(DRAFT)

 

FOOD AND DRUG ADMINISTRATION

 

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

 

Holiday Inn, Ballroom 2

2 Montgomery Village Avenue

Gaithersburg, MD 20879

February 20, 2003

 

DRAFT AGENDA (revised 2/14/03)

 

 

Thursday, February 20, 2003

 

OPEN SESSION

 

8:00 a.m. Administrative Remarks,

William Freas, Ph.D., Executive Secretary

8:10 a.m. Presentation of Plaques to Former Members

Lester Crawford, D.V.M., Ph.D.

Deputy Commissioner, FDA

8:20 a.m. Opening Remarks

Suzette Priola, Ph.D., Acting Chairperson

 

8:25 a.m. Update #1: Implementation vCJD Guidance - Blood Supply

after Implementation of European Donor Deferral

Overview of Blood Supply Monitoring (25 minutes)

Alan Williams, Director, Division of Blood Applications,

OBRR, FDA

 

Blood Supply Monitoring

DHHS: Capt. Lawrence McMurtry

Acting Executive Secretary, DHHS Advisory Committee on Blood Safety and Availability

ABC: Celso Bianco, M.D.

Executive Vice President, ABC

ARC: Peter L. Page, M.D.

Senior Medical Officer, ARCBS-BHQ

NYBC: Robert Jones, M.D.

President, New York Blood Center

AABB: Kay Gregory, MS, MT(ASCP)SBB

Director Regulatory Affairs, AABB

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE AGENDA

 

 

Thursday, February 20, 2003 (Continued)

 

9:55 a.m. Questions for Presenters

 

10:10a.m OPEN PUBLIC HEARING (20 minutes)

 

10:30 a.m. BREAK

 

10:45 a.m. Update #2: BSE Epidemiology and Food Chain Controls

David Asher, M.D., OBRR, FDA

 

11:15 a.m. Topic #1: Consideration of Labeling Claims for Transmissible Spongiform Encephalopathy (TSE) Agent Clearance in Plasma Derivatives

 

Introduction

Dorothy Scott, M.D., OBRR, FDA

 

Virus Removal from Blood Products: Validation, Label Claims and Possible Paradigm for Removal of TSE Agents Mahmood Farshid, Ph.D., OBRR, FDA (15 minutes)

 

TSE Agent Clearance Issues (15 minutes)

Dorothy Scott, M.D., OBRR, FDA

 

Risk Analysis for TSE and Plasma Derivatives

Steven Anderson, Ph.D., OBE, FDA (30 min)

 

European Perspective on TSE Agent Clearance in Plasma Derivatives

Sol Ruiz, Ph.D., Division of Biologicals and Biotechnology, Spanish Medicines Agency (20 minutes)

12:45 p.m. LUNCH

 

1:45 p.m. Committee Discussion

2:05 p.m. TSE Clearance Studies Scientific Presentations from Industry

Confirmed by PPTA:

 

 

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE AGENDA

 

Thursday, February 20, 2003 (Continued)

 

3:35 p.m. OPEN PUBLIC HEARING

 

4:15 p.m. BREAK

 

4:30 p.m. Questions to the Committee

 

4:35 p.m. Committee Discussion and Vote

 

5:35 p.m. ADJOURN