SBIR: A More Viable NIH Grant Option?

1. SBIR: A More Viable NIH Grant Option? Mark S. Slaughter, MD Professor and Chief Division of Thoracic and Cardiovascular Surgery University of Louisville

2. Disclosures Thoratec Corp – education/training grant HeartWare Inc - education/training grant *no personal remuneration

3. Mission of the SBIR/STTR Program To support scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy… one small business at a time.

4. Goals of the SBIR/STTR Program Meet Federal research and development needs Increase private-sector commercialization of innovations derived from Federal research and development funding Stimulate technological innovation Foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons

5. SBIR/STTR Program History • The SBIR program started as a pilot program at the NSF in the late-1970’s • Three legislative acts have been passed that govern its existence and execution • The Small Business Innovation Development Act of 1982 • The Small Business Research and Development Enhancement Act of 1992 • The Small Business Innovation Research Program Reauthorization Act of 2000 • The program was reauthorized for 6 more years on December 31st, 2011

6. SBIR/STTR Program Descriptions • Small Business Innovation Research (SBIR) • A set-aside program for small business to engage in Federal R&D – with potential for commercialization • 2.6% of the extramural research budget for all agencies with a budget greater than $100M per year • Small Business Technology Transfer (STTR) • A set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization. • 0.35% of the extramural research budget for all agencies with a budget greater than $1B per year

7. Why develop medical devices through SBIR program? • Develop industry partnerships • Experience • Validation and Verification (V&V) resources • Manufacturing • Commercialization • Clinical-Translation Research • Fill clinical need(s) • Develop innovative clinical paradigms • First-in-Man (FIM) experience • Industry Experience • Learning opportunity

8. SBIR Program Basic Structure The program runs as a series of sequential phases. • Phase I • Feasibility Study or Prototype • $150k Max and 6 Months • Phase II • Full Research and Development Effort • $1M Max and 24 Months • Phase III • Commercialization Stage • Seek External Funding [No Use of SBIR funds]

9. Current SBIR Program Eligibility Criteria (See new additional proposed rules governing eligibility) • Organized for-profit business based in the U.S. • 500 employees or less, including affiliates • PI’s primary employment must be with the small business • At least 51% U.S.- owned by individuals and independently operated OR • At least 51% owned and controlled by another (one) for-profit business concern that is at least 51% owned and controlled by one or more individuals

10. About 6-9 Months Standard SBIR Phase I Process Solicitation Topics Proposal Submission Evaluation Ph I award

11. Standard SBIR/STTR Phase I Process These are rough numbers for the SBIR/STTR budgets for FY2009. In total, the program gives roughly $2.5B to small business to perform research and development.

12. Answers to Frequently Asked Questions Eligibility is determined at time of award – not application No appendices are allowed in Phase I The PI is not required to have a Ph.D. or M.D. – but is required to have expertise to oversee project scientifically and technically Applications may be submitted to different agencies for similar work – but awards may not be accepted for duplicative projects

13. Key Components of SBIR Grants • Helpful Hints • Every section well-written and presented • Pictures, Tables, Graphs • Preliminary Data to demonstrate strong potential for successful outcome(s) • Well-balanced, multi-disciplinary, and experienced team(s) • Specific Aims (1 page) • Research Strategy (12 pages) • Commercialization Plan (12 pages) • Budget and Justification • Biosketches • Resources and Equipment

14. Specific Aims • Helpful Hints • Must tell a ‘good story’ • Strong clinical need • Identify limitation(s) of current technology • How proposed technology overcomes current limitation(s) • Brief description (lay) of technology .. Include photo(s) • Clearly state aim(s) and long-term objective(s) • Clearly state ready for ‘next step’ once funded (i.e. ready for fabrication and testing) • If team successful, what is next step(s)

15. Research Strategy

16. Commercialization Plan - Value, Expected Outcomes, Impact - Company - Market, Customer, and Competition - Intellectual Property - Finance Plan - Production and Marketing Plan - Revenue Stream

17. Biosketches • Helpful Hints • Demonstrate experience and skill set with educational training • Personal Statement – demonstrate commitment, resources, expertise, and role on project • Publications (15 max) – must be related to proposed SBIR topic to demonstrate expertise and experience • Research Support – demonstrate track record of success; and no overlay with other on-going or completed funded projects

18. Know your Study Section

19. How to ‘Tell a Story’ … • Think of your audience (reviewers) • Easy to read (succinct – ‘less is more’; pictures/diagrams • Fills an important ‘unmet’ clinical need • Specific Aims – most of our time • Overall Study Design (1 page summary) – snapshot of project • Appeal to physicians, engineers, scientists, and industry • Demonstrate early feasibility (never enough preliminary data) • Establish experienced ‘team’ with expertise to accomplish aims • Proven ‘track record’ of clinical translation • Strong industry partnership

20. Grant Submission Strategy • Time is ‘ticking’ … • Start early … aims 1st, then outline and assemble team • Select an ‘arbitrary deadline’ to meet, but … • Ask for help? • NIH SBIR – April 5, August 5, and December 5 • High Quality Proposals • Establish ‘track record’ for ‘well written’ proposals • Don’t ‘waste’ study section time with ‘incomplete’ or ‘poor’ quality proposals • Request ‘outside’ unbiased review prior to submission • Delay submission, if not ‘best work’ • No ‘errors’, ‘typos’, ‘missing data’, ‘missing sections’, or ‘missing documents’

21. ExamplesNIH-SBIR Funding Symphony (SCR, Abiomed) • 1R43HL083586-01 ($295,000) • KSTC-184-512-07-011 ($100,000) • 2R44HL083586-02A1  ($1.6M) • KSTC-184-512-08-054 ($500,000) • 1R43HL088760-01  ($225,000) • KSTC-184-512-07-021 ($100,000) • 2R44HL088760-02 ($2.1M) • KSTC-184-512-08-054 ($500,000) • R43HL102981 ($235,000) • 2R44HL102981-02A1 ($1.2M) • KSTC-17-OICS-189 ($500,000) • Apical Connector (APK Medical) • 1R44HL117426-01 ($2.8 million) • tMVAD (HeartWare) • R43 HL103014-01A1 ($400,000) • R44 HL103014-01 ($3.6M) • Atrial Appendage (Coulter Foundation) • $100,000 initial investment

22. Cassandra The “art” of grant writing Divination, prophecy or insight Persuasion

23. Conclusions SBIR grants support translational research accelerate “bench to bedside” Extramural funding that counts towards promotion and tenure Helps support lab/personnel while submitting other grants (AHA, RO1, etc) Grant proposal and submission very similar to other NIH grants

24. Thank You! “I have gathered what I observed to be useful, and brought it together as a single body” Vitruvius Ten Books on Architecture (c. 25 B.C.)