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

1. Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH “Lab to Life”NIH SBIR/STTR Funding Opportu“NIH”tieS National Institutes of Health NIH Regional SeminarJune 2010Portland, OR

2. Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics • Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow Lights • Answer Your Questions!

3. The largest, most accessible source of SEED CAPITALfor the nation’s innovative small businesses$2.4 Billion in FY 2010 SBIR/STTR Programs NIH SBIR: $616 M NIH STTR: $ 74 M Total: $690M

4. And…. • This capital is in the form of • grants and contracts • no repayment • no debt service • no equity forfeiture • no IP forfeiture

5. 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 businesses and research institutions -- with potential for commercialization. 2.5% 0.3% The best way to predict the future… is to create it.

6. 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 extended program through 09/30/2008) SBIR/STTR Program Overview

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

8. SBIR/STTR Extension SBIR and STTR Program Extended Temporarily Through April 30, 2010 P.L. 111-136 temporarily extends all programs authorized under the Small Business Act and the Small Business Investment Act of 1958. (Extension includes SBIR) Apr 30 SBIR/STTR Program Overview

9. 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 • Must use non-SBIR/STTR Funds SBIR/STTR: 3-Phase Program SBIR/STTR Program Overview

10. SBIR/STTR Eligibility Criteria • U.S. small business organized for-profit • At least 51% U.S.- owned by individuals and independently operated or, for SBIR, at least 51% owned and controlledby another (one)business concern that is at least 51% owned and controlled by one or more individuals • 500 or fewer employees, including affiliates • SBIR:PI primarily employed with the small business (STTR: primary employment not stipulated) • STTR:Formal collaboration between small • business and research institution SBIR/STTR Program Overview

11. More SBIR/STTR Eligibility Checkpoints • STTR: Formal collaborative effort means: • Minimum 40% by small business • Minimum 30% by U.S. research institution • STTR: Intellectual Property Agreement Needed • Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization • SBIR/STTR: Applicant is Small Business Concern • SBIR/STTR: All of the work must be done in the US • (unless a waiver is issued) SBIR/STTR Program Overview

12. University-Industry Partnership Opportunities • Own small firm (assign someone else PD/PI) • Principal Investigator • with official permission from university • NIH allows multiple PD/PIs • Senior Personnel on SBIR/STTR • Consultant on SBIR/STTR • Subcontract work on SBIR/STTR • Use university facilities for analytical and other service support

13. SBIR and STTR: Critical Differences • Principal Investigator Employment • SBIR: Primary employment (>50%) must be with small business concern • STTR: PI may be employed by either research institution or small business concern • Multiple PD/PI allowable • 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%) Award is always made to Small Business Concern

14. Important Facts to Remember • Eligibility is determined attime of award • Noappendices allowed in Phase I • The PD/PI is notrequired to have a Ph.D. • The P/PI isrequired to have expertise to oversee project scientifically and technically • Applicationsmay besubmitted to different agenciesfor similar work • Awards may notbe accepted from different agencies for duplicative projects

15. Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics • Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow Lights • Answer Your Questions!

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

17. 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

18. NIH Institute/Center SBIR/STTR Budget Allocations FY 2010 SBIR/STTR Budget Allocations to NIH ICs: SBIR: $616 M STTR:$ 74 M Total: $690 M NIGMS NIDDK

19. PHASE I(Feasibility Study) • Average award: $170K • Project Period: Varies. Most awards on a 1-yr NCE • PHASE II (Full Research/R&D) • Average $850K and 2-years; can be longer • PHASE II+ (Competing Renewal/R&D) • Clinical R&D; Complex Instrumentation/Tools • Many, 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

20. 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

21. Bridging the Phase I - II Funding Gap 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? “In-NIH-vative” Approaches

22. Phase II Competing Renewal Award Purpose • To take existing, promising compounds or devicesdeveloped under a Phase II through the next step of drug discovery / medical device refinement and development (see SBIR/STTR Solicitation) • OR…. • To support complex instrumentation, clinical research tools, behavior interventions/treatments • (seePA-08-056) “In-NIH-vative” Approaches

23. Phase II Competing Renewal Award Eligibility Contact NIH Program Staff to discuss • SBIR Phase II awardee • Promising pharmacologic compound identified in original Phase II • Device prototype developed in original Phase II • Instrumentation/Interventional technologies not subject to FDA regulatory approval but require extraordinary time/effort to develop Parameters • Maximum of $1M/year for up to 3 years • IC must accept Competing Renewal applications • (NIA, NIAAA, NIAID,NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and NCRR) “In-NIH-vative” Approaches

24. Solicitations and Due Dates http://grants.nih.gov/grants/funding/sbir.htm

25. 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 Suggested topic areas Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Biosilicon devices Biocompatible materials Acousto-optics /opto-electronics Imaging devices Genetically engineered proteins Proteomics / Genomics … Keyword search the Solicitation Ctrl - F

26. Cover Letter: A Valuable Tool • Suggest potential awarding component(s): NIH Institutes/Centers • Request study section • Suggest key areas of expertise required • Indicate individual(s) or organization(s) in conflict • For resubmission, indicate review history • Justify your requests

27. Targeted SBIR/STTR Funding Opportunity Announcements http://grants.nih.gov/grants/funding/sbir_announcements.htm • NIH Guide for Grants and Contracts • High priority areas for ICs • Various IC participation • Nuances: • Various due dates • Additional review criteria • Limited funds and project duration periods • Etc.

28. Electronic Submission • SBIR/STTR grant applications must be submitted electronically. (SBIR contract proposals still in paper form) • Registrations are required!!! • Grants.gov (company) • eRA Commons (company and all PD/PIs) http://era.nih.gov/ElectronicReceipt/index.htm

29. Important Application Changes (Effective January 25, 2010) • Research Plan Restructure • Page Limits • Introduction (resubmission or revision) – 1page • Specific Aims – 1page • Research Strategy • Phase I – 6 pages • Phase II – 12 pages • Phase II Commercialization Plan – 12 pages Research Plan Background & Significance Preliminary Studies/Progress Report Research Design and Methods Research Strategy Significance Innovation Approach Guide Notice: NOT-OD-09-149

30. Small Business Concern Applicant Initiates Research Idea Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds NIH Application and Review Process Remember: First get registered in Grants.gov AND eRA Commons! NIH Center for Scientific Review Assign to IC and IRG 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 NIH SBIR/STTR Program Specifics

31. Review Criteria • Overall Impact Score • Scored Review Criteria (score 1-9) • Significance (Real Problem/Commercial Potential) • Investigators (PI and team) • Innovation (New or Improved?) • Approach (Research Design, Feasible) • Environment (Facilities/Resources) • Additional Review Criteria (not scored individually) • Protection of Human Subjects • Inclusion of Women, Minorities & Children • Vertebrate Animals • Biohazards

32. NIH SBIR/STTR Success Rates PRELIMINARY -- Fiscal Year 2009 $672 M SBIR/STTR 262 40.6% 33 54 31.1% Success Rate (%) 654 105 7 23.1% 22% 19.6% # Awards 14.9% % funded

33. Competing Successfully for SBIR/STTR Funding • Understand our mission. • Review Funding Opportunity Announcements (FOAs). • Propose innovative ideas with significance as well as scientific and technical merit. • Give yourself ample time to prepare application. • Communication. Communication. Communication. • Contact NIH Staff to discuss • your research idea. • outcome of your review. • challenges and opportunities.

34. Mt. “FDA” ??? NIH Technical Assistance Program Helping Companies cross the “Valley of Death” Niche Assessment Program Commercialization Assistance Program Phase I Phase II Phase III “In-NIH-vative” Approaches

35. Technical Assistance Programs Understanding the “B” in SBIR Niche Assessment Identifies other uses of technology Determines competitive advantages Develops market entry strategy (Phase I awardees) 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 awardees)

36. Finding a Partner NIH Pipeline to Partnerships • Showcases SBIR/STTR (Phase I and Phase II) technologies and NIH-licensed technologies • Facilitates matchmaking between NIH SBIR/STTR awardees and potential strategic partners and investors • Searches by application category (diagnostics, therapeutic, tool, etc.) and/or disease “In-NIH-vative” Approaches

37. NIH Pipeline to Partnerships (P2P) SBIR/STTR awardees and NIH licensees can showcase technologies in a virtual space for potential partners. http://www.ott.nih.gov/p2p/index.aspx

38. NIH Pipeline to Partnerships (P2P) POTENTIAL PARTNERS / INVESTORS   Identifies technology of interest and contacts company

39. Topics to Discuss Today • SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics • Partnering Incentives for Research Institutions and Industry through SBIR/STTR • Red Lights and Yellow Lights • Answer Your Questions!

40. SBIR/STTR Historical Relationships Federal Government  Quasi-Government Corporations  Economic Development Entities  Technology Centers Academia  University Research Parks  Faculty & Graduate Students  Technology Incubators  Research Foundations Small Businesses 1982 2008 State Government

41. University Roles in SBIR/STTR Programs • Universities are the intellectual capital of scientific and engineering knowledge. • Small Businesses are a vehicle for channeling scientific discovery to the benefit of society. • Partnerships between the University and the Small Business benefits BOTH.

42. Research Institution 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

43. UNIVERSITY AND INDUSTRY:Two diverse cultures Industry Researchers are from MARS University Researchers are from Venus

44. 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

45. 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

46. CULTURAL DIVERSITY FLEXIBILITY and UNDERSTANDING IP ISSUES is KEY! University - Industry PartnershipsCritical dimension of the new “Innovation-based Economy” • Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property • Universities and Industry learning to work together

47. Entrepreneurial Research Institution Key Ingredients • Synergistic goals between faculty-initiated business and mission of research institution • Environment that enables innovation and entrepreneurship • Agreement on IP issues • Policies to manage, reduce or eliminate conflict of interest (COI)

48. Examples of Successful Entrepreneurial Research Institutions • The Ohio State University • Purdue University • University of Wisconsin • N.C. State University • Georgia Tech • Virginia Tech • Texas A&M University • Penn. State University • UC San Diego • University of Utah • Carnegie Mellon University • Stanford University Source: Innovation U. “New University Roles in A Knowledge Economy” Southern Technology Council and Southern Growth Policies Board

49. “Land” of Opportunities • Providing incubator facilities on university property • Taking equity position (e.g., 5%) in commercial ventures • Investing funds in new companies • Providing technical and business services to new firms (e.g., alumni, business school) • Entering into joint ventures with private entities • Modernizing the tenure process

50. Case Study: Texas A&M