Secretary's Advisory Committee on Xenotransplantation

(February 2001)

BIOSKETCHES

The chair of the SACX is Harold Y. Vanderpool, Ph.D., Th.M., Professor in the History and Philosophy of Medicine, Institute for the Medical Humanities, University of Texas Medical Branch, Galveston. Dr. Vanderpool is a nationally and internationally recognized authority on the ethics and regulation of research involving human subjects, including ethical and social issues related to xenotransplantation. He has served as a member of the Institute of Medicine's Committee on Xenograft Transplantation and of the Xenotransplantation Subcommittee of the Food and Drug Administration’s Biologic Response Modifiers Advisory Committee. Dr. Vanderpool's scholarly work has addressed the ethical, historical, cultural, personal, and public policy dimensions of innovative science, clinical care, and medical research.

The members of the committee are:

Jonathan S. Allan, D.V.M., Scientist, Department of Virology and Immunology, Southwest Foundation for Biomedical Research, San Antonio, Texas. Dr. Allan is a virologist whose laboratory research has centered on simian retroviruses, and in particular on simian AIDS, its origins, and natural host resistance to disease in African nonhuman primates. Since 1994, Dr. Allan has emphasized the risks of infectious diseases from animals to humans in the transplant setting. He also serves on the Food and Drug Administration’s Advisory Subcommittee on Xenotransplantation.

Alan H. Berger, M.B.A., C.P.A., Executive Director/CEO, John Ancrum SPCA (JASPC), Charleston, SC. Prior to joining the JASPCA, Mr. Berger served for nine years as the Executive Director/CEO of the Animal Protection Institute (API), a national animal advocacy nonprofit organization. His prior experience with both nonprofit organizations and private industry covers many diverse areas, including health care and human social services. Since 1994, one of Mr. Berger's main area of interest regarding animal welfare has been xenotransplantation. His research in this field includes animal/human ethics, organ procurement, cost-benefit-analysis, health care allocation, prevention, and alternatives to xenotransplantation.

Bradley H. Collins, M.D., Assistant Professor of Surgery, Chief of Kidney-Pancreas Transplantation, Department of Surgery, Duke University Medical Center, Durham, NC. Dr. Collins is a transplant surgeon whose clinical practice includes liver, pancreas, and kidney transplantation. His basic science research interests are in the fields of xenotransplantation and immunology. One of the preclinical projects that he is actively investigating is the transplantation of microencapsulated porcine islets into non-human primates.

Catherine Crone, M.D., Assistant Clinical Professor of Psychiatry, Georgetown Medical Center and Director of Psychiatric Services, Inova Transplant Center, Falls Church, VA. Dr. Crone's focus is on the care and understanding of psychiatric/psychosocial needs in medically ill patient populations. She has particular expertise in the field of organ transplantation and has actively fostered research, education, and policy development to address psychosocial issues in transplantation.

James C. Finn is a xenotransplantation recipient. He is a member of the first group of patients to receive porcine cells injected into the brain in a research study. As a patient with a twenty year history of Parkinson’s disease, he is acutely aware of the medical, financial and social problems caused by chronic illness. Also, Mr. Finn has been extensively interviewed by the media (print and broadcast) about his experiences with this medical technology. He has authored a detailed diary of his involvement with this procedure that is published on the Internet.

Richard A. Kaslow, M.D., M.P.H., is Professor of Epidemiology and International Health, Medicine and Microbiology at the University of Alabama at Birmingham. Dr. Kaslow is an internist board certified in internal medicine, infectious diseases and preventive medicine with graduate training in epidemiology. As Co-Director of the Clinical Research Training Program, he teaches the principles and practice of population research. His research interests include immunogenetic and other host factors in infectious and immunologic diseases, chronic complications of infection, natural history, determinants and expression of disease following HIV infection. As an expert in infectious diseases, he has a special interest in the natural history of HIV progression in a large 15-year study of homosexual men. Dr. Kaslow heads the Program in Epidemiology of Infection and Immunity and has appointments in the AIDS, Cancer and Arthritis Centers.

Sharon C. Kiely, M.D., M.P.M., Director, Medical Ambulatory Clinic and Center for the Study and Care of the Medically Underserved, Department of Medicine, Allegheny General Hospital, Pittsburgh, PA. Dr. Kiely is a primary care physician with experience in medical education, health policy and community primary health care. Dr. Kiely has established and directed clinical service programs in community health to homeless and homebound populations. Dr. Kiely’s academic interests include issues of equity, access to care, professionalism and social determinants of health. Dr. Kiely is an experienced advocate for transplant issues as a volunteer for the Juvenile Diabetes Foundation International. She has served on the National Advisory Council for Health Care, Policy and Research.

Karren King, MSW, ACSW, LCSW has been a nephrology social worker for over 20 years, working with both the dialysis and kidney transplant populations. She is Past-President of the Council of Nephrology Social Workers and has served on both the Executive Committee and Board of Directors of the National Kidney Foundation, Inc. (NKF). Ms. King participated in the NKF surveys that assessed the attitudes of the public, transplant recipients, and physicians in regard to xenotransplantation. Ms. King currently serves as President of the Board of Consultants and as a member of the Board of Directors of the Midwest Bioethics Center.

Dr. Anthony S. Lubiniecki is Vice President and Director of Worldwide Biopharmaceutical Development, Research and Development, GlaxoSmithKline, King of Prussia, PA and Adjunct Professor of Chemical and Biochemical Engineering at the University of Maryland, Baltimore County Campus. Dr. Lubiniecki has extensive experience in the development of therapeutic, prophylactic, and diagnostic biopharmaceutical products for human and animal use. He is a recognized leader in development of manufacturing processes and control methods for biopharmaceutical products which effectively protect product recipients from exposure to viral contaminants inherent in manufacturing processes.

Robert Mendez, M.D., F.A.C.S., Professor of Urology and Surgery, USC School of Medicine; Director, Multi-Organ Transplant Programs, St. Vincent Medical Center, Los Angeles; President, National Institute of Transplantation (NIT); President and Chairman of the Board, Southern California Organ Procurement center (SCOPC); and past President, United Network for Organ sharing (UNOS). Research interests involve crossing the ABO blood barriers as a preliminary step towards Xenography; the use of porcine islet cells in Type I insulin-dependent diabetics, the role of histocompatibility in allograft survival, and the development of tolerance in organ transplantation. He also serves on the Board of the University of Southern California School of Law, Center for Medical Ethics and the Law. He is a member, and past president of numerous urological and transplant societies.

Dr. Marian G. Michaels is an Associate Professor of Pediatrics and Surgery at the University of Pittsburgh School of Medicine in the Division of Allergy, Immunology, and Infectious Diseases at the Children's Hospital of Pittsburgh. Dr. Michaels is an experienced researcher in the field of infectious diseases associated with transplantation. She has served as a member of the Institute of Medicine’s Xenograft Transplantation: Ethical Issues and Public Policy Committee and of the World Health Organization’s Consultation on Xenotransplantation: Infectious Disease Prevention and Ethical Considerations. In addition, she has served as a consultant for the Public Health Service and the Food and Drug Administration on issues concerning the potential transmission of infectious diseases through xenotransplantation.

Lilly-Marlene Russow received her Ph.D. in Philosophy from Princeton University in 1976. She is currently a Full Professor in the Department of Philosophy, and an Adjunct Professor in the Department of Veterinary Pathobiology at Purdue University. She has taught courses in Ethics and Animals, Environmental Ethics, and Ethical Issues in Biomedical Research since 1977. She has published widely on these topics in both philosophical and scientific journals, and is currently the Executive Secretary for the Scientists Center for Animal Welfare, and a member of governing council for the Institute for Laboratory Animal Welfare (ILAR), a division of the National Academy of Sciences.

Daniel R. Salomon, M.D., Associate Professor, Department of Molecular and Experimental Medicine, The Scripps Research Institute, La Jolla, California. Dr. Salomon is the Director of Transplantation Research and the Kidney Transplant Program for the Scripps Clinic and Director of the Core Laboratory for the General Clinical Research Center. Dr. Salomon’s research focuses on pancreatic islet development, transplantation, angiogenesis, tissue engineering, T cell gene therapy approaches for allogeneic stem cell transplantation, tolerance, and xenogeneic infection risk associated with pig islet xenotransplantation. Dr. Salomon’s policy work has focused on xenotransplantation and gene therapy. He is presently the Chair of the Biological Response Modifiers Advisory Committee for the FDA.

William E. Scheckler, M.D., Professor of Family Medicine, University of Wisconsin Medical School and Hospital Epidemiologist at St. Marys Hospital Medical Center in Madison, Wisconsin. Dr. Scheckler is a primary care physician with expertise in hospital infection control and prevention, infectious disease and antibiotic use, continuous quality improvement and family medicine education. He served as an Epidemic Intelligence Service officer at the Centers for Disease Control and Prevention, and helped develop the National Nosocomial Infection Surveillance System. He is a founder and past president of The Society for Healthcare Epidemiology of America. Dr. Scheckler is active in the Wisconsin State Division of Health and the Bureau of Public Health and chaired the committee that revised the Wisconsin Public Health Statutes. He also serves on the CDC's Hospital Infection Control Practices Advisory Committee. At the University, he has held positions of Research Director, Vice Chair and Chair of the Department of Family Medicine.

Robyn S. Shapiro, J.D., a graduate of Harvard Law School, is Director of the Center for the Study of Bioethics and the Ursula Von der Ruhr Professor of Bioethics at the Medical College of Wisconsin. Professor Shapiro serves on the Board of the American Society for Bioethics and Humanities, the Ethics Committee of the American Society of Transplant Surgeons, and the American Bar Association’s Coordinating Group on Bioethics and the Law. Professor Shapiro has published numerous articles and book chapters and lectured nationally on legal and ethical issues surrounding transplantation, genetics, treatment decision-making and health care delivery. At the invitation of the U.S. House of Representatives and the U.S. Senate, she has provided testimony on transplantation issues and on health information privacy. In addition to her positions at the Medical College of Wisconsin, Professor Shapiro practices health law as a Partner at Michael, Best and Friedrich, LLP in Milwaukee, Wisconsin.

M. Michael Swindle, DVM is Professor and Chairman of the Department of Comparative Medicine at the Medical University of South Carolina, Charleston, SC. His academic career has included development of swine models of human disease, especially in the area of experimental surgery. He serves on the editorial boards of journals in those areas of expertise. He also serves on the boards of several professional societies involved in research activities. He has numerous publications and professional presentations in his field of expertise.

Megan Sykes, M.D., Immunologist, Departments of Surgery and Medicine, Massachusetts General Hospital, Professor of Surgery and Medicine, Harvard Medical School. Dr. Sykes is a transplantation immunologist whose research interests include graft-versus-tumor effects in bone marrow transplantation and the induction of transplantation tolerance. A major area of her work has focused on altering the immune response to xenografts, and she has expertise in the immunology of and other aspects of xenotransplantation.