NIH at the Crossroads: Myths, Realities and Strategies for the

FutureElias 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

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?

56.6%53.9% 55.2% 56.4%

52.1%

53.0%

55.2% 55.8%55.2%

56.1%

40.5%39.2%

38.4% 38.5%

39.8%

40.8%

43.5%41.0% 41.0% 40.8%

5.0%7.0%

3.7%5.7% 5.5% 5.2% 4.8%

3.6%

3.1% 3.1%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

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

Basic and Applied Research

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?

Grants: Unsolicited Far Outnumber Solicited

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1994 1996 1998 2000 2002 2004 2006

Fiscal Year

Per

cen

tag

e o

f G

ran

ts

Unsolicited Solicited

91% 93%

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

Roadmap0.8%

($237 Million)

Non-Roadmap99.2%

($28,520 Million)

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

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

New Grant Applications and Success Rates During and After

Doubling Period

Success Rates Applications

Projected

Num

ber of Applications

% S

ucce

ss R

ate

of G

rant

s F

unde

d

31%

19%

0%

5%

10%

15%

20%

25%

30%

35%

1998 19992000 200120022003 2004 20052006 20070

10,000

20,000

30,000

40,000

50,000

60,000

+8,303

+8,359

22%

49,656

43,069

24,154

As Many New Applicants in the Last 2 years as during the

previous 5 years!

≈

26583 - 21249

(2003) – (1999)Period of doubling

5334

31791 - 26583

(2005) – (2003)

5208

The Budget Cycling Phenomenon:What Funds are Really Available in Any One

Year?

NIH Appropriations

Committed Funds

Uncommitted Funds

Budget Increase

From ending grants

started 4-5 years ago

From current year to previous year

Continuing grants

NIH Congressional Appropriations B

illi

on

s o

f D

oll

ars

DOUBLING

$13.7$15.6

$17.8

$20.5

$23.3

$27.1$28.0 $28.6 $28.6 $28.6

$0

$5

$10

$15

$20

$25

$30

FY1998

FY1999

FY2000

FY2001

FY2002

FY2003

FY2004

FY2005

FY2006

FY2007

?

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

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

Success Rate is Higher than the Percentile Payline

0 10 20 30 40

100

0

-

75 -

50 -

25 -

Percentile Score

Perc

ent

R01s

Funded

>99% of grants under the payline are funded

Success Rateper application

Payline

0%

5%

10%

15%

20%

25%

30%

35%

40%

1995

1997

1999

2001

2003

2005

Applicant

Applications

Succ

ess

Rate

for

R01 E

qu

ivale

nts

Fiscal Year

Success Rates are always higher for Applicants than for

Applications

Success Rate files as of May 3, 2006. Program srf_indiv_060103_rfmIndividuals 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

The First HapMap Success Story:Age-Related Macular Degeneration

Two other risk variants havebeen identified in the last two months

Together these account for 74%of risk, and point to powerfulnew approaches to preventionand treatment

Human Genome Project and HapMap: The Foundation of a New Medical Era

1990 - 1997

1998 - 2002

2003 - 2006

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

17-year investmentper American:

~$16.50Total

Average investment

per American

~$1per year

Basic Discovery Today Provides the Foundation for

Tomorrow’s Medicine

Basic Researchand

Technology Development

Translational Research

Clinical Applications

The Future Paradigm: Transform Medicine from Curative to

Preemptive

Preemptive

Personalized

Predictive

Participatory

Elias A. Zerhouni, MD, Director, NIH May 4, 2006

NIHTransforming medicine through discovery