How To Fund Research At The National Health Institute

Transcription

1 Topics to Discuss Medical and Health Research Funding Environment NIH Small Business Innovation Research & Small Business Technology Transfer (SBIR & STTR) Program Awards Academic Research Enhancement Awards (R15s)

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3 Federal Allocations National Institutes of Health...34, % 29, % 30,012 Department of Defense (medical research, chemical and biological defense)...2,667-12% 2, % 2,412 Department of Homeland Security (biodefense)...2, % % 234 Department of Agriculture (Agricultural Research Service, National Institute of Food and Agriculture, Economic Research Service)...2, % 1, % 1,953 National Science Foundation (biological sciences, bioengineering, behavioral sciences, computer and information science and engineering)...1, % 1, % 2,075 Department of Energy (biological and environmental research, advanced scientific computing research)...1, % 1, % 1,020 Environmental Protection Agency (clean air, clean water, health and human ecosystems, pesticides and toxics) % % 568 National Institute of Standards and Technology % % 557 Department of Veterans Affairs (medical and prosthetic research) % 580 0% 580 Agency for Healthcare Research and Quality % % 394 Centers for Disease Control and Prevention (disease control, research and training) % % 408 Food and Drug Administration % % 406 NASA (Human Research Program) % % 158 U.S. Agency for International Development % % 188 Administration for Children and Families (children s research) % % 10 Ctrs. for Medicare & Medicaid Services (health services research, demonstration, evaluation) % % 21 Health Resources and Services Administration % 12 0% 12 Patient Centered Outcomes Research Institute % 8 3

4 SBIR/STTR Programs Overview SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM Set-aside program for small business concerns to engage in Federal R&D with potential for commercialization SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with potential for commercialization 2.9% 0.40%

5 NIDA NIH SBIR/STTR Budget Allocations FY2014 NIEHS NCATS NEI NIAAA NHGRI NIAMS NIDCR NIBIB NIDCD NIMHD NINR ORIP NCCAM NLM NCI 2.8% SBIR $663M 0.40% STTR $95M Total FY2014 $758M FY15 pending NIA NIAID NICHD NIMH NINDS NIDDK NIGMS NHLBI

6 NIH SBIR/STTR 3-Phase Program PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR) PHASE II Full Research/R&D $1M (SBIR), $1M (STTR) over two years PHASE IIB Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many, but not all, ICs participate Varies ~$1M/year; 3 years PHASE III Commercialization Stage NIH, generally, not the customer Consider partnering and exit strategy early

7 SBIR and STTR Critical Differences Partnering Requirement Principal Investigator Work Requirement SBIR Permits partnering Primary employment (>50%) must be with the small business May outsource up to 33% (Phase I), 50% (Phase II) STTR Requires a non-profit research institution partner PI may be employed by either the research institution partner or small business 40% Small Business 30% Research Institution/Partner Award is always made to Small Business Concern

8 Success Rate of SBIR/STTR 2012 and 2013 by Phase SBIR 39.9% 34.4% STTR 39.4% 32.8% 28.6% 26.4% 15.9% 15.7% 15.6% 13.2% 20.3% 18.7% Fast Track Phase I Phase II Fast Track Phase I Phase II Success Rates Posted Online:

9 Solicitations and Due Dates NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation Parent FOAs: SBIR: PA STTR: PA Release: January Standard Due Dates: April 5, August 5, December 5 (AIDS/AIDS-related: May 7, September 7, January 7) SBIR Contract Solicitation (NIH, CDC) Release: August 15, 2014 November 5, 2014 close date NIH Guide for Grants and Contracts Release: Weekly Receipt dates specified in each FOA (

10 Most Important Piece of Advice Talk to an NIH Program Officer about your application and SUBMIT EARLY (days not hours and minutes)! Program Officer contact information found in the NIH SBIR/STTR Solicitation on Questions about who to contact?

11 Michelle M. Timmerman, Ph.D. Director, AREA Program National Institutes of Health INBRE PI/PC Meeting September 25, 2014

12 Key features Project period is limited to 3 years Direct cost limited to $300,000 over entire project period Multiple PIs are allowed, if all eligible Research Strategy limited to 12 pages Grants are renewable Preliminary data not required but can be provided Can t be PI on another NIH research grant at time of award

13 PI Eligibility Primary appointment at eligible institution Not OK: Also serve as PI of other NIH research grants at time of award Also serve as Multiple PI on another NIH research grant at time of award OK: Be Key Personnel on another grant Have a grant from another agency 13

14 Institutional eligibility Can a satellite campus be considered separately from the flagship? Where is degree issued? At level of flagship campus = not considered separately At level of satellite campus = considered separately 14

15 R15 limits consider inflation Currently (April 2014 March 2015) 29 institutions are eligible with $6 million cap but not $3 million cap FY DC limit/3 years Institutional cap FY 85 $50 K (2 years) FY 96 $75 K $2 million FY 99 $100 K $2 million FY 03 $150 K $3 million ARRA (FY10) & Parent FY11 onward $300 K $6 million FY11 ICs R15 spending doubled compared to FY09 ~50% increase in # of applications (sustained) 200 newly eligible institutions (100 from cap increase) 15% of applications 15

16 unique review criteria PA & PA Significance Strengthen research environment? Expose students to research? Investigator Experience supervising students in research? Approach Can project stimulate students interest so they consider biomedical/behavioral science career? Environment Well qualified students available? Have or likely will students pursue biomedical/ behavioral science careers?

17 Advice for Grants Offices Understand the NIH extramural research program Know guidelines, deadlines, submission & correction process, and review criteria Make a commitment to establishing an environment in which research can succeed Start up packages for equipment and supplies Pilot grants, student research grants Credit for student involvement in research Consider the importance of collaborative research in establishing a successful research environment

18 More Advice for Grants Offices Do not pressure investigators to apply if their projects are not ready for peer review Quality over quantity; submit best application Get some feedback from the reviewers Help investigators with the Facilities and Other Resources section of application Profile of student body Description of the institution and research environment Letter of institutional commitment to research project Maintain as resource & revise per Summary Statements

19 Strategies of Successful PIs Include a collaborator with a well-justified role if you don t have the necessary expertise or resources Understand the review criteria and the review criteria questions Each question should be addressed in the application In A1, respond thoroughly and diplomatically to all of the reviewer comments AREA grant is research award, not training award Focus on hands-on research not course work Describe PI s role in research & supervision

20 More Strategies of Successful PIs Address the AREA-specific programmatic goals in the application Support meritorious research Research should contribute to the field Results should be publishable Expose students to research Profile of available and former students at the institution Experience of the investigator in working with students How students will be incorporated into the research project How students will benefit from this research experience Strengthen the research environment The suitability of the institution for an award The impact the AREA grant will have on the institution Involve freshman & sophomores Consider a tech, given academic year fluctuations

21 Current Opportunity FYI - please share this R15 AREA FOA with interested PUI faculty in your INBRE networks. Thanks, NIMHD Academic Research Enhancement Award: Enhancing Health Disparities Research at Undergraduate Institutions (R15) (RFA-MD ) National Institute on Minority Health and Health Disparities Application Receipt Date(s): January 12, 2015 The NIMHD encourages institutions that are eligible to apply for support through the NIH Academic Research Enhancement Awards (AREA) program to submit applications for innovative research projects focused on minority health and health disparities. Awards are intended to support small-scale projects proposed by faculty members at eligible institutions to expose students to meritorious research and to strengthen the research environment of participating institutions. This initiative also seeks to stimulate interest in health disparities research careers among undergraduate students through hands-on participation in original research. - See more at:

22 Current Opportunity Funds Available and Anticipated Number of Awards NIMHD intends to commit $5,000,000 in FY 2015 to fund approximately awards, contingent on the availability of funds and receipt of a sufficient number of meritorious applications. Award Budget Applications may request up to $300,000 in direct costs plus applicable Facilities & Administrative (F&A) costs for the entire project period of up to 3 years. Note: When a consortium is involved, the $300,000 direct cost limit is exclusive of consortium F&A costs; these can be requested in addition to the $300,000 direct costs limit. Award Project Period The scope of the proposed project should determine the project period. The maximum project period is 3 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. - See more at: