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“Pre-Clinical Evaluation of Red Blood Cells for Transfusion” Public Workshop

October 6th-7th, 2016

Ruth Kirschstein Auditorium, Natcher Building,
NIH Campus Bethesda, Maryland

Purpose and Scope of the Meeting

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.

Thursday – October 6, 2016

Session 1 - Introduction - Red Blood Cells as Transfusion Products

(Focus: State of the science overview of assessing quality and efficacy of red blood cells (RBCs))

8:00-8:05Workshop Introduction - Peter Marks, MD, PhD
Director, Center for Biologics Evaluation and Research
Food and Drug Administration, Silver Spring, MD
8:05-8:45Influence 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
8:45-9:25Insights 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
9:25-9:35Supporting 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
Session 2 - Determination of Suitability of Red Blood Cells for Transfusion

(Focus: What we currently are doing and what could be done to improve RBCs as transfusion products)

9:35-9:50FDA’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
9:50-10:05Clinical 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
10:05-10:25Break (20 minutes)
10:25-10:40Evaluation of RBC Products for Transfusion - Harvey G. Klein, MD
Chief, Department of Transfusion Medicine
NIH Clinical Center, Bethesda, MD
10:40-10:55Predictive 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
10:55-11:25Discussion 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
Session 3 - Methods for the Detection of Red Blood Cell Processing and Storage Lesions

(Focus: Overview of new methods for assessing the physiologic and biochemicalstate of red blood cells)

11:25-11:40Omics 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
11:40-11:55Systems 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
11:55-12:10Genetics 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
12:10-12:25REDS-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
12:25-12:55Discussion panel: - Mike Busch, Angelo D’Alessandro, Bernhard Paulson
Panel discussion leader: Thomas J. Raife
12:55-2:00Lunch-60’
Session 4 - Animal Models of Oxygen Delivery to Tissues by Transfused Products

(Focus: How can we best use animal models to develop biomarkers of red blood cell quality and efficacy)

Oxygen Delivery and Perfusion
2:00-2:15Potential 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
2:15-2:30Correction of Anemia: Humanized and Other Mouse Models – Timothy J. McMahon, MD, PhD
Associate Professor of Medicine
Duke University, Durham, NC
2:30-2:45Hamster Microcirculation - Marcos Intaglietta, PhD
Professor, Bioengineering
Institute of Engineering in Medicine
UC San Diego, Jacobs School of Engineering
La Jolla, CA
2:45-3:00How 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
3:00-3:30Panel discussion: Paul Buehler, Marcos Intaglietta, Timothy J. McMahon, Harold M. Swartz
Panel discussion leader: Harvey Klein
3:30-4:00Break-30’
Shock/Trauma Resuscitation
4:00-4:20Non-Human Primate Transfusion Models - Sylvain Cardin, PhD
Chief Science Director
Naval Medical Research Unit-San Antonio
JBSA Ft. Sam Houston, San Antonio, TX
4:20-4:35Swine 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
4:35-4:50Effect of Transfused RBC Storage Age on Outcome in Infected Canines - Charles Natanson, MD
Senior Investigator, Critical Care Medicine Department
NIH Clinical Center, Bethesda, MD
4:50-5:20Panel discussion: Sylvain Carden, Michael Dubick, Charles Natanson
Panel discussion leader: Philip C. Spinella

Friday – October 7, 2016

Session 5 - Potential Mechanisms of Red Blood Cell Transfusion Associated Toxicity

(Focus: How does red blood cell quality correlate with transfusion adverse events)

9:00-9:15Toxicity 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
9:15-9:30Role 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
9:30-9:45Coagulation Changes Related to RBC Transfusion - John W. Weisel, PhD
Professor, Cell and Developmental Biology
Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
9:45-10:00Microparticle 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
10:00-10:15Transfusion 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
10:15-10:45Panel members: Abdu I. Alayash, Jennifer A. Muszynski, Philip J. Norris, Rakesh P. Patel, John W. Weisel
Panel discussion leader: Paul Buehler
10:45-11:05Break-20’
Session 6 - Summary of Panel Discussions with Gaps Identified and Future Directions- Presented by the Panel Leaders
11:05-11:20Determination of Suitability of RBCs for Transfusion – Philip C. Spinella
11:20-11:35Methods for Detection of RBC Processing and Storage Lesions – Thomas J. Raife
11:35-11:50Animal Models –Oxygen Delivery and Perfusion- Harvey G. Klein [Presentation not Available]
11:50-12:05Animal Models –Shock/Trauma Resuscitation – Philip C. Spinella [Presentation not Available]
12:05-12:20Potential Mechanisms of RBC Transfusion Associated Toxicity - Paul Buehler [Presentation not Available]
12:20-12:30Final Thoughts - Paul M. Ness, MD
Director, Division of Transfusion Medicine
Professor of Pathology, Medicine and Oncology
Johns Hopkins University School of Medicine, Baltimore, MD
12:30Adjourn