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

Opening Remarks

Suzette Priola, PhD, NIAID, NIH, Chairperson TSEAC

Informational Presentations

 

 

8:15

Update on US and worldwide BSE status

Lisa Ferguson, DVM, APHIS, USDA

8:30

Criteria for considering label claims of effective decontamination for surgical instruments exposed to TSE agents: discussions of a recent FDA Device Panel

Sheila Murphey, MD, or other, CDRH

8:45

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

9:45

Questions for speakers

 

10:15 Break

 

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

10:35

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

Steven Anderson, PhD, OBE, CBER

10:50

Prevalence estimates for vCJD in the UK

David Asher, MD, OBRR, CBER

11:05

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

Alan Williams, PhD, OBRR, CBER

11:20

VCJD infectivity of plasma estimates from experimental models

David Asher, MD, OBRR, CBER

11:35

Review of TSE clearance in FVIII product manufacturing

Dorothy Scott, MD, OBRR, CBER

11:50

FVIII product usage in clinical settings

Mark Weinstein, PhD, OBRR, CBER

12:05

Summary of FDA proposals for FVIII risk assessment input parameters

Steven Anderson, PhD, OBE, CBER

12:20 Open Public Hearing

1:00 Lunch

2:00 Committee discussion and recommendations

 

TSEAC Agenda, October 31, 2005, (continued)

 

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

3:00

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

3:15

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

Pall Corporation representative

3:35

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

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

3:55

Other industry/academic filter/chromatography developer

Alicon AG, Schlieren, Switzerland, representative

 

4:15

Open Public Hearing

 

4:45

Committee discussion and recommendations

 

5:30 Adjourn