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U.S. Department of Health and Human Services

Advisory Committees

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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 RemarksPatricia Ferrieri, M.D., Acting Chair
9:05 a.m.Conflict of Interest StatementDonald 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), CBERKonstantin Chumakov, Ph.D., FDA
9:35 a.m.Overview of Division of Bacterial, Parasitic & Allergenic Products (DBPAP), OVRRJay Slater, M.D., FDA
9:45 a.m.Laboratory of Bacterial PolysaccharidesWillie 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/BackgroundLucia 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 AssayWendell Zollinger, Ph.D.
1:40 p.m.Approach to Licensure of Meningococcal Conjugate Vaccines in Children Less than 2 Years of AgeLucia 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 RemarksPatricia Ferrieri, M.D., Acting Chair
8:35 a.m.Conflict of Interest StatementDonald Jehn, M.S., FDA

Topic 3: Approaches to Licensure of Meningococcal Serogroup B Vaccines

8:45 a.m.Introduction/BackgroundMargaret 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 TargetsLeonard 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 AssaysMargaret Bash, M.D., MPH, FDA
11:15 a.m.Licensure ApproachRino Rappuoli, Ph.D.,
John Donnelly, Ph.D.
Novartis
11:45 a.m.Lunch 
1:00 p.m.Licensure ApproachKathrin 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