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Description
This webinar focuses on ethical and policy challenges for performing xenotransplants under the U.S. Food and Drug Administration’s Expanded Access/Compassionate Use program. It explains how this program allows patients to get access to an investigational drug/biologic when certain conditions are met and describes the four xenotransplants that were performed under this program. The webinar also identifies ethical concerns about informed consent for patients obtaining a xenotransplant under the expanded access/compassionate pathway and describes ethical and policy implications of expanded access/compassionate use xenotransplants for first-in-human xenotransplant clinical trials.
Audience
Clinicians, Postdocs, Research Personnel, Researchers, Students
Meet the Presenters
Elisa J. Gordon, PhD, MPH – Vanderbilt University Medical Center
Elisa J. Gordon, PhD, MPH is Professor in the Department of Surgery, and the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center, Nashville, TN. Dr. Gordon is a medical anthropologist, and trained in clinical medical ethics. Her scholarship focuses on transplant ethics, health disparities, and treatment decision-making.
Michael K. Gusmano, PhD – Lehigh University
Michael K. Gusmano is a Professor of Health Policy the College of Health at Lehigh University. He also serves as the Associate Dean for Academic Programs, and the Director of the Center for Ethics at Lehigh. His scholarship focuses on health and social policy in the United States and internationally.
Karen J. Maschke, PhD – The Hastings Center
Karen J. Maschke, PhD, is a Senior Research Scholar at The Hastings Center, Garrison, NY, and editor of the journal, Ethics & Human Research. Dr. Maschke has a PhD in political science from Johns Hopkins University and a master’s in bioethics from Case Western Reserve University.