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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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.

9. 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