DRAFT AGENDA – (revised 6/20/01)

FOOD AND DRUG ADMINISTRATION

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

 Holiday Inn
Versailles Ballrooms I & II
Bethesda, Maryland 20814

June 28 & 29, 2001

FIRST DAY,  Thursday, June 28, 2001, OPEN SESSION

8:00 a.m.      Administrative Remarks,
                     William Freas, PhD., Executive Secretary

8:10 a.m.      Opening Remarks
                      David Bolton, PhD., Committee Chairman

8:20 a.m.      Committee Update:
                      Summary of DHHS Action Plan on BSE/TSE
                      Stephen D. Nightengale, M.D.
                      Executive Secretary, DHHS Advisory Committee on
                      Blood Safety and Availability 

TOPIC 1.  Review of on suitability of blood donors who have lived or traveled in various countries based on recent information concerning new-variant Creutzfeldt-Jakob disease (vCJD) and bovine spongiform encephalopathy (BSE)

8:30 a.m.       Introduction, Charge and Questions                       
                      FDA TBA

Estimated Potential Human Exposures to the BSE Agent in Various Countries

8:50                The Geographic BSE Risk Assessment (GBR) Conducted for the  European Commission
                       Joachim Kreysa, PhD.
                                Scientific Steering Committee, European Commission
                                Brussels, Belgium

9:20                vCJD and Blood Product, Risk Assessment, an EU Policy Position                    
Professor Jean-Hugues Trouvin
        Director, Directorate for Evaluation of Medicinal Products and Biologicals
        French Medicine Agency

TSEAC AGENDA, June 28, 2001 (continued)

9:35                Mathematical Modeling of Potential Human BSE Exposures in Various BSE Countries
          Cristl Donnely, PhD.
                      Department of Epidemiology, University of London
                      London, UK  

BSE Exposure, Risk Reduction and Projected Effects on Blood Supply

9:55                Potential Exposures to BSE of Canadian Traveler, Possible Blood and Plasma Donor Deferral                          Policies and Projected Effects on the Canadian Blood Supply
                      Antonio Giulivi, MD.
                                    Associate Director, Bureau of Infectious Diseases,
                                    BloodBorne Pathogens Division
                                    Health Canada

 10:05               Break

 10:25               Estimated Effects of Possible Changes in Blood Donor Deferral Policies on Potential Exposure
                        to BSE Agent and on the Regional and National Blood Supply in the USA
                        Allan Williams, PhD.
                                    Director, Division of Blood Applications
                                    Office of Blood Research and Review
                                    FDA, Rockville, MD

10:55               Open Public Hearing

11:35               Committee Discussion, Conclusions, Votes

12:35               Lunch

Topic 2.            Safety of FDA-Regulated Plasma Derivatives Prepared in Establishments Proposing to Use on the Same Manufacturing Line, Plasma Which Does and Plasma Which Does Not Comply with Potential European Donor Deferrals for vCJD Risk Factors

1:30                 Introduction, Charge and Questions
                       Dorothy Scott, MD., OBRR, FDA

1:40                 Scientific Aspects of Decontamination Methods For Transmissible Spongiform Encephalopathies
Robert Rohwer, PhD.
Director, Molecular Neuro-virology Unit, VA Medical Center, Baltimore

TSEAC AGENDA, June 28, 2001 (continued)

2:25                 Industry Presentations:

                                    vCJD Risk Assessment
                    Dr. Henry Baron, Senior Director - Prion Research,
                    Aventis Behring
             Considerations for Facility Cleaning
                     Jeff Davis, Head of Research and Development,
                    ZLB Switzerland
             Complexities of Manufacturing
                    Gordon Busenbark, Vice President/General Manager
                    Hyland Immuno Plasma
             Impact of vCJD measures re European Donor Deferrals
                     Christopher Healey, President, ABRA

3:25                 Break

3: 40               Open Public Hearing

4:20                 Committee Discussion, Conclusions, Votes

5:30                 Adjourn for day 1

FOOD AND DRUG ADMINISTRATION

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

SECOND DAY,  Friday, June 29, 2001, OPEN SESSION

TOPIC 3.            Update:  Interim results of a new study on the inactivation of TSE agent by the manufacturing process of gelatin

 8:00 a.m.        FDA Introduction
                        Yuan Yuan Chiu, Ph.D., CDER, FDA

  8:15                European Gelatin Industry, Policy and Measures Ensuring TSE Safety
 Michel Schoentjes, Ph.D.   
 Vice President GME

  8:45                Inactivation study: Overview and Results
Robert Rohwer, Ph.D.

  9:45                Break

 10:00               Open Public Hearing

 10:30               FDA Summary
John, Bailey, Ph.D., CFSAN, FDA

10:45               Committee Discussion Committee Discussion        

 11:45               Adjourn