1. National Institutes of Health Office of Extramural Research Overview of the NIH SBIR/STTR Programs June 26, 2014 Betty Royster NIH SBIR/STTR Communications Specialist Office of Extramural Research, NIH

2. National Institutes of Health Office of Extramural Research Agenda Overview of NIH SBIR and STTR Programs Technical Assistance/Reauthorization Updates Electronic Submission Peer Review Overview Case Studies Questions and Answers!

3. National Institutes of Health Office of Extramural Research 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 2.8% 0.40%

4. National Institutes of Health Office of Extramural Research SBIR/STTR Programs The largest, most accessible source of SEED CAPITAL in the nation for innovative small businesses Over 2 Billion $$$$ in FY 14

5. National Institutes of Health Office of Extramural Research And….. The seed capital is in the form of grants and contracts…. Not a loan - no repayment No debt service Non-dilutive funding Maintain IP rights

6. National Institutes of Health Office of Extramural Research SBIR Purpose and Goals Small Business Innovation Development Act of 1982 P.L. 112-81 Re-Authorizes program through FY2017 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

7. National Institutes of Health Office of Extramural Research STTR Purpose and Goals Small Business Research and Development Enhancement Act of 1992 P.L. 112-81 Re-Authorizes program through FY2017 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

8. National Institutes of Health Office of Extramural Research SBIR/STTR Budgets by Agency, FY 2013 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 ~ $2.3B in FY13 Across all agencies

9. 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.

10. 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

11. National Institutes of Health Office of Extramural Research PHASE II Full Research/R&D  $1M (SBIR), $1M (STTR) 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

12. 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

13. National Institutes of Health Office of Extramural Research 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 STTR Eligibility Criteria

14. 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

15. National Institutes of Health Office of Extramural Research 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%) Award is always made to Small Business Concern SBIR and STTR Critical Differences 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

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

17. 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 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 Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx

18. National Institutes of Health Office of Extramural Research HHS/NIH Program Funding 2014 BudgetSBIR STTR NIH$663M$95M CDC FDA ACF $8.97M $1.29M $81K N/A Phase I$150K* 6 months* $150K* 1 year* Phase II$1M* 2 years* $1M* 2 years*

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 & Research Topics

20. 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

21. National Institutes of Health Office of Extramural Research Solicitations and Due Dates NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation 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 (http://grants.nih.gov/grants/guide/index.html)http://grants.nih.gov/grants/guide/index.html “Parent” FOAs: SBIR: PA-14-071 STTR: PA-14-072PA-14-071PA-14-072

22. National Institutes of Health Office of Extramural Research NIH SBIR/STTR FOAs SBIR/STTR Omnibus Solicitation NIH SBIR Direct Phase II Targeted FOAs NIH SBIR Contract Solicitation Located on the NIH SBIR/STTR Homepage: http://sbir.nih.govhttp://sbir.nih.gov

23. National Institutes of Health Office of Extramural Research Targeted FOAs http://grants.nih.gov/grants/funding/sbir_announcements.htm Over 60 IC Specific Targeted FOAs

24. National Institutes of Health Office of Extramural Research NIH SBIR/STTR FOAs Which FOA is best for you? SBIR vs STTR? Phase I vs Fast-track vs Direct Phase II? **Contact your NIH SBIR/STTR Program Officer!**

25. National Institutes of Health Office of Extramural Research Technical Assistance Programs Phase I Phase II Phase III Mt. “FDA” ??? Commercialization Assistance Program Niche Assessment Program Helping Companies cross the “Valley of Death”

26. National Institutes of Health Office of Extramural Research Technical Assistance Programs Commercialization Assistance “Menu” of technical assistance/training programs in: Strategic/business planning FDA requirements Technology valuation Manufacturing issues Patent and licensing issues Helps build strategic alliances Facilitates investor partnerships Individualized mentoring/consulting (Phase II or IIB awardees) Niche Assessment Identifies other uses of technology Determines competitive advantages Performs market research (Active Phase I awardees)

27. National Institutes of Health Office of Extramural Research Gap Funding Programs Additional Commercialization Resources No-cost extension −Extends project period by 6 months or 1 year Fast-track application −One application for Phase I and Phase II that is submitted and reviewed together Phase IIB awards −$1M per year for up to 3 years; not offered by all ICs Administrative supplements −Adds money to parent grant Commercialization Readiness Pilot Program −Additional gap funding opportunity – stay tuned for details! Always talk to Program Officer!

28. 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 document: http://1.usa.gov/1iUa5Khhttp://1.usa.gov/1iUa5Kh 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

29. 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 SBA Company Registry Full list of changes located here: http://grants.nih.gov/grants/funding/sbir/reauthorization.htm Questions? – Talk to your NIH IC Program Officer!

30. National Institutes of Health Office of Extramural Research Gap Funding Programs  Phase IIB Competing Renewals  Phase I/Phase II Fast Track  Administrative Supplements 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 Budget and Project Period  $150K/6 - 12 months (Phase I)  $1M/2 years (Phase II) 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 Technical Assistance Programs  Technology Niche Assessment  Commercialization Assistance Multiple Receipt Dates (Grants)  April 5, August 5, December 5  May 7, Sept 7, Jan 7 (AIDS)  Contracts: November

31. National Institutes of Health Office of Extramural Research Next Steps You’ve convinced me to apply…… NOW WHAT?!?!

32. 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 Application & Review Process

33. 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

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!!!  DUNS Number (Company)  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

35. National Institutes of Health Office of Extramural Research WOSB What is a Women-Owned Small Business? A firm must be at least 51% owned and controlled by one or more women, and primarily managed by one or more women (who must be US citizens). The firm must be “small” in its primary industry in accordance with SBA’s size standards for that industry. SBCs self certify on the SF 424 (R&R) Form. http://1.usa.gov/1d10b5q

36. National Institutes of Health Office of Extramural Research SDB What is a Socially and Economically Disadvantaged Business (SDB)? The firm must be 51% or more owned and control by one or more disadvantaged persons. The disadvantaged person or persons must be socially disadvantaged and economically disadvantaged, The firm must be small, according to SBA’s size standards.size standards You must self-certify by registering your business in the System for Award Management.System for Award Management http://1.usa.gov/1mKnU0a

37. 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 on http://sbir.nih.govhttp://sbir.nih.gov –Questions about who to contact? Email sbir@od.nih.gov sbir@od.nih.gov

38. National Institutes of Health Office of Extramural Research Other Presentations to Check Out NIH Peer Review Process –By: How Well Do You Know the eRA Commons? –By:

39. National Institutes of Health Office of Extramural Research Case Study Case Study – SBIR or STTR? An SBC is developing a novel therapeutic for hepatitis B. The PI has primary employment at the SBC, and the SBC wants to partner with a university to complete the animal studies? Would SBIR or STTR be most appropriate?

40. National Institutes of Health Office of Extramural Research Case Study Case Study – SBIR or STTR? It depends! For both SBIR and STTR, the SBC can partner with a research institution, but an STTR requires that a research partner complete at least 30% of the overall work No research partner is required for SBIR Which one is right for you? Talk to your Program Officer!

41. National Institutes of Health Office of Extramural Research Case Study Case Study – PI Eligibility for SBIR? A researcher has primary employment at a university, but wants to lead the research project for an SBIR award. Would the SBC be eligible to apply for an SBIR?

42. National Institutes of Health Office of Extramural Research Case Study Case Study – PI Eligibility for SBIC? No, not under current circumstances. The PI must have primary employment at the SBC at the time of award to be eligible for an SBIR. Before Notice of Award is sent out, SBC will be asked to submit Just-in-Time information, which will access the PI’s employment status. What about an STTR?

43. National Institutes of Health Office of Extramural Research Case Study Case Study – PI Eligibility for STTR? Yes, as long as the SBC completes at least 40% of the overall work for a Phase I and Phase II, and the partnering non-profit research institution completes at least 30% of the work. The remaining 30% can go to the SBC, the RI or another third party organization.

44. National Institutes of Health Office of Extramural Research Case Study Case Study – Budget Hard Caps? An SBC wants to submit a Phase I budget for $300,000 to develop the proof-of-concept for a tool to improve diabetes care. Is this permitted?

45. National Institutes of Health Office of Extramural Research Case Study Case Study – Budget Hard Caps? Perhaps! Look on Appendix A of the 2014 SBIR/STTR Topics Document to see if this topic has been granted a waiver by the Small Business Administration (SBA). Either way – Seek the advice of your Program Officer!

46. 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 Program Analyst Phone: 301-435-0921 Email: lenka@nih.govlenka@nih.gov Robert Vinson SBIR/STTR Program Analyst 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@nih.govjulie.beaver@nih.gov

47. 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) http://grants.nih.gov/grants/guide/listserv.htm Follow us on Twitter: @NIHsbir Submit your SBIR/STTR Success Story at: http://sbir.nih.gov http://sbir.nih.gov Email: sbir@od.nih.govsbir@od.nih.gov

48. National Institutes of Health Office of Extramural Research Save the Date 16 th Annual NIH SBIR/STTR Conference October 21 – 23, 2014 Albuquerque, New Mexico Host: University of New Mexico Health Sciences Center Stay tuned – details to come!

49. National Institutes of Health Office of Extramural Research More Information Questions and Answers!