FOOD
AND DRUG ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
DRAFT AGENDA
November 16 - 17,
2005 8:30 AM EST
Holiday Inn Select,
8120 Wisconsin Avenue, Bethesda, MD 20814
Day 1
Open Session
8:30 a.m. Call to Order
and Opening Remarks Gary D.
Overturf, M.D., Chair
8:35 Administrative Matters Christine Walsh, R.N., FDA
Use of MDCK Cells for Manufacture of Inactivated
Influenza Virus Vaccines
8:45 a.m. Introduction
and Overview Philip
Krause, M.D., FDA
9:30 Tumorigenicity
Presentation Andrew
Lewis, M.D., FDA
10:15 Break
10:30 Adventitious
Agent Presentation Arifa
Khan, Ph.D., FDA
11:15 Issues
Associated with Residual Keith
Peden, Ph.D., FDA
Cell
Substrate DNA
12:00 noon Lunch
1:00 p.m. Open Public Hearing
1:30 Manufacturer’s
Presentation Rina
Rappuoli, Ph.D.
Chiron
Corporation
2:15 Manufacturer’s
Presentation Jeroen Medema
Solvay
Pharmaceuticals, Inc.
3:00 Break
3:15 Committee
Discussion
5:15 p.m. Adjourn for the day
FOOD
AND DRUG ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
DRAFT AGENDA
November 16 - 17,
2005 8:30 AM EST
Holiday Inn Select,
8120 Wisconsin Avenue, Bethesda, MD 20814
Day 2
8:30 a.m. Closed Session
Open Session
10:00 a.m. Call to Order and
Opening Remarks Gary D. Overturf,
M.D., Chair
10:05 Administrative Matters Christine Walsh, R.N., FDA
Developing New
Pneumococcal Vaccines for U.S. Licensure for Adults
10:20 a.m. FDA Presentation Douglas Pratt, M.D., M.P.H., FDA
Presentation of Questions
10:50 Opsonophagocytic Activity (OPA) Assays Sandra Steiner, Ph.D., CDC
11:20 Epidemiology of Invasive Pneumococcal Matthew R. Moore, M.D., M.P.H., C.D.C.
Disease in Adults
12:00 p.m. Lunch
1:00 p.m. Open Public
Hearing
1:30 Presentation Jan Poolman, Ph.D.
GlaxoSmithKline, Inc.
2:00 Presentation George Siber, M.D.
Wyeth
2:40 Presentation Louis Fries, M.D.
ID Biomedical Corporation
3:10 FDA Presentation of Questions Marion Gruber, Ph.D., FDA
3:15 Break
3:30 Committee Discussion of FDA Questions/
Committee Recommendations
5:30 Adjourn
Meeting