1. National Institutes of Health SBIR/STTR Program: Features and Nuances Jo Anne Goodnight SBIR/STTR Program Coordinator National Institutes of Health 6701 Rockledge Drive Room 6186 - MSC 7910 Bethesda, MD 20892 Phone: 301-435-2688 Email: jg128w@nih.gov

2. SBIR/STTR: 3-Phase Program PHASE I Feasibility study (no preliminary data needed) $100K and 6 months (SBIR) or 12 months(STTR) PHASE II Full R/R&D 2-Year Award and $750K (SBIR) or $500K (STTR) PHASE III Commercialization Stage Without SBIR Support

3. Organized for- profit U.S. business At least 51% U.S.-owned and independently operated Small Business located in the U.S. P.I.’s primary employment with small business during project 500 or fewer employees SBIR PROGRAM ELIGIBILITY CHECKPOINTS

4. FORMAL COOPERATIVE R&D EFFORT Minimum 40% by small business Minimum 30% by research institution U.S. RESEARCH INSTITUTION (RI) College or University; other non-profit research organization; federal R&D center PRINCIPAL INVESTIGATOR FROM SMALL BUSINESS and/or RESEARCH INST. AWARD MADE TO SMALL BUSINESS STTR PROGRAM

5. CRITICAL DIFFERENCES SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Research Partner SBIR: Allows for, but does not require, research institution partners STTR: Requires partners from research institutions (e.g., universities) = 40% work by small business and 30% work by research institution

6. CRITICAL DIFFERENCES SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Principal Investigator SBIR: PI’s primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated = PI can be from research institution or from small business concern

7. Faculty Partnership Opportunities Own small firms (assign someone else PI) Principal Investigator (w/ official permission from University) Senior Personnel on SBIR Consultants on SBIR Subcontract on SBIR University facilities can provide analytical and other service support

8. The NIH SBIR/STTR Application Process: A closer look …..

9. NATIONAL INSTITUTES OF HEALTH SBIR/STTR REVIEW/AWARD PROCESS SBIR/STTR Scientific/TechnicalAdv Council Awd Receipt Dates Peer ReviewBoard Review Date Apr 1, 2000 June/JulySept/Oct Nov Aug 1, 2000 Oct/NovJan/Feb Mar Dec 1, 2000 Feb/MarchMay/June July 90-Day pre-award costs are allowable: At your own risk…..

10. NATIONAL INSTITUTES OF HEALTH SBIR/STTR PROGRAM Communication l NIH Program Director AG Advice and Guidance W What’s Hot: New initiatives A Answer your questions R Review Issues: Dos and Don’ts Discuss Discuss funding alternatives

11. APPLICATION PROCEDURES NIH SBIR/STTR APPLICATION PROCEDURES Up to $100,000 Total Costs – Omit Detailed Budget Form Pg. 3 – Include Narrative Justification: l Personnel l Fixed Fee l Consultant Costs l Contractual Costs Budget Justification Narrative ONLY Form Page 4

12. Applications Submitted to NIH Center for Scientific Review Approximately 40,000 grant applications are submitted to NIH each year, of which 25-30% are funded Competing grant applications are received for three review cycles per year

13. 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) that would be in conflict

14. NIH SBIR Review Criteria Scientific and Technical Merit based on…. l Significance Ù Commercial Potential? Ù Anticipated commercial and societal benefits? Ù Advancement of scientific knowledge? l Approach l Innovation l Investigators l Environment

15. NIH SBIR Review Criteria Other factors considered…. l Safeguards for animal and human subjects l Appropriateness of the budget Justify costs that deviate from the guidelines!

16. NIH SBIR Review Criteria (cont.) l Phase II: Standard review criteria and degree to which Phase I feasibility was demonstrated l Fast Track (Phase I/Phase II)  Specification of measurable goals to be achieved prior to initiating Phase II  Concise Product Development Plan  Extent to which applicant was able to obtain letters of interest, additional funding commitments and/or other non-SBIR/STTR resources

17. Streamlined Procedures of NIH Grant Application Review l Reviewers –Rate applications: 100-500 priority score –Discuss at review applications identified between 100 and 300 – “Triage”/ UNscore applications between 300-500…. generally l Applicants: ALL – Automatically receive essentially verbatim written critiques (Summary Statements)

18. 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 l An opportunity to revise and improve your application

19. Common Problems with Applications l Inadequately defined test of feasibility l Diffuse, superficial, or unfocused research plan –Lack of sufficient experimental detail l Questionable reasoning in experimental approach –Uncritical approach –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

20. What Reviewers Say About Outstanding Phase II Applications “principals … highly experienced in their respective roles” “ detailed Ph I Data Summary 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”

21. 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…”

22. What Reviewers Say About Outstanding Ph II Applications “strengths include satisfactory feasibility demonstration of prototype during Ph I, innovation and technical merit of the concept…expertise of staff” “Ph I aims were met as was proof of feasibility… ” “Ph I data are presented to support their claims that a successful Ph II effort will be accomplished” “..one of the best this reviewer has seen.. Data presented from Ph I are convincing, proposed research is very sound. And PI and staff are well- versed..”

23. WHERE’S THE MONEY? WHY THE AWARD MAY BE DELAYED OPRR Issues  IRB (Human Subjects) http://ohrp.osophs.dhhs.gov/index.htm  IACUC (Animal Involvement) http://grants.nih.gov/grants/olaw/olaw.htm EIN (Entity Identification Number) Third Party Involvement  Contracts, Consortia, Consultants

24. SBIR/STTR TIPS CHECKLIST agency Program Manager Get to know your agency Program Manager agency’s mission & needs Understand agency’s mission & needs follow instructions Read solicitation and follow instructions solely Do not depend solely on SBIR funding alone Don’t go it alone outcome Have an outcome PERSISTENT Be PERSISTENT

25. NIH Program Activities and 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

26. NIH Program Activities and Areas of Research (cont.) 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

27. NIH Program Activities and Areas of Research (cont.) 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

28. NIH Program Activities and Areas of Research (cont.) NIHGRI-- 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

29. Innovative ideas that change the way we work, think and live.