Michael Huerta, PhD Associate Director for Program Development National Library of Medicine, NIH

1. Michael Huerta, PhD Associate Director for Program Development National Library of Medicine, NIH From the Lab to the Marketplace NIH SBIR/STTR Programs National Institutes of Health NIH Regional SeminarJune 2011

2. SBIR & STTR Purpose • Stimulate technological innovation • Commercialize innovative technologies • Stimulate small business & economic growth • Foster technology transfer between small business concerns and research institutions

3. Achieving the Purpose • Through SBIR & STTR awards • To small businesses • Supporting research & development of commercializable, innovative technologies • Serving the mission & priority of the awarding unit (Institute or Center)

4. Achieving the Purpose • Through SBIR & STTR awards • To small businesses • Supporting research & development of commercializable, innovative technologies • Serving the mission of the awarding unit SBIR/STTR Program Overview

5. SBIR & STTR Awards • Awards are funds to the small business from the federal government – control levels vary • Grants • Cooperative Agreements • Contracts • Awards support specific R & D projects (not general business costs, infrastructure, etc.) • Awards do not require • Repayment or debt service • Equity or intellectual property forfeiture

6. How much is awarded through SBIR & STTR programs?

7. How much is awarded through SBIR & STTR programs? $2.4 Billion in FY 2010

8. How much is awarded through SBIR & STTR programs? $2.4 Billion in FY 2010

9. How much is awarded through SBIR & STTR programs? $2.4 Billion in FY 2010 NIH SBIR: $616 M NIH STTR: $ 74 M Total: $690M

10. How much is awarded through SBIR & STTR programs? $2.4 Billion in FY 2010 NIH SBIR: $616 M NIH STTR: $ 74 M Total: $690M SBIR 2.5 % STTR 0.3 %

11. NIH SBIR & STTR Programs Summary of Key Features • SBIR & STTR Programs • Single SBIR/STTR grant solicitation • Investigator-initiated research ideas • Special FOAs (see NIH Guide for Grants and Contracts) • Electronic Submission (grants only) • Awards always made to small business concern • External Peer Review • Option to request review group • Experts from Academia/Industry • 5 Criteria: Significance, Approach, PI(s), Innovation, Environment • Summary Statement for all applicants • Revise & resubmit once • Multiple Receipt Dates (Grants) • April 5, August 5, December 5 • May 7, September 7, January 7 (AIDS) • Contracts: Early November • Gap Funding Programs • Phase IIB Competing Renewals • Ph I/Ph II Fast Track • Administrative Supplements • Budget and Project Period – Guidelines • $100-150K/6 -12months (Ph I) • $750K-1M/2 yrs (Ph II) • Deviations permitted where scientifically appropriate (eg, FOAs) • Technical Assistance Programs • Technology Niche Assessment • Commercialization Assistance • Pipeline to Partnerships (P2P)

12. SBIR and STTR: Critical Differences • PI 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 – for SBIR only one PI must be primarily employed by SBC • 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

13. PHASE I Feasibility Study • Budget Guide: $150K (SBIR) or $100K (STTR) Total Costs • Project Period: 6 months (SBIR) or 1 year (STTR) • PHASE II Full Research/R&D • $750K (STTR) or $1M (SBIR) 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 – not funded by gov’t • NIH is generally not the “customer” • Consider partnering and exit strategy early NIH SBIR/STTR: 3-Phase Program Per Congressional Guidelines – FOAs Vary

14. Phase IIB Competing Renewal Award • Purpose: Peer-reviewed continuation of Phase II R & D for complex projects • Parameters: Up to $1M/year for up to 3 years • Eligibility: Must have Phase II award // contact program officer for eligibility • Participating ICs:NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and NCRR

15. Beyond the Guidelines • The duration and amount of the SBIR or STTR award may exceed the congressional guidelines • As required by the project – contact program officer before submitting the application to find out what would be allowed • As allowed by special funding opportunity announcements (FOAs), for example PA-11-134, Lab to Marketplace: • Phase I – up to $350,000 per year for up to two years • Phase II – up to $600,000 per year for up to three years • Phase IIB – up to $800,000 per year for up to three years

16. Beyond the Guidelines The duration and amount of the SBIR or STTR award may exceed the congressional guidelines One project could be supported with ~ $6 million over 8 years (Ph I, II, & IIB)!

17. Mt. “FDA” Mind the Gap Phase IIB Competing Renewal Award Phase I Phase II Phase III • No-Cost Extension • Phase I / Phase II Fast Track • Administrative / Competitive Supplements

18. 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?

19. Achieving the Purpose • Through SBIR & STTR awards • To small businesses • Supporting research & development of commercializable, innovative technologies • Serving the mission of the awarding unit

20. Achieving the Purpose • Through SBIR & STTR awards • To small businesses • Supporting research & development of commercializable, innovative technologies • Serving the mission of the awarding unit

21. 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:At least one PI primarily employed with the small business (STTR: not stipulated) • STTR:Formal collaboration between small • business and research institution

22. 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

23. Additional Eligibility Issues • Eligibility is determined attime of award • Noappendices allowed in Phase I • The PD/PI is notrequired to have a Ph.D. • The PD/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

24. Achieving the Purpose • Through SBIR & STTR awards • To small businesses • Supporting research & development of commercializable, innovative technologies • Serving the mission of the awarding unit

25. Achieving the Purpose • Through SBIR & STTR awards • To small businesses • Supporting research & development of commercializable, innovative technologies • Serving the mission & priority of the awarding unit (Institute or Center)

26. NIH Institutes and Centers (ICs) 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 Research Resources National Library of Medicine No funding authority

27. NIH Institutes & Centers SBIR & STTR Budget Allocations FY 2010 SBIR/STTR Budget Allocations to NIH ICs: SBIR: $616 M STTR:$ 74 M Total: $690 M NIGMS NIDDK

28. Submitted grant applications get appropriate assignment • Applications received by CSR and assigned to: • A CSR (usually) study section for peer review • An IC for programmatic (funding) consideration

29. Submitted grant applications get appropriate assignment • Applications received by CSR and assigned to: • A CSR (usually) study section for peer review • An IC for programmatic (funding) consideration • Appropriate, however, is not necessarily optimal • You can help determine optimal assignment

30. Relationship between project and study section • Dozens of study sections with different • Areas of review responsibility • Expertise of peer reviewers • Overlap from one study section to another

31. Relationship between project and study section • Dozens of study sections with different • Areas of review responsibility • Expertise of peer reviewers • Overlap from one study section to another • Each study section has unique scientific focus and each reviewer has unique perspective • Determine the best match for your project

32. How to determine which study section is best for your project • Center for Scientific Review (CSR) web site: • Scientific focus of each study section • List of study sections with similar scientific foci • Roster of members of each study section

33. How to determine which study section is best for your project • Center for Scientific Review (CSR) web site: • Scientific focus of each study section • List of study sections with similar scientific foci • Roster of members of each study section • If more than one seems great, • Communicate with scientific review officers of those study sections for further guidance

34. Relationship between project and IC • Dozens of ICs with different • Missions – purviews of responsibility • Priorities – areas of special interest or emphasis • A project could match mission, but not priority!

35. Relationship between project and IC • Dozens of ICs with different • Missions – purviews of responsibility • Priorities – areas of special interest or emphasis • A project could match mission, but not priority! • Technologies are often cross-cutting, e.g.: • Neuroimaging tool – cancer or stroke • Microfluidic chamber – deliver drug or growth factor • Context of grant application or test bed for proposed feasibility test may determine IC

36. How to determine which IC is the best fit for your project • Web sites of ICs • List research priorities, strategic plans, etc. • Annual Omnibus Solicitation for SBIR and STTR Grant Applications • ICs list specific research topics • Special FOAs • Clear indication of participating ICs’ interests

37. How to determine which IC is the best fit for your project • Web sites of ICs • List research priorities, strategic plans, etc. • Annual Omnibus Solicitation for SBIR and STTR Grant Applications • ICs list specific research topics • Special FOAs • Clear indication of participating ICs’ interests • After narrowing down list of possible ICs, talk to the program officer(s) about your specific idea

38. Cover Letter - Follow up for optimal assignment • Request potential awarding component(s): NIH Institutes/Centers – refer to program officer communication as appropriate • Request SBIR/STTR study section • Indicate key areas of review expertise required • Indicate individual(s)/organization(s) in conflict • For resubmission, indicate review history • Justifyall the requests you make

39. SBIR & STTR Purpose • Stimulate technological innovation • Commercialize innovative technologies • Stimulate small business & economic growth • Foster technology transfer between small business concerns and research institutions

40. Achieving the Purpose • Through SBIR & STTR awards • To small businesses • Supporting research & development of commercializable, innovative technologies • Serving the mission & priority of the awarding unit (Institute or Center)

41. Drilling Down Further Information, Details, and Tips

42. Small Business Concern Research idea – then contact NIH Scientific Review Groups Evaluate Scientific Merit IC Advisory Council or Board Concurs with Review IC Allocates Funds Application & Review Process Remember: First get registered in Grants.gov AND eRA Commons! NIH Center for Scientific Review Assign to IC and Study Section 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

43. 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

44. NIH SBIR/STTR Success Rates FY2010

45. Keys to Success • Understand mission & priorities • IC Web sites, Omnibus Solicitation, FOAs • Propose innovative ideas with significance as well as scientific and technical merit • Give yourself ample time to prepare application • Contact NIH Staff to discuss: • Research idea early on – program staff • Assignment issues – program and review staff • Outcome of your review – program staff

46. 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

47. 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)

48. 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

49. 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

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