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