Agenda

FOOD AND DRUG ADMINISTRATION

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

February 8, 2005

Hilton Hotel

8727 Colesville Road

Silver Spring, MD

8:00 a.m. Administrative Remarks

8:10 Opening Remarks

Suzette Priola, Ph.D., Chairperson

8:20 Informational Presentation

Update on BSE surveillance in the U.S., Lisa Ferguson, DVM, USDA

8:30 Topic # 1 - Possible vCJD Risk from Investigational Coagulation Factor XI Manufactured before 1998 from Plasma of Donors Residing in the United Kingdom

A. Introduction (10’), Mark Weinstein, Ph.D., OBRR, FDA

B. Risk Assessment – U.K. plasma derivatives

Risk assessment methods and assumptions and U.K. actions based on risk assessment (40’), Kate Soldan, Ph.D., and Anna Molesworth, MSc, U.K. Health Protection Agency

C. Risk assessment for U.K. FXI (45’), Steven. Anderson, Ph.D., OBE, FDA

D. Current public health recommendations on management of surgical instruments used on patients with TSE or TSE risk (10’), Lynne Sehulster, Ph.D., CDC

10:15 Questions for Speakers

10:25 Open Public Hearing

10:40 Break

10:50 a.m. Committee Discussion and Vote

TSEAC AGENDA, February 8, 2005, page 2

11:30 Topic # 2 – Risk Assessment Models for Potential Risk of Exposure to variant Creutzfeldt-Jakob Disease (vCJD) Agent in Plasma Products

A. Introduction – Rationale for risk assessments; question to Committee (10’) Dorothy Scott, M.D., OBRR, FDA

B. Preliminary Risk Assessment – U.S.

1. Potential TSE clearance steps in U.S. products - FVIII, FIX, IGIV (10’), Dorothy Scott, M.D., OBRR, FDA

2. Risk Assessment Model for U.S. plasma derivatives (40’) Steve Anderson, Ph.D., OBE, FDA

12:30 p.m. Questions for Speakers

12:40 Lunch

1:40 Open Public Hearing

2:10 Committee Discussion and Vote

3:05 Break

3:15 Topic # 3 – Potential Deferral of Blood and Plasma Donors for History of Transfusion in European Countries

A. Introduction (10’), Alan Williams, Ph.D., OBRR, FDA

B. Epidemiology of vCJD in France and risk assessments for blood and plasma derivatives (25’), Dr. Jean-Philippe Brandel, Neurologist, Epidemiosurveillance Network

C. Estimates of blood-borne vCJD risk in the U.K. and other European populations (20’), Sheila M. Bird, M.A., Ph.D, Medical Research Council Biostatistics Unit, Institute of Public Health, Cambridge University, UK

D. Risks and benefits of deferring donors transfused in France and other European countries: potential impact on blood and plasma supplies, and presentation of questions for the committee (20’), Alan Williams, Ph.D.

4:30 Open Public Hearing

4:50 Committee Discussion and Vote

5:35 p.m. Adjourn