APPENDIX B Workshop Agenda and Speaker Biographies

Stem Cells and the Future of Regenerative Medicine

June 22, 2001

National Academy of Sciences Building

Washington, D.C.

Agenda

OVERVIEW TALKS

8:30-9:30 am

Bert Vogelstein

Johns Hopkins University

Opening Remarks

Irving Weissman

Stanford University

School of Medicine

Overview of Stem Cell Biology

James Thomson

University of WisconsinMadison

Human Embryonic Stem Cells

STEM CELLS IN DIFFERENT ORGAN SYSTEMS SESSION I

9:30-10:45am

Ernest Beutler

The Scripps Research Institute

Bone Marrow Transplantation

Margaret Goodell

Texas Medical Center

Stem Cells from Muscle and Bone

Markus Grompe

Oregon Health Sciences University

Gene Therapy in the Liver



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Stem Cells and the Future of Regenerative Medicine APPENDIX B Workshop Agenda and Speaker Biographies Stem Cells and the Future of Regenerative Medicine June 22, 2001 National Academy of Sciences Building Washington, D.C. Agenda OVERVIEW TALKS 8:30-9:30 am Bert Vogelstein Johns Hopkins University Opening Remarks Irving Weissman Stanford University School of Medicine Overview of Stem Cell Biology James Thomson University of WisconsinMadison Human Embryonic Stem Cells STEM CELLS IN DIFFERENT ORGAN SYSTEMS SESSION I 9:30-10:45am Ernest Beutler The Scripps Research Institute Bone Marrow Transplantation Margaret Goodell Texas Medical Center Stem Cells from Muscle and Bone Markus Grompe Oregon Health Sciences University Gene Therapy in the Liver

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Stem Cells and the Future of Regenerative Medicine   Ihor Lemishka Princeton University Fetal Liver Stem Cells STEM CELLS IN DIFFERENT ORGAN SYSTEMS SESSION II 11:00am-12:15pm Ron McKay National Institutes of Health Insulin-Producing Stem Cells Iqbal Ahmad University of Nebraska Medical Center Stem Cells in the Retina Fred Gage The Salk Institute for Biological Studies Repairing the Damaged Brain Olle Lindvall Lund University, Sweden Transplantation of Neural Stem Cells in Humans 12:15-1:15pm LUNCH   PUBLIC POLICY PERSPECTIVES SESSION I 1:15-2:30pm Thomas Okarma Geron Group Biotech Industry and Public Funding Arti Rai Washington University Law School Implications of Restrictions on Stem Cell Research Jay Siegel FDA, Office of Therapeutics Research and Review FDA Perspectives on the Challenges of Stem Cell Therapies PUBLIC POLICY PERSPECTIVES SESSION II 2:45-4:30pm LeRoy Walters Georgetown University Kennedy Institute of Ethics Perspectives on Stem Cell Research form Other Countries

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Stem Cells and the Future of Regenerative Medicine   Kevin FitzGerald Georgetown University Medical Center Arguments Against the Use of Human Embryonic Stem Cells David Prentice Indiana State University Alternatives to Human Embryonic Stem Cells George Annas Boston University School of Public Health Arguments in Favor of the Use of Excess Human Embryos 4:30-5:00pm Bert Vogelstein Summary and Discussion   5:00pm ADJOURN   Audio files from the workshop are available until December 31, 2002, on the Web at http://www.nationalacademies.org/stemcells.

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Stem Cells and the Future of Regenerative Medicine SPEAKER BIOGRAPHIES Iqbal Ahmad, PhD, is associate professor in the Department of Ophthalmology at University of Nebraska Medical Center in Omaha. His main research interest is the role of cell-intrinsic and cell-extrinsic factors in maintenance and differentiation of retinal progenitors. George J. Annas, JD, MPH, is Edward R. Utley Professor and chair, Health Law Department, Boston University Schools of Medicine and Public Health, where he teaches bioethics. He is the author or editor of a dozen books on health law and ethics, including The Rights of Patients, Judging Medicine, American Health Law, Standard of Care, Some Choice, and Health and Human Rights. He has held a variety of regulatory positions including chair of the Massachusetts Health Facilities Appeals Board, vice-chair of the Massachusetts Board of Registration in Medicine, and chair of the Massachusetts Organ Transplant Task Force. Ernest Beutler, MD, received his degree at the University of Chicago in 1950 and remained at the University of Chicago as house officer and faculty member until 1959 when he became chairman of the Department of Medicine at the City of Hope Medical Center in Duarte, California. In 1979 he assumed the chairmanship of the Department of Molecular and Experimental Medicine at the Scripps Research Institute and position as head of the Division of Hematology/Oncology at the Scripps Clinic. In 1974 while at the City of Hope he initiated one of the early and very successful marrow transplant programs. In 1979 he also organized a marrow transplant program at the Scripps Clinic. Dr. Beutler is editor-in-chief of Williams Hematology. He has received the Gairdner Award and has been elected to membership in the American Academy of Arts and Sciences (1975) and the National Academy of Sciences (1976). Father Kevin T. FitzGerald, SJ, PhD, is the Dr. David Lauler Chair in Catholic Health Care Ethics and associate professor of oncology at Georgetown Medical Center. He received a PhD in molecular genetics

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Stem Cells and the Future of Regenerative Medicine and a PhD in bioethics from Georgetown University. His research has focused on the investigation of abnormal gene regulation in cancer and research on ethical issues in human genetics. For the past 10 years he has served as ethics consultant to the National Society of Genetic Counselors. He also serves as a consultant to the Juvenile Diabetes Research Foundation, the United States Catholic Conference, and as a member of the American Association for the Advancement of Science Program of Dialogue on Science, Ethics, and Religion. He is a founding member of Do No Harm: Coalition of Americans for Research Ethics, an organization dedicated to the promotion of scientific research and health care that does no harm to human life. Fred H. Gage, PhD, is a professor in the Laboratory of Genetics at the Salk Institute and adjunct professor of neurosciences at the University of California at San Diego. Dr. Gage studies regeneration and neurogenesis in the adult brain and spinal cord. He is presently on the National Advisory Council on Aging of the National Institutes of Health and the Advisory Board of the American Society of Gene Therapy. In addition to editorial board duties for a variety of scientific journals, he is chairman of the Scientific Advisory Board of the Christopher Reeve Paralysis Foundation. He is the recipient of several research awards including the Christopher Reeve Second Annual Medal Award, the Mathilde Solowey Lecture Award in Neuroscience, the Robert J. and Claire Pasarow Foundation Award, the Max Planck Research Award, the Theobald-Smith Award, and the Bass Foundation Lecture Award. Margaret Goodell, PhD, is an assistant professor in the Center for Cell and Gene Therapy Departments of Pediatrics, Molecular and Human Genetics, and Microbiology and Immunology at Baylor College of Medicine. Dr. Goodell has worked on stem cells derived from adult tissues for over 10 years, first focusing on those in the hematopoietic system and more recently from a number of other tissues. Her work has indicated that adult stem cells (mesenchymal stem cells) can differentiate in bone, cartilage, and brain cells (astrocytes) in culture.

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Stem Cells and the Future of Regenerative Medicine Marcus Grompe, MD, PhD, is a pediatrician in the Department of Molecular and Medical Genetics, Oregon Health Sciences University. Using a mouse model of hereditary tyrosinemia (a genetic disease that is associated with severe liver deficiency in infants), his laboratory has found that more than 90% of host hepatocytes can be replaced by a small number of transplanted donor cells in a process called “therapeutic liver repopulation,” which is analogous to repopulation of the hematopoietic system after bone marrow transplantation. Ihor Lemischka, PhD, is professor in the Department of Genetics, Genomics, and Bioinformatics at Princeton University. His research analyzes hemopoietic differentiation using retroviruses as markers and has focused on gaining insight into the in vivo clonal behavior of the most primitive fetal liver or adult bone marrow hematopoietic stem cells. In particular, his laboratory is interested in understanding the mechanistic aspects of: (1) self-renewal vs. commitment decisions during stem cell proliferation and (2) the nature of commitment decisions as they partition the complete set of developmental potential into subsets or, in other words, the establishment of the primitive portion of the hematopoietic hierarchy. Olle Lindvall, MD, PhD, is professor of neurology and chairman of the Department of Clinical Neuroscience, Lund University, Lund, Sweden. Dr. Lindvall’s current main research interests are the use of cell and gene therapy for preservation and restoration of function in acute and chronic brain diseases. Since 1983 he has been in charge of the clinical cell transplantation program for patients with Parkinson’s disease at Lund University. Ron McKay, MD, is the chief of the Laboratory of Molecular Biology at the National Institute of Neurological Disorders and Stroke. Dr. McKay has made major contributions to the identification of stem cells in the nervous system. His group is developing cell therapies for diabetes, neurological, and cardiac disease.

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Stem Cells and the Future of Regenerative Medicine Thomas Okarma, MD, PhD, is president and chief executive officer of Geron Corporation. After receiving his PhD and MD degrees at Stanford University, Dr. Okarma became a member of the faculty in the Department of Medicine at Stanford University School of Medicine in 1980. Dr. Okarma left Stanford in 1985 and founded Applied Immune Sciences, Inc. (AIS) where he was chief executive officer. By the time of its acquisition by Rhone-Poulenc Rorer in 1995, AIS was in advanced cell therapy human clinical trials in cancer and bone marrow transplantation and in early gene therapy human trials in breast cancer. David A. Prentice, PhD, is professor of life sciences at Indiana State University, adjunct professor of Medical and Molecular Genetics for Indiana University School of Medicine, and a founding member of Do No Harm: The Coalition of Americans for Research Ethics, an organization dedicated to the promotion of scientific research and health care that does no harm to human life. One current focus of his research is on adult stem cells and their differentiation signals. Arti Rai, JD, is assistant professor of law at the University of Pennsylvania School of Law. She attended Harvard Medical School prior to receiving her law degree from Harvard Law School. Professor Rai teaches and writes in the areas of biotechnology and the law, patent law, and health care regulation. Her recent work addresses the interaction between the public and private sectors in biomedical research. She is a co-author of Law and the Mental Health System (West Publishing) and serves on the Board of Editors of the American Journal of Law and Medicine. Jay Siegel, MD, is director of the Office of Therapeutics Research and Review (OTRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). His office has responsibility for regulation of biological therapeutics, including cell therapies, gene therapies, monoclonal antibodies, cytokines, and other proteins. This office has over a decade of experience in applications review,

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Stem Cells and the Future of Regenerative Medicine research, and development of scientific standards and policy with regard to hematopoietic stem cell related products and, in 2000, convened the first FDA advisory committee conference on neurologic stem cell products. Since joining CBER in 1982, Dr. Siegel has served as founding director of the Division of Clinical Trial Design and Analysis, deputy director of the Division of Cytokine Biology, chief of the Laboratory of Cellular Immunology, and senior investigator in the Division of Virology. He trained in medicine and infectious diseases at Stanford University School of Medicine, in internal medicine at the University of California, San Francisco, and in biological sciences at the California Institute of Technology. James A. Thomson, DVM, PhD, is a University of Wisconsin-Madison developmental biologist in the Department of Anatomy in the School of Medicine and also serves as the chief pathologist at the Wisconsin Regional Primate Research Center on the UW-Madison campus. Dr. Thomson received his doctorate in veterinary medicine in 1985 and his doctorate in molecular biology in 1988, both at the University of Pennsylvania. Since joining the Wisconsin Regional Primate Research Center, he has conducted work on the isolation and culture of non-human primate and human embryonic stem cells, undifferentiated cells that have the ability to become any of the cells that make up the tissues of the body. Dr. Thomson directed the group that reported the first isolation of embryonic stem cell lines from a non-human primate in 1995, work that led his group to the first successful isolation of human embryonic stem cell lines in 1998. Dr. Thomson is the scientific director of the WiCell Research Institute, a private subsidiary established by the Wisconsin Alumni Research Foundation to supply cells to support research for both academic and non-academic researchers. LeRoy Walters, PhD, is the Joseph P. Kennedy Professor of Christian Ethics at the Kennedy Institute of Ethics and professor of philosophy at Georgetown University. He chaired the Recombinant DNA Advisory Committee from 1993 to 1996. He is the author of The Ethics of Human

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Stem Cells and the Future of Regenerative Medicine Gene Therapy (1996) and co-editor of Source Book in Bioethics: A Documentary History (2000). Irving L. Weissman, MD, is Karel and Avice Beekhuis Professor of Cancer Biology, Cell and Developmental Biology at Stanford University. His research encompasses the phylogeny and developmental biology of the cells that make up the blood forming and immune systems. His laboratory has identified and isolated the blood-forming stem cell from mice and has defined, by lineage analysis, the stages of development between the stem cells and mature progeny. In addition, the Weissman laboratory has pioneered the study of the genes and proteins involved in cell adhesion events required for lymphocyte homing to lymphoid organs in vivo, either as a normal function or as events involved in malignant leukemic metastases. Dr. Weissman has been elected to the National Academy of Sciences and to the American Association for the Advancement of Science. He has received the Kaiser Award for Excellence in Preclinical Teaching, the Pasarow Award, and the Outstanding Investigator Award from the National Institutes of Health.

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