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Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH

Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH. NIH SBIR/STTR Funding Opportu “NIH” tie $. National Institutes of Health. 11 th Annual NIH SBIR/STTR Conference June 30 – July 1, 2009 Omaha, Nebraska. CONFERENCE GOALS. We really ARE here to help you

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Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH

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  1. Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health 11th Annual NIH SBIR/STTR Conference June 30 – July 1, 2009 Omaha, Nebraska

  2. CONFERENCE GOALS • We really ARE here to help you • Understand NIH SBIR/STTR Program and Funding Opportunities • Understand NIH application, review and award process better • More confident about submitting a competitive application • Take advantage of the one-on-one and networking opportunities • Enjoy yourself!

  3. Topics to Discuss • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics • Solicitations and Funding Opportunities • The NIH Peer-Review Process • Industry- University Partnership Opportunities • Gap-Funding Programs • Transitioning to the Marketplace

  4. SBIR/STTR Program 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. 2.5% 0.3% SBIR/STTR Program Overview

  5. SBIR Purpose and Goals “We in government must work in partnership with small businesses to ensure that technologies and processes are readily transferred to commercial applications.” – Ronald Reagan, July 22, 1982. • 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. 106-554 (Signed 12/21/2000 extends program through 09/30/2008) SBIR/STTR Program Overview

  6. SBIR Program Update SBIR Program Extended Temporarily Until July 31, 2009 P.L. 111-10 temporarily extends programs authorized under the Small Business Act and the Small Business Investment Act of 1958. (Extension includes SBIR) -- signed into law on March 19, 2009 Jul 31 SBIR/STTR Program Overview

  7. SBIR Legislative Update • S.1233:A bill to reauthorize and improve the SBIR and STTR programs and for other purposes.Introduced Jun 10, 2009 • H.R. 2747: To amend the Small Business Act to improve outreach and support activities and to increase award recipients from rural areas with respect to the Small Business Innovation Research Program and the Small Business Technology Transfer Program, and for other purposes.Introduced Jun 8, 2009 • H.R. 2769: Commercializing Small Business Research and Development Act Introduced Jun 9, 2009 • H.R. 2767: Investing in Tomorrow's Technology Act Introduced Jun 9, 2009 • H.R. 2772:SBIR and STTR Enhancement Act Introduced Jun 9, 2009 SBIR/STTR Program Overview

  8. 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. 107-50 (Program reauthorized through 09/30/2009) SBIR/STTR Program Overview

  9. The largest, most accessible source of SEED CAPITALfor the nation’s innovative small businesses~$2.3 Billion in 2009 SBIR/STTR Programs25 years later… DOD SBIR/STTR HHS SBIR/STTR NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHS SBIR USDA SBIR DOC SBIR ED SBIR EPA SBIR DOT SBIR $670M

  10. …and This capital is in the form of grantsandcontracts no repayment no debt service no equity forfeiture no IP forfeiture SBIR/STTR Program Overview

  11. PHASE I • Feasibility Study • $100K and 6-month (SBIR) or 12-month (STTR) Award • PHASE II • Full Research/R&D • $750K and 2-year Award (SBIR & STTR) • Pre-requisite: Phase I award • PHASE III • Commercialization Stage • Use of non-SBIR/STTR Funds SBIR/STTR: 3-Phase Program SBIR/STTR Program Overview

  12. SBIR/STTR Program Overview

  13. SBIR Eligibility Criteria • Applicant must be a Small Business Concern • 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 (unless a waiver is granted) • At least 51% U.S.- owned by individuals and independently operated or At least 51% owned and controlledby another (one)business concern that is at least 51% owned and controlled by one or more individuals SBIR/STTR Program Overview

  14. STTR Eligibility Criteria • Applicant must be a 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 SBIR/STTR Program Overview

  15. STTR Research Institution Partner • U.S. non-profit organization owned and operated exclusively for scientific or educational purposes • U.S. non-profit medical and surgical hospitals • eligible as partner as long as these institutions are exclusively engaged in scientific research and/or application of scientific principles and techniques SBIR/STTR Program Overview

  16. 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 SBIR/STTR Program Overview

  17. 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 Face Page is agreement to conforming to Solicitation requirements SBIR/STTR Program Overview

  18. SBIR vs STTR: Which Program is Best for You?Consider major differences • Principal Investigator • SBIR: Primary employment must be with small business concern • STTR: PI may be employed by research institution or small business concern • Research Partner • SBIR: Permits partnering • STTR: Requirespartnering with Research Institution Small Business Concern is ALWAYS Applicant/Awardee Organization SBIR/STTR Program Overview

  19. Important Facts to Remember • Eligibility is determined at time of award • PD/PI is not required to have a Ph.D./M.D. • PD/PI is required to have expertise to oversee project scientifically and technically • Applications may be submitted to different agencies for similar work • Awards may not be accepted from different agencies for duplicative projects SBIR/STTR Program Overview

  20. Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics • Solicitations and Funding Opportunities • The NIH Peer-Review Process • Industry- University Partnership Opportunities • Gap-Funding Programs • Transitioning to the Marketplace

  21. NIH Mission:Improve Human Health Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability—from the rarest genetic disorder to the common cold. NIH SBIR/STTR Program Specifics

  22. Bridging the Discovery to Development Gap SBIR/STTR Programs Are Fully Integrated Within NIH Research Agenda • Improve human health through prevention, detection, diagnosis and treatment of disease or disability • Speed process of discovery • Reduce cost of medical care • Improve research tools/ reduce • cost of research • Increase health knowledge base NIH SBIR/STTR Program Specifics

  23. Organizational Structure of NIH 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 Center 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 Research Resources National Library of Medicine No funding authority

  24. NIH Institute/Center SBIR/STTR Budget Allocations (FY2009) Extramural R&D Set-Asides: SBIR = 2.5% STTR = 0.3% $600 M (SBIR) $ 72 M (STTR) Total: $672 M NIGMS NIDDK NIH SBIR/STTR Program Specifics

  25. PHASE I Feasibility Study • Average award: $170K • Project Period: Most awards on a 1-yr NCE • PHASE II Full Research/R&D • Average $850K and 2-years • PHASE II Competing Renewal/R&D • Clinical R&D; Complex Instrumentation/Tools • Some, but not all, ICs participate • $1M/year; 3 years • PHASE III Commercialization Stage • NIH, generally, not the “customer” • Consider exit strategy early NIH SBIR/STTR: 3-Phase Program NIH SBIR/STTR Program Specifics

  26. Mt. “FDA” Gap Funding Programs Phase II Competing Renewal Award Phase I Phase II Phase III • No-Cost Extension • Phase I / Phase II Fast Track • Administrative / Competitive Supplements NIH SBIR/STTR Program Specifics

  27. Phase I Final Report 7-9 months Phase I Award Aims/Milestones Met Phase II award Phase II award Aims/Milestones NOT Met NIH Phase I/Phase II Fast-Track SBIR/STTR Phase I + Phase II (Simultaneous Submission and Concurrent Review) Program Staff assess completion of specific aims and milestones Completion of Phase I Go? No Go? NIH SBIR/STTR Program Specifics

  28. Important Considerations NIH Phase I/Phase II Fast-Track • Convincing preliminary data • Clear, measurable, achievable milestones • Well-conceived Commercialization Plan • Letters of Phase III support/interest? • Track record for commercializing? • Discussed with NIH Program Staff? NIH SBIR/STTR Program Specifics

  29. Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics • Solicitations and Funding Opportunities • The NIH Peer-Review Process • Industry- University Partnership Opportunities • Gap-Funding Programs • Transitioning to the Marketplace

  30. Solicitations and Due Dates http://grants.nih.gov/grants/funding/sbir.htm • NIH, CDC & FDA SBIR/STTR Grant Solicitation • Release: January • Standard Due Dates: April 5, Aug 5, Dec 5 • (AIDS/AIDS-related: May 7, Sept 7, Jan 7) • SBIR Contract Solicitation (NIH, CDC) • Release: August November receipt 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-09-080STTR:PA-09-081 Solicitations and Funding Opportunities

  31. SBIR/STTR and ARRA • Small Businesses can apply for NIH Recovery Act funding opportunities: • Challenge Grants (RC1) • Grand Opportunities [“GO” Grants] (RC2) • Administrative Supplements • Competing Supplements (“Revisions”) • Biomedical Research, Development and Growth [BRDG-SPAN] (RC3) • Catalyst Awards (R43) NIH Recovery Act Funding Opportunities: http://grants.nih.gov/recovery/ Solicitations and Funding Opportunities

  32. NIH SBIR/STTR Web Site http://grants.nih.gov/grants/funding/sbir.htm Solicitation and Funding Opportunities

  33. NIH SBIR/STTR Solicitation Research Topics Our Ideas* Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Biosilicon devices Biocompatible materials Acousto-optics /opto-electronics Imaging devices Genetically engineered proteins Proteomics / Genomics *Examples from 200+ pages of topics! Parent Solicitations SBIR:PA-09-080andSTTR: PA-09-081

  34. NIH SBIR/STTR Research Topics Investigator-initiated Ideas (a.k.a. “I can’t find a topic match”) • Research projects related to NIH mission • “Other” areas of research within mission of an awarding component Keyword search the Solicitation Ctrl - F Solicitations and Funding Opportunities

  35. 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 • Lack of sufficient experimental detail • 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 Solicitations and Funding Opportunities

  36. Solicitations and Funding Opportunity Announcements • Identifying Funding Opportunities • Electronic Submission Using • Grants.gov and the NIH eRA Commons Solicitations and Funding Opportunities

  37. Small Business Concern NIH Center for Scientific Review Assign to IC and IRG Applicant Initiates Research Idea Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds NIH Application and 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 Solicitations and Funding Opportunities

  38. Timeline: New Applications Due Date April 5 August 5 December 5 <……………….……6-9 months…………………….> 1.7 2.5 2.2 Council Review October January May Award Date (earliest) December April July Scientific Review July October March Solicitations and Funding Opportunities

  39. NIH Application Submission and Review Process • An In-Depth Look at the NIH SBIR/STTR Receipt, Referral, and Review Process • All You Ever Wanted to Know About the Electronic Submission Process Solicitations and Funding Opportunities

  40. NIH SBIR/STTR Success Rates:FY 2008 288 $650 M SBIR/STTR 46 48.3% 66 39% 739 Success Rate (%) 32% 109 27.2% 4 16% 9.5% Solicitations and Funding Opportunities

  41. Preparing a Successful Application • Pre-Award and Post Award Issues • Indirect Cost Rates and Accounting Systems: Workshop Solicitations and Funding Opportunities

  42. Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics • Solicitations and Funding Opportunities • The NIH Peer-Review Process • Industry- University Partnership Opportunities • Gap-Funding Programs • Transitioning to the Marketplace

  43. SBIR/STTR Historical Relationships Federal Government Small Businesses 1982 1997 Industry-University Partnerships

  44. SBIR/STTR Historical Relationships Federal Government State Government •  Quasi-Government Corporations •  Economic Development Entities • Technology Centers • State Venture Funds Small Businesses 1998 1982 Industry-University Partnerships

  45. SBIR/STTR Historical Relationships Federal Government State Government  Quasi-Government Corporations  Economic Development Entities  Technology Centers Academia Small Businesses •  University Research Parks •  Faculty & Graduate Students •  Technology Incubators • Research Foundations • University Start-Ups 2000- 2009 1982 Industry-University Partnerships

  46. University Start-Ups:Roles in the SBIR/STTR Programs • University is the intellectual capital of scientific and engineering knowledge • Small Business is a vehicle for channeling scientific discovery to the benefit of society • Partnership between the University and the Small Business benefits BOTH Industry-University Partnerships

  47. University-Business Partnership Opportunities • Own small firms (assign someone else PI) • Principal Investigator (with official permission from university) • Senior Personnel on SBIR/STTR • Consultants on SBIR/STTR • Subcontracts on SBIR/STTR • University facilities provide analytical and other service support Industry-University Partnerships

  48. University and Industry:Two diverse cultures Industry Researchers are from MARS! University Researchers are from Venus! Industry-University Partnerships

  49. University and Industry:Two diverse cultures University culture • Research, discover, educate and train future • workforce • Pace is slower - aligned to academic cycle • Mission = basic and applied research • Technology transfer activities are companion • to applied research mission • Fertile ground for economic development Industry-University Partnerships

  50. University and Industry:Two diverse cultures Industry culture • Missiontoward research/R&D/commercialization • Quick-paced • Solve problems - develop new products  profit • Maintain control of science to explore full • potential of discovery (initially) • Economic impact: Jobs, societal benefit Industry-University Partnerships

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