Food and Drug Administration

Transmissible Spongiform Encephalopathies

Advisory Committee

Monday, October 31, 2005

Holiday Inn Bethesda

 

8:00 a.m.

Administrative Remarks

William Freas, PhD, CBER, Executive Secretary TSEAC

8:10

Recognition of Committee Service

Jesse L. Goodman, MD, MPH Director, CBER

8:15

Opening Remarks

Suzette Priola, PhD, NIAID, NIH, Chairperson TSEAC

Informational Presentations

 

 

8:20

Update on US and worldwide BSE status

Lisa Ferguson, DVM, APHIS, USDA

8:35

Scientific issues in evaluating products intended to decontaminate surgical instruments exposed to TSE agents: discussions of a recent FDA Device Panel

Sheila Murphey, MD, CDRH

 

Topic 1: Progress Report on FDAs Risk Assessment for Potential Exposure to Variant Creutzfeldt-Jakob Disease in Human Plasma-Derived Antihemophilic Factor (FVIII) Products

8:50

Introduction and Questions to the Committee

Dorothy Scott, MD, OBRR, CBER

9:00

Variant CJD risk associated with human plasma derivatives: Introduction and overview of risk model

Steven Anderson, PhD, OBE, CBER

9:30

Update on vCJD in UK and other countries: estimates of prevalence

Azra C. Ghani, PhD, London School of Hygiene and Tropical Medicine

Richard Knight, MD UK, Director, CJD Surveillance Unit, Edinburgh

10:30

Break

 

10:50

Modeling risk of vCJD in US donors residual risk and efficiency of donor deferral

Alan Williams, PhD, OBRR, CBER

11:05

VCJD infectivity of plasma estimates from experimental models

David Asher, MD, OBRR, CBER

11:15

Review of TSE clearance in FVIII product manufacturing

Dorothy Scott, MD, OBRR, CBER

11:30

FVIII product usage in clinical settings

Mark Weinstein, PhD, OBRR, CBER

 

 

 

 

 

 

TSEAC Agenda, October 31, 2005, (continued)

 

11:45

Open Public Hearing (30 min)

 

12:15 Lunch

1:15 Committee discussion and recommendations

 

Topic 2: Labeling Claims for Filters Intended to Remove TSE Infectivity from Blood Components

2:45

Prospects for reduction or removal of TSE agent infectivity from blood components by filtration and criteria for allowing claims: Introduction

Jaroslav Vostal, MD, PhD, OBRR, CBER

3:00

Evaluation of prion reduction filters

Marc Turner, MB ChB, PhD, FCRP(Lond) University of Edinburgh

3:10

Performance of Pall Corporation Leukoreduction filters on TSE infectivity of blood components: experimental studies and European experience

Dr. Sam Coker, Pall Corporation

3:30

Selection and performance of resin-bound ligands for removal of TSE infectivity from plasma

Robert Rohwer, PhD, PRDT (with ProMetic and ARC), Rockville MD

3:50

Other industry/academic filter/chromatography developer

Dr. Ralph Zahn, CEO Alicon AG, Schlieren, Switzerland

4:10

Open Public Hearing

 

4:40

Committee discussion and recommendations

 

5:30 Adjourn