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

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.	Open Public Hearing
10:35 a.m.	Break
10:50 a.m.	Closed Session
11:30 a.m.	Lunch

Topic 2: Demonstration of Effectiveness of Meningococcal Serogroups A, C, Y, and W-135 Conjugate Vaccines in Children Younger 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.	Measurement of Serum Bactericidal Antibody as an Indicator of Vaccine Effectiveness	Wendell Zollinger, Ph.D., Meningococcal Vaccines Consultant
1:40 p.m.	An Approach to Demonstrate Meningococcal Conjugate Vaccine Effectiveness 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	Lucia Lee, M.D., FDA
	Committee Discussion
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 Demonstrate Effectiveness 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.	An Approach to the Evaluation of Vaccines To Prevent Group B Meningococcal Disease	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