Research Peer-Review at CDER

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Research Peer-Review at CDER Past and
Present Jerry M. Collins, Ph.D. Director,
Laboratory of Clinical Pharmacology, OTR Acting
Director, Division of Applied Pharmacology
Research, OTR
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Peer Review of Individual CDER Scientists
Systems for ongoing peer-review of individual
senior scientists in all Centers have more
similarities among the Centers than
differences. Semi-Annual Management Review in All
Cases.
Non-Lab Scientists Hired or Promoted to GS-14 or
GS-15 via Expert or Master Reviewer Committees
(Internal FDA Members) Mostly
Non-Managers Promotions permanent, not
periodically re-certified
Title 42 or Title 38 (M.D.s) also used for
Non-Lab Personnel No Committees No
Re-Certification Some Use of SBRS ltdiscussed on
next slidegt
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Peer Review of Individual CDER Lab Scientists
CDER Laboratory Scientist Peer Review
Committee 50 members outside CDER NIH,other
FDA Centers Hiring or Promotion of Scientists to
GS-14 or GS15 3-Year Renewable Promotion
ltnon-managersgt
Senior Biomedical Research Service
(SBRS) Agency-Wide Credentials Comm,External
Consultants GS-15 and Above 4-Year
Re-Certification Cycle
Title 42 No Committees No Re-Certification
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Peer Review of CDER Research Programs
Peer-review of research programs varies across
FDA Centers. In general, it is polarized into 2
different approaches. For the past 20 years,
CBER and NCTR have evaluated lab research
programs via an "academic" model, i.e., through
site visits conducted by advisory committees.
The other 5 units at FDA with lab programs (CDRH,
CFSAN, CVM, ORA, and CDER) have used a
"corporate" model, i.e., primary evaluation of
research programs via internal Center (or ORA)
management. At CDER, the internal review of lab
and non-lab research programs has been
occasionally supplemented by external review.
However, external reviews have been episodic
rather than formally established and regularly
conducted.
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Examples Prior Ad Hoc External Reviews of CDER
Programs FDA Science Board ltexternal advisory
committeegt. Usually, one topic at a time, rather
than full set of programs. Ad Hoc review by
Generic Drug Advisory Committee, GDAC
(predecessor of ACPS). Information Briefings for
ACPS. Continuing the tradition begun in GDAC,
ACPS receives periodic briefings (e.g., October
2004 March 2003) and occasional training
sessions (e.g., May 2005 July 2001) regarding
OTR lab programs. In each case, there are
opportunities to comment and provide feedback,
but the sessions not formally organized as a
peer-review process.
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Examples Prior Ad Hoc External Reviews of CDER
Programs continued
Ad Hoc review of antiviral labs - actually, part
of the charter of the Antiviral Drug Products
Advisory Committee was to review the research
programs of this lab. (Note this lab has been
abolished.) Ad Hoc review of cardiovascular lab
support (Note this lab has been abolished)
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Examples of Ad Hoc Internal Reviews of CDER
Programs 1 Annual Presentations to Center
Director / Deputy Director 2 CDER Research
Coordinating Committee, RCC Mission-oriented
research at CDER not limited to lab programs.
RCC established in various forms over last 15
years to provide advice to Center management
regarding full range of internal research
programs. Current RCC is chaired by the Deputy
Center Director. Within OPS, research is also
conducted in the immediate office, e.g., by the
Informatics and Computational Safety Analysis
Staff. Elsewhere in CDER, research is
conducted in various units, especially the Office
of Biometrics, Office of Drug Safety, Office of
Information Management and Office of Clinical
Pharmacology and Biopharmaceutics.
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• Funding and Peer Revew of CDER Research Programs
• 1 Funding for research, lab or non-lab,
  primarily determined by Office management.
• 2 In addition to funds from individual
  organizational budgets, some central funding is
  available from CDERs Review Science and
  Research (RSR) program.
• Funding areas are determined by CDER management
• Proposals are reviewed by a committee of CDER
  scientists
• ? Generally, funds are not for laboratory
  research, but foster activities such as database
  generation within review divisions

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Funding and Peer Revew of CDER Research Programs
External Sources of Research Funds 1
Other FDA sources of peer-reviewed funding for
research are the FDA Office of Health Science
Coordination and the FDA Office of Womens
Health. ? Priorities for these programs are
set by the management of the funding
Office ? Proposals are peer-reviewed for quality
relevance ? Only internal FDA staff conduct
the reviews. ? Lab and non-lab proposals are
accepted. 2 CRADAs and Inter-Agency Agreements