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NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D. Director National Institutes of Health Competition for funds from the NIH and other sponsors, intensifying year by year, now stands at an unprecedented level, and shows no sign of abating. Never before have so many established investigators faced so much uncertainty about their longevity as active scientists. Never before have so many novices faced so many disincentives to entering or continuing a research career. Dr. William F. Raub, NIH Associate Director for Research and Training, strategy paper, 1982 NIH Budget Facing a “Perfect Storm” in 2006  Federal & Trade Deficits  Defense and Homeland Security needs  Katrina  Pandemic flu  Post- Doubling effects  Physical Sciences focus  Biomedical research inflation- 3 to 5% NIH Budget: Myths and Realities… What is Driving Success Rates?  Is NIH placing more emphasis on applied as opposed to basic science  Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research?  Is it due to the Roadmap? Basic and Applied Research 60.0% 53.9% 55.2% 56.4% 56.6% 55.2% 55.2% 55.8% 56.1% 52.1% 53.0% 43.5% 50.0% 40.5% 40.0% 39.2% 38.4% 38.5% 39.8% 40.8% 41.0% 41.0% 40.8% 30.0% 20.0% 10.0% 5.7% 5.5% 5.2% 4.8% 5.0% 7.0% 3.7% 3.6% 3.1% 3.1% 0.0% FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 Basic Research Applied Research Other What is Driving Success Rates?  Is NIH placing too much emphasis on translational science at the expense of basic research?  Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research?  Is it due to the Roadmap? What is Driving Success Rates?  Is NIH placing too much emphasis on translational science at the expense of basic research?  Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research?  Is it due to the Roadmap? NIH Roadmap for Medical Research FY2005 Request = $28,757M Non-Roadmap 99.2% ($28,520 Million)  Developed to increase synergy across NIH  Not a single initiative but over 345 individual awards in FY 2005: ― 40% basic ― 40% translational ― 20% high risk ($237 Million) Roadmap 0.8% What Is Really Happening? 3 Fundamental Drivers  Large capacity building throughout U.S. research institutions and increase in number of tenure-track faculty  Appropriations below inflation after 2003  Increases of +3 % in „04, 2.2% in „05 and 0% in 06  Biomedical Inflation in 2004 was ~ 5%  Budget cycling phenomenon New Grant Applications and Success Rates During and After Doubling Period 35% 60,000 49,656 % Success Rate of Grants Funded 30% 25% 20% 31% 43,069 50,000 Number of Applications 40,000 22% 24,154 Projected 19% 30,000 20,000 10,000 0 15% 10% 5% 0% +8,359 +8,303 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Success Rates Applications As Many Applicants in Past 2 Years as During Previous 5 Years! 5334 5208 ≈ 26583 - 21249 31791 - 26583 (2003) – (1999) Period of doubling (2005) – (2003) The Budget Cycling Phenomenon: What Funds are Available in any One Year? Budget Increase Uncommitted Funds From current year to previous year From ending grants started 4-5 years ago Committed Funds Continuing grants NIH Appropriations NIH Congressional Appropriations $30 $25 $27.1 $23.3 $28.0 $28.6 $28.6 $28.6 Billions of Dollars $20 $17.8 $20.5 $15.6 $13.7 ? $15 $10 $5 $0 FY FY FY FY FY FY FY FY FY FY 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 DOUBLING The Bottom Line: Demand for Grants “Took Off” Just as NIH Budget Was “Landing!”  NIH managed well despite small increases in 2004 (2.9%) and 2005 (2%) by shifting “one time” funds from 2003 to 2004  Budget cycling effect will improve demand vs supply of grants in 2007 but we need to educate public about need for sustainability in research The Question on Everyone’s Mind: What are MY chances of being funded? Payline Is Not Funding Cut-off Line >99% of grants under the payline are funded 100 Percent R01s Funded 75 50 25 0 0 10 20 Percentile Score 30 40 Payline Success Rate per application Success Rate per Application Understates Funding Rate per Applicant Success Rate for R01 Equivalents 40% 35% 30% 25% 20% Applicant 27.6% Applications 22.3% 15% 10% 5% 0% Fiscal Year Success Rate files as of May 3, 2006. Program srf_indiv_060103_rfm Individuals are determined using the pi_profile_person_id in IMPAC-II Where Do We Go From Here? Adaptive Strategies A Vision for the Future Strategies  First: Know the facts  Second: Develop adaptive strategies  Protect the essential: Knowledge and Discovery  Increase number of competing grants (supply/demand management)  Support new investigators  New Pathway to Independence Program  Institutes and Centers efforts to assist new investigators  Third: Convey a unified message  Increase communications about positive impact of NIH at local, regional and national levels  Fourth: NIH‟s exciting vision for the future Biomedical Research Has Delivered Coronary Heart Disease Average investment per American ~$3.70 per year 63% decrease in Mortality ~ 1 million early deaths averted per year Deaths per 100,000 500 400 300 200 100 Actual Total Deaths 95 2000 in 00 50 55 60 65 70 75 80 85 90 Year $2.6 trillion in ~$110 economic return ~ 514,000 per American: ~ 1,329,000 Projected Deaths in 2000 30-year investment New, effective treatments and prevention strategies Biomedical Research Has Delivered Cancer For the first time in recorded history, Average investment annual cancer deaths per American in ~$8.60the United States per year have fallen 10 million survivors Millions of People 9 6 3 1971 1986 1990 2003 30-year investment per American: Advent of early ~$260 detection and Total screening Basic Discovery Today Provides the Foundation for Tomorrow’s Medicine Clinical Applications Translational Research Basic Research and Technology Development The Future Paradigm: Transform Medicine from Curative to Preemptive Predictive Personalized Preemptive Participatory NIH Transforming medicine through discovery Elias A. Zerhouni, MD, Director, NIH May 4, 2006

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