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November 16-17, 2010: 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 Meeting

Hilton Silver Spring Hotel, Silver Spring, MD
November 16 - 17, 2010
DRAFT AGENDA

Day 1

Topic 1: Pathway to Licensure for Protective Antigen-based Anthrax Vaccines for a Post-exposure Prophylaxis Indication Using the Animal Rule

Open Session

9:00 a.m.Call to Order
Administrative Remarks
Jack Stapleton, M.D., Chair
Don Jehn, M.S., FDA
9:05CBER Introduction/Presentation of DiscussionDrusilla Burns, Ph.D., FDA
9:25 - 10:05NIAID Studies Q&AEdwin Nuzum, DVM, Ph.D., NIH
10:20 - 10:45CDC Studies Q&AConrad Quinn, Ph.D., CDC
11:00 - 11:30CBER Summary Q&ADrusilla Burns, Ph.D., FDA
11:45Break and Clear Room for Closed Session 

Closed Session

12:00 p.m. 
12:30Lunch

Closed Session

1:30

Open Session

2:00Public Entry 
2:15Open Public Hearing 
2:45Committee Discussion and Recommendations 
4:00Adjourn for the Day
 
 

Day 2

Topic 2: Effectiveness of Vaccinating Males and Females with Gardasil for the Prevention of Anal Dysplasia and Anal Cancer

Open Session

8:30

Call to Order
Administrative Issues
Presentation of Retirement Plaques

Jose Romero, M.D., Acting Chair
Don Jehn, MS, FDA
Norman Baylor, Ph.D., FDA
8:45CBER Introduction/Presentation of DiscussionJeffrey Roberts, M.D., FDA
 Merck & Co. Presentation 
8:55Overview of Anal HPV Infection, Anal Intraepithelial Neoplasia, and Anal CancerJoel Palefsky, MD, FRCP (C)
Professor of Medicine, UCSF
9:40GARDASIL in the Prevention of Anal CancerPatrick Brill-Edwards, MD, FRCP (C)
Director, Regulatory Affairs
Merck & Co.
 Results of the AIN StudyElizabeth Garner, MD, MPH
Director, Clinical Research
Merck & Co.
10:40Break 
11:00Clinical Review of Data Supporting the Efficacy of Gardasil in the Prevention of
Anal Dysplasia and Anal Cancer
Jeffrey Roberts, M.D., FDA
11:45Open Public Hearing 
12:15 p.m.Committee Discussion and Recommendations 
1:15Adjourn Meeting