National Institutes of Health Office of Extramural Research • Matthew Portnoy, Ph.D. • SBIR/STTR Program Manager • Office of Extramural Research, NIH Commercialization Best Practices: Agencies and Support Services They Provide – NIH/HHS National Institutes of Health
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National Institutes of Health Office of Extramural Research Matthew Portnoy, Ph.D. SBIR/STTR Program Manager Office of Extramural Research, NIH Commercialization.
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National Institutes of HealthOffice of Extramural Research
• Matthew Portnoy, Ph.D.• SBIR/STTR Program Manager• Office of Extramural
Research, NIH
Commercialization Best Practices: Agencies and Support Services They
Provide – NIH/HHS
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National Institutes of HealthOffice of Extramural Research
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Suite of Resources for companies
• Technical Assistance Programs– Niche Assessment Program– Commercialization Assistance Program
• Phase IIB Program• Phase 0 Proof of Concept Centers
– REACH Hubs• iCorps @ NIH Pilot
National Institutes of HealthOffice of Extramural Research
NIH Technical Assistance Program
Helping Companies cross the “Valley of Death”sbir.nih.gov/tap
Phase I Phase II Phase III
Commercialization AssistanceProgram
Niche Assessment
Program
Valley of
Death
Phase IIB
Market-Ready
Technology
Early-Stage
Technology
?
National Institutes of HealthOffice of Extramural Research
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”
National Institutes of HealthOffice of Extramural Research
Niche Assessment Program
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)
Foresight S&T
National Institutes of HealthOffice of Extramural Research
Commercialization Assistance Program (CAP)
Personalized Business Mentoring; Knowledge Transfer; Business Outcomes!
National Institutes of HealthOffice of Extramural Research
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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
National Institutes of HealthOffice of Extramural Research
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
National Institutes of HealthOffice of Extramural Research
WHY NIH-CAP MATTERS!
Results directly attributed by the
companies to their participation in CAP
Strategic Introductions4,400+
New Jobs Created
Millions Raised
Acquisitions
$586+
1,680+
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National Institutes of HealthOffice of Extramural Research
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Phase IIB Competing Renewal Award
Parameters• SBIR/STTR Phase II awardee
• Promising pharmacologic compound identified in original Phase II
• Device prototype developed in original Phase II
• Instrumentation/Interventional technologies not subject to FDA regulatory approval but require extraordinary time/effort to develop
National Institutes of HealthOffice of Extramural Research
Phase 0 POC: NCAI and REACH
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2
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Infrastructure for identifying the most promising technologies
Funding for product definition studies (e.g. feasibility studies, prototype development or proof-of-concept studies)
Access to expertise in areas required for early stage technology development (scientific, regulatory, reimbursement, business, legal and project management)
Skills development and hands-on experience in entrepreneurism
Purpose: To support proof-of-concept centers (Hubs) that facilitate and accelerate the translation of biomedical innovations into commercial products that improve patient care and enhance health
Long-term goals: To foster commercialization success, economic development and culture change at the Hub institutions
Program Components:
Section 5127 of the SBIR/STTR Reauthorization Act of 2011
National Institutes of HealthOffice of Extramural Research
Commercially Relevant Technology Sourcing Followed by Milestone-Driven Development
Sol
icita
tion
NCAI and REACH
Scientific Resources
Commercial Resources
EXIT
NewCo Generation
License
ESC
TRC
Preliminary Screen
Secondary Screen
TechnologyOpportunities
Federal Resources
External Advisory Board (EAB)
Relevant Partners
NIH Centers for Accelerated Innovations: Boston Biomedical Innovation Center, Cleveland Clinic Innovation Center, UC BRAID Center for Accelerated Innovation
Research Evaluation and Commercialization Hubs: University of Minnesota, Long Island Biomedical Hub, University of Louisville
National Institutes of Health: NSF, FDA, USPTO, CMS, Kaiser
National Institutes of HealthOffice of Extramural Research
Pilot Program was developed specifically for NIH SBIR & STTR Phase I grantees
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I-Corps™ at NIH
• Administrative supplements to current SBIR/STTR Phase I grants to support I-Corps™ training
• Provide three-member project teams with access to instruction and mentoring
• Adjustments to the I-Corps curriculum to address challenges unique to life science companies
National Institutes of HealthOffice of Extramural Research
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• 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