1. Innovation Corps (I-Corps) at NIH: Hypothesis-Driven Customer Discovery for SBIR/STTR Grantees Bench 2 Business (B2B) – University of Kentucky May 19, 2015 Andrew J. Kurtz National Cancer Institute (NCI)

2. 2 sbir.nih.gov

3. Congressionally-Mandated Programs 2.8% 0.4% Set Aside (FY14) (FY15) ~$763M annually at NIH ~$120M annually at NCI  Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in Federal R&D with the potential for commercialization Federal agencies with an extramural R&D budget > $100M  Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with the potential for commercialization Federal agencies with an extramural R&D budget > $1B 2.9% 0.4% 3

4. NIH = 27 Institutes & Centers 23 Participate in the SBIR/STTR Program 4 The Office of the Director (OD) National Institute on Alcohol Abuse & Alcoholism (NIAAA) National Institute of Arthritis & Musculoskeletal & Skin Diseases (NIAMS) National Cancer Institute (NCI) National Institute on Aging (NIA) National Institute of Child Health & Human Development (NICHD) National Institute of Allergy & Infectious Diseases (NIAID) National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) National Institute of Dental and Craniofacial Research (NIDCR) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute on Deafness & Other Communication Disorders (NIDCD) National Eye Institute (NEI) National Human Genome Research Institute (NHGRI) National Heart, Lung, & Blood Institute (NHLBI) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders & Stroke (NINDS) National Institute of General Medical Sciences (NIGMS) National Institute of Nursing Research (NINR) No funding authority National Institute on Minority Health & Health Disparities (NIMHD) National Library of Medicine (NLM) National Center for Complementary & Alternative Medicine (NCCAM) Fogarty International Center (FIC) National Institute of Biomedical Imaging & Bioengineering (NIBIB) National Center for Advancing Translational Sciences (NCATS) Center for Information Technology (CIT) Center for Scientific Review (CSR) NIH Clinical Center (CC)

5. What is the NIH looking for? Innovative solution to significant unmet need Solution that has significant commercial potential Projects that leverage company/founder expertise Start-up company too early for private investment Established small business pursuing a new project 5

6. Phase III COMMERCIALIZATION Phase II DEVELOPMENT Phase I FEASIBILITY Phase II Research & Development Commercialization plan required $1-2 million 2 years Commercialization stage Use of non-SBIR/STTR funds Fast Track Application Combined Phase I & II Fast Track Application Combined Phase I & II SBIR & STTR: Three-Phase Program Phase I Proof-of-Concept study $150-300K 6-12 months Direct to Phase II (Skip Phase I) 6

7. 7 NIH SBIR/STTR Resources DiscoveryManufacturing/ Delivery Product Design Proof of Concept Product Development Idea Operating Capital Seed Funding Pre-seed Funding Expansion/Mezzanine Start-up Funding SBIR Phase ISBIR Phase II NCISBIR Phase IIB Bridge Phase III CROSSING THE VALLEY OF DEATH Third-Party Funds Founder Friends & Family Angels Angel Groups Seed Funds Venture Funds Institutional Equity Loans/Bonds Non-Federal Funds

8. 8 NIH SBIR/STTR Resources DiscoveryManufacturing/ Delivery Product Design Proof of Concept Product Development Idea Operating Capital Seed Funding Pre-seed Funding Expansion/Mezzanine Start-up Funding SBIR Phase ISBIR Phase II NCISBIR Phase IIB Bridge Phase III CROSSING THE VALLEY OF DEATH Third-Party Funds Founder Friends & Family Angels Angel Groups Seed Funds Venture Funds Institutional Equity Loans/Bonds I-Corps @ NIH Non-Federal Funds

9. Pilot Program was developed specifically for NIH SBIR & STTR Phase I grantees 9 I-Corps™ at NIH $25K administrative supplements to current SBIR/STTR Phase I grantees to support I-Corps™ training Three-member project teams Same fundamental curriculum that was pioneered at NSF A few programmatic adjustments to develop a format tailored for life science companies

10. Business Model Canvas 10 “ Product -Market Fit ”

11. Hypotheses Testing and Insight… 11 Customer Development

12. 12 SBIR/STTR Phase II grant applications have two components 1.The Research Strategy 2.The Commercialization Plan Phase II applicants often focus on #1 The strongest Phase II applications focus on both I-Corps™ @NIH Important goal of I-Corps™ at NIH is to inform the Commercialization Plan

13. 13 I-Corps participants gain new insights into: Value proposition (e.g., clinical utility) Customers / customer segments Aspects of the product that are (& are not) valuable Data & data quality that is needed Roles of partners and collaborators I-Corps™ @NIH We are also learning something else very important at the NIH…

14. 14 Science/Technology Research Strategy (Grant Application) Business Model Commercialization Plan (Grant application) I-Corps™ @NIH Testing commercial hypotheses can dramatically affect the technical aims of a future Phase II SBIR

15. I-Corps™ @NIH - Format I-Corps Node Instructor THERAPEUTICS Expert I-Corps Node Instructor DIAGNOSTICS Expert I-Corps Node Instructor MED DEVICE Expert 4 x 3 x 4 x 1 x 3 x 1 x Three Tracks Therapeutics, Diagnostics, Medical Devices Team Teaching I-Corps (NSF) Node Instructor + Life Science Domain Expert Special supplemental lectures tailored to life sciences 15 THERAPEUTICS TRACK DIAGNOSTICS TRACK MEDICAL DEVICES TRACK

16. 16 C-Level Corporate Officer “Chief” Executive Officer (CEO), “Chief” Operating Officer (COO), etc. Relevant knowledge of the technology Deep commitment to investigate the commercial landscape Substantial decision-making authority within the company Industry Expert Experience in translating technologies to the marketplace Can be someone that has an established relationship with the company OR someone selected as a third-party resource PD/PI PD/PI on the SBIR/STTR Phase I award Three-Member Teams

17. From I-Corps™ at NIH Pilot Program Summary 19 teams conducted 2,128 customer discovery interviews 82% found the program “very good” or “excellent” 82% would recommend I-Corps™ at NIH to other companies All made possible with significant planning and financial support from NSF “After going through I-Corps we understand we have to focus on a small subset [of customers] and prioritize segments based on their value propositions.” “We clarified the value propositions, who our target customers would be, revenue streams, customer relationships…” 17

18. Innovation Corps (I-Corps) at NIH: Hypothesis-Driven Customer Discovery for SBIR/STTR Grantees Bench 2 Business (B2B) – University of Kentucky May 19, 2015 Andrew J. Kurtz National Cancer Institute (NCI)