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Overview of the NIH SBIR/STTR Programs

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

  2. Agenda • Overview of NIH SBIR and STTR Programs • Technical Assistance/Reauthorization Updates • Electronic Submission • Peer Review Overview • Case Studies • 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

  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 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. 112-81 Re-Authorizes program through FY2017

  7. STTR Purpose and Goals • Stimulate and foster scientific and technological innovation through cooperative research and development carried out betweensmall 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

  8. SBIR/STTR Budgets by Agency, FY 2013 ~ $2.3B in FY13 Across all agencies

  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 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 of Dental and Craniofacial Research National Institute on Deafness and Other Communication Disorders 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 Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine NIH Clinical Center Center for Information Technology Center for Scientific Review No funding authority

  11. 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 IIBCompeting 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 NIH SBIR/STTR 3-Phase Program

  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 controlledby 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 • STTR:Requirespartnering 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

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

  17. NIH-wide SBIR/STTR Success Rates Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx

  18. HHS/NIH Program Funding

  19. 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 …

  20. Your Ideas: Investigator-initiated R&D • Research projects related to the NIH mission • “Other” areas of research within the mission of an awarding component SBIR/STTR Program Descriptions and 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 … Keyword search the Solicitation Ctrl - F

  21. 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: August November2014close date • NIH Guide for Grants and Contracts • Release: Weekly Receipt dates specified in each FOA • (http://grants.nih.gov/grants/guide/index.html) “Parent” FOAs:SBIR:PA-14-071STTR: PA-14-072

  22. 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

  23. Targeted FOAs http://grants.nih.gov/grants/funding/sbir_announcements.htm Over 60 IC Specific Targeted FOAs

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

  26. Niche Assessment Identifies other uses of technology Determines competitive advantages Performs market research (Active Phase I awardees) 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)

  27. 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. 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

  29. 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. 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 • 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 • 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

  31. Next Steps • You’ve convinced me to apply…… • NOW WHAT?!?!

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

  33. Timeline: New Applications Due Date April 5 August 5 December 5 <……………….……6-9 months…………………….> 2 4 5 Award Date (earliest) December April July Council Review October January May Scientific Review July November March

  34. 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. 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. 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

  37. 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.gov • Questions about who to contact? Email sbir@od.nih.gov

  38. Other Presentations to Check Out • NIH Peer Review Process • By: • How Well Do You Know the eRA Commons? • By:

  39. 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. 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. 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. 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. 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. 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. 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. Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Email: mportnoy@mail.nih.gov For More Information Lenka Fedorkova, PhD SBIR/STTR Program Analyst Phone: 301-435-0921 Email: lenka@nih.gov Robert Vinson SBIR/STTR Program Analyst Phone: 301-435-2713 Email: vinsonr@mail.nih.gov Julie Beaver SBIR/STTR Statistician Phone: 301-496-8807 Email: julie.beaver@nih.gov Betty Royster SBIR/STTR Communications Specialist Phone: 301-402-1632 Email: roysterbr@mail.nih.gov

  47. Get Connected! • Subscribe to the SBIR/STTR Listserv: • EmailLISTSERV@LIST.NIH.GOVwith 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: sbir@od.nih.gov More Information

  48. 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! Save the Date

  49. More Information Questions and Answers!