidance on the new FOA, It’s too early to know the volume or the success rate! 31

32. National Institutes of Health Office of Extramural Research SBIR/STTR Program Descriptions & Research Topics Our Ideas: Suggested topic areas* 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 32

33. National Institutes of Health Office of Extramural Research SBIR/STTR Program Descriptions & Research Topics (cont.) 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 33

34. 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

35. 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)! – Program Officer contact information found in the NIH SBIR/STTR Solicitation SBIR/STTR Solicitation –Questions about who to contact? Email sbir@od.nih.gov sbir@od.nih.gov

36. National Institutes of Health Office of Extramural Research Application & Review Process 1.Small Business Concern (Applicant Initiates Research Idea) 2.Submits SBIR/STTR Grant Application to NIH Electronically 3.NIH Center for Scientific Review Assign to IC and IRG 4.Scientific Review Groups Evaluate Scientific Merit – (~2- 3 months after submission) 5.Advisory Council or Board Recommend approval – (~2-3 months after review) 6.IC Staff Prepare funding Plan for IC Director 7.IC Allocates Funds 8.Grantee Conducts Research 36

37. 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 37

38. National Institutes of Health Office of Extramural Research Timeline: New Applications Entire Process = 6-9 months  Due Date - April 5 Scientific Review – July Council Review – October Award Date (earliest) – December  Due Date - August 5 Scientific Review – November Council Review – January Award Date (earliest) – April  Due Date - December 5 Scientific Review – March Council Review – May Award Date (earliest) – July 38

39. 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 39

40. National Institutes of Health Office of Extramural Research Competing Successfully for SBIR/STTR 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 opportunitie s 40

41. National Institutes of Health Office of Extramural Research NIH SBIR/STTR: 3-Phase Program Plus Gap Funding Phase I – Feasibility Phase II – Full R&D (Phase I Phase II Fast Track) Phase II Competing Renewal Award ($3M/3 years) Phase III 41

42. National Institutes of Health Office of Extramural Research NIH Phase I/Phase II Fast-Track SBIR/STTR Phase I + Phase II (Simultaneous Submission and Concurrent Review) 7-9 months to Phase I Award Completion of Phase I Phase I Final Report Program Staff assess completion of specific aims and milestones Go?Aims/Milestones Met = Phase II award No Go? Aims/Milestones NOT Met = Phase II no award 42

43. National Institutes of Health Office of Extramural Research Phase IIB Competing Renewal Award Parameters 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! 43

44. National Institutes of Health Office of Extramural Research Niche Assessment Program Provides active Phase I awardees with market research, and consumer and competition analysis Helps small businesses complete their commercialization plans as part of their Phase II applications Learn more at the Niche Assessment Program websiteNiche Assessment Program

45. National Institutes of Health Office of Extramural Research Commercialization Assessment Trains Phase II awardees to: –Develop tailored market entry strategies; –Build strategic partnerships; –Develop FDA regulatory and reimbursement paths; and –Identify financing strategies and expertise on intellectual property matters –Learn more at the Commercialization Assistance Program (CAP) websiteCommercialization Assistance Program (CAP)

46. 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 & Contracts) Electronic Submission (grants only) Awards: Grants, Contracts, Cooperative Agreements External Peer Review Option to request review group Experts from academia/industry Five Criteria: Significance, Approach, PI(s), Innovation, Environment Summary statement for all applicants Revise & resubmit Multiple Receipt Dates (Grants ) April 5, August 5, December 5 May 7, Sept. 7, Jan. 7 (AIDS) Contracts: November

47. National Institutes of Health Office of Extramural Research NIH SBIR/STTR Program Summary of Key Features (cont.) Gap Funding Programs Phase IIB Competing Renewals Phase I/Phase II Fast Track Administrative Supplements Budget and Project Period $150K/6 - 12 months (Phase I) $1M/2 years (Phase II) Technical Assistance Programs Technology Niche Assessment Commercialization Assistance 47

48. 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.govmportnoy@mail.nih.gov Lenka Fedorkova, PhD SBIR/STTR Asst. Program Manager Phone: 301-435-0921 Email: lenka@nih.govlenka@nih.gov Robert Vinson SBIR/STTR Asst. Program Manager Phone: 301-435-2713 Email: vinsonr@mail.nih.govvinsonr@mail.nih.gov Betty Royster SBIR/STTR Communications Specialist Phone: 301-402-1632 Email: roysterbr@mail.nih.govroysterbr@mail.nih.gov Julie Beaver SBIR/STTR Statistician Phone: 301-496-8807 Email: julie.beaver@nihjulie.beaver@nih. 48

49. National Institutes of Health Office of Extramural Research More Information Get Connected! Subscribe to the SBIR/STTR Listserv: 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)NIH Guide for Grants and Contracts Follow us on Twitter: @NIHsbir Submit your SBIR/STTR Success StorySBIR/STTR Email: sbir@od.nih.govsbir@od.nih.gov 49

50. National Institutes of Health Office of Extramural Research Save the Date 16th Annual NIH SBIR/STTR Conference October 21 – 23, 2014 Albuquerque, New Mexico Host: University of New Mexico Health Sciences Center Early Bird Registration $350 through 8/22/14 50

51. National Institutes of Health Office of Extramural Research Questions Questions and Answers! 51