Advisory Committee
Holiday Inn Bethesda
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8:00 a.m. |
Administrative
Remarks |
William
Freas, PhD, CBER, Executive Secretary
TSEAC |
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8:10 |
Recognition
of Committee Service |
Jesse
L. Goodman, MD, MPH Director, CBER |
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8:15 |
Opening
Remarks |
Suzette
Priola, PhD, NIAID, NIH, Chairperson TSEAC |
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Informational
Presentations
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8:20 |
Update
on US and worldwide BSE status |
Lisa
Ferguson, DVM, APHIS, USDA |
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8:35 |
Scientific
issues in evaluating products intended to decontaminate surgical instruments
exposed to TSE agents: discussions of a recent FDA Device Panel |
Sheila
Murphey, MD, CDRH |
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Topic 1: Progress Report on FDA’s Risk Assessment
for Potential Exposure to Variant Creutzfeldt-Jakob Disease in Human Plasma-Derived
Antihemophilic Factor (FVIII) Products |
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8:50 |
Introduction
and Questions to the Committee |
Dorothy
Scott, MD, OBRR, CBER |
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9:00 |
Variant
CJD risk associated with human plasma derivatives: Introduction and overview of risk model |
Steven
Anderson, PhD, OBE, CBER |
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9:30 |
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 |
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10:30 |
Break |
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10:50 |
Modeling
risk of vCJD in US donors – residual risk and efficiency of donor deferral |
Alan
Williams, PhD, OBRR, CBER |
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11:05 |
VCJD
infectivity of plasma – estimates from experimental models |
David
Asher, MD, OBRR, CBER |
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11:15 |
Review
of TSE clearance in FVIII product manufacturing |
Dorothy
Scott, MD, OBRR, CBER |
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11:30 |
FVIII
product usage in clinical settings |
Mark
Weinstein, PhD, OBRR, CBER |
TSEAC Agenda, October 31, 2005, (continued)
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11:45 |
Open
Public Hearing (30 min) |
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12:15 Lunch
1:15 Committee discussion and
recommendations
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Topic 2:
Labeling Claims for Filters Intended to Remove TSE Infectivity from
Blood Components |
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2:45 |
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 |
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3:00 |
Evaluation
of prion reduction filters |
Marc
Turner, MB ChB, PhD, FCRP(Lond) University of Edinburgh |
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3:10 |
Performance
of Pall Corporation Leukoreduction filters on TSE infectivity of blood
components: experimental studies and European experience |
Dr.
Sam Coker, Pall Corporation |
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3:30 |
Selection
and performance of resin-bound ligands for removal of TSE infectivity from
plasma |
Robert
Rohwer, PhD, PRDT (with ProMetic and ARC), Rockville MD |
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3:50 |
Other
industry/academic filter/chromatography developer |
Dr. Ralph Zahn, CEO Alicon AG, Schlieren,
Switzerland |
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4:10 |
Open Public Hearing |
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4:40 |
Committee
discussion and recommendations |
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5:30
Adjourn