I-Corps at NIH 11/14/2017. Lili Portilla, MPA. Director, Office of Strategic Alliance November 8, Participating ICs in 2018

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I-Corps at NIH Lili Portilla, MPA Director, Office of Strategic Alliance November 8, 2017 16 Participating ICs in 2018 National Cancer Institute (NCI) National Human Genome Research Institute (NHGRI)

1 I-Corps at NIH Lili Portilla, MPA Director, Office of Strategic Alliance November 8, Participating ICs in 2018 National Cancer Institute (NCI) National Human Genome Research Institute (NHGRI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) National Center for Advancing Translational Sciences (NCATS) National Center for Emerging Zoonotic and Infectious Diseases (NCEZID/CDC) National Institute for Occupational Safety and Health (NIOSH/CDC) 1

5 cohorts to date 100 teams conducted 10,000+ customer discovery interviews 90% found the program very good or excellent 90% would recommend I-Corps at NIH to other companies We clarified the value

2 5 cohorts to date 100 teams conducted 10,000+ customer discovery interviews 90% found the program very good or excellent 90% would recommend I-Corps at NIH to other companies We clarified the value propositions, who our target customers would be, revenue streams, customer relationships 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. I-CORPS AT NIH Intensive Entrepreneurial Immersion course aimed at providing teams with skills and strategies to reduce commercialization risk Curriculum emphasizes Reaching out to Customers to test hypotheses about the market(s) for the technology Teams are expected to conduct over 100 interviews in 8 weeks Format is focused on Experiential Learning NCI SBIR designed, launched, and manages the program for NIH 16 Institutes at NIH and CDC participate #ICorpsNIH 2

3 Focus on Learning Customer development is NOT sales! Teams are not pitching their product or technology Teams are listening to potential customers and other stakeholders and learning about: What customers want and need Pain points in their customers daily routines Features of a technology that would provide value I-Corps at NIH Program for SBIR Phase I grantees to help: Define the value proposition (e.g., clinical utility) early before spending millions saves time AND money Assess IP and regulatory risk before design and build Better understand core customers and the specific steps required for downstream commercialization Teams are required to conduct 100 interviews Gather information essential to customer partnerships/ collaborations/ purchases before doing the science Identify financing vehicles before they are needed (helping to avoid the Valley of Death ) 3

I-Corps at NIH Benefits to Translational Researchers

around their technology Goal is to actively

greatest impact and largest benefit in the life

4 I-Corps at NIH Benefits to Translational Researchers Teaches the researcher how to build a business model around their technology Goal is to actively investigate where the technology can provide greatest impact and largest benefit in the life sciences ecosystem Customer Development Hypotheses Testing and Insight 4

5 Experimental Format Online Curriculum During the program, online content is used to track the progress of the teams Each team s progress is shared with the entire cohort of teams to facilitate group learning Teaching Philosophy A key part of this class is seeing how various teams solve similar problems through listening to the instructors coach and critique The program provides a forum for participants to bounce ideas off their peers The success of the team is less about the original idea and more about the learning, discovery, and execution I-Corps at NIH Program Format THERAPEUTICS TRACK DIAGNOSTIC TOOLS TRACK MEDICAL DEVICES TRACK THERAPEUTICS Expert DIAGNOSTICS & ehealth Expert MED DEVICE Expert I-Corps Node Instructor I-Corps Node Instructor I-Corps Node Instructor COURSE FORMAT 3-Day Kick-off Event 6 Weekly web classes 2-Day Lessons Learned LIFE SCIENCE TRACKS Therapeutics Diagnostics/eHealth Medical Devices Teams are distributed among track rooms TEACHING TEAM I-Corps Node Instructors Industry Domain Experts Curriculum tailored to life sciences 5

6 Next Application Deadline: December 18, 2017 Application Due Date December 18, 2017 Phone Interview January 29, 2018 (estimated) Notice of Award February 19, 2018 (estimated) Kick-off/Close-out Venue TBD Course Kick-off April 9-12, 2018 (Monday- Thursday) Web-Ex Courses Wednesdays, 1-5PM ET Apr 18 Apr 25 May 2 May 9 May 16 May 23 Course Close-out/ May 31 Jun 1, 2018 Lessons Learned Cohort Size 24 teams PA I-Corps at NIH Administrative Supplement $50,000 budget cap CrossLife Technologies An Example Hypothesis The company first heard from medical missionaries in Cambodia about a need for an early dengue diagnostic at point of care so that patients can be monitored for dengue hemorrhagic fever or dengue shock syndrome. No need for FDA approval After 112 interviews village doctors hospital doctors in Southeast Asia & South America vaccine developers DOD CDC WHO KOLs Learnings & Pivot 1) they should pursue clinical validation leading to WHO or FDA approval, which will enable clinical adoption of their test; 2) their customers are clinicians in Southeast Asia, South America, Ministry of Health, DOD, and WHO; and 3) vaccine developers are not the customers. 6

Nortis an Example Developed a solution to a long-term problem in the stem cell research field: the need for a fast, accurate test that could gauge the quality of stem cells.

7 Nortis an Example Developed a solution to a long-term problem in the stem cell research field: the need for a fast, accurate test that could gauge the quality of stem cells. Interviewed more than 100 potential customers, Nortis researchers were disappointed to learn that few people were interested in a new test. Pivot Nortis researchers discovered that there was a need for a tissue chip with a stem cellbased model to study kidney function. Nortis polled potential customers again: 99 percent of those interviewed said they would use such a tissue chip. Business Model Canvas Knowledge Spring 2016 Cohort 7

8 Life Science Commercialization Knowledge Spring 2016 Cohort Status of Technology and Future Plans Spring 2016 Cohort 8

9 Pilot Cohort Pilot Cohort (0) ended Dec teams 2 spinoff companies 1 M&A $60M + raised in strategic partnerships/investments 17 of 19 were granted additional Phase I/II awards based on pivots, etc. 14 of 19 attempted Phase II continuing award 3 of 14 converted to Phase II Success rates (awards/all application type*company) are anecdotal at this time, given sample size (21 companies). We will be collecting more data. I Corps teams success rate: 30.5% Non I Corps team success rate: 23.6% Cohort 1 Cohort 1 ended Apr/May NIH teams 9 of 14 were granted new Phase I/II awards based on pivots, etc. Many applications are still in IRG and Council review 9 of 14 attempted Phase II continuing award 4 of 9 converted to Phase II Some companies still have 01 or A1 opportunities 9

10 Additional Metrics for Longitudinal Studies For longitudinal assessment of I-Corps participants, we anticipate collecting data including (non exhaustive): Licensing & IP activity Capital raised (government or non-government) Sales/Generated revenue New partnerships and ventures Job creation Questions? 10

Learn more about NCATS Website: www.ncats.nih.

11 Learn more about NCATS Website: Facebook: facebook.com/ncats.nih.gov Twitter: twitter.com/ncats_nih_gov YouTube: youtube.com/user/ncatsmedia E-Newsletter: ncats.nih.gov/news-andevents/e-news/e-news.html us: 11

NIH Mission Improve human health through biomedical and behavioral research, research training and communications.

Overview of the NIH SBIR/STTR Program NCET2 March 21, 2013 Matthew Portnoy, Ph.D. SBIR/STTR Program Coordinator, NIH 1 NIH Mission Improve human health through biomedical and behavioral research, research