Grantsmanship at the NIH and the Device Research Landscape. Michael Wolfson, Ph.D. Program Director NIH/NIBIB 11/8/17

Transcription

1 Grantsmanship at the NIH and the Device Research Landscape Michael Wolfson, Ph.D. Program Director NIH/NIBIB 11/8/17

2 The Three Gatekeepers Funder Regulator Payer Impact > Cost & Technical risk Benefit > Risk Benefit > Cost

3 Value Chain TRL Cost Value 1 $2M Research Psychophysics Prototype Animal model $0.5M 3 $8M Applied Research Clinical device fabrication Clinical trial design FIH clinical trial $2M 5 $10M Developmen t Device design finalized Supply chain Quality management $10M 7 $50M Phase 3 trial Safety Efficacy $100M 9 $10M Approvals Regulatory Payer $200M

4 NIH uses a Variety of Translational Mechanisms Early Research Prototype Optimization Pre-IDE Studies Early Feasibility Feasibility NIH Research Programs (R21/R01) Bioengineering Research Grants/Partnerships (R21/R01/U01) Small Business Program: SBIR & STTR Stimulating Peripheral Activity to Relieve Conditions (SPARC) Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Translational Neural Devices (NINDS) Exploratory Clinical Trials (NINDS) NeuroNEXT (NINDS)

5 NIH FY17 Budget NIH Divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers), with 5% allocated to trans-nih initiatives. NIAAA NHGRI NIAMS NCATS NEI NIEHS NIDA NICHD NIMHD NIDCD NLM NINR NIDCR NIBIB FIC NCCIH NCI Total = $33 B NIAID NIMH OD NHLBI NIA NINDS NIDDK NIGMS About 85% distributed via Extramural grants, contracts, cooperative agreements

6 Each Institute/Center Has a Webpage

7 Need Help? Who Ya Gonna Call? scientific and technical aspects of your application Find them on the solicitation See the IC s programmatic descriptions ( questions during review Listed on the era Commons link to your submitted proposal See also the review group rosters at the CSR web site for help with the business aspects of a proposal Listed on the era Commons link to your submitted proposal when all else fails Listed on IC website Program Director Scientific Review Officer Grants Specialist Leadership

8 NIH Program Officials: your primary contact Pre-Application Assess the fit to the IC, Program(s) Start the conversation early: develop your ideas together Choose the right activity/mechanism Brief on Review Issues: Dos/Don ts During the Award Discuss problems in execution (rebudeting, rescoping, extensions ) Find an administrator to address unusual issues Brag about important discoveries Post Review Analyze the Summary Statement: deeper insights from the Review Understand the rating and assess the likelihood of funding BEWARE! Nothing is certain until you have it in writing Anytime Arrange introductions so you can serve on advisory boards workshop panels, etc. to help set the research agenda Discover what s New and Coming Soon in Funding Opportunities Application Review Award improving health by leading the development and accelerating the application of biomedical technologies

9 Targeting IC Priorities: an example NIBIB mission accelerating the application of biomedical technologies [via] integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. NINDS mission seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. Device design, development, and manufacture Validation of a new technology Using a device to study pathology or for therapy

10 NIBIB BIOENGINEERING is the BRIDGE Applied Science Science Engineering Translation Other ICs study basic biology and pathology Research Engineering Other ICs develop medical solutions Bioengineering: Translating Science into Action Science: Gaining fundamental knowledge and understanding through open-ended study. Applied Science: Knowing the desired outcome, exploring solutions. Engineering: Harnessing what is known to build a solution to a problem. Research Engineering: Adapting technology solutions to drive science that fills the knowledge gaps. Translation: Bringing the solution to practice.

11 NIBIB Offers Funding Opportunities to Support Investigators at Every Stage of Their Career GRADUATE/ MEDICAL STUDENT Predoctoral Institutional Training Grant (T32) Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) POST DOCTORAL Postdoctoral Institutional Training Grant (T32) Postdoctoral Individual NRSA (F32) NIH Pathway to Independence (PI) Award (K99/R00) Research Project Grant (R01) Small Grant (R03) Exploratory/ Developmental Grant (R21) CAREER EARLY MIDDLE SENIOR Trailblazer (R21) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25) Independent Scientist Award (K02) Midcareer Investigator Award in Patient-Oriented Research (K24)

12 Non-Hypothesis Driven Research Bioengineering Research Grant (R01) An application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research R01 funding policies (e.g. payline plus EOZ) Bioengineering Research Project (U01) Path to translation PI(s) experienced with managing complex projects Not percentiled Special Emphasis Panel review

13 R21 Exploratory/Developmental Grant NIBIB is not participating in parent R21 NIBIB-specific PAR Applicants are expected to propose novel biomedical research approaches for which there is no preliminary data to demonstrate the feasibility of the proposed project New Investigator-only Trailblazer PAR Applicants are expected to propose research approaches for which there are minimal or no preliminary data

14 NIH SBIR/STTR Budget Allocations Applications come to the NIH (not to a specific IC) Important to know which IC will take assignment Each IC has a different mission/focus Different policies, budget guidelines, and resources Contact NIH Program Staff well in advance of applying We can help! Contacts for each IC: Questions who to contact? sbir@od.nih.gov SBIR $763M (~3%) STTR $114M (~0.5%) Total FY16 $877M

15 NIH SBIR/STTR 3-Phase Program Discovery Phase I Development Phase II Competing Renewal Award Phase IIB Commercialization Phase III $3M for up to 3 years Feasibility Full R/D Additional R/D Only Some ICs Participate Phase I: Guidelines: $150K/6 months Hard Cap*: $225K/1-2 years Phase II: Guidelines: $1M/1 year Hard Cap*: $1.5M/1-3 years *NIH has a wavier to exceed these Hard Caps Pre-Approved Topics List in Appendix A of the Program Descriptions and Research Topics Document of the Omnibus Solicitation

16 NIH-wide SBIR/STTR Success Rates Each NIH Institute/Center manages their own budget and success rates can vary Bonus Tip: Across NIH all new application types (Phase I, Fast- Track, Direct to Phase II) have roughly the same success rate Contact Program Staff! They can help you determine what might be the best program for you Success Rates Posted Online:

17 Awardee Development Programs Phase I: Niche Assessment Program (NAP): Market Analysis NIH I-Corps TM and C3i Programs: Entrepreneurial Assistance/ Training Phase II/IIB: Commercialization Accelerator Program (CAP): Menu of Technical Assistance/ Training Investor Forum Partnering Opportunities: Sponsored/Discounted Attendance at Events/Conferences

18 Contact me Implantable, assistive, and rehabilitation devices CNS: BRAIN Initiative SCI rehabilitation tech PNS: SPARC Rehabilitation (prosthetics, orthotics, etc) Robotics Sensing (magnetic, biomagnetic and bioelectric devices) improving health by leading the development and accelerating the application of biomedical technologies