Food and Drug
Administration
Transmissible
Spongiform Encephalopathies Advisory Committee
September 18-19, 2006
Slides
September 18, 2006
BSE: World Update, L. Ferguson, DVM, USDA (ppt)
(htm)
Update: - vCJD Epidemiology and Transfusion-transmission,
D. Scott, M.D., FDA (ppt)
(htm)
Draft Guidance for Industry: Amendment (Donor Deferral for
Transfusion in France Since 1980), A. Williams, Ph.D., FDA
(ppt) (htm)
Critical Factors Iinfluencing Prion Decontamination Using
Sodium Hydroxide – PPTA Collaborative Study, K. Cai,
Ph.D, PPTA, Talecris Biotherapeutics (ppt)
(htm)
TSE Clearance Studies for pdFVIII: Study Methods and Clearance
Levels, D. Scott, M.D., FDA (ppt)
(htm)
Industry TSE Clearance Studies for pdFVIII, T. Kreil, Ph.D.,
PPTA, Baxter Bioscience (ppt)
(htm)
Update: Status of FDA’s Initiative on Communication
of the Potential Exposure to vCJD Risk from an Investigational
Product, Plasma Derived Factor XI that was Manufactured from
UK Donor Plasma, M. Weinstein, Ph.D., FDA (ppt)
(htm)
Summary of World Health Organization Consultation on Distribution
of Iinfectivity in Tissues of Animals and Humans with Transmissible
Spongiform Encephalopathies, D. Asher, M.D., FDA (ppt)
(htm)
September 19, 2006
Potential Screening Assays to Detect Blood and Plasma Donors
Infected with TSE Agents: Possible Criteria for Validation,
P. Piccardo, MD, FDA (ppt)
(htm)
Proposed Algorithm for Approval of Human TSE Tests in Europe,
M. Turner, MBChB, PhD, FRCP, FRCPath, University of Edinburgh
(ppt) (htm)
Objective: To define a process such that if an assay method
successfully completes it, it is justifiable to try it in
the Blood Transfusion Service at some scale. (ppt)
(htm)
Development of Rapid Blood Screening Tests for vCJD, Alex
Raeber, Prionics AG (ppt)
(htm)
Use of PMCA for Biochemical Diagnosis of Prion Diseases,
Claudio Soto, PhD, University of Texas Medical Branch and
Aprion Inc. (ppt) (htm)
The Seprion Separation System: Development of a feasible
blood screening protocol for abnormal prion protein, Stuart
Wilson, Microsens Biotechnologies (ppt)
(htm)
Detection of PrPres in Plasma, H. Perron, Biomerieux (ppt)
(htm)
Pronucleon Amplified Misfolded Protein Diagnostic Assay (AMP-D)
Kenton Lohman, Ph.D., Adlyfe Inc. (ppt)
(htm)
CHIRON Submission, David Peretz, M.Sc., D.Sc. (ppt)
(htm)
Open Public Hearing Speakers
List of Speakers for September 18-19, 2006 (pdf)
Committee of Ten Thousand (pdf)
Transmissible Spongiform Encephalopthy Advisory Committe,
Charles Sims, MD, FDA (pdf)
The Case for Reconsidering the FDA Restriction on the Use
of Cells and Tissues from Individuals Having Resided in Europe
for 5 or More Years (pdf)
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