The ACBTSA Charter calls for the Committee to be comprised of:
In accordance with the charter, the committee may consist of up to 23 voting members, who represent a diverse group of patient advocates, subject matter experts, and health professionals.
Public Members
The Committee includes 14 public members, selected from state and local organizations, patient advocacy groups, provider organizations, academic researchers, ethicists, physicians, surgeons, scientists, risk communication experts, consumer advocates, and from among communities of persons who are frequent recipients of blood or blood products or who have received tissues or organs. Public members are Special Government Employees and are subject to conflict of interest laws and regulations.
ACBTSA Chair
Jacquelyn Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH
Retired, President and CEO of Versiti, Inc.
Retired CEO and President, BloodCenter of Wisconsin and the BloodCenter Research Institute
(Special Government Employee)
Term: 8/17/18 – 8/16/2021
Jacquelyn Fredrick retired as the fourth President and CEO of BloodCenter of Wisconsin and the BloodCenter Research Institute and the first President and CEO of Versiti, Inc. in February 2017. As President and CEO, she led an internationally respected transfusion medicine organization that supplies blood products to Wisconsin, Illinois, Indiana, and Michigan hospitals and provides blood services and donor testing nationally to other organizations in need.
She previously served in various leadership capacities at the National American Red Cross, including establishing the National Testing Laboratories and oversight of $2 billion in revenue, 15,000 employees, and service to 3,000 hospitals as well as field operations. Ms. Fredrick has also served as Past President of the AABB, former Chairman of the Board for the Blood Centers of America, Inc., and on the America's Blood Centers Board of Directors and serves as Chairman of the Board of Froedtert Health System. Ms. Fredrick received an honorary doctorate of business and public health, a master's degree in business administration from the University of Wisconsin-Milwaukee, and a bachelor's degree in medical technology from the University of Wisconsin Madison.
Biree Andemariam, MD
Associate Professor, Department of Medicine, Neag Comprehensive Cancer Center, Division of Hematology/Oncology, University of Connecticut (UConn Health)
Chief Medical Officer, Sickle Cell Disease Association of America, Inc.
(Special Government Employee)
Term: 8/26/2020 – 8/25/2023
Dr. Andemariam is an Associate Professor of Medicine at the University of Connecticut in the Division of Hematology/Oncology, Founding Director of the New England Sickle Cell Institute (NESCI), Director of the Connecticut Bleeding Disorders Center, and Chief Medical Officer of the Sickle Cell Disease Association of America, Inc. She joined UConn in 2007 as a physician-investigator and established the region's only adult sickle cell disease (SCD) program.
She received an undergraduate degree in molecular biology and African studies from Princeton University, a medical degree from Tufts University School of Medicine, graduating with research honors, and completed medical training at New York Presbyterian Hospital–Cornell University.
Sally Caglioti, MS, MT (ASCP)
President and CEO, Creative Testing Solutions
(Special Government Employee)
Term: 8/26/2020 – 8/25/2023
Sally Caglioti is the President and Chief Executive Officer of Creative Testing Solutions (CTS), a joint venture among the American Red Cross, Vitalant and OneBlood. With donor testing laboratories in Dallas, Phoenix, Tampa, Charlotte, and St. Louis, CTS performs blood donor testing for approximately 70% of the U.S. blood supply.
Sally is actively involved in educational and scientific activities related to laboratory testing. She initiated the development of two Specialist in Blood Bank Technology (BBT) Programs, served as an AABB BBT Program auditor, and presents at numerous workshops and meetings. She has also led test system clinical trials, participated in infectious disease reagent and epidemiologic studies, and collaborated on publications. Sally received the America's Blood Centers (ABC) Thomas F. Zuck Lifetime Achievement Award for and the South Central Association of Blood Banks (SCABB) Larry Trow Education, Scientific Lectureship and Karen Williams Memorial awards. She has participated on multiple committees, task forces, and advisory panels for the SCABB, ABC, and the AABB and served on the AABB Board of Directors and Group Services for America's Blood Centers (GSABC) Board of Directors.
Andrew Cap, MD, PhD
Colonel, Medical Corps, US Army
Director of Research, US Army Institute of Surgical Research
Associate Professor of Medicine, Uniformed Services University
Hematologist-Oncologist, San Antonio Military Medical Center
(Special Government Employee)
Term: 8/26/2020 – 8/25/2024
Dr. Andrew Cap is a hematologist conducting basic and translational research on coagulation system function and cellular therapy products for use in trauma and burn care. His mission is to lead the U.S. Army Institute of Surgical Research Coagulation and Blood Research Group. He also serves as a staff Hematologist-Oncologist at the San Antonio Military Medical Center (SAMMC), as a core faculty member of its Hematology-Oncology Fellowship Program, as Program Director for the Clinical Investigation Fellowship Program, and as an Associate Professor of Medicine at the Uniformed Services University. He is a board certified internist and hematologist-oncologist and serves as hematology and blood products subject matter expert advisor to the US Army Surgeon General, Joint Trauma System (JTS), US Pacific Command, and the US Special Operations Command (SOCOM). Dr. Cap serves as co-chair of the NATO Blood Panel.
His overall research goals are to decrease battlefield mortality, with emphasis on providing diagnostic and therapeutic interventions to treat hemorrhage and the coagulopathy of trauma. Dr. Cap received his bachelor's degree from Harvard University, master's degree from Massachusetts Institute of Technology, and medical and doctoral degrees from Boston University.
Claudia Cohn, MD, PhD
Associate Professor, Department of Laboratory Medicine and Pathology and Associate Director, Laboratories and Director, Blood Bank Laboratory at University of Minnesota
(Special Government Employee)
Term: 8/26/2020 – 8/25/2024
After finishing her Transfusion Medicine fellowship at University of California, San Francisco, Dr. Cohn joined the faculty at the University of Minnesota where she is Medical Director of the Blood Bank, Associate Medical Director of the HLA lab and Associate Head of Labs. She is also the Chief Medical Officer of the AABB (formerly American Association of Blood Banks).
Dr. Cohn conducts research in the field of transfusion medicine and her major interests include platelet support for stem cell transplant patients, hemovigilance and appropriate use of blood components. She is Editor-in-Chief of current AABB Technical Manual (20th edition), and Associate Editor of the International Society of Blood Transfusion (ISBT) Science Series. Dr. Cohn has served on the AABB Clinical Transfusion Medicine committee, Transfusion Standards committee and the Transfusion Transmitted Disease committee. She has a doctorate degree in immunology and infectious diseases from Johns Hopkins University and medical degree from Louisiana State University.
Raymond Goodrich, PhD
Executive Director, Infectious Disease Research Center and Professor, Department of Microbiology, Immunology, and Pathology, Colorado State University
(Special Government Employee)
Term: 8/26/2020 – 8/25/2024
As the Executive Director of the Infectious Disease Research Center, Dr. Goodrich has responsibility for oversight of the Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC), the Regional Biocontainment Labs (RBL) and the Research Innovation Center (RIC). He holds a faculty appointment as a tenured Professor in the Department of Microbiology, Immunology and Pathology at Colorado State University and an adjunct position as a Professor of Chemistry at The Ohio State University.
Dr. Goodrich has worked in medical research for over 30 years in the fields of transfusion, transplantation medicine, and pathogen reduction technologies. He holds over 50 patents and has co-authored 200 peer-reviewed publications. His most recent work funded by the NIH, Biomedical Advanced Research and Development Authority, and Department of Defense and DOD is focused on the development of new methods for vaccine production. He is a 2018 honorary recipient of the Order of Military Medical Merit (O2M3) for his work on programs of importance to the US Army Medical Command. Dr. Goodrich has a bachelor's degree in chemistry from The Ohio State University and doctorate degree in chemistry from the California Institute of Technology.
Elisa Gordon, PhD, MPH
Professor, Department of Surgery, Division of Organ Transplantation, Northwestern University
(Special Government Employee)
Term: 8/26/2020 – 8/25/2024
Dr. Gordon is Professor in the Department of Surgery, Division of Organ Transplantation at the Northwestern University Feinberg School of Medicine. She trained as a medical anthropologist and clinical ethicist, using interdisciplinary and mixed-methods approaches to advance patient-centered care. Dr. Gordon has been conducting research in bioethics and health services research for over 20 years, with over 130 peer-reviewed publications. She specializes in ethical and empirical research on organ donation and transplantation and conducts multi-site clinical trials to evaluate interventions designed to facilitate informed consent for transplantation and to reduce racial/ethnic disparities in access to living donor kidney transplantation.
Dr. Gordon serves as the ex-officio Chair of the OPTN/UNOS Ethics Committee, the co-Chair of the American Society of Transplantation's Psychosocial and Ethics Community of Practice, member of the NIAID DSMB, and as Associate Editor of the American Journal of Transplantation. Dr. Gordon has a bachelor's degree in anthropology from the University of California, Santa Cruz, a doctorate degree in medical anthropology from Case Western Reserve University, and a master's of public health degree focusing on community health from the University of Illinois at Chicago. Dr. Gordon completed a post-doctoral fellowship in clinical medical ethics at The University of Chicago.
Jed B. Gorlin, MD, MBA
Vice President, Medical and Quality Affairs, Memorial Blood Centers and Nebraska Community Blood Bank Divisions, Innovative Blood Resources
Assistant Professor of Pediatrics and Laboratory Medicine, University of Minnesota
(Special Government Employee)
Term: 8/26/2020 – 8/25/2024
Dr. Gorlin is the Vice President of Medical and Quality Affairs for Memorial Blood Center and Nebraska Community Blood Bank divisions of Innovative Blood Resources. He is also an associate clinical professor of laboratory medicine at University of Minnesota and the co-director of Transfusion Medicine at Hennepin County Medical Center and Children's Hospitals and Clinics in Minneapolis and St. Paul, MN.
Dr. Gorlin has authored over 60 journal articles and a dozen chapters in various blood banking texts has provided expert consultation to AABB, CDC, and NIH for blood collection capacity building projects in Africa and Central Asia. He is the 2019 recipient of the John Elliott Memorial Award from the American Association of Blood Banks (AABB). Dr. Gorlin has served on the board of AABB and the National Blood Foundation, acted as the AABB liaison to several professional medical associations for obstetric hemorrhage, and served as the America's Blood Centers liaison to AABB Transfusion Transmitted Diseases committee. He holds a bachelor's degree from Stanford University, master's degree in business administration from the University of Minnesota, and a medical degree from Yale University and trained in pediatrics and pediatric hematology/oncology at Boston Children's Hospital.
Daryl Kor, M.D., MSc
Professor of Anesthesiology, Mayo Clinic College of Medicine
(Special Government Employee)
Term: 8/26/2020 – 8/25/2023
Dr. Daryl Kor practices and teaches anesthesiology at Mayo Clinic Rochester where he is a Professor of Anesthesiology in the Mayo Clinic College of Medicine. Dr. Kor's research focuses on the risks and efficacy of transfusion therapies with an emphasis on transfusion-related respiratory complications. He has received a number of federal and foundation grant awards and has a National Heart, Lung, and Blood Institute (NHLBI) grant to improve understanding of the mechanisms underlying postoperative transfusion-related respiratory complications.
Dr. Kor is chair the Mayo Clinic's Committee on Transfusion Medicine, vice-chairs the Mayo Clinic Critical Care Research Subcommittee, and serves as a clinical consultant to the NHLBI sponsored, Recipient Epidemiology and Donor Evaluation study as well as the AABB TRALI and TACO task forces. He also serves as Medical Director for the Mayo Clinic Department of Data and Analytics and has leveraged this experience to better understand the role of clinical informatics and data science in optimizing transfusion practices. He has received several academic (Clinician of the Year, Teacher of the Year) as well as research (FAER grant, KL2, K23, RO1) awards. Dr. Kor received his medical degree from the University of Minnesota and completed an Anesthesiology Residency Program, a Critical Care Medicine Fellowship, and completed his master's degree in clinical and translational science at the Mayo Clinic College of Medicine. He is board-certified in anesthesiology and critical care medicine.
Jim MacPhearson, MS, MT (ASCP)
President and CEO, MacPherson Strategies
(Special Government Employee)
Term: 8/26/2020 – 8/25/2023
For over 50 years, Jim MacPherson has been in the healthcare field, specializing in blood transfusion and cell therapy. He currently is President and CEO of MacPherson Strategies, a healthcare consulting firm specializing in strategic initiatives as well as executive and marketing research services.
Jim also is the volunteer President of the Board of Directors and Acting CEO for Global Healing, a developmental non-governmental organization with maternal and pediatric healthcare projects in Southeast Asia, Eastern Europe, and Latin America. From 1986 to 2013, Jim was CEO of America's Blood Centers (ABC). Under his leadership, ABC membership more than tripled; an affiliated group purchasing organization was developed and achieved over $450 million in annual sales; a healthcare liability insurance company (BCx) was founded; a charitable foundation was established and provided over $7 million to support blood donation awareness; and a blood management software was developed and used by over 650 hospitals in the United States. Previously, Jim served as American Red Cross Blood Services' Director of Hemapheresis, Regulatory Affairs and Operations Research. Before that, he served as the Clinical Associate Professor of Hematology at University of Rochester Medical Center and directed the Research and Cell Therapy Support unit at the Red Cross blood center in Rochester, New York. He has master's degrees in cellular physiology from George Washington University and in pathophysiology from the University of Buffalo. He has written hundreds of papers in transfusion medicine and authored several books in the field.
Paul M. Ness, MD
Senior Director, Transfusion Medicine, Johns Hopkins Hospital
Professor of Pathology, Medicine, and Oncology, Johns Hopkins University
(Special Government Employee)
Term: 8/26/2020 – 8/25/2024
Dr. Ness is Senior Director of the Transfusion Medicine Division at The Johns Hopkins Hospital and Professor of Pathology, Medicine, and Oncology at The Johns Hopkins University School of Medicine in Baltimore, Maryland; he served as Director from 1979-2018. He has extensive experience in transfusion related research with an emphasis upon transfusion related complications. Dr. Ness has served as the Principal Investigator for the Johns Hopkins site of the Transfusion Medicine Hemostasis Clinical Trial Network, funded by NHLBI. He was also the co-PI for a project funded by the NHLBI REDS III program to study donor virus epidemiology and blood utilization issues in China. Dr. Ness has served as a consultant to the coordinating centers of REDS II, REDS III, and REDS IV. From 1972-1974, Dr. Ness was a staff associate in the Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute at the NIH in Bethesda.
As a long-time member of the AABB Board of Directors, he became President in 1999. Dr. Ness has written over 250 articles for medical journals, three texts, and served as editor of Transfusion from 2003-2018. He received an undergraduate degree at the Massachusetts Institute of Technology and a medical degree from the SUNY Buffalo. His postgraduate work includes residency in internal medicine at Johns Hopkins, fellowship training in hematology-oncology at the University of California San Francisco, and transfusion medicine fellowship at Irwin Memorial Blood Bank in San Francisco.
David B. Perez
Retired CEO, Terumo BCT
(Special Government Employee)
Term: 8/26/2020 – 8/25/2023
For more than 18 years, David Perez led Terumo BCT as CEO. The company is now a $1 billion, mission-driven biomedical company focused on unlocking the potential of blood and cell-based therapies through its technologies in blood banking, transfusion medicine and cell therapy. Under Perez's leadership, Terumo BCT grew from a single manufacturing and R&D site to employing over 7000 associates worldwide at five regional headquarters, five R&D development centers, and six manufacturing plants located around the world, serving customers and patients in more than 130 countries across five business areas and twelve product categories. Perez also served on the Terumo Corporation Board of Directors where he was one of fewer than 300 non-Japanese board members of all publicly traded companies in Japan.
Now retired with more than 39 years of experience in the medical device and healthcare services industries, Perez continues his career serving as a board member to multiple companies and organizations including Ortho Clinical Diagnostics, Mesa Labs, Laborie, Sarnova and Molnlycke. Mr. Perez offers a deep portfolio of experience, expertise, and lessons learned. Perez is a 1981 graduate of Texas Tech University and resides in Denver, CO.
Ron Waeckerlin, M.D.
Retired Community Pathologist
Immediate Past Chair Vitalant Board of Trustees (formerly Blood Systems Inc.)
Secretary Treasurer CTS (Creative Testing Solutions) Board of Directors
(Special Government Employee)
TERM: 11/1/2020 – 10/31/2023
Dr. Waeckerlin is a retired community pathologist with a special interest in transfusion medicine. He practiced anatomical and clinical pathology in Casper and Cheyenne Wyoming for 34 years. He served as local and regional medical director for United Blood Services (part of Blood Systems Inc., now Vitalant) from 1981-2008. He joined the Vitalant Board of Trustees in 2008 and chaired the Quality and Ethics Committee for 8 years before a tenure on the executive committee and served as board chair 2017-2019. He is also a member of CTS (national blood testing organization) Board of Directors, currently serving as secretary treasurer. Dr. Waeckerlin received an undergraduate degree from the University of Wyoming and a medical degree from the University of Utah. He completed training in anatomic, clinical, and forensic pathology at the University of New Mexico.
Representative Members
The Committee includes nine voting representative members who are designated to serve by the blood, tissue and organ professional organizations and/or business sectors. Representative members are selected from the AABB, American Association of Tissue Banks, the Eye Bank Association of America, the Association of Organ Procurement Organization, and either the American National Red Cross or America's Blood Centers on a rotating basis. The Committee composition can include four additional representative members. These members are not regular government employees (federal employees) or special government employees.
AABB
Lynne Uhl, MD
Vice Chair, Division of Laboratory and Transfusion Medicine, Beth Israel Deaconess Medical Center
Associate Professor of Pathology, Harvard Medical School
(Representative Member)
Term: 8/26/2020-8/25/2024
Dr. Lynne Uhl is the Vice Chair, Division of Laboratory and Transfusion Medicine at the Beth Israel Deaconess Medical Center and an Associate Professor of Pathology at Harvard Medical School. Her areas of interest include evidence-based clinical transfusion practice, hematopoietic stem cell transplant and immune-based cellular therapies, and therapeutic apheresis. She is board certified in anatomic and clinical pathology and has subspecialty certification in blood banking and transfusion medicine.
As Vice Chair of Laboratory and Transfusion Medicine, Dr. Uhl is responsible for physician oversight of clinical laboratory operations (blood bank, hematology, clinical chemistry, and microbiology), ensuring operational compliance with regulatory organizations, overseeing quality assurance programs and quality initiatives, participating in clinical resource activities, and strategic planning.
In addition to her administrative duties, Dr. Uhl devotes a considerable portion of her time to Harvard Medical School teaching activities and participates in national and international organizations within her area of expertise. She previously served on the AABB Board of Directors and as President of AABB in 2015. She received her bachelor's degree in biology from Bucknell University, master's degree in nutrition science from Pennsylvania State University, and medical degree from University of Cincinnati College of Medicine. Dr. Uhl completed residency training in pathology at Beth Israel Hospital and Harvard Medical School.
American Association of Tissue Banks
Vice-Chair
Matthew J. Kuehnert, MD, FACP, FIDSA
Chief Medical Officer, MTF Biologics
Professor of Medicine, Hackensack Meridian School of Medicine
(Representative Member)
Term: 8/26/2020-8/25/2024
Dr. Kuehnert is the Chief Medical Officer of MTF Biologics, a nonprofit tissue processor founded in 1987 and Professor of Medicine at Hackensack Meridian School of Medicine. He is also a fellow of the American College of Physicians and the Infectious Diseases Society of America and the incoming Chair of the American Association of Tissue Banks Physicians Council.
Before joining MTF Biologics, Dr. Kuehnert was Director of the Office of Blood, Organ, and Other Tissue Safety at the Centers for Disease Control and Prevention (CDC). He was an ex-officio member of the ACBTSA from 2003-2017 while at CDC. He holds an undergraduate degree from the University of California at San Diego and medical degree from Columbia University's College of Physicians & Surgeons. Dr. Kuehnert trained in internal medicine at Stanford University and the University of California at San Francisco and in infectious diseases at Emory University.
Association of Organ Procurement Organizations
Gary Marklin, MD
Chief Medical and Research Officer, Mid-America Transplant
(Representative Member)
Term: 8/26/2020 – 8/25/2023
Dr. Gary Marklin has been the Chief Medical and Research Officer at Mid-America Transplant since 2014 and he serves as the medical director of the tissue bank. From 2008 to 2014, he served as the Associate Medical Director at Mid-America Transplant. Prior to joining Mid-America Transplant, Dr. Marklin served as a pulmonary and critical care physician at St Anthony's Medical Center in St Louis where he was the medical director of the intensive care units, respiratory therapy department, blood gas lab, bronchoscopy suite, and pulmonary rehabilitation for more than 10 years.
Dr. Marklin is a board certified pulmonary and critical care physician with over 30 years of experience in private practice in St Louis. He personally manages the care of the organ donors in their independent organ recovery intensive care unit and conducts donor management research. His published research includes the use of corticosteroids, naloxone, T3 / T4, stroke-volume based fluid resuscitation, and prone ventilation in the brain-dead donor. Dr. Marklin holds a bachelor's degree in chemistry summa cum laude, master's degree in anatomy, and a medical degree magna cum laude from University of Missouri-Columbia.
Eye Bank Association of America
Bennie H. Jeng, MD
Professor and Chair, Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine
(Representative Member)
Term: 8/26/2020 – 8/25/2024
Bennie H. Jeng is the Professor and Chair of the Department of Ophthalmology and Visual Sciences at the University of Maryland School of Medicine. He previously served as the Chief of Ophthalmology at the San Francisco General Hospital and held faculty positions at the Cole Eye Institute, Cleveland Clinic and the Proctor Foundation for Research in Ophthalmology/Department of Ophthalmology at the University of California San Francisco (UCSF). Dr. Jeng oversees an active research program in eye banking and serves as co-chair of the National Eye Institute's Zoster Eye Disease Study. He has also received K- and R01-grants from the National Institutes of Health,
Dr. Jeng has published and lectured extensively, serves on the editorial boards for Ophthalmology, Cornea, and Eye and Contact Lens, and held leadership roles with the Cornea Society, the American Board of Ophthalmology, the Eye and Contact Lens Association, the Eye Bank Association of America, the Ocular Microbiology Immunology Group, and on several committees of the American Academy of Ophthalmology. He received the Senior Achievement Award and the Secretariat Award from the American Academy of Ophthalmology. Dr. Jeng earned a bachelor's degree summa cum laude from Washington University, a master's degree in clinical investigation from Case Western Reserve University, and his medical degree from the University of Pennsylvania School of Medicine. He completed his ophthalmology residency and chief residency at the Cole Eye Institute of the Cleveland Clinic and a fellowship in cornea and external diseases at the Francis I. Proctor Foundation/UCSF.
Major Blood Supplier
J. Chris Hrouda, MT (ASCP)
President, Biomedical Services, American Red Cross
(Representative Member)
Term: 8/26/2020 – 8/25/2022
J. Chris Hrouda is the president of Biomedical Services at the American Red Cross, overseeing the nation's largest blood collection organization. Recognized as one of the leading experts in the blood industry, Mr. Hrouda brings 30 years of Red Cross Blood Program experience to the position, and is responsible for blood collections, manufacturing, and distribution operations throughout the Red Cross.
Mr. Hrouda currently serves as the chair of the National Blood Foundation and he recently served as the chair of the Alliance of Blood Operators. Prior to his current position, he was the executive vice president of Blood Services. Previously, he held the position of vice president of Blood Services' Southeast Division and CEO of the Southern Blood Services Region in Georgia and Heart of American Region in Illinois. He began his career with the Red Cross Biomedical Services in 1988 as a medical technologist with the University of Missouri Hospital & Clinics in the Missouri-Illinois Region. Mr. Hrouda holds a bachelor's degree magna cum laude in health sciences from the University of Missouri. He is a certified medical technologist, a member of AABB, AABB Public Policy Strategy Committee, and previously served as the president of the Heart of America Association of Blood Banks.
Plasma Protein Fraction Community
Mary Gustafson, MS, MT (ASCP) SBB
Vice President Global Regulatory Policy, Plasma Protein Therapeutics Association
(Representative Member)
Term: 8/26/2020 – 8/25/2024
Mary Gustafson is Vice President, Global Regulatory Policy, Plasma Protein Therapeutics Association (PPTA). Prior to joining PPTA, Ms. Gustafson served as Senior Director, Regulatory Affairs at Nabi Biopharmaceuticals, Boca Raton, FL and in regulatory positions at the U.S. Food and Drug Administration (FDA). At FDA, she directed the Division of Blood Applications, Office of Blood and Research and Review, Center for Biologics Evaluation and Research, as well as holding earlier positions in biologics and sterile drug compliance and product certification.
Before her regulatory career, she worked in clinical blood banking at the National Institutes of Health and several hospitals. Ms. Gustafson has a master's degree in pathology, is certified as a medical technologist and specialist in blood banking by the American Society for Clinical Pathology, and quality manager and auditor by the American Society for Quality.
Manufacturer/Supplier of Blood Donor Testing and Screening
Susan Galel, MD
Senior Director of Medical Affairs, Blood Screening, Roche Molecular Diagnostics
(Representative Member)
Term: 8/26/2020 – 8/25/2023
Dr. Galel has been Senior Director of Medical Affairs, Blood Screening at Roche Molecular Diagnostics since 2014. In this role she provides medical support for activities related to donor screening for infectious diseases. Prior to joining Roche, Dr. Galel served for many years as Medical Director of the blood donor center and donor testing laboratory at the Stanford University School of Medicine and as Associate Director of the Stanford Hospital Transfusion Service.
Dr. Galel received her medical degree from Harvard Medical School and completed clinical training in pediatrics, pediatric hematology/oncology, and transfusion medicine at Stanford University. Dr. Galel has served on multiple AABB committees and task forces, including the Transfusion-Transmitted Diseases and Blood Banks and Transfusion Service Standards committees. She has authored numerous manuscripts and book chapters on transfusion medicine and donor infectious disease screening.
Ex-officio Members
The Committee includes six non-voting ex-officio members representing the Centers for Disease Control and Prevention; Centers for Medicare and Medicaid Services; Food and Drug Administration, Health Resources and Services Administration; and National Institutes of Health. Other HHS officials may be invited to participate as non-voting ex-officio members, as the Secretary or designee deem necessary.
Centers for Disease Control and Prevention
Sridhar Basavaraju, MD, FACEP, CDR USPHS
Director, Office of Blood, Organ, and Other Tissue Safety, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention
(Regular Government Employee)
Centers for Medicare and Medicaid Services
Diane H. Corning RN, JD
Health Insurance Specialist, Office of Clinical Standards and Quality, Clinical Standards Group, Centers for Medicare and Medicaid Services
(Regular Government Employee)
Food and Drug Administration
Scott A. Brubaker
Director, Division of Human Tissues, Office of Tissues and Advanced Therapies, Center for Biologics and Evaluation, Food and Drug Administration
(Regular Government Employee)
Mr. Brubaker was selected in October 2016 as the Director, Division of Human Tissues (DHT) in the Office of Tissues & Advanced Therapies (OTAT) within the Center for Biologics Evaluation & Research (CBER) at the Food & Drug Administration (FDA). Prior to that he served 12 years as Senior Vice President of Policy at the American Association of Tissue Banks (AATB) where duties included oversight of the Accreditation Program and the development and management of the Association's policies, professional standards and guidance documents. Before joining AATB, Scott acquired 18 years of practical experience involving organ donation and tissue banking while holding various management positions at an OPO/Tissue Bank in Virginia. Scott is co-editor of three "Essential Guide" books covering cell and tissue donation, processing, and clinical use, and has authored or co-authored more than 40 scientific publications.
Nicole Verdun, MD
Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration
(Regular Government Employee)
Dr. Nicole Verdun is the Director of the Office of Blood Research and Review at the Food and Drug Administration (FDA) in the Center for Biologics Evaluation and Research (CBER). Dr. Verdun received her undergraduate degree from Duke University and her medical degree from the University of Chicago-Pritzker School of Medicine. She then completed a Residency in Pediatrics at Children's Memorial Hospital-Northwestern University and a Hematology-Oncology Fellowship at the Children's Hospital of Philadelphia (CHOP). She practiced as an attending physician at CHOP and Children's National Medical Center, with a focus on thrombosis and hemostasis. She has been an active participant in many American Society of Hematology initiatives, including receiving the ASH Research Training Award and participating in the ASH Advocacy Leadership Institute. Dr. Verdun joined FDA in 2012, and has served in various prior capacities, including in the Office of Hematology Oncology Products, Liaison for Sickle Cell Therapeutics and Anticoagulants, and in Therapeutic Biosimilars. She was appointed as the Deputy Director of the Office of Blood Research and Review in October 2016 and appointed Director of the Office in 2018. The mission of the Office includes ensuring the safety of blood and blood products through policy and regulatory oversight, including assays used to prevent transfusion transmitted infections. She overseas both a research and regulatory portfolio in CBER.
Health Resources and Services Administration
Marilyn E. Levi, MD
Medical Officer, Division of Transplantation, Health Resources and Services Administration
(Regular Government Employee)
Dr. Marilyn E. Levi joined the Division of Transplantation at the Health Resources and Services Administration (HRSA) in Rockville, Maryland as physician in July 2017. Prior to her position at HRSA, she was an Associate Professor of Medicine in the Division of Infectious Diseases at the University of Colorado, where she instituted and directed the Transplant Infectious Diseases division from 2003-2017.
Dr. Levi is a fellow of the American Society of Transplantation, a member of the Cellular Therapy committee of the American Association of Blood Banking (AABB), and reviewer for the NOTIFY project. She has published in peer review transplant and infectious diseases journals on donor transmission studies of West Nile Virus, treatment of multiresistant cytomegalovirus infections in transplant recipients and other immunocompromised patients, complications of cannabis use in transplantation and donor screening for infectious agents. Currently, she is an ad hoc reviewer for journals including the American Journal of Transplantation, Clinical Transplantation, Transplantation, and Transplant Infectious Diseases. She is a former member of the Donor Transmission Advisory Committee of the OPTN and the Executive Committee of the American Society of Transplantation Infectious Diseases Community of Practice. Dr. Levi graduated from the University of Texas Southwestern Medical School, completed an internship and residency in internal medicine and fellowship in infectious diseases at Parkland Hospital/Dallas VA Medical Center/UT Southwestern.
National Institutes of Health
Barbara J. Bryant, MD
Chief, Department of Transfusion Medicine and Center for Cellular Engineering, Clinical Center, National Institutes of Health
(Regular Government Employee)
Barbara J. Bryant, MD is the Chief of the Department of Transfusion Medicine and Center for Cellular Engineering at the National Institutes of Health in Bethesda, Maryland. Prior to joining the NIH as Department Chief, she was Professor and Vice Chair of the Department of Pathology, Medical Director of Transfusion Medicine and Apheresis, Director of Pathology Quality Management, and Director of the Academy of Master Clinicians at the University of Texas Medical Branch (UTMB) in Galveston, Texas. Dr. Bryant also served as the Medical Director of the Walking Blood Bank Program at the Center for Polar Medical Operations in Antarctica.
Dr. Bryant received her undergraduate degree from the University of New Orleans and LSU Medical Center. She was a blood bank medical technologist and specialist in blood banking for 17 years before attending medical school. She earned her medical degree from the UTMB where she completed a residency in Pathology. She did her fellowship training in Transfusion Medicine/Blood Banking at the National Institutes of Health. Dr. Bryant has served on the AABB Board of Directors, FDA Blood Product Advisory Committee, multiple AABB committees, and is a past president of the South Central Association of Blood Banks.
