Lenka Fedorkova, Ph.D. Assistant Manager NIH SBIR/STTR Programs

1. Lenka Fedorkova, Ph.D. Assistant Manager NIH SBIR/STTR Programs CEO Roundtable: Technical Assistance Programs National Institutes of Health

2. Mt. “FDA” ??? NIH Technical Assistance Programs Niche Assessment Program Commercialization Assistance Program Phase I Phase II Phase III “Valley of Death”

3. NIH Awardee Needs • Investment = Cash Flow “Valley of Death” • Market Validation = who will buy your product or pay for your service? • Defining Your Customer – Is your technology a “needed” solution to a defined problem? • Penetrating well-established/ crowded markets = Who is your competition versus strategic partner? • Protecting Intellectual Property = your “worth”

4. Technology Niche Analysis ™ Report helps Phase II submissions: Identify other uses of technology Determines competitive advantages Market size and potential Barriers to entry & strategy Feedback from potential end-users Phase I SBIR/STTR awardees With current or soon to be awarded Phase I (Notice of Award) Niche Assessment Program

5. Commercialization Assistance Program (CAP) • Personalized Business Mentoring; Knowledge Transfer; Business Outcomes! • Business & strategic planning • Investor & partnership pitch • Technology Value Proposition • FDA regulatory requirements • IP & Licensing Issues • Market Readiness Phase II SBIR/STTR awardees Active or 5 years since completion of project

6. NIH-CAP PARTICIPANTS: 2004-2013 Biotechnology 116 Companies Other* 142 Companies Diagnostics 97 Companies Pharmaceuticals 89 Companies Healthcare IT 99 Companies Medical Devices 215 Companies *Includes Clinical Research, Instrumentation, Research Tools

7. How CAP Works • Customized Approach • Commercialization Training Track • Accelerated Commercialization Track • Regulatory Training Track • High-level industry and commercial expertise • Live feedback from active industry contacts • Mediated connections to industry partners and investors • High-quality workshops and events • Nationwide network of resources, referrals

8. The Impact • How do we measure SUCCESS? • Met with or closed deals with investors • Met with the FDA or obtained approval • Launched a product • Achieved revenue • Signed licensing agreements • Hired new employees • Established partnerships • Signed CDA

9. NIH-CAP RESULTS: 2004-2012 • Deals: Signed legal documents committing partners to a process, timeframe and outcome, including.: • Acquisitions • Distribution Agreements • Investment • - Licensing Agreements • - Technical Collaborations

10. Strategic Introductions Acquisitions New Jobs Created Millions Raised WHY NIH-CAP MATTERS! 27 $586+ Results directly attributed by the companies to their participation in CAP 1,680+ 4,400+

11. Get Connected • NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm • NIH SBIR/STTR Notification • Email LISTSERV@list.nih.gov with ‘subscribe SBIR-STTR your name’ in the message body: • Follow us on Twitter: @NIHsbir • Submit your SBIR/STTR Success Story at our Website: http://nih.sbir.gov

12. CEO Roundtable

13. InvivoSciences, Inc. • Provides phenotypic compound screening services for first-in-class drug discovery and drug repositioning • Madison, WI Ayla Annac, MBACo-Founder& CEO • http://www.invivosciences.com/

14. SenesTech, Inc. • Revolutionary technology for animal pest control that targets the heart of the problem: Reproduction • Flagstaff, AZ • http://senestech.com/ Loretta Mayer, Ph.D. Founder & CEO

15. Actuated Medical, Inc. • Designs and develops next-generation, FDA-compliant medical devices • Bellefonte, PA Maureen Mulvihill, Ph.D. Co-Founder & CEO • http://www.actuatedmedical.com/

16. Biopsy Sciences, LLC. • A medical device company best known for their lead products, the BioSEAL and the HydroMARK • Clearwater, FL • http://www.hydromark.com/ John Fisher, M.D. Founder & CEO

17. Learn More at sbir.nih.gov/tap