DRAFT
FOOD AND DRUG
ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
RESEARCH REVIEW
SUBCOMMITTEE OF THE
VACCINES AND
RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
AGENDA
Walter Royal, M.D., Chair
Christine
Walsh, R.N., Executive Secretary
Jesse L. Goodman, M.D., M.P.H.
Director, Center for Biologics Evaluation and Research
CBER
CBER Program Structure
8:35 Overview of CBER Research Programs
Kathryn Carbone, M.D.
Associate Director for Research, CBER
9:00 Overview of the Office of Vaccines Research and Review (OVRR)
Norman Baylor, Ph.D., Director
Office
Regulatory Activities and Priorities
Research Program Introduction
9:30 Q & A
9:50 a.m. Break
Research Review
Subcommittee of the
Vaccines and
Related Biological Products Advisory Committee
Office of Vaccines Research and Review
AGENDA (Cont’d)
Open
Committee Discussion
Michael Brennan, Ph.D., Associate Director of Research, OVRR
Research
Management, Accomplishments and Future Plans
10:40 a.m. Overview of the Division of Viral Products
Jerry Weir,
Ph.D., Director DVP
Mission/Philosophy/Regulatory Activities and
Public Health Impact
Regulatory and Research Expertise
Research Program Structure and Research
Activities and Priorities
11:15 a.m. Overview of the Division of Bacterial Parasitic and Allergenic Products
Richard
Walker, Ph.D., Director DBPAP
Mission/Philosophy/Regulatory Activities and
Public Health Impact
Regulatory and Research Expertise
Research Program Structure and Research
Activities and Priorities
11:45 a.m. Q&A
12:00 p.m. Open Public Hearing
1:00 p.m. Adjourn
Open Session/Lunch
4:30 p.m. Adjourn Closed Session