1. 11 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 Seminar June 2011

2. 22 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. 33 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. 44 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. 55 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. 66 How much is awarded through SBIR & STTR programs?

7. 77 $2.4 Billion in FY 2010

8. 88 How much is awarded through SBIR & STTR programs? $2.4 Billion in FY 2010

9. 99 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. 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. 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 Multiple Receipt Dates (Grants)  April 5, August 5, December 5  May 7, September 7, January 7 (AIDS)  Contracts: Early November Budget and Project Period – Guidelines  $100-150K/6 -12months (Ph I)  $750K-1M/2 yrs (Ph II)  Deviations permitted where scientifically appropriate (eg, FOAs) 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 Gap Funding Programs  Phase IIB Competing Renewals  Ph I/Ph II Fast Track  Administrative Supplements Technical Assistance Programs  Technology Niche Assessment  Commercialization Assistance  Pipeline to Partnerships (P2P)

12. 12 Research Partner  SBIR: Permits partnering 33% Phase I and 50% Phase II  STTR: Requires partnering with Research Institution Small business (40%) and U.S. research institution (30%) Award is always made to Small Business Concern 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

13. 13 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 PHASE I Feasibility Study  Budget Guide: $150K (SBIR) or $100K (STTR) Total Costs  Project Period: 6 months (SBIR) or 1 year (STTR) NIH SBIR/STTR: 3-Phase Program Per Congressional Guidelines – FOAs Vary

14. 14 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 Phase IIB Competing Renewal Award

15. 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. 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. 17 Phase IPhase IIPhase III Mind the Gap Mt. “FDA” No-Cost Extension Phase I / Phase II Fast Track Administrative / Competitive Supplements Phase IIB Competing Renewal Award

18. 18 Bridging the Phase I - II Funding Gap (Simultaneous Submission and Concurrent Review) SBIR/STTR Phase I + Phase II Phase I Award 7-9 months Completion of Phase I Phase I Final ReportProgram Staff assess completion of specific aims and milestones Phase II award Aims/Milestones Met Phase II award Aims/Milestones NOT Met Go? No Go? NIH Phase I/Phase II Fast-Track

19. 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. 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. 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 controlled by 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. 22 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 More SBIR/STTR Eligibility Checkpoints

23. 23 Additional Eligibility Issues Eligibility is determined at time of award No appendices allowed in Phase I The PD/PI is not required to have a Ph.D. The 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

24. 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. 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. 26 Office of the Director National Institute On Minority Health and Health Disparities NIH Institutes and Centers (ICs) http://www.nih.gov/icd National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of Nursing Research National Library of Medicine National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Institute of Biomedical Imaging and Bioengineering No funding authority

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

28. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 38 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 Justify all the requests you make Cover Letter - Follow up for optimal assignment

39. 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. 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. 41 Drilling Down Further Information, Details, and Tips

42. 42 Timeline Due Date April 5 August 5 December 5 Scientific Review July November March Council Review October January May Award Date (earliest) December April July 2 2 4 4 5 5

43. 43 Small Business Concern Research idea – then contact NIH Grantee Conducts Research IC Staff Prepare funding Plan for IC Director NIH Center for Scientific Review Assign to IC and Study Section Scientific Review Groups Evaluate Scientific Merit IC Advisory Council or Board Concurs with Review IC Allocates Funds Submits SBIR/STTR Grant Application to NIH Electronically ~2-3 months after submission ~2-3 months after review Application & Review Process NIH SBIR/STTR Program Specifics Remember: First get registered in Grants.gov AND eRA Commons!

44. 44 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

45. 45 NIH SBIR/STTR Success Rates FY2010

46. 46 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 Keys to Success

47. 47 Phase IPhase IIPhase III NIH Technical Assistance Program Mt. “FDA” ??? Commercialization Assistance Program Niche Assessment Program Helping Companies cross the “Valley of Death”

48. 48 Technical Assistance Programs Understanding the “B” in SBIR 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) Niche Assessment Identifies other uses of technology Determines competitive advantages Develops market entry strategy (Phase I awardees)

49. 49 NIH Pipeline to Partnerships Finding a Partner 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

50. 50 NIH Pipeline to Partnerships (P2P) http://www.ott.nih.gov/p2p/index.aspx SBIR/STTR awardees and NIH licensees can showcase technologies in a virtual space for potential partners.

51. 51 POTENTIAL PARTNERS / INVESTORS Identifies technology of interest and contacts company NIH Pipeline to Partnerships (P2P)

52. 52 Summary of NIH SBIR & STTR Investments in innovation & economic growth Advance the NIH mission & human health Support and validate small business R & D Extraordinary latitude in awards Extraordinary assistance from idea to market Scientific aspects Administrative aspects Business aspects

53. 53

54. 54 NIH ICs and General Areas of Research NCI -- cancer cause, prevention, detection, diagnosis, treatment and control NHLBI -- diseases of heart, blood vessels, lungs, blood, and transfusion medicine NINDS -- diagnosis, treatment, and prevention of disorders of the nervous system, neuromuscular apparatus, and special senses of touch/pain NIDDK -- diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; kidney, urologic and hematologic diseases NIAID -- understand, treat and prevent infectious, immunologic, and allergic diseases NIDCR -- understand, treat and prevent infectious and inherited craniofacial-oral-dental diseases and disorders

55. 55 NICHD -- fertility, pregnancy, growth, development, and medical rehabilitation NEI -- blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, requirements of the blind NIEHS -- identification, assessment, and mechanism of action of environmental agents that are potentially harmful to human health NIA -- biomedical, social, and behavioral aspects of aging process; prevention of age-related diseases and disabilities; promotion of better QOL for older Americans NIGMS -- basic biomedical research not targeted to diseases or disorders; recombinant DNA technology NIH ICs and General Areas of Research

56. 56 NIDCD -- normal mechanisms diseases, and disorders of hearing, balance, smell, taste, voice, speech and language NIMH -- understanding, treating, preventing behavioral and mental disorders (including HIV prevention, neuro-AIDS research) NIDA -- treatment of drug addiction; behavioral strategies for treatment medication; training in drug abuse treatment techniques; drug abuse treatment NIAAA -- treatment and prevention of alcoholism and alcohol-related problems NIAMS -- arthritis/rheumatic diseases, connective tissue diseases, musculoskeletal and skin disorders NINR-- understand effects of acute and chronic illness, improving QOL, approaches to promote health and prevent disease, improving clinical environments NIH ICs and General Areas of Research

57. 57 NHGRI -- efforts toward achieving the goals of the Human Genome Project (Science vol. 262, pp.43-46; Oct. 1, 1993) NCRR -- R&D in instrumentation and specialized technologies for biomedical research; R&D in comparative medicine; discovery- oriented software for science education NCCAM -- complementary and alternative treatment, diagnostic, and prevention modalities, disciplines and systems: education and public information; patient management; botanical products; research- related issues (e.g., models, methods) NLM -- innovative methods, systems, and services for managing health knowledge and information NIH ICs and General Areas of Research

58. 58 Eligibility Criteria Ownership: US-owned, independently operated Affiliations: Research Institutions, Foundations, Foreign “Parents” Size: 500 employees maximum Business Structure: Inc, LLP, LLC,... Principal Investigator: Employment

59. 59 Ownership And Affiliations Eligibility of wholly-owned subsidiary Owners of the SBIR organization must be "individuals" who are "citizens of, or permanent resident aliens in, the United States." The regulations nowhere provide that corporations or artificial entities may qualify as "individuals" who are U.S. citizens.

60. 60 Ownership And Affiliations Parent of wholly-owned subsidiary is FOREIGN Sum TOTAL of ALL employees more than 500 (parent + subsidiary) Sharing of officers on Board of Directors

61. 61 PD/PI Eligibility on SBIR PI must have primary employment with SBC (unless waiver is granted) More than 50% of PI’s time spent in employ of SBC Primary employment with SBC precludes full-time employment at another organization Eligibility is determined at the time of award

62. 62 STTR Eligibility Criteria Applicant Organization Research Institution Partner Project Director/Principal Investigator

63. 63 STTR Applicant Organization Small Business Concern is ALWAYS the applicant/awardee organization

64. 64 STTR Research Institution Partner Must establish formal collaborative relationship with SBC Must perform minimum of 30% of the research/R&D (maximum 60%) Non-profit organization owned and operated exclusively for scientific or educational purposes 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

65. 65 PD/PI Eligibility on STTR PD/PI: Not required to be employed by SBC PD/PI: Must commit 10% effort (minimum) PD/PI at RI: Must establish contract between RI and SBC describing PD/PI’s involvement PD/PI’s “signature” on Face Page represents agreement to conforming to Solicitation requirements

66. 66 PD/PI Role on STTR BUDGET PAGE PI must be on SBC or RI budget, but NOT BOTH PI and co-PI must be paid at either SBC or RI, but NOT BOTH PI oversees all research activities on behalf of SBC

67. 67 PI Role on STTR NIH requires documentation from original employer/RI confirming change in employment status (e.g., sabbatical) for duration of SBIR/STTR project PI cannot serve as consultant on same project