2. Kathleen Shino, MBA NIH SBIR/STTR Program An In-Depth Look at the NIH SBIR and STTR Programs Connecticut SBIR/STTR Conference April 2005

3. Issues Discussed  Review of NIH SBIR/STTR Nuances  NIH Evaluation/Review/Selection Process  Updates & Reminders  Identifying Funding Opportunities  Communication & Other Tips  Technical Assistance Program  NIH Resources  Q&A

4. NIH Mission IMPROVE HUMAN HEALTH through biomedical and behavioral research, research training and communications.

5. Small Companies Can Help NIH meet its mission Conduct innovative R/R&D that results in product, process, or service that will... l Improve patient health l Speed process of discovery l Reduce cost of medical care/cost of research l Improve research & communication tools

6. Small Business Innovation Research (SBIR) Program Descriptions and Goals 2.5% Stimulate technological innovation Meet Federal R&D needs Foster and encourage participation by minorities and disadvantaged persons in technological innovation Increase private-sector commercialization of innovations derived from Federal R&D Small Business Innovation Development Act of 1982 Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization.

7. Small Business Technology Transfer (STTR) Program Descriptions and Goals 0.30% Small Business Research and Development Enhancement Act of 1992 Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization. Stimulate and foster scientific and technological innovation through cooperative research Foster technology transfer between small business concerns and research institutions

8. Organized for- profit U.S. business in U.S. At least 51% U.S.- owned by individuals and independently operated or (2) SBIR it must be a for-profit business concern that is at least 51% owned and controlled by another SBC that is 51% U.S.- owned by individuals and independently operated & < 500 Employees P.I.’s primary employment with SBC SBIR PROGRAM ELIGIBILITY CHECKPOINTS ELIGIBILITY CHECKPOINTS

9. Applicant is Small Business Concern Formal Cooperative R&D Effort Ü Minimum 40% by small business Ü Minimum 30% by U.S. research institution U.S. Research Institution Ü College or University; other non-profit research organization; Federal R&D center Intellectual Property Agreement ÜAllocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization STTR PROGRAM ELIGIBILITY CHECKPOINTS

10. CRITICAL DIFFERENCES SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Research Partner Research Partner SBIR: Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Requires research institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)] AWARD ALWAYS MADE TO SMALL BUSINESS

11. Principal Investigator Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated [PI can be from research institution and/or from small business concern*] *DISCUSS WITH AGENCIES CRITICAL DIFFERENCES SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES

12. SBIR / STTR ELIGIBILITY OWNERSHIP AND CONTROL Contact the SBA Size Specialists Request an eligibility determination http://www.sba.gov/size/indexcontacts.html got questions?

13. Important Facts to Remember Eligibility is determined at time of award No appendices allowed in Phase I The PI is not required to have a Ph.D. The 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

14. DODSBIR/STTR NASASBIR/STTR DOESBIR/STTR NSFSBIR/STTR DHSSBIR USDASBIR DOCSBIR EDSBIR EPASBIR DOTSBIR SBIR/STTR Participating Agencies NIH: $ 571 M SBIR $ 69 M STTR $640 M Total CDC: $ 8.0 M SBIR FDA: ~ $ 0.8 M SBIR AHRQ: ~$ 2.1 M SBIR HHS SBIR/STTR TOTAL ~ $2.0 B FY 2005

15. NIH SBIR/STTR FUNDING RATES FISCAL YEAR 2004 (Preliminary) Success Rate (%) 44% 49.2% $631 M SBIR/STTR 20% 973 302 32 59 215 15 37% 18% 37% 49% 39%

16. National Institutes of Health Office of the Director National Center on Minority Health and Health Disparities http://www.nih.gov/icd /

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

18. NUANCES NIH SBIR & STTR Programs l SBIR and STTR Program l Multiple Award Mechanisms l Multiple Receipt Dates l Budget Guidelines ~$100K/ $750K l External Peer Review Critiques sent to all applicants l Revise & Resubmit è Single Solicitation è ~ 95% Awards are grants è April 1, Aug 1, Dec 1 è Realistic & appropriate è Academia and industry è Original + 2 amendments

19. Our Ideas … 1. SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA) Release: JanuaryApril 1, Aug 1, Dec 1 receipt dates 2. SBIR Contract Solicitation (NIH, CDC) Release: AugustEarly November receipt date 3. NIH Guide for Grants and Contracts Release: WeeklyVarious r eceipt dates http://grants.nih.gov/grants/funding/sbir.htm

20. l Research projects related to the NIH mission l “Other” areas of research within the mission of an awarding component Your Ideas … Investigator-initiated R&D

21. SBIR “FAST-TRACK” Standard application, review, award process Fast-Track review option Satisfactory Phase I Final Report Phase I 7-9 months Simultaneous submission/review Phase I + Phase II 7-9 months Phase II 6 months 24 months 6 months Phase II 7-9 months

22. NIH SBIR “FAST-TRACK” Best Option For Everyone? l Convincing preliminary data? l Clear, measurable, achievable milestones? l Well-conceived Commercialization Plan ? l Letters of Phase III support/interest? l Track record for commercializing? No! !

23. NIH SBIR/STTR Program Gap Funding Options  Phase I / Phase II Fast Track Simultaneous submission / concurrent review  No-Cost Extension (Ph I or Ph II) Extension in time with no additional funds  Administrative / Competitive Supplements Discuss with Program Director  Phase II Competing Continuation Maximum of $1M/yr for 3 years Response to IC-specific PA

24. Phase II Competing Continuations Goal: Provide additional research funds to move already identified drugs or devices requiring regulatory approval into clinical trials Stipulations: Available only to Phase II grantees preparing for clinical trials Focus -- Diagnostics, devices, tissue engineering, drug development, biologics Funding level: Maximum $1M per year for maximum of 3 years IC must have announced the opportunity Speak with Program Staff Prior to Submission

25. Peer Review of SBIR/STTR Grant Applications

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

27. APPLICATION, REVIEW, and AWARD TIMELINE SBIR/STTR Scientific/TechnicalAdv Council Awd Receipt Dates Peer ReviewBoard Review Date Apr 1 June/JulySept/Oct Nov Aug 1 Oct/NovJan/Feb Mar Dec 1 Feb/MarchMay/June July 90-Day pre-award costs are allowable: At your own risk….. 7 to 9 months

28. Application Assignments Institutes/Centers Center for Scientific Review Receipt & Referral Office Match between proposed research and IC’s mission Scientific Review Group Match between proposed research and review groups for scientific/technical merit for funding

29. REVIEW CRITERIA (Phase I) l Significance (Real Problem/Real People) l Approach (Research Design, Feasible) l Innovation (New or Improved?) l Investigators (PI and team) l Environment (Facilities/Resources) Protection of Human Subjects … Protection of Human Subjects … Animal Welfare … Budget

30. Phase II Review Criteria l Same as Phase I l Demonstrated Feasibility in Phase I l High Degree of Commercial Potential based on Commercialization Plan Protection of Human Subjects … Protection of Human Subjects … Animal Welfare … Budget

31. Phase II Commercialization Plan 1.Value of the SBIR/STTR Project, Expected Outcomes, and Impact 2.Company Description 3.Market, Customer, and Competition 4.Intellectual Property (IP) Protection 5.Finance Plan 6.Production and Marketing Plan 7.Revenue Stream Included in ALL Phase II applications. Detailed instructions provided.

32. WHAT HAPPENS IN A STUDY SECTION MEETING? Closed Orientation Streamlining Application by application discussion Every member scores every application Assignment of gender, minority, and children codes, human subjects codes; Recommended changes to budget

33. SCIENTIFIC REVIEW GROUP Scientific Review Administrator Recruits and selects reviewers Insures review that is competent, thorough and fair (unbiased) Proper review criteria used to evaluate application Reviewers All ad hoc reviewers Scientists with appropriate expertise High professional profiles Dependable, reasonable, open minded Grants Technical Assistant Mails material to reviewers Handles paperwork Organizes meeting room Enters scores and codes Assists with summary statements

34. Criteria for Selection of Peer Reviewers Demonstrated Scientific Expertise Doctoral Degree or Equivalent Mature Judgment Work Effectively in a Group Context Breadth of Perspective Impartiality Interest in Serving Diversity (Women and Minority Scientists) Business skills/experience You can be a reviewer too!!!

35. Scientific Review Group or Study Section Actions Scored, Scientific Merit Rating (priority scores 100 to 300, typically) Unscored (lower half; priority scores 301- 500) Deferral STUDY SECTIONS DO NOT FUND! INSTITUTES FUND!

36. NIH Allows Amended Applications l Two amended applications allowed l Generally half of the reviewers are new l Request for change of reviewers must be supported An opportunity to revise and improve your application

37. What Reviewers Say… Common Pitfalls with Applications l Inadequately defined test of feasibility l Lack of sufficient experimental detail l Questionable reasoning in experimental approach l Failure to consider potential pitfalls and alternatives l Lack of innovation l Unconvincing case for commercial potential or societal impact l Lack of experience with essential methodologies l Unfamiliar with relevant published work l Unrealistically large amount of work proposed

38. What Reviewers Say About Outstanding Phase II Applications “principals … highly experienced in their respective roles” “ detailed Ph I Final Report was included” Ph I effort was substantial and addressed reservations of the Ph I review solidly” “…product promises to fill a long-felt need in neuroscience and in the larger community” “… resources are outstanding” “limitations of the project have been realistically addressed”

39. What Reviewers Say About Outstanding Phase II Applications “A prototype has been developed… pre-tested in Phase I… good feasibility results “…well-defined goals presented in the work plan… to address required improvements that arose during testing in Phase I” “clearly stated rationale for developing such a program is a major strength” “commercial applications for the … are significant” “innovative with high promise of producing a major advance in…”

40. Update: 2005 SBIR/STTR NIH Omnibus Solicitation Changes Modular budget no longer applicable to SBIR/STTR Fonts – Must use Helvetica or Arial, 11 points or larger Review criteria updated (interdisciplinary, translational, clinical projects) Final reports format changed PHS 398 Forms Required after May 9, 2005

41. Reminders Similar, Essentially Identical or Identical Applications to NIH awarding components (ICs) NOT allowed Submission Dates: Postmark Date acceptable for applications submitted in response to PHS 2005-2

42. Funding Opportunities 1. SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA) Release: JanuaryApril 1, Aug 1, Dec 1 receipt dates 2. SBIR Contract Solicitation (NIH, CDC) Release: AugustEarly November receipt date 3. NIH Guide for Grants and Contracts Release: WeeklyVarious r eceipt dates http://grants.nih.gov/grants/funding/sbir.htm

43. Latest Funding Opportunities (Samples) http://grants.nih.gov/grants/funding/sbir_announcements.htm RFA-06-005: Innovative Technologies for Molecular Analysis of Cancer PA-04-156: Bioengineering Approaches to Energy Balance and Obesity PAR-03-119: Innovations in Biomedical Computational Science and Technology PA-04-161: Manufacturing Processes of Medical, Dental, & Biological Technologies PA--05-014: Molecular Libraries Screening Instrumentation

44. PAR-03-119: Innovations in Biomedical Computational Science and Technology Unique Features: Special receipt dates (Oct ’04, Feb ’05, Oct ’05, Feb ’06) Trans-NIH opportunity Flexible budget and project durations Phase I: 2 yrs, $100K direct costs each year Phase II: 3 yrs, no official budget limit Parallel Announcement (PAR-03-106) Objective: To support research and development of tools and approaches for computing on data

45. RFA-AT-05-005: Improving Measurement Tools for Sternal Skin Conductance & Hot Flashes Unique Features: Special receipt date (Jan 25, 2005) Letter of Intent Receipt Date: (Dec 20, 2004) Only SBIR Phase I apps. accepted Flexible budget and project durations 1 yr, $200K total costs Multiple IC participation (NCCAM, NIA, NIBIB) Objective: To improve measurement tools or devices for sternal skin conductance.

46. Key to the NIH Application, Review, and Award Process Communication Tips/Suggestions

47. Contact NIH Staff Program Staff : Pre- Application Assess the “fit” What’s New: PAs/RFAs Assist in finding collaborators Review Issues: Dos and Don’ts Define product and focus application ApplicationReviewAward Identification Tools: Solicitation Part II & CRISP Database

48. Contact NIH Staff Program Staff : Post Review Discuss outcome of peer review  Review Summary Statement  What the rating means (numeric vs. **)  Strengths and weaknesses  Likelihood of funding  Next steps ApplicationReviewAward If at first you don’t succeed…. Revise and resubmit Identification Tool: Summary Statement

49. Contact NIH Staff Review Staff Scientific Review Administrator…. u Point of contact during review process u Recruitment/Assignment of Reviewers u Concerns about I/C Assignment or Review Review Identification Tool: Grant Receipt Notice

50. Contact NIH Staff Grants Management Staff u Pre-Award Steps u Budget, Eligibility, Submission u Post-Award Advice Guidance u Prior approval requirements u Changes in PI, organization, scope u Final reporting requirements Award Identification Tools: Solicitation Part I & Notice of Grant Award

51. Tips/Suggestions READ Solicitation INSTRUCTIONS--MOST important Submit to multiple agencies to increase chances of winning Submit multiple INDEPENDENT grants to support one product Be cautious of 25-page limitation Include well-designed graphics, tables, figures Be persistent – revise and resubmit Get help Don’t miss the deadline Don’t leave $$$$ on the table

52. Tips/Suggestions Cover Letter: A Valuable Tool l Suggest potential awarding component(s) l Discuss areas of expertise appropriate for the application’s review l Indicate individual(s) or organization(s) in conflict

53. When You Get Your Summary Statement… Read it and then put it down for 24 hours Don’t take it personally Contact Program Director for advice (upper left corner of Summary Statement) Consider revising and resubmitting Tips/Suggestions

54. Entrepreneurial Research Institutions Universities / Industry Partnerships and Cultural Differences

55. UNIVERSITY AND INDUSTRY: Two diverse cultures Industry Researchers are from MARS are from MARS University Researchers University Researchers are from VENUS are from VENUS

56. University Partnerships 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 Applicant is always the small business University facilities provide analytical and other service support

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

58. UNIVERSITY AND INDUSTRY: Two diverse cultures Industry culture u Mission toward research / R&D / commercialization u Quick-paced u Solve problems - develop new products  profit u Maintain control of science to explore full potential of discovery (initially) u Economic impact: Jobs, societal benefit

59. CULTURAL DIVERSITY Critical dimension of the new “Knowledge-based Economy” u Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property u Universities and Industry learning to work together This is now… That was then… is KEY!

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

61. The Ohio State University Purdue University University of Wisconsin N.C. State University Georgia Tech Virginia Tech Examples of Successful Entrepreneurial Research Institutions 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

62. FINDING A PARTNER CRISP Award Database http://crisp.oit.nih.gov NIH Collaboration Opportunities and Research Partnerships http://grants.nih.gov/grants/funding/corp.htm NIH Office of Technology Transfer http://ott.od.nih.gov/

63. Commercialization Valley Phase I Phase II Phase III 3 months? 2 years? 10 years? $$$$$

64. Technical Assistance Programs Commercialization Assistance Business & strategic planning Builds alliances and investor partnerships Pilot Niche Assessment Identify other uses of technology Determines competitive advantages Develops market entry strategy (Phase II awardees) (Phase I awardees)

65. Alerts/News Flashes Solicitations Targeted Research Opportunities Award Information Collaborative Opportunities Success Stories Resources http://grants.nih.gov/grants/funding/sbir.htm

66. Stay Informed… Listserves  NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm  NIH SBIR/STTR Notification http://grants.nih.gov/grants/funding/listserv.htm

67. 7 th Annual NIH SBIR/STTR Conference July 28-29, 2005 Natcher Conference Center NIH Campus Bethesda, Maryland http://grants.nih.gov/grants/funding/SBIRConf2005/index.htm

68. RESOURCES A GOOD STARTING POINT  NIH Small Business Funding Site http://grants.nih.gov/grants/funding/sbir.htm  Computer Retrieval of Information on Scientific Projects (CRISP) http://crisp.cit.nih.gov  Contacts at NIH http://grants.nih.gov/grants/contacts.htm  National SBIR/STTR Resource Center http://www.sbirworld.com

69. http://grants1.nih.gov/grants/grant_tips.htm http://grants1.nih.gov/grants/funding/sbir_policy.htm http://www.niaid.nih.gov/ncn/grants/ http://deainfo.nci.nih.gov/EXTRA/EXTDOCS/gntapp.htm http://www.nlm.nih.gov/ep/Tutorial.html Grant Application Preparation RESOURCES HOW TO WRITE A GRANT APPLICATION

70. National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute 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 Aging National Institute of Child Health and Human Development 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 National Institute of Allergy and Infectious Diseases Fogarty International Center National Center for Research Resources Largest SBIR/STTR set-asides National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities New!

71. National Institutes of Health Office of the Director National Center on Minority Health and Health Disparities http://www.nih.gov/icd /

72. Kathleen Shino Acting NIH SBIR/STTR Program Coordinator Phone: 301-435-2689 Fax: 301-480-0146 Email: shinok@mail.nih.gov Kay Etzler SBIR/STTR Program Phone: 301-435-2713 Fax: 301-480-0146 Email: etzlerk@od.nih.gov