October 2011
Sally J. Rockey, PhD
Deputy Director for Extramural Research
1 Institutes of Health
National
“To win the future, America
needs to out-educate,
out-innovate, and out-build
the rest of the world.”
President Barack Obama,
Weekly Address
February 5, 2011
NIH: Steward of Biomedical &
Behavioral Research for the
Nation
“Science in pursuit of fundamental
knowledge about the nature and
behavior of living systems . . .
and the application of that knowledge
to extend healthy life and reduce the
burdens of illness and disability
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NIH Appropriation History vs. Actual
Purchasing Power - BRDPI*
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*Adjustment to FY 1998 dollars based on Biomedical Research & Development Price Index (BRDPI)
NIH Extramural & Intramural Funding
FY 2011 Enacted: $30.9 Billion
Spending
at NIH
$5.0 B
– $3.3 B Intramural Research
– $1.5 B Research Management & Support
– $0.2 B Buildings and Facilities, Other
16%
Spending Outside NIH
$25.9 B
84%
– Supports over 325,000 Scientists &
Research Personnel
– Supports over 3,000 Institutions
FY 2010 Percent Distribution of Basic and
Clinical Research
R&D Facilities
0.3%
Training &
Overhead
2.6%
Applied Research
(Other)
10.5%
Applied Research
(Clinical)
34.6%
Basic Research
52.0%
Research Project Grants
Applications, Awards, and Success Rates
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"Cutting the deficit by gutting our investments in
innovation and education is like lightening an
overloaded airplane by removing its engine. It may
make you feel like you're flying high at first, but it
won't take long before you'll feel the impact.“
President Obama
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Bridging the Gap
Directions for NIH Supported Research
Basic Research
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Drugs
The Therapeutic Development Pipeline
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HTS
Probe
to
Lead
NIH Molecular
Libraries
Initiative
PreClinical
NIH RAID
NIH
Supported
Basic
Research
Assay
Dev.
NIH TRND
Disease
Target
ID
FDA
IND
FDA
Ph. 0 Ph. I Ph. II Ph. III Review
Pharma, Biotech, NIH
Clinical Center, CTSAs
New NIH FDA Partnerships
Creation of the
National Center for Advancing
Translational Sciences (NCATS)
To catalyze the development of innovative methods
and technologies that will enhance the
development, testing, and implementation of
diagnostics and therapeutics across a wide range of
human diseases and conditions.
Updated 5.18.11
NCATS: Challenges & Opportunities
• Deluge of new discoveries of potential targets
• Unmet therapeutic needs for many conditions,
especially rare and neglected diseases
• Need to view drug development pipeline as a
scientific problem – ripe for experimentation and
process engineering
NCATS: Functions
Improve the processes of diagnostics and
therapeutics development, testing, and
implementation by:
• Experimenting with innovative approaches in an open-access model
• Choosing therapeutic projects to evaluate these innovative
approaches
• Promoting interactions to advance the field of regulatory science
Catalyze the development and implementation of
new diagnostics and therapeutics by:
• Encouraging collaborations across all sectors
• Providing resources to enable diagnostics and therapeutic
development and implementation
• Enhancing training in relevant disciplines
NCATS will:
• Facilitate – not duplicate – other translational
research activities supported by NIH
• Complement – not compete with – the private
sector
• Reinforce – not reduce – NIH’s commitment to
basic research
Better Ways to Predict Drug Safety
New NIH-DARPA-FDA Collaboration
• Part of President’s “Lab to Market” initiatives
• Goal: Develop chip to screen for safe, effective drugs
▫ Liver, heart, lung, other cell types
▫ Designed for multiple different readouts
• NIH, DARPA to commit ~$70 million each over 5 years
• FDA to offer guidance
• Fall: First Requests for Proposals
▫ Seeking best ideas in engineering, biology,
toxicology
Future of the Biomedical
Research Workforce
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NIH Establishes Working Group to Examine
the Future Biomedical Workforce
Using appropriate expertise from NIH and external sources, the group
will develop a model for a sustainable and diverse U.S. biomedical
research workforce that can inform decisions about training of the
optimal number of people for the appropriate types of positions that
will advance science and promote health.
Based on this analysis and the input
gathered from the extramural
community, the committee will make
recommendations for actions that NIH
should take to support a future
sustainable biomedical infrastructure.
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Distribution of FY2009 RPG Support
to Principal Investigators
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Number of RPG Awards per PI – Top 20%
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Distribution of FY2009 RPG Funding Across
Institutions
100%
Percent of
All RPG Funding
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0%
10%
20%
30%
0
120
240
360
40%
50%
60%
480
600
720
Percent / Number of Organizations
70%
80%
90%
100%
840
960
1080
1200
Distribution of Principal Investigators by Degree Type
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36.0
34.0
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
Age at First R01 Award
Age at First R01 Equivalent Award from NIH
FY 1980 to 2010
48.0
46.0
44.0
42.0
40.0
38.0
MD-PhD
MD Only
PhD Only
32.0
Fiscal Year
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NIH Exceeds New Investigator Goals since FY 2007
Used the rolling average
of the previous 5 years
Used equalized success
rates between new and
established
R01-Equivalent awards include R01, R23, R29, and R37 grants.
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R01-Equivalent Grants Funding Rates by
Gender and Type of Application
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Race and Ethnicity of Reporting Principal
Investigators on Research Project Grants
2009
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Career Stages of Funding Programs
Kirschstein-NRSA Training Grants
and Fellowships - Numbers
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Estimated Number of NIH-Supported
Graduate Students
Sources: NSF Survey of Graduate Students and Postdoctorates in Science and Engineering
and the NIH Data Book
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Estimated Number of NIH-Supported Postdocs
Sources: NSF Survey of Graduate Students and Postdoctorates in Science and Engineering
and the NIH Data Book
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Potential Levers for Dealing
with Budget Challenges
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Trim Spending Across the Board
• No systematic changes
• Annual belt-tightening for all programs
• Consequences:
▫ Darwinian approach; survival of the fittest
▫ Success rates will likely continue to fall
▫ Risk of reduced emphasis on innovation as
applicants play it safe to get through peer review
Evaluate, Rearrange Research Portfolio
• Focus on scientific priorities
• Conduct rigorous evaluation of entire NIH
research portfolio
• Reset priorities in focused, intentional way to:
▫ eliminate duplications
▫ reduce support for less innovative research
▫ increase support for highly innovative research
Change Ways of Managing NIH Resources
• Investigators:
▫ Limit PI’s # of Research Program Grant (RPG)
awards
▫ Limit PI’s total amount of awards
▫ Limit size of awards
▫ Limit PI salaries
• NIH Intramural
• Grantee Institutions
▫ Limit cost-recovery (indirect costs)
▫ Reduce burdens on institutions
Other Issues of Interest – Common Rule
Federal Policy for the Protection of Human Subjects (in place since 1991)
HHS and OSTP issued an Advanced Notice of Proposed Rulemaking on July 26,
2011 requesting comment on proposed changes
(http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf)
Changes proposed in the following areas:
1. Revising the existing risk-based framework to more accurately calibrate the
level of review to the level of risk.
2. Using a single Institutional Review Board review for all domestic sites of
multi-site studies.
3. Updating the forms and processes used for informed consent.
4. Establishing mandatory data security and information protection standards
for all studies involving identifiable or potentially identifiable data.
5. Implementing a systematic approach to the collection and analysis of data on
unanticipated problems and adverse events across all trials to harmonize the
complicated array of definitions and reporting requirements, and to make the
collection of data more efficient.
6. Extending federal regulatory protections to apply to all research conducted at
U.S. institutions receiving funding from the Common Rule agencies.
7. Providing uniform guidance on federal regulations
• Comments will be received through October 26, 2011 (see
http://www.hhs.gov/ohrp/humansubjects/submitanprmcomment.html)
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Find Grants Info at:
http://www.grants.nih.gov/
Finding Funded Research: http://RePORT.NIH.Gov
RePORT &
RePORTER (Formally known as CRISP)
•Quick access to “Frequently Requested Reports” (e.g. Funding by State,
Funding by Award Mechanism, etc.)
•Efficient search tools for locating data and reports
•Links to funding estimates for certain research areas, conditions, & diseases.
•Includes ARRA-specific data queries
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