Advisory Committees

March 4, 2015: 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
137th Meeting

DoubleTree by Hilton Hotel
Pinnacle Ballroom
8727 Colesville Road
Silver Spring, MD 20910
Tel: (301)-589-5200

Wednesday, March 4, 2015
Live Webcast link (a.m.): https://event.webcasts.com/starthere.jsp?ei=1051813
Live Webcast link (p.m.): https://event.webcasts.com/starthere.jsp?ei=1051814

Draft Agenda
Time Presentation/Presenter
8:30 a.m. Call to Order and Opening Remarks
Introduction of Committee

Robert Daum, M.D.
Chair, VRBPAC
  Conflict of Interest Statement
Sujata Vijh, Ph.D.
Designated Federal Officer, VRBPAC
  Topic: Strain Selection for the Influenza Virus Vaccines for the 2015-2016 Influenza Season
8:45 a.m. Introduction
Anissa Cheung, M.Sc.
Regulatory Coordinator
Division of Viral Products
Office of Vaccines Research and Review
CBER/FDA
8:55 a.m. U.S. Surveillance
Lisa Grohskopf, M.D.
CAPT, USPHS
Associate Chief for Policy & Liaison Activities,
Epidemiology & Prevention Branch
Influenza Division
Centers for Disease Control and Prevention
9:15 a.m. World Surveillance/Virus Characterization
Jacqueline Katz, Ph.D.
Deputy Director (Acting)
Influenza Division
Director, WHO Collaborating Center for Surveillance,
Epidemiology and Control of Influenza,
Center for Immunization & Respiratory Diseases
Centers for Disease Control and Prevention
10:00 a.m. BREAK
10:15 a.m. DoD Vaccine Effectiveness Report
Michael Cooper, Ph.D.
CAPT, PHS
Leader, Respiratory Pillar Activities
Division of Global Emerging Infection Surveillance
Armed Forces Health Surveillance Center
10:35 a.m. Vaccine Responses
Zhiping Ye, M.D., Ph.D.
Senior Investigator
Division of Viral Products
Office of Vaccines Research and Review
CBER/FDA
10:55 a.m. Candidate Vaccine Strains & Potency Reagents
Manju Joshi, Ph.D.
Lead Biologist
Division of Biological Standards & Quality Control
Office of Compliance and Biologics Quality
CBER/FDA
11:15 a.m. Comments from Manufacturers
Sam Lee, Ph.D.
Senior Director, Pandemic & New Influenza Products
Franchise & Product Strategy
Sanofi Pasteur
11:35 a.m. LUNCH
12:40 p.m. Open Public Hearing
1:40 p.m. Committee Discussion, Voting, and Recommendations
3:00 p.m. Adjournment

Page Last Updated: 03/02/2015
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