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February 28, 2014: 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
135th Meeting
FDA White Oak Campus, Bldg 31, Great Room
Silver Spring, Maryland
February 28, 2014

DRAFT AGENDA
8:00 a.m Call to Order and Opening Remarks
Introduction of Committee
Robert Daum, M.D.
Chair, VRBPAC
Conflicts of Interest Statement Prabha Atreya, Ph.D. 
Designated Federal Officer, VRBPAC
Topic I: Presentation of Laboratory of Respiratory Viral Diseases, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research
8:15 a.m. Overview of the CBER and OVRR Research and Site Visit process Carolyn Wilson, Ph.D.
Associate Director for Research
CBER/FDA
8:45 a.m. Overview of the Division of Viral Products & Laboratory of Respiratory Viral Diseases Jerry Weir, Ph.D.
Director
Division of Viral Products and Acting Chief, LRVD
OVRR/CBER/FDA
9:30 a.m. Closed Session
10:00 a.m. Break
Topic II:  Strain Selection for the Influenza Virus Vaccine for the 2014-2015 Influenza Season
10:30 a.m. Conflict of Interest Statement Prabha Atreya, Ph.D.
Designated Federal Officer
10:45 a.m. Topic Introduction Jerry Weir, Ph.D.
Director
Division of Viral Products
OVRR/CBER/FDA
10:55 a.m. U.S. Surveillance Lisa Grohskopf, M.D.
CAPT, USPHS
Associate Chief for Policy & Liaison Activities, Epidemiology & Prevention Branch, Influenza Division, CDC
11:15 a.m. World Surveillance/Virus Characterization Nancy Cox, Ph.D.
Director, Influenza  Division
Director, WHO Collaborating Center
Center for Surveillance, Epidemiology and Control of Influenza, and National Center for Immunization & Respiratory Diseases, CDC
12:00 p.m. DoD Vaccine Effectiveness Report CAPT Michael J. Cooper, Ph.D.
USPHS
Leader, Respiratory Pillar Activities
Division of GEIS
Armed Forces Health Surveillance Center
12:20 p.m. Lunch
1:20 p.m. Vaccine Responses Zhiping Ye, M.D., Ph.D.
Senior Investigator
Division of Viral Products
OVRR/CBER/FDA
1:40 p.m. Availability of Vaccine Viruses & Reagents Manju Joshi, Ph.D.
Lead Biologist
Division of Biological Standards & Quality Control,
OCBQ/CBER/FDA
2:00 p.m. Comments from Manufacturers Sam Lee, Ph.D.
Senior Director, Pandemic Influenza Strategy
Sanofi Pasteur
2:20 p.m. Open Public Hearing
3:20 p.m. Committee Discussion and Recommendations
4:20 p.m. Adjourn