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


Opening Remarks

Suzette Priola, PhD, NIAID, NIH, Chairperson TSEAC

Informational Presentations




Update on US and worldwide BSE status

Lisa Ferguson, DVM, APHIS, USDA


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


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


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


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

Steven Anderson, PhD, OBE, CBER


Prevalence estimates for vCJD in the UK

David Asher, MD, OBRR, CBER


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

Alan Williams, PhD, OBRR, CBER


VCJD infectivity of plasma estimates from experimental models

David Asher, MD, OBRR, CBER


Review of TSE clearance in FVIII product manufacturing

Dorothy Scott, MD, OBRR, CBER


FVIII product usage in clinical settings

Mark Weinstein, PhD, OBRR, CBER


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


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


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

Pall Corporation representative


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

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


Other industry/academic filter/chromatography developer

Alicon AG, Schlieren, Switzerland, representative



Open Public Hearing



Committee discussion and recommendations


5:30 Adjourn