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NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D.

NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D. Director, National Institutes of Health. NIH Budget Facing a “Perfect Storm” in 2006. Federal & Trade Deficits Defense and Homeland Security needs Katrina Pandemic flu Post- Doubling effects

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NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D.

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  1. NIH at the Crossroads: Myths, Realities and Strategies for the Future Elias A. Zerhouni, M.D. Director, National Institutes of Health

  2. 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%

  3. NIH Budget: Myths and Realities…

  4. 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?

  5. Basic and Applied Research 60.0% 56.4% 55.8% 55.2% 55.2% 55.2% 53.9% 56.6% 52.1% 56.1% 53.0% 50.0% 43.5% 41.0% 40.8% 40.5% 41.0% 39.8% 39.2% 40.0% 40.8% 38.5% 38.4% 30.0% 20.0% 10.0% 7.0% 5.7% 5.0% 5.5% 5.2% 4.8% 3.7% 3.1% 3.1% 3.6% 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

  6. 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?

  7. Grants: Unsolicited Far Outnumber Solicited 100% 90% 93% 91% 80% 70% 60% Percentage of Grants Unsolicited Solicited 50% 40% 30% 20% 10% 0% 1994 1996 1998 2000 2002 2004 2006 Fiscal Year

  8. 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?

  9. NIH Roadmap for Medical Research FY2005 Request = $28,757M • Developed to increase synergy across NIH • Not a single initiative but over 345 individual awards in FY05: • 40% basic • 40% translational • 20% high risk Non-Roadmap 99.2% ($28,520 Million) Roadmap 0.8% ($237 Million)

  10. What Is Really Happening?3 Fundamental Drivers • Large capacity building throughout U.S. research institutions and increase in number of tenure-track faculty • Large increase in applicants and applications occurring after 2003 • Budgets: • Appropriations below inflation after 2003 ( +3 % in ‘04, 2.2% in ‘05 and 0% in 06 ) while BRDPI in 2004 was ~ 5% • Budget cycling phenomenon

  11. +8,359 +8,303 New Grant Applications and Success RatesDuring and After Doubling Period 35% 60,000 49,656 30% 31% 50,000 43,069 25% 40,000 Projected 22% 20% Number of Applications % Success Rate of Grants Funded 30,000 19% 24,154 15% 20,000 10% 10,000 5% 0% 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Success Rates Applications

  12. ≈ 5208 5334 26583 - 21249 31791 - 26583 (2003) – (1999) (2005) – (2003) Period of doubling As Many New Applicants in the Last 2 years as during the previous 5 years!

  13. The Budget Cycling Phenomenon:What Funds are Really Available in Any One Year? From current year to previous year Budget Increase Uncommitted Funds From ending grants started 4-5 years ago Continuing grants Committed Funds NIH Appropriations

  14. NIH Congressional Appropriations $30 $28.6 $28.6 $28.6 $28.0 $27.1 $25 ? $23.3 $20 $20.5 $17.8 $15 Billions of Dollars $15.6 $13.7 $10 $5 $0 FY FY FY FY FY FY FY FY FY FY 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 DOUBLING

  15. The Bottom Line: Demand for Grants “Took Off” Just as NIH Budget Was “Landing!” • NIH managed well in 2004 and 2005 by shifting “one time” funds from 2003 to 2004, and obtaining small increases in 2004 (2.9%) and 2005 (2%) • Katrina requirements led to a flat 2006 NIH while rest of HHS underwent a 2.5% cut • Budget cycling effect will improve demand vs supply of grants in 2007 but we need to educate public about need for sustainability in research

  16. The Question on Everyone’s Mind:“What are MY chances of being funded?” • Payline is not the funding cut-off line! • Success rate per application understates funding rate per applicant • FY 2005- 22.3% success rate for applications, but 27.6% for applicants • FY 2006- 19.8% for applications, but ~25% for applicants

  17. >99% of grants under the payline are funded Payline - Success Rate per application 75 50 - 25 - Success Rate is Higher than the Percentile Payline - 100 Percent R01s Funded 0 0 10 20 30 40 Percentile Score

  18. Success Rates are always higher for Applicants than for Applications 40% Applicant 35% 30% 25% Success Rate for R01 Equivalents 20% Applications 15% 10% 5% 0% 1995 1997 1999 2001 2003 2005 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

  19. Where Do We Go From Here?Adaptive Strategies A Vision for the Future

  20. 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

  21. The First HapMap Success Story:Age-Related Macular Degeneration • Two other risk variants have been identified in the last two months • Together these account for 74% of risk, and point to powerful new approaches to prevention and treatment

  22. Average investment per American ~$1 per year 17-year investment per American: ~$16.50 Total Human Genome Project and HapMap: The Foundation of a New Medical Era 1990 - 1997 • New powerful DNA sequencing technologies • Transformation of Genomics from technology to biology- driven science • 2007 Genes, Environment, and Health Initiative • Identify roots of 10 most common diseases within 3 years • Devise new ways of monitoring personal environmental exposures • Guide new treatments 1998 - 2002 2003 - 2006

  23. Basic Discovery Today Provides the Foundation for Tomorrow’s Medicine Clinical Applications Translational Research Basic Research and Technology Development

  24. Participatory The Future Paradigm: Transform Medicine from Curative to Preemptive Predictive Personalized Preemptive

  25. Transforming medicine through discovery NIH

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