April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Draft Agenda

Food and Drug Administration
Center for Biologics Evaluation and Research
Vaccines and Related Biological Products Advisory Committee
126th Meeting

Hilton Hotel Washington DC North/Gaithersburg
620 Perry Parkway Gaithersburg, MD
April 6 – 7, 2011

Open Session
9:00 a.m.	Call to Order and Opening Remarks	Patricia Ferrieri, M.D., Acting Chair
9:05 a.m.	Conflict of Interest Statement	Donald Jehn, M.S., FDA

Topic 1: Presentation of Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, & Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research

9:15 a.m.	Overview of Research/Site Visit Process, Center for Biologics Evaluation and Research (CBER)	Carolyn Wilson, Ph.D., FDA
9:25 a.m.	Overview of Office of Vaccines Research and Review (OVRR), CBER	Konstantin Chumakov, Ph.D., FDA
9:35 a.m.	Overview of Division of Bacterial, Parasitic & Allergenic Products (DBPAP), OVRR	Jay Slater, M.D., FDA
9:45 a.m.	Laboratory of Bacterial Polysaccharides	Willie Vann, Ph.D., FDA
10:00 a.m.	Q & A
10:05 a.m.	Break
10:20 a.m.	Open Public Hearing
10:50 a.m.	Closed Session
11:30 a.m.	Lunch

Topic 2: Immunologic Markers for Demonstration of Effectiveness of Meningococcal Serogroups A, C, Y, and W-135 Conjugate Vaccines Administered to Children Less Than 2 Years of Age

Open Session
12:30 p.m.	Introduction/Background	Lucia Lee, M.D., FDA
12:40 p.m.	Epidemiology of Meningococcal Disease in the U.S.	Amanda Cohn, M.D., CDC
1:10 p.m.	Serum Bactericidal Antibody Assay	Wendell Zollinger, Ph.D.
1:40 p.m.	Approach to Licensure of Meningococcal Conjugate Vaccines in Children Less than 2 Years of Age	Lucia Lee, M.D., FDA
2:10 p.m.	Break
2:30 p.m.	Open Public Hearing
3:00 p.m.	Presentation of Discussion Points Committee Discussion	Lucia Lee, M.D., FDA
4:00 p.m.	Adjourn for the Day

Day 2 – April 7, 2011

Open Session
8:30 a.m.	Call to Order and Opening Remarks	Patricia Ferrieri, M.D., Acting Chair
8:35 a.m.	Conflict of Interest Statement	Donald Jehn, M.S., FDA

Topic 3: Approaches to Licensure of Meningococcal Serogroup B Vaccines

8:45 a.m.	Introduction/Background	Margaret Bash, M.D., MPH, FDA
9:00 a.m.	Epidemiology of N. meningitis Serogroup B Disease (U.S./Worldwide)	Thomas Clark, M.D., MPH, CDC
9:30 a.m.	Molecular Epidemiology and Antigen Diversity of Candidate Vaccine Targets	Leonard Mayer, Ph.D., CDC
10:15 a.m.	Break
10:30 a.m.	Immune Parameters/Assays Selection of Serogroup B Strains to be Used in Assays	Margaret Bash, M.D., MPH, FDA
11:15 a.m.	Licensure Approach	Rino Rappuoli, Ph.D., John Donnelly, Ph.D. Novartis
11:45 a.m.	Lunch
1:00 p.m.	Licensure Approach	Kathrin Jansen, Ph.D. Pfizer, Inc.
1:30 p.m.	Open Public Hearing
2:00 p.m.	Break
2:15 p.m.	Presentation of Discussion Points Committee Discussion	Margaret Bash, M.D., MPH, FDA
3:30 p.m.		Adjourn Meeting