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Research Peer-Review at CDER Past and Present Jerry M. Collins, Ph.D.

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. Peer Review of Individual CDER Scientists.

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Research Peer-Review at CDER Past and Present Jerry M. Collins, Ph.D.

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  1. 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

  2. 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 <discussed on next slide>

  3. 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 <non-managers> 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

  4. 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.

  5. Examples: Prior Ad Hoc External Reviews of CDER Programs FDA Science Board <external advisory committee>. 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.

  6. 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)

  7. 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.

  8. 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 CDER’s “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

  9. 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 Women’s 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

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