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Food and Drug Administration

Center for Biologics Evaluation and Research

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

AGENDA

Meeting #31, Holiday Inn, Gaithersburg, MD

October 25-26, 2001

 

Thursday, October 25

8:00 a.m. Opening Remarks

Dr. Daniel Salomon, Chair

8:15 Conflict of Interest Statement

Gail Dapolito, Executive Secretary

8:20 Introduction of Committee

Topic 1 – Lentivirus Vectors in Gene Transfer Clinical Trials

Introduction

8:30 Dr. Inder Verma, Salk Institute

9:00 Q&A

FDA Perspective

9:15 Dr. Daniel Takefman

9:45 Q&A

10:00 Break

Guest Presentations

10:15 Dr. Dale Ando, Cell Genesys, Inc.

Dr. Gabor Veres, Cell Genesys, Inc.

11:00 Q&A

11:15 Dr. Jeffrey Kordower, Rush Presbyterian Medical Center

12:00 Q&A

12:15 p.m. Lunch

1:15 Dr. Susan Kingsman, Oxford BioMedica (UK) Ltd.

2:00 Q&A

 

BRMAC Meeting #31

Agenda – Page 2

Thursday, October 25 (cont’d)

2:15 p.m. Dr. John Kappes, University of Alabama at Birmingham

2:45 Q&A

3:00 Open Public Hearing

3:15 Break

3:30 Committee Discussion of Questions

5:30 – 6:00 Adjourn

 

Friday, October 26

8:00 a.m. Opening Remarks

Dr. Daniel Salomon, Chair

Topic 2 – Lentivirus Vector Gene Transfer Product for Treatment of People with HIV

Guest Presentation

8:15 Dr. Boro Dropulic, VIRxSYS Corp.

9:45 Q&A

10:00 Break

10:15 Open Public Hearing

10:30 Committee Discussion of Questions

12:00 noon Lunch

12:30 p.m. Committee Discussion (cont’d)

2:00 Adjourn