CAN Provides a Framework for Integration
And for Process Engineering
Disease
Target
ID
Assay
Dev.
HTS
Probe to
Lead
Pre-
Clinical
FDA
IND
Ph. I Ph. II Ph. III
FDA
Review
NIH Molecular
Libraries
Initiative
NIH Clinical Center,CTSAs
New NIH FDA Partnerships
1

NIH Offers Funding Programs to Support
Scientists at Every Stage of Their Career
Approx. Stage of Research
Training and Development
GRADUATE/
MEDICAL
STUDENT
Mechanism of Support
Predoctoral Institutional Training Grant (T32)
Predoctoral Individual NRSA (F31)
Predoctoral Individual MD/PhD NRSA (F30)
Postdoctoral Institutional Training Grant (T32)
Postdoctoral Individual NRSA (F32)
POST
DOCTORAL
EARLY
NIH Pathway to Independence (PI) Award (K99/R00)
Mentored Research Scientist Development Award (K01)
Mentored Clinical Scientist Development Award (K08)
Mentored Patient-Oriented RCDA (K23)
Mentored Quantitative RCDA (K25)
Small Grant (R03)
Research Project
Grant (R01)
Exploratory/Develop ment Grant (R21)
MIDDLE
Independent Scientist Award (K02)
Midcareer Investigator Award in
Patient-Oriented Research (K24)
SENIOR
Senior Scientist Award (K05 )
*Graph represents a small sample of NIH funding mechanisms available
.
2

Opportunities for Tomorrow:
Investing in Innovative Researchers
• NIH Director’s ARRA Funded Pathfinder Award to Promote
Diversity
– Supports investigators who intend to pursue new research directions related to workforce diversity
– Total funding ~ Up to $2M total costs over 3 year period
• New Innovator Award
– Supports small number of exceptionally creative new investigators
– Provides up to $300,000 in direct costs
• Transformative R01
– Common Fund initiative for exceptionally innovative, high risk, original and/or unconventional research projects
– Supports both individuals and collaborative investigative teams
– Total funding ~ Up to $25 million total costs for 5 year period
• NIH Director’s Pioneer Award
– Supports exceptionally creative individual scientists
– Total funding ~ $5 million for 5 year period
3

EARLY STAGE &
NEW INVESTIGATORS
NIH fosters research independence of early career investigators.
4

NEW DIRECTIONS IN PEER REVIEW
5

Enhancing Peer Review
A Self-Study by the NIH in Partnership with the Scientific
Community to Strengthen Peer Review in Changing Times
Keeping the Goal in Mind:
“Fund the Best Science, by the Best Scientists, with the Least
Administrative Burden.”
Former NIH Director, Dr. Elias A. Zerhouni
6

Summary of Recommendations
More at: http://enhancing-peer-review.nih.gov
7

Enhancing Peer Review at NIH: Timeline
January
2009
•Phase out of
A2 applications
•Identification of
Early Stage Inv. applications
Changes
SO FAR
Changes
NOW
May/June
2009
January 2010
Submissions
•Enhanced review criteria
•New scoring system
•Criterion scoring
•Structured critiques
•Clustering of New
Inv. Applications
•Score order review
•Alignment of applications & review criteria
•Shorter
Research Plans
8

Human Embryonic Stem Cells
Executive Order 13505
Removing Barriers to Responsible Research Involving Human Stem
Cells - March 9, 2009
9

NIH Guidelines for
Human Stem Cell Research
Effective July 7, 2009
•
Establish criteria for NIH review of Human Embryonic Stem Cells (hESCs) to be included in new Registry as eligible for use in NIH funding
• All hESCs must be:
• Derived from embryos created by IVF for reproductive purposes and no longer needed for that purpose
• Donated by individuals who sought reproductive treatment and who gave voluntary written consent for human embryos to be used for research purposes
•
Centralize processes and procedures for NIH reviews of hESCs
•
64 lines now approved on the Registry including H7 & H9
• Applicants will cite hESCs from the Registry in grant applications
•
NOT-OD-10-056 - Review Considerations for Applications and
Awards under the New NIH Guidelines for Human Stem Cell Research
• NOT-OD-10-063 - Status of Certain Human Embryonic Stem Cell Lines http://hescregapp.od.nih.gov/comments/FR_Notice_2-23-2010.pdf
More at: http://stemcells.nih.gov
10

Financial Conflict of Interest
(FCOI)
11

Federal Regulation on
Financial Conflict of Interest (FCOI)
42 CFR Part 50, Subpart F
Purpose:
The regulation promotes objectivity by NIHfunded research by ensuring that the research is not biased by an Investigator’s conflicting financial interests.
Who is Responsible?
 Investigator Responsible for complying with his/her Institution’s policies and procedures and for disclosing the necessary financial information.
 Institution Responsible for compliance including developing, maintaining, and communicating a written and enforced FCOI plan.
 NIH As the grantor agency, NIH has primary is responsible for oversight and compliance by reviewing all Institutional reports of FCOI.
12

Major Areas Addressed in the NPRM
13

Future Challenges for NIH
• Translation of Basic Science
• Scientific Workforce
• Emerging Technologies and Data Needs
• Ethical and Social Implications of Research
• Economic Impact of Research
• Academic/Biomedical Industry Relationships
• Post-ARRA Funding Issues
• Accountability and Transparency – making the case
14

Communicating Research Intent
NIH encourages applicants to describe their research in terms that are easily understood by:

Congress

Public

Scientists

Administrators

Peer Reviewers
____________________________________
Titles, abstracts and statements of public health relevance should:
• Convey the value of the research in plain language – clear, succinct, and professional
• Be comprehensible to both scientists and the public
• Relay the potential impact of the research on health
This information on funded grant applications is publicly available on NIH’s
RePORTER Web Site at http://ProjectRePORTER.NIH.gov.