FOOD AND DRUG
ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
November
28-29, 2001
Holiday Inn, Bethesda
8:30 am Session 1, 2, 3
- CLOSED SESSIONS
12:30 pm Session 4 -
OPEN Session
Efficacy
Trial Endpoints for Vaccines for the Prevention of Human Papilloma Virus
12:30 Call to Order, Dr.
Robert S. Daum,
Introductions,
Administrative Matters Committee
Chair
12:45 Introduction
to Session and Dr.
Karen Goldenthal, FDA
Presentation of Questions or
Dr. Douglas Pratt, FDA
1:00 Natural History and Virology Dr. Beth Unger
1:45 Clinical
Management/Natural History Dr.
Edward Wilkinson
of
Cervical Dysplasia and Related Findings
2:30 Break
2:45 Endpoints Dr.
Karen L. Goldenthal, FDA
Re-introduction
of Questions and Q & A
3:30 Open Public
Hearing
4:45 Adjourn for the Day
FOOD AND DRUG
ADMINISTRATION
CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH
November
28-29, 2001
Holiday Inn, Bethesda
DRAFT AGENDA
Thursday, November 29, 2001
8:30
AM Session 4 – Open Session
-- Continued
8:30 Call
to Order Dr.
Robert S. Daum
8:40 Committee
Discussion and Recommendations
12:00
noon Lunch
1 PM Session 5 – Open Session
Briefing
on Activities in the Laboratory of Bacterial Toxins
1:00 Organizational
Structure and Overview of Dr. Richard Walker, FDA
Research
and Regulatory Responsibilities in the
Division
of Bacterial, Parasitic and Allergenic Products
1:10 Organizational
Structure and Overview of Regulatory Dr.
Willie Vann, FDA
Responsibilities
in the Laboratory of Bacterial Toxins
1:15 Description
of Research Activities Dr.
Willie Vann, FDA
1:25 Description
of Research Activities Dr.
Michael Schmitt
1:35 End
of Open Sessions
1:45 Session 6
– CLOSED SESSION
2:30 End
of Closed Session; Adjournment of Meeting