The purpose of the public workshop is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products. The workshop has been planned in partnership with the National Heart, Lung, and Blood Institute; National Institutes of Health (NIH); the Department of Defense; and the Office of the Assistant Secretary for Health, Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government Agencies.
(Focus: State of the science overview of assessing quality and efficacy of red blood cells (RBCs))
| 8:00-8:05 | Workshop Introduction - Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research Food and Drug Administration, Silver Spring, MD |
| 8:05-8:45 | Influence of Transfused RBC Physiology upon Recipient Oxygen Delivery Homeostasis - Alan Doctor, MD Director, Pediatric Critical Care Medicine St. Louis Children’s Hospital, St. Louis, MO |
| 8:45-9:25 | Insights into RBC Quality, A Century of Analysis – James C. Zimring, MD, PhD Chief Scientific Officer, Bloodworks Northwest Director, Bloodworks NW Research Institute Professor of Laboratory Medicine, Professor of Hematology, University of Washington School of Medicine Seattle, WA |
| 9:25-9:35 | Supporting a Strategic Research Agenda in Transfusion Medicine at NHLBI: RBC Products – Simone Glynn, MD, MSc, MPH Branch Chief, Blood Epidemiology and Clinical Therapeutics Branch Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute, NIH Bethesda, MD |
(Focus: What we currently are doing and what could be done to improve RBCs as transfusion products)
| 9:35-9:50 | FDA’s Approval Process for RBC Transfusion Products - Jaro Vostal, MD, PhD Chief, Laboratory of Cellular Hematology DHRR, CBER, Food and Drug Administration, Silver Spring, MD |
| 9:50-10:05 | Clinical Use of RBCs for Transfusion - John R. Hess, MD, MPH, FACP, FAAAS Professor of Laboratory Medicine and Hematology University of Washington, Harborview Medical Center Seattle, WA |
| 10:05-10:25 | Break (20 minutes) |
| 10:25-10:40 | Evaluation of RBC Products for Transfusion - Harvey G. Klein, MD Chief, Department of Transfusion Medicine NIH Clinical Center, Bethesda, MD |
| 10:40-10:55 | Predictive Clinical Value of in vitro Measures of RBC Quality - Jason Acker, MBA, PhD Senior Development Scientist, Canadian Blood Services Professor, University of Alberta Edmonton, Alberta, Canada |
| 10:55-11:25 | Discussion Panel: Jason Acker, Alan Doctor, John R. Hess, Harvey G. Klein, Jaro Vostal, James C. Zimring Panel Discussion Leader: Philip C. Spinella, MD, FCCM Associate Professor and Director, Translational Research Program Division of Critical Care, Department Pediatrics Washington University in St Louis, St Louis, MO |
(Focus: Overview of new methods for assessing the physiologic and biochemicalstate of red blood cells)
| 11:25-11:40 | Omics of RBC Storage Lesions (Proteomics, Metabolomics, microRNAs) - Angelo D'Alessandro, PhD Metabolomics Core Director University of Colorado Denver Department of Biochemistry and Molecular Genetics University of Colorado–Anschutz Medical Campus, Aurora, CO |
| 11:40-11:55 | Systems Biology of RBC Storage Lesions - Bernhard Paulson, PhD Professor of Bioengineering, Professor of Pediatrics, Systems Biology Research Group, Department of Bioengineering University of California, San Diego, La Jolla, CA |
| 11:55-12:10 | Genetics of RBC Storage-Studies of Twins – Thomas J. Raife, MD Clinical Professor (CHS), Director of Transfusion Services Department of Pathology and Laboratory Medicine University of Wisconsin-Madison, Madison, WI |
| 12:10-12:25 | REDS-III RBC-Omics Study - Mike Busch, MD, PhD [Presentation not Available] Co-Director, Blood Systems Research Institute (BSRI) Senior Vice President, Research and Scientific Affairs, Blood Systems Inc., Scottsdale, AZ Professor of Laboratory Medicine, University of California, San Francisco, CA |
| 12:25-12:55 | Discussion panel: - Mike Busch, Angelo D’Alessandro, Bernhard Paulson Panel discussion leader: Thomas J. Raife |
| 12:55-2:00 | Lunch-60’ |
(Focus: How can we best use animal models to develop biomarkers of red blood cell quality and efficacy)
| 2:00-2:15 | Potential Biomarkers of RBC Function in Animal Studies – Paul Buehler, PharmD, PhD Pharmacologist, Senior Scientist, Laboratory of Biochemistry and Vascular Biology DHRR, CBER, Food and Drug Administration, Silver Spring, MD |
| 2:15-2:30 | Correction of Anemia: Humanized and Other Mouse Models – Timothy J. McMahon, MD, PhD Associate Professor of Medicine Duke University, Durham, NC |
| 2:30-2:45 | Hamster Microcirculation - Marcos Intaglietta, PhD Professor, Bioengineering Institute of Engineering in Medicine UC San Diego, Jacobs School of Engineering La Jolla, CA |
| 2:45-3:00 | How to Measure the Effective Oxygenation of the Target Tissues – Harold M. Swartz, MD, PhD, MSPH Professor of Radiology, Department of Radiology, The Geisel School of Medicine at Dartmouth, Lebanon, NH |
| 3:00-3:30 | Panel discussion: Paul Buehler, Marcos Intaglietta, Timothy J. McMahon, Harold M. Swartz Panel discussion leader: Harvey Klein |
| 3:30-4:00 | Break-30’ |
| 4:00-4:20 | Non-Human Primate Transfusion Models - Sylvain Cardin, PhD Chief Science Director Naval Medical Research Unit-San Antonio JBSA Ft. Sam Houston, San Antonio, TX |
| 4:20-4:35 | Swine Models for Shock/Trauma Resuscitation Research -Michael Dubick , PhD, FCCM, FACN [Presentation not Available] Supervisory Research Pharmacologist Chief, Damage Control Resuscitation Program US Army Institute of Surgical Research San Antonio, TX |
| 4:35-4:50 | Effect of Transfused RBC Storage Age on Outcome in Infected Canines - Charles Natanson, MD Senior Investigator, Critical Care Medicine Department NIH Clinical Center, Bethesda, MD |
| 4:50-5:20 | Panel discussion: Sylvain Carden, Michael Dubick, Charles Natanson Panel discussion leader: Philip C. Spinella |
(Focus: How does red blood cell quality correlate with transfusion adverse events)
| 9:00-9:15 | Toxicity of Acellular and Cellular Hemoglobins - Abdu I. Alayash, PhD, DSc Chief, Laboratory of Biochemistry and Vascular Biology DHRR, CBER, Food and Drug Administration, Silver Spring, MD |
| 9:15-9:30 | Role of Nitric Oxide and Free Heme in Mediating RBC Transfusion Toxicity - Rakesh P. Patel, PhD Professor, Department of Pathology, Director, Center for Free Radical Biology and Translational and Molecular Sciences Certificate Program, University of Alabama at Birmingham, AL |
| 9:30-9:45 | Coagulation Changes Related to RBC Transfusion - John W. Weisel, PhD Professor, Cell and Developmental Biology Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA |
| 9:45-10:00 | Microparticle mediated toxicity - Jennifer A. Muszynski, MD Assistant Professor of Pediatrics, Division of Critical Care Medicine The Ohio State University College of Medicine and Nationwide Children’s Hospital, Columbus OH |
| 10:00-10:15 | Transfusion Related Immune Modulation (TRIM) Safety Issues - Philip J. Norris, MD Co-Director, Blood Systems Research Institute VP Research and Scientific Programs, Blood Systems, Inc. Professor of Laboratory Medicine and Medicine University of California, San Francisco, CA |
| 10:15-10:45 | Panel members: Abdu I. Alayash, Jennifer A. Muszynski, Philip J. Norris, Rakesh P. Patel, John W. Weisel Panel discussion leader: Paul Buehler |
| 10:45-11:05 | Break-20’ |
| 11:05-11:20 | Determination of Suitability of RBCs for Transfusion – Philip C. Spinella |
| 11:20-11:35 | Methods for Detection of RBC Processing and Storage Lesions – Thomas J. Raife |
| 11:35-11:50 | Animal Models –Oxygen Delivery and Perfusion- Harvey G. Klein [Presentation not Available] |
| 11:50-12:05 | Animal Models –Shock/Trauma Resuscitation – Philip C. Spinella [Presentation not Available] |
| 12:05-12:20 | Potential Mechanisms of RBC Transfusion Associated Toxicity - Paul Buehler [Presentation not Available] |
| 12:20-12:30 | Final Thoughts - Paul M. Ness, MD Director, Division of Transfusion Medicine Professor of Pathology, Medicine and Oncology Johns Hopkins University School of Medicine, Baltimore, MD |
| 12:30 | Adjourn |
October 24, 2023
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