Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

Chintamani Atreya, Simone Glynn, Michael Busch, Steve Kleinman, Edward Snyder, Sara Rutter, James AuBuchon, Willy Flegel, David Reeve, Dana Divine, Claudia Cohn, Brian Custer, Raymond Goodrich, Richard J. Benjamin, Anna Razatos, Jose Cancelas, Stephen Wagner, Michelle MacLean, Monique Gelderman, Andrew CapPaul Ness

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Abstract

On November 29, 2018, experts in the field of infectious diseases, pathogen reduction technologies (PRTs) and other participants from blood centers, academia, and industry gathered at the Food and Drug Administration (FDA) White Oak Campus in Silver Spring, Maryland, for a 2‐day public workshop entitled “Pathogen Reduction Technologies for Blood Safety.” The workshop opened with welcome remarks from Dr. Nicole Verdun, Director, Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), FDA, followed by introductory remarks from Dr. Peter Marks, Director, CBER, FDA. The first day of the workshop focused on blood‐borne infectious agents and their impact on blood safety, experiences of the American Red Cross, and other blood establishments in implementing FDA‐approved pathogen inactivation (PI) technology for plasma and platelets (PLTs) in the United States and novel PRTs under consideration for whole blood (WB) and red blood cells (RBCs).

The second day opened with welcome remarks from Dr. Chintamani Atreya, Associate Director for Research, OBRR, CBER, FDA. The focus was on emerging innovations relevant to PRTs and potential alternatives to PRTs. The workshop concluded with remarks on insights for future research and development in this area for blood and blood product safety from infectious agents.

A brief introduction of each session by the session moderator followed by a summary of the speaker presentation as submitted by the moderator and speaker are reported here.
Original languageEnglish
Pages (from-to)3002-3025
Number of pages24
JournalTransfusion
Volume59
Issue number9
Early online date29 May 2019
DOIs
Publication statusPublished - 30 Sept 2019

Keywords

  • pathogen reduction technologies (PRTs)
  • infectious diseases
  • blood-borne infectious agents
  • blood safety
  • pathogen inactivation
  • plasma and platelets

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