1. Peer Review of OBP Research Division of Monoclonal Antibodies
Kathleen A. Clouse, Ph.D.
Acting Director
Division of Monoclonal Antibodies
OBP/OPS/CDER/FDA

2. Discussion Topics Researcher/Reviewer Model (PCE) Committee
Program Monitoring
External Scientific Review
Promotion and Conversion Evaluation
(PCE) Committee

3. Researcher/Reviewer Model
Conduct research relevant to FDA mission
- On specific products (mechanism of action, toxicity,
surrogate measures of efficacy)
- Related to product class/disease/therapeutic modality
- Associated with the development of methods &
standards by which products can be prepared
Perform regulatory review
- INDs/BLAs
Contribute to policy development

4. Funding of OBP Research
Majority of funding provided at the OBP level from Operating Funds and distributed on a per capita basis
Additional funds distributed by OBP based on Research Prioritization
Competitive funding through CDER Review Science & Research (RSR) program
Competitive funding through OWH grants
Competitive funding through NIH Intramural grants (AIDS, CBT)
CRADAs and Inter-Agency agreements

5. Program Monitoring Lab Chief Division Director
- Does not determine research focus; helps assess
research productivity of principle investigators
- Evaluates ability to perform regulatory review
Division Director
- Discusses scientific productivity and regulatory
abilities at least twice per year
Office Director/Associate Director for Research
- Assess scientific productivity via publications
External Scientific Review

6. Purpose of External Scientific Review
Determine relevance of research program to FDA mission
Evaluate research productivity
Assess regulatory contribution
Provide input regarding resource allocations

7. External Scientific Review
Frequency
- Every 4 years (ideally)
Research Group Reviewed
- All Principal Investigators (PI) within a specific
research lab
Site Visit Committee
- Chair: Member of parent Advisory Committee
(previously BRMAC; currently CTGTAC)
- 1 or 2 external scientists with relevant research
expertise for each PI under review

8. External Scientific Review Format
Committee reviews scientific program
Preliminary written report sent to Center for review
Ratification of report by Advisory Committee
Copy of official report provided to Center/ Office Directors and individual reports given to scientists under review

9. Use of Site Visit Report
For tenure/conversion (within 2 years)
For promotion (GS-14/15; within 4 years)
As supporting documentation for internal grant applications

10. Promotion & Conversion Evaluation (PCE) Committee
Purpose
- Conversion of Staff Fellows to tenured civil
service research/regulatory positions
- Promote tenured civil service research/regulatory
scientists to the next grade level
Committee Members
- 2 tenured PIs from each research/review Office
- 1 Full-time reviewer
- 1 representative from OPM
- 1 representative from CBER OD

11. Promotion & Conversion Evaluation (PCE) Committee
Guidances for promotion/conversion
- General: CBER “Guide for the Evaluation of
research/regulatory scientists from GS-13 to GS-15”
- Research Grade Evaluation Guide (from the General
Schedule Position Classification Guides)
Additional information requested
- Publication summary
- Regulatory summary & review examples
- External review report
- Letters of recommendation from experts outside
FDA familiar with investigator’s research

12. Use of Site Visit and PCE Committee Systems for Promotions/Conversions
Current advantages
- Scientific/technical positions are evaluated by
scientists familiar with activities performed
- Scientific community expected to have greater
confidence in decisions made by peer scientists
Current disadvantages
- Cost to OBP/OPS/CDER (SV & PCE)
- Difficult to coordinate Site Visits across Centers (SV)
- Change in expertise of Advisory Committee (SV)
- Differences in regulatory workload (PCE)
- Differences in systems for performing review (PCE)