Overview of the NIH SBIR/STTR Programs

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1 Overview of the NIH SBIR/STTR Programs Institute SBIR/STTR Training UMBC, South Campus May 27, 2014 Robert Vinson NIH SBIR/STTR Assistant Program Manager, NIH

2 Agenda Overview of NIH SBIR and STTR Programs Technical Assistance Reauthorization Updates Electronic Submission Peer Review Overview Questions and Answers!

3 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 SBIR/STTR Programs The largest, most accessible source of SEED CAPITAL in the nation for innovative small businesses Over 2 Billion $$$ in FY 14 NIH SBIR $663 M NIH STTR $ 95 M NIH FY 14 TOTAL $758M

5 and... The seed capital is in the form of grants and contracts. Not a loan - no repayment No debt service Non-dilutive funding Maintain intellectual property (IP) rights

6 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 Re-Authorizes program through FY2017

7 STTR Purpose and Goals 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 Re-Authorizes program through FY2017

DOE NSF NASA All Others SBIR/STTR Budgets by Agency, FY 2013 Agencies with SBIR and STTR Programs Department of Defense (DOD) Department of Health and Human Services: National Institutes of Health

8 M DOD Agencies with SBIR Programs U.S. Department of Agriculture (USDA) $18.4M ~ $2.

8 DOE NSF NASA All Others SBIR/STTR Budgets by Agency, FY 2013 Agencies with SBIR and STTR Programs Department of Defense (DOD) Department of Health and Human Services: National Institutes of Health (NIH) Department of Energy (DOE), including ARPA-E $ 1.0 B $697.0 M $183.9M NIH National Science Foundation (NSF) National Aeronautics and Space Administration (NASA) $153.0 M $ M DOD Agencies with SBIR Programs U.S. Department of Agriculture (USDA) $18.4M ~ $2.3B in FY13 Across all agencies Department of Homeland Security (DHS): Science and Technology Directorate (S&T) and Domestic Nuclear Detection Office (DNDO) Department of Education (ED) Department of Transportation (DOT) Department of Commerce: National Oceanic and Atmospheric Administration (NOAA) and National Institute of Standards and Technology (NIST) Environmental Protection Agency (EPA) $15.7 M $13.4 M $7.6 M $7.4 M $3.8 M

9 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 Research Infrastructure Programs Office of the Director 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 Alternative Medicine Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine National Institute of Biomedical Imaging and Bioengineering NIH Clinical Center Center for Information Technology Center for Scientific Review No funding authority

11 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 (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

12 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 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

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

16 NIDA NIH SBIR/STTR Budget Allocations FY2014 NIEHS NCATS NEI NIAAA NHGRI NIAMS NIDCR NIBIB NIDCD NIMHD NINR ORIP NCCAM NLM NCI 2.8% SBIR $663M 0.40% STTR $95M Total FY2014 $758M NIA NIAID NICHD NIMH NINDS NIDDK NIGMS NHLBI

17 NIH-wide SBIR/STTR Success Rates Fiscal Year SBIR/STTR Phase Number of Applications Reviewed Number of Applications Awarded Success Rate Total Funding 2012 SBIR Fast Track % $13,985, SBIR Phase 1 4, % $154,237, SBIR Phase % $153,650, STTR Fast Track % $2,840, STTR Phase % $23,857, STTR Phase % $18,240, FY TOTAL 5,847 1, % $366,812, SBIR Fast Track % $13,981, SBIR Phase I 3, % $114,040, SBIR Phase II % $136,348, STTR Fast Track % $2,542, STTR Phase I % $24,138, STTR Phase II % $10,985, FY TOTAL 5, % $302,036,519 Success Rates Posted Online:

18 Success Rate of SBIR/STTR 2012 and 2013 by Phase SBIR 39.9% 34.4% STTR 39.4% 32.8% 28.6% 26.4% 15.9% 15.7% 15.6% 13.2% 20.3% 18.7% Fast Track Phase I Phase II Fast Track Phase I Phase II Success Rates Posted Online: 18

19 Success Rate of SBIR 2012 and 2013 by Phase 39.9% 32.8% 15.9% 15.7% 15.6% 13.2% Fast Track Phase I Phase II 19

20 Success Rate of STTR 2012 and 2013 by Phase 39.4% 34.4% 28.6% 26.4% 20.3% 18.7% Fast Track Phase I Phase II 20

21 HHS/NIH Program Funding 2014 Budget SBIR STTR NIH $663M $95M CDC FDA ACF Phase I Phase II $8.97M $1.29M $81K $150K* 6 months* $1M* 2 years* N/A $150K* 1 year* $1M* 2 years*

SBIR/STTR Program Descriptions & Research Topics Our Ideas: Suggested topic areas* Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic

22 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 / optoelectronics Health IT Imaging devices Genetically engineered proteins

SBIR/STTR Program Descriptions and Research Topics Our Ideas: Suggested topic areas* Biodefense Biosilicon devices Biosensors Research projects Biocompatible related to the materials NIH mission

23 SBIR/STTR Program Descriptions and Research Topics Our Ideas: Suggested topic areas* Biodefense Biosilicon devices Biosensors Research projects Biocompatible related to the materials NIH mission Nanotechnologies Acousto-optics / optoelectronics Bioinformatics Other areas of research within the mission of an Health awarding IT component Diagnostic Keyword and search the Solicitation Therapeutic Devices Imaging devices Telehealth Proteomics / Genomics Your Ideas: Investigator-initiated R&D Genetically engineered proteins Ctrl - F

24 Solicitations and Due Dates NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation Parent FOAs: SBIR: PA STTR: PA 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: August November 2014 close date NIH Guide for Grants and Contracts Release: Weekly Receipt dates specified in each FOA (

25 NIH SBIR/STTR FOAs Located on the NIH SBIR/STTR Homepage: SBIR/STTR Omnibus Solicitation NIH SBIR Direct Phase II Targeted FOAs NIH SBIR Contract Solicitation

26 Targeted FOAs Over 60 IC Specific Targeted FOAs

27 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!**

28 Technical Assistance Programs Helping Companies cross the Valley of Death Niche Assessment Program Mt. FDA??? Commercialization Assistance Program Phase I Phase II Phase III

29 Technical Assistance Programs Niche Assessment (Active Phase I awardees) Commercialization Assistance (Phase II or IIB awardees) Identifies other uses of technology Determines competitive advantages Performs market research 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

30 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!

31 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: 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

Registry Full list of changes located here: http://grants.nih.

32 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: Questions? Talk to your NIH IC Program Officer!

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

34 Next Steps You ve convinced me to apply NOW WHAT?!?!

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

36 Timeline: New Applications <. 6-9 months.> Due Date Scientific Review Council Review Award Date (earliest) April 5 July October December August 5 November January April December 5 March May July

37 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

38 Women-Owned Small Business What is a Women-Owned Small Business (WOSB)? 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.

39 Socially and Economically Disadvantaged Business 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. You must self-certify by registering your business in the System for Award Management.

40 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 Questions about who to contact?

41 For More Information Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: Lenka Fedorkova, PhD SBIR/STTR Asst. Program Manager Phone: Robert Vinson SBIR/STTR Asst. Program Manager Phone: Betty Royster SBIR/STTR Communications Specialist Phone: Julie Beaver SBIR/STTR Statistician Phone:

42 More Information Get Connected! Subscribe to the SBIR/STTR Listserv: with the following text in the message body: subscribe SBIR-STTR your name NIH Guide for Grants and Contracts (weekly notification) Follow us on Submit your SBIR/STTR Success Story at:

43 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!

44 More Information Questions and Answers!

NIH Mission Improve human health through biomedical and behavioral research, research training and communications.

Overview of the NIH SBIR/STTR Program NCET2 March 21, 2013 Matthew Portnoy, Ph.D. SBIR/STTR Program Coordinator, NIH 1 NIH Mission Improve human health through biomedical and behavioral research, research