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Managing Biomedical Research to Prevent and Cure Disease in the 21st Century: Matching NIH Policy with Science Joint Hearing before the Senate Committee on Health, Education, Labor and Pensions and House Committee on Energy and Commerce October 2, 2003. 11.8%. National Institutes - PowerPoint PPT Presentation
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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