Post on 03-Jan-2016
Workshop on Leukocyte Reduction of Blood and Blood Components:
An Update
Alan E. Williams, Ph.D.
Division of Blood Applications
OBRR/CBER/FDA
July 20, 2005
Workshop Goals:
• Review new evidence regarding leukocyte reduction for non-targeted recipient populations. (Assume accepted medical value of leukocyte reduction for targeted recipient populations)
• Update on leukoreduction failures and adverse events– Incomplete filtration – Incomplete WBC removal– Recipient adverse events – Blood establishment experiences
• Practical, effective process control
Morning Agenda:
Welcome and Introduction Jay S. Epstein, M.D.
Director, Office of Blood Research and Review, (OBRR), CBER, FDA
U.S. Regulatory Considerations and International Policies Regarding Leukocyte ReductionAlan E. Williams, Ph.D.
Director, Division of Blood Applications, OBRR, CBER, FDA
Morning Agenda (cont.):
Recent Studies Addressing the Value of Pre-storage Leukoreduction for Non-Targeted Recipients Robertson Davenport, MD, University of Michigan
The Yale-New Haven Hospital Universal Leukocyte Reduction Program Edward Snyder, M.D. Yale University School of Medicine
Morning Agenda (cont.):
The Impact of Pre-storage Leukoreduction Among Transfused Trauma PatientsAvery Nathans, MD, PhD, MPH , Univ of Washington
Adverse Events and Manufacturing Failures Associated with Leukoreduction. David Stroncek, MD, Department of Transfusion Medicine, NIH
Questions for morning speakers and Open Public Hearing
Afternoon Agenda:
Practical Aspects of Pre-storage Leukoreduction in a Blood Establishment, including Use of Pooled Samples for Enumeration of Residual LeukocytesTimothy Malone, Florida Blood Services
Practical Aspects of Pre-storage Leukoreduction in Blood EstablishmentsDan Waxman, M.D., America’s Blood CentersFred Walker, Ph.D. American National Red Cross
Afternoon Agenda (cont.):
FDA Current Considerations: Pre-Storage Leukoreduction: Process Validation, Quality Assurance and Monitoring, Processing, Testing, and LicensureAlan Williams, PhD and Sharyn Orton, PhD, Division of Blood
Application, OBRR, CBER
Questions for Afternoon Speakers and Open Public Hearing
Afternoon Agenda (cont.):
Panel Discussion: Dana Devine, Ph.D.
Larry Dumont,Ph.D.
Celso Bianco, MD
Michael Busch, MD Ph.D.
Harvey Klein MD
Gary Moroff, Ph.D.
Moderator: Alan E. Williams, Ph.D.
Afternoon Agenda (cont.):
Prion Reduction by FiltrationLuisa Gregori, Ph.D. University of Maryland
Pall Leukotrap Affinity Filtration System:UpdateJerry Ortolano, PhD, Pall Corporation