Workshop on Leukocyte Reduction of Blood and Blood Components: An Update

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 Reduction

• Alan 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 Patients

• Avery 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 Leukocytes

• Timothy Malone, Florida Blood Services

• Practical Aspects of Pre-storage Leukoreduction in Blood Establishments

• Dan Waxman, M.D., America’s Blood Centers
• Fred 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 Licensure

• Alan 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 Filtration

• Luisa Gregori, Ph.D. University of Maryland

• Pall Leukotrap Affinity Filtration System:Update

• Jerry Ortolano, PhD, Pall Corporation