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 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! National Institutes of Health Office of Extramural Research SBIR/STTR Programs Overview SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM 2.8% Set-aside program for small business concerns to engage in Federal R&D – with potential for commercialization SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM 0.40% Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization National Institutes of Health SBIR/STTR Programs Office of Extramural Research The largest, most accessible source of SEED CAPITAL in the nation for innovative small businesses Over 2 Billion $$$$ in FY 14 NIH SBIR NIH STTR $663 M $ 95 M NIH FY 14 TOTAL $758M National Institutes of Health And….. Office of Extramural Research 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 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 National Institutes of Health Office of Extramural Research 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. 112-81 Re-Authorizes program through FY2017 SBIR/STTR Budgets by Agency, FY 2013 National Institutes of Health Office of Extramural Research Agencies with SBIR and STTR Programs DOE NSF NASA All Others NIH 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 DOD ~ $2.3B in FY13 Across all agencies 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 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. National Institutes of Health Office of Extramural Research Office of Research Infrastructure Programs National Institutes of Health Office of the Director http://www.nih.gov/icd 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 NIH Clinical Center Center for Information Technology National Library of Medicine Center for Scientific Review National Institute of Biomedical Imaging and Bioengineering No funding authority 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 (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 National Institutes of Health SBIR Eligibility Criteria Office of Extramural Research 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 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 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 National Institutes of Health Office of Extramural Research • Research Partner SBIR and STTR Critical Differences • Principal Investigator SBIR: Primary (>50%) 33% Phase I and 50% Phase employment must be with small business concern II SBIR: Permits partnering STTR: Requires partnering STTR: PI may be employed with research institution. by either research institution Small business (40%) and or small business concern U.S. research institution (30%) Award is always made to Small Business Concern NIH SBIR/STTR Budget Allocations FY2013 NIAAA NIEHS NHGRI NIBIB NINR NCCAM NIDCR ORIP NIDCD NIMHD NLM NIAMS NIDA 2.7% SBIR $617M 0.35% STTR $80M Total FY2013 $697M NCI NCATS NEI NIAID NIA NICHD NIMH NHLBI NINDS NIDDK NIGMS NIH-wide SBIR/STTR Success Rates National Institutes of Health Office of Extramural Research Fiscal Year SBIR/STTR Phase 2012 2012 2012 2012 2012 2012 2012 2013 2013 2013 2013 2013 2013 2013 SBIR SBIR SBIR STTR STTR STTR FY TOTAL SBIR SBIR SBIR STTR STTR STTR FY TOTAL Fast Track Phase 1 Phase 2 Fast Track Phase 1 Phase 2 Fast Track Phase I Phase II Fast Track Phase I Phase II Number of Applications Reviewed Number of Applications Awarded Success Rate Total Funding 358 4,287 557 32 542 71 5,847 313 3,738 542 42 583 72 5,290 57 667 222 11 110 28 1,095 49 495 178 12 109 19 862 15.9% 15.6% 39.9% 34.4% 20.3% 39.4% 18.7% 15.7% 13.2% 32.8% 28.6% 18.7% 26.4% 16.3% $13,985,802 $154,237,890 $153,650,162 $2,840,632 $23,857,700 $18,240,418 $366,812,604 $13,981,386 $114,040,157 $136,348,846 $2,542,128 $24,138,629 $10,985,373 $302,036,519 Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx National Institutes of Health Office of Extramural Research HHS/NIH Program Funding 2014 Budget NIH SBIR $663M CDC FDA ACF Phase I $8.97M $1.29M $81K $150K* 6 months* $1M* 2 years* Phase II STTR $95M N/A $150K* 1 year* $1M* 2 years* National Institutes of Health Office of Extramural Research SBIR/STTR Program Descriptions & Research Topics Our Ideas: Suggested topic areas* Biodefense Biosilicon devices Biosensors Biocompatible materials Nanotechnologies Acousto-optics / optoelectronics Bioinformatics Diagnostic and Therapeutic Devices Telehealth Health IT Imaging devices Genetically engineered proteins Proteomics / Genomics … SBIR/STTR Program Descriptions and Research Topics National Institutes of Health Office of Extramural Research Our Ideas: Suggested topic areas* Your Ideas: R&D Biosilicon devices Biodefense Investigator-initiated related to the NIH Biocompatible materials Biosensors Research projects mission Acousto-optics / optoNanotechnologies “Other” areas electronics of research within the Bioinformatics IT component mission of an Health awarding Diagnostic and Keyword search the devices Solicitation Imaging Therapeutic Devices Telehealth Proteomics / Genomics Genetically engineered proteins Ctrl -F … National Institutes of Health Office of Extramural Research Solicitations and Due Dates • NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation “Parent” FOAs: SBIR: PA-14-071 STTR: PA-14-072 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 (http://grants.nih.gov/grants/guide/index.html) National Institutes of Health Office of Extramural Research NIH SBIR/STTR FOAs Located on the NIH SBIR/STTR Homepage: http://sbir.nih.gov SBIR/STTR Omnibus Solicitation NIH SBIR Direct Phase II Targeted FOAs NIH SBIR Contract Solicitation 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 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!** Technical Assistance Programs National Institutes of Health Office of Extramural Research Helping Companies cross the “Valley of Death” Niche Assessment Program Mt. “FDA” ??? Commercialization Assistance Program Phase I Phase II Phase III National Institutes of Health Technical Assistance Programs Office of Extramural Research Niche Assessment Identifies other uses of technology (Active Phase I awardees) Determines competitive advantages Performs market research Commercialization Assistance (Phase II or IIB awardees) “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 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! 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/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 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! National Institutes of Health Office of Extramural Research 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 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 National Institutes of Health Office of Extramural Research Next Steps You’ve convinced me to apply…… NOW WHAT?!?! National Institutes of Health Office of Extramural Research Small Business Concern Applicant Initiates Research Idea Application & Review Process Submits SBIR/STTR Grant Application to NIH Electronically NIH Center for Scientific ReviewAssign to IC and IRG Scientific Review Groups Evaluate Scientific Merit ~2-3 months after submission ~2-3 months after review Grantee Conducts Research IC Allocates Funds Advisory Council or Board Recommend approval IC Staff Prepare funding Plan for IC Director Timeline: New Applications National Institutes of Health Office of Extramural Research <……………….……6-9 months…………………….> 2 4 5 Due Date Scientific Review Council Review Award Date (earliest) April 5 July October December August 5 November January April May July December 5 March 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 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 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. • You must self-certify by registering your business in the System for Award Management. • http://1.usa.gov/1mKnU0a National Institutes of Health Most Important Piece of Advice Office of Extramural Research • 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.gov – Questions about who to contact? Email email@example.com National Institutes of Health Other Presentations to Check Out Office of Extramural Research • NIH Peer Review Process – By: • How Well Do You Know the eRA Commons? – By: National Institutes of Health Case Study Office of Extramural Research • 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? National Institutes of Health Case Study Office of Extramural Research • 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! National Institutes of Health Case Study Office of Extramural Research • 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? National Institutes of Health Case Study Office of Extramural Research • 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? National Institutes of Health Case Study Office of Extramural Research • 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. National Institutes of Health Case Study Office of Extramural Research • 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? National Institutes of Health Case Study Office of Extramural Research • 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! National Institutes of Health For More Information Office of Extramural Research Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Email: firstname.lastname@example.org Lenka Fedorkova, PhD Robert Vinson SBIR/STTR Program Analyst Phone: 301-435-0921 Email: email@example.com SBIR/STTR Program Analyst Phone: 301-435-2713 Email: firstname.lastname@example.org Betty Royster SBIR/STTR Communications Specialist Phone: 301-402-1632 Email: email@example.com Julie Beaver SBIR/STTR Statistician Phone: 301-496-8807 Email: firstname.lastname@example.org 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 name • 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 • Email: email@example.com 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 • Stay tuned – details to come! National Institutes of Health More Information Office of Extramural Research Questions and Answers!