national institutes of health fy 2003 budget

Managing Biomedical Research to Prevent and Cure Disease in the 21st Century: Matching NIH

Policy with Science

Joint Hearing before theSenate Committee on Health, Education, Labor

and Pensionsand

House Committee on Energy and Commerce

October 2, 2003

National Institutes of HealthFY 2003 Budget

(Total Budget: $27.2 Billion)

11.8%

Spending Outside NIHSpending Outside NIH

85 %(83% Extramural Research)

3.2% Management

National Institutesof Health

National Institutesof Health

Coronary Heart DiseaseAge-Adjusted Death Rates: Actual and Expected

United States, 1950-2000500

400

300

200

100

01950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000

Dea

ths

per

100,

000

Year

~ 514,000 Actual Deathsin 2000

~ 1,329,000 Projected Deaths in 2000

815,000 Deaths Prevented in 2000

Q u a r t e r - Y e a r * A d j u s t e d f o r r e p o r t i n g d e l a y s

Number of Case

s or Deaths Prevalence

1 9 9 3 d e fi n i t i o ni m p l e m e n t a t i o n

Adjusted for reporting delays

0

10

20

30

40

50

60

70

80

90

81 83 85 87 89 91 93 95 97 9982 84 86 88 90 92 94 96 98 00 01

Year

Incidence

Deaths

Nu

mb

er o

f C

ases

/Dea

ths

(Th

ou

san

ds)

1993

Estimated U.S. Incidence of and Mortality from AIDS

1981-2001

More than 80 new drugs in development

Nearly 3 times the number of vaccines in Phase I since 2001

The 2003 SARS outbreak and

The doubling of the NIH budget• Increased investments in Human

Genome

• Better DNA sequencing technology

• Finished the Human genome faster

• Allowed powerful ways to identify Microbes and Viruses thru their genomes

• Cause of SARS identified in record time!

Acute to Acute to chronicchronic conditions conditions

Evolving Challenges

Health DisparitiesHealth Disparities

Emerging DiseasesEmerging Diseases

Aging PopulationAging Population

BiodefenseBiodefense

IMPERATIVES FOR NIH

• Accelerate the pace of discoveries in the life sciences.

• Need for more rapid translation from laboratories to patients

• Need for novel approaches that are orders of magnitude more effective.

• NEED FOR NEW STRATEGIES “NIH ROADMAP “

NIH RoadmapThree CORE Themes

• New Pathways to Discovery

• Research Teams of the Future

• Re-engineering the Clinical Research Enterprise

COMPLEXITY OF BIOLOGICAL NETWORKS OF MOLECULES

Architecture of an 11,000 kDa pyruvate dehydrogenase complex

475 Å

J. Milne and S. Subramaniam, National Cancer Institute, NIH

Scale and complexity of 21st C. researchrequire new organizational models for

scientific teams

NIH RoadmapResearch Teams of the Future

•Multi-disciplinary teams•Larger, coordinated, resource-sharing teams•Combine physical, biological and information sciences•High Risk/ High Impact

NIH RoadmapRe-engineering the Clinical Research

Enterprise

“We need to more quickly translate our discoveries into practice.”

Integrated Clinical Research NetworksClinical Research InformaticsTrainingPublic TrustTranslational Research

National Clinical Research System

Regional NetworksLocal NetworksNational Network

HI

AK

Roadmap Implementation• All NIH ICs made the corporate decision to

have a common pool of resources that will be used for all current and future investment in the Roadmap initiative

• $128M in FY 2004

• Over $2.1B cumulative by FY 2009

CHALLENGES FOR NIH

• Revolutionary and rapid changes in Science

• Increasing breadth of mission and growth

• Complex organization with many units

( 27 institutes and centers, multiple program offices- OWHR, OAR, ORD….)

• Disease, organ, life stage….

• CONVERGENCE OF SCIENCE

Ideas fromIndividualScientists

ScientificReview

InstituteNational Advisory

Councils

NIHGrantees

NIH receives~43,000 research

project grantApplicationseach year

Group ofScientistsEvaluate

Scientific Merit

~30 percent of NIH applications

succeed ingaining research

funding

Access programsApprove applicationsPublic MembersProvide policy advice

WORLD CLASS PEER REVIEW SYSTEM

Science Public Health

Society

EFFECTIVE PORTFOLIOMANAGEMENT

IdeasPeople

Resources

NIH

Standard Model

Laboratory Research

Translational Research

Population Research

Clinical Research

PublicHealth

The Way it Should Work

Laboratory Research

Patient-oriented Clinical Research

Population-based Clinical Research

Clinical Trials

• Better management of portfolio

• Better management of organizational resources of NIH

• Improved governance