Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

February 16 - 17, 2005

Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD 20814

AGENDA

Day 1

8:30 a.m. Call to Order Dr. Gary Overturf, Chair

8:35 Administrative Matters Christine Walsh R.N., FDA

Session 1 – Open Committee Discussion – Strain Selection for

Influenza Virus for the 2005 – 2006 Season

8:45 Introduction Dr. Roland Levandowski, FDA

9:45 U.S. Surveillance Dr. Keiji Fukuda, CDC

10:15 Break

10:30 World Surveillance and Strain Dr. Nancy Cox, CDC

Characterization

11:00 Additional Reports Linda Canas, DOD

12:00 Lunch

1:00 Open Public Hearing

1:30 Vaccine Responses Dr. Roland Levandowski

2:00 Availability of Strain and Reagents Dr. Zhiping Ye, FDA

2:15 Comments from Manufacturers Albert Thomas, sanofi pasteur

3:00 Break

3:15 Options for Strain Selection Dr. Roland Levandowski

3:30 Committee Discussion and Recommendation

5:00 Adjourn for the day

Food And Drug Administration

Center For Biologics Evaluation And Research

Vaccines And Related Biological Products Advisory Committee Meeting

February 16 - 17, 2005

AGENDA

Day 2

8:30 a.m. Call to Order Dr. Gary Overturf, Chair

8:35 Announcements Christine Walsh, R.N.

8:45 Open Public Hearing

Session II – Open Committee Discussion – FDA Critical Path Initiative Update

9:15 Presentation to Committee Dr. Mary Foulkes, FDA

Dr. Jerry Weir, FDA

9:45 Q&A

9:50 Break

Session III – Open Committee Discussion – Committee Presentation;

Laboratory of Biophysics and Laboratory of Pediatrics &

Respiratory Viral Diseases

10:05 Overview – Laboratory of Biophysics Dr. Richard Walker, FDA/

Dr. Richard Pastor, FD

10:35 Q&A

10:45 Overview - Laboratory of Pediatrics & Dr. Jerry Weir, FDA

Respiratory Viral Diseases

11:15 Q&A

11:25 Break/Adjourn Open Session

12:00 p.m. Closed Session I

1:00 Break/Adjourn Closed Session 1

1:05 Closed Session II

2:05 Adjourn