# Presentation: 425277

## 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

**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>**

**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.**

## Peer Review of Individual CDER Lab Scientists

**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**

**Peer Review of Individual CDER Lab Scientists**

## Peer Review of CDER Research Programs

- 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.

**Peer Review of CDER Research Programs**

## 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.

## 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)

## 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.

## 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

## 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