National Institutes of Health SBIR/STTR Program: Features and Nuances

1. National Institutes of HealthSBIR/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. SBIR PROGRAM ELIGIBILITY CHECKPOINTS • 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 employmentwith small business during project • 500 or fewer employees

4. STTR PROGRAM • 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

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

6. SBIR AND STTR PROGRAMSCRITICAL 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 HEALTHSBIR/STTR REVIEW/AWARD PROCESS SBIR/STTR Scientific/Technical Adv Council Awd Receipt Dates Peer Review Board Review Date Apr 1, 2000 June/July Sept/Oct Nov Aug 1, 2000 Oct/Nov Jan/Feb Mar Dec 1, 2000 Feb/March May/June July 90-Day pre-award costs are allowable: At your own risk…..

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

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

12. Applications Submitted to NIHCenter 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 • Suggest potential awarding component(s) • Discuss areas of expertise appropriate for the application’s review • Indicate individual(s) or organization(s) that would be in conflict

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

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

16. NIH SBIR Review Criteria (cont.) • Phase II: Standard review criteria and degree to which Phase I feasibility was demonstrated • 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 • Reviewers • Rate applications: 100-500 priority score • Discuss at review applications identified between 100 and 300 • “Triage”/ UNscore applications between • 300-500…. generally • Applicants: ALL • Automatically receive essentially verbatim • written critiques (Summary Statements)

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

19. Common Problems with Applications • Inadequately defined test of feasibility • Diffuse, superficial, or unfocused research plan • Lack of sufficient experimental detail • Questionable reasoning in experimental approach • Uncritical approach • Failure to consider potential pitfalls and alternatives • Lack of innovation • Unconvincing case for commercial potential or societal impact • Lack of experience with essential methodologies • Unfamiliar with relevant published work • 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 • Get to know your agency Program Manager • Understand agency’s mission & needs • Read solicitation and follow instructions • Do not depend solely on SBIR funding • Don’t go it alone • Have an outcome • 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 NIDCR-- understand, treat and prevent infectious and inherited craniofacial-oral-dental diseases and disorders 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

26. NIH Program Activities and Areas of Research (cont.) NIGMS-- basic biomedical research not targeted to diseases or disorders; recombinant DNA technology 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

27. NIH Program Activities and Areas of Research (cont.) NIAMS-- arthritis/rheumatic diseases, connective tissue diseases, musculoskeletal and skin disorders 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 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. SBIR/STTR