Appendix C
Workshop Agenda and Speaker Biographies

Board on Life Sciences

The National Academies

and

Board on Health Sciences Policy

Institute of Medicine

Guidelines for Human Embryonic Stem Cell Research

Public Workshop

Agenda, Tuesday, October 12, 2004

Main Auditorium

National Academy of Sciences

2101 Constitution Ave., NW Washington, D.C.

8:30 a.m.

Welcome: Bruce Alberts, President, National Academy of Sciences

Harvey Fineberg, President, Institute of Medicine

8:45 a.m.

Introduction and Mandate of the Committee on Guidelines for Human Embryonic Stem Cell Research:

 

Richard Hynes, Massachusetts Institute of Technology and Co-Chair, Committee on Guidelines for Human Embryonic Stem Cell Research



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Guidelines for Human Embryonic Stem Cell Research Appendix C Workshop Agenda and Speaker Biographies Board on Life Sciences The National Academies and Board on Health Sciences Policy Institute of Medicine Guidelines for Human Embryonic Stem Cell Research Public Workshop Agenda, Tuesday, October 12, 2004 Main Auditorium National Academy of Sciences 2101 Constitution Ave., NW Washington, D.C. 8:30 a.m. Welcome: Bruce Alberts, President, National Academy of Sciences Harvey Fineberg, President, Institute of Medicine 8:45 a.m. Introduction and Mandate of the Committee on Guidelines for Human Embryonic Stem Cell Research:   Richard Hynes, Massachusetts Institute of Technology and Co-Chair, Committee on Guidelines for Human Embryonic Stem Cell Research

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Guidelines for Human Embryonic Stem Cell Research 9:00 a.m. Overview of the Human Embryonic Stem Cell Science and Policy Issues   Moderator: Richard Hynes   Stem Cell Science—Where Have We Come From, Where Are We Going? Martin Raff, University College London Overview of Policies and Rules—An International Perspective LeRoy Walters, Georgetown University Discussant: Anne McLaren, Centre for Medical Genetics and Policy, University of Cambridge 9:50 a.m. Q & A 10:15 a.m. Break 10:30 a.m. Derivation and Use of Human Embryonic Stem Cells—General Issues   Moderator: Janet Rossant, Mount Sinai Hospital, Toronto   Panel: George Daley, Harvard Medical School Fred (Rusty) Gage, the Salk Institute   Discussants: James Battey, National Institutes of Health Leonard Zon, Harvard Medical School 11:30 p.m. Q & A 12:00 p.m. Lunch 1:00 p.m. Stem Cells and Somatic Cell Nuclear Transfer   Moderator: H. Robert Horvitz, MIT and Howard Hughes Medical Institute   Panel: Rudolf Jaenisch, Whitehead Institute Davor Solter, Max Planck Institute of Immunobiology   Discussant: Kevin Eggan, Harvard University

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Guidelines for Human Embryonic Stem Cell Research 1:50 p.m. Q&A 2:20 p.m. Break 2:35 p.m. Interspecies Mixing and Chimeras   Moderator: Terry Magnusson, University of North Carolina   Panel: Irving Weissman, Stanford University School of Medicine David Garbers, University of Texas Southwestern Medical Center at Dallas   Discussant: Brigid Hogan, Duke University 3:25 p.m. Q&A 3:55 p.m. Current Legal and Regulatory Requirements That May Affect Human Embryonic Stem Cell Research   Panel: Alta Charo, University of Wisconsin School of Law Michael Malinowski, Louisiana State University School of Law 4:35 p.m. Q&A 5:00 p.m. Public Comment 5:30 p.m. Adjourn Agenda, Wednesday, October 13, 2004 Lecture Room National Academy of Sciences 2101 Constitution Ave., NW Washington, D.C. 8:30 a.m. Opening Remarks: Jonathan Moreno, University of Virginia, and Co-Chair, Committee on Guidelines for Human Embryonic Stem Cell Research

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Guidelines for Human Embryonic Stem Cell Research 8:45 a.m. Informed Consent and Procurement   Moderator: Jonathan Moreno   Presentation: Ruth Faden, Phoebe R. Berman Bioethics Institute, Johns Hopkins University   Discussants: Alison Murdoch, Department of Reproductive Medicine, International Centre for Life Catherine Racowsky, Brigham and Women’s Hospital, Division of Reproductive Medicine 9:25 a.m. Q&A 9:40 a.m. Derivation of Stem Cell Lines—Ethics and Policy Concerns   Moderator: Janet Rowley, University of Chicago   Panel on SCNT for human embryonic stem cell research Dan Brock, Harvard Medical School Leon Kass, President’s Council on Bioethics Panel on species mixing/chimeras for human embryonic stem cell research Henry Greely, Stanford Law School Cynthia Cohen, Georgetown University William Hurlbut, Stanford University (20 minutes) 11:20 a.m. Q&A 11:45 a.m. Patenting, Licensing, and Material Transfer Agreements in Relation to Human Embryonic Stem Cell Research   Moderator: Elizabeth Price Foley, Florida International University College of Law   Presentation: Carl Gulbrandsen, Wisconsin Alumni Research Foundation 12:15 p.m. Q&A 12:30 p.m. Lunch

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Guidelines for Human Embryonic Stem Cell Research 1:05 p.m. Mechanisms for Oversight of Human Embryonic Stem Cell Research   Moderator: Norman Fost, University of Wisconsin   Panel: Laurie Zoloth, Center for Genetic Medicine, Northwestern University Franco Furger, Executive Director, Human Biotechnology Governance Forum, Johns Hopkins University 1:40 p.m. Q&A 1:55 p.m. Industry Perspective: What Is Industry’s Role in Monitoring the Ethics of Human Embryonic Stem Cell Research?   Moderator: Marcia Imbrescia, Arthritis Foundation Board of Trustees   Presentation: Michael Werner, Chief of Policy, Biotechnology Industry Organization 2:15 p.m. Q&A 2:30 p.m. Serving the Public Interest: Conducting Human Embryonic Stem Cell Research in a Democratic Society   Moderator: Cheryl Mwaria, Hofstra University   Panel: Dan Hausman, University of Wisconsin Robert Goldstein, Juvenile Diabetes Research Foundation Bruce Jennings, The Hastings Institute 3:30 p.m. Q&A 3:45 p.m. Public Comment 4:15 p.m. Summary and Concluding Remarks: Jonathan Moreno and Richard Hynes 4:30 p.m. Adjourn

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Guidelines for Human Embryonic Stem Cell Research SPEAKER BIOGRAPHIES James F. Battey, Jr., MD, PhD, received his BS in physics from the California Institute of Technology in 1974 and his MD and PhD in biophysics from Stanford University School of Medicine in 1980. After receiving training in pediatrics, Dr. Battey pursued a postdoctoral fellowship in genetics at Harvard Medical School under the mentorship of Philip Leder. Since completing his postdoctoral fellowship in 1983, he has held a variety of positions at the National Institutes of Health, serving in the National Cancer Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute on Deafness and Other Communication Disorders, of which he is currently the director. Until recently he also served as the chair of the NIH Stem Cell Task Force. Dan W. Brock, PhD, is a former senior scientist and member of the Department of Clinical Bioethics at the National Institutes of Health and former professor of philosophy and biomedical ethics at Brown University, where he was also the Charles C. Tillinghast, Jr. University Professor, professor of philosophy and biomedical ethics, and director of the Center for Biomedical Ethics through June 2002. He is professor of medical ethics in the Department of Social Science at Harvard Medical School. Dr. Brock works on such subjects as genes and justice, health care resource prioritization and rationing, and end of life care and euthanasia. He has published numerous papers in bioethics and in moral and political philosophy. His most recent works include “Priority to the Worst Off in Health Care Resource Prioritization” and “Broadening the Bioethics Agenda.” He is also the author of Deciding For Others: The Ethics of Surrogate Decision Making (with Allen E. Buchanan, 1989); Life and Death: Philosophical Essays in Biomedical Ethics (1993); and From Chance to Choice: Genetics and Justice (with Allen Buchanan, Norman Daniels, and Daniel Wikler, 2000). R. Alta Charo, JD, is the Elizabeth S. Wilson-Bascom Professor of Law and Bioethics at the University of Wisconsin Law and Medical Schools, and Associate Dean for Research and Faculty Development at the University of Wisconsin Law School at Madison. Professor Charo is the author of over 75 articles, book chapters, and government reports on topics including voting rights, environmental law, reproductive rights, medical genetics law, reproductive technology policy, and science policy. She serves on the expert advisory boards of several organizations with an interest in stem cell research, including the Juvenile Diabetes Research Foundation, WiCell, and the Wisconsin Stem Cell Research Program. She is also a consultant to the California Institute for Regenerative Medicine. In 1994, Professor Charo served on the NIH Human Embryo Research Panel, and from 1996-2001 she was a member of the presidential National Bioethics Advisory Commission, where she participated

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Guidelines for Human Embryonic Stem Cell Research in writing its reports on research ethics and cloning. Since 2001 she has been a member of the National Academies’ Board on Life Sciences. Cynthia Cohen, PhD, JD, is a faculty affiliate of the Kennedy Institute of Ethics at Georgetown University in Washington, D.C., and a fellow at the Hastings Center in Garrison, New York. She is the former executive director of the National Advisory Board on Ethics in Reproduction in Washington, DC, associate for ethical studies at the Hastings Center, associate to the legal counsel of the University of Michigan Hospitals, and chair of the Philosophy Department at the University of Denver. She is a member of the Canadian Stem Cell Oversight Committee and has served as a consultant to such groups as the National Institutes of Health, the American Association for the Advancement of Science, and the Stem Cell Network. Dr. Cohen has written or edited eight books and some 150 articles on ethical issues, including stem cell research, genetic testing, reproductive and therapeutic cloning, the new reproductive technologies, organ transplantation, mandatory drug testing, and religion and public policy. George Q. Daley, MD, PhD, is an associate professor of biological chemistry and molecular pharmacology at Harvard Medical School. He received a bachelor’s degree (1982) from Harvard University, his PhD (1989) in biology from the Massachusetts Institute of Technology (MIT), and his MD (1991) from Harvard Medical School through the Harvard-MIT Division of Health Sciences and Technology. Dr. Daley’s laboratory studies stem cell development and differentiation, emphasizing derivation of functional hematopoietic and germ cell elements from embryonic stem cells and the genetic mechanisms that predispose to malignancy. Dr. Daley is Board Certified in Internal Medicine and Hematology, and is a staff physician in Hematology/Oncology at the Children’s Hospital, the Dana Farber Cancer Institute, and the Brigham and Women’s Hospital in Boston. He has been elected to the American Society for Clinical Investigation and has received research awards from Harvard Medical School, the National Institutes of Health, the New England Cancer Society, the Burroughs Wellcome Fund, the Edward Mallinckrodt, Jr. Foundation, and the Leukemia and Lymphoma Society of America. Dr. Daley was recently named a recipient of the NIH Director’s Pioneer Award, an unrestricted grant to pursue highly innovative avenues of research. Kevin Eggan, PhD, is a junior fellow in the Harvard Society of Fellows at Harvard University, having recently completed postdoctoral studies in the laboratory of Rudy Jaenisch at the Whitehead Institute for Biomedical Research. At Harvard, Dr. Eggan is establishing an independent research group to study the molecular and genetic control of mouse preimplantation development, investigate epigenetic reprogramming after somatic cell nuclear transfer, and derive disease-specific human embryonic stem cell lines from diabetic and Parkinson’s disease patients by nuclear transfer. Dr. Eggan has been invited to present his work at numerous symposia and

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Guidelines for Human Embryonic Stem Cell Research workshops. He received a BS degree from the University of Illinois and a PhD from the Massachusetts Institute of Technology. Ruth Faden, MPH, PhD, (IOM) is the Philip Franklin Wagley Professor of Biomedical Ethics and executive director of the Phoebe R. Berman Bioethics Institute at Johns Hopkins University. She is also a senior research scholar at the Kennedy Institute of Ethics, Georgetown University. Dr. Faden is the author and editor of numerous books and articles on biomedical ethics and health policy, including A History and Theory of Informed Consent (with Tom L. Beauchamp), AIDS, Women and the Next Generation (Ruth Faden, Gail Geller, and Madison Powers, eds.), and HIV, AIDS and Childbearing: Public Policy, Private Lives (Ruth Faden and Nancy Kass, eds.). She is a fellow of the Hastings Center and the American Psychological Association. She has served on several national advisory committees and commissions including the President’s Advisory Committee on Human Radiation Experiments, which she chaired. Dr. Faden holds a BA from the University of Pennsylvania, an MA in general studies in humanities from the University of Chicago, and an MPH and PhD (Program in Attitudes and Behavior) from the University of California, Berkeley. Franco Furger, PhD, is the executive director of the Human Biotechnology Governance Forum at the Foreign Policy Institute of the Paul H. Nitze School of Advanced International Studies at Johns Hopkins University. The 2-year project is exploring options for controlling research in and applications of “reprogenetics,” research activities that focus on the beginning of life and procedures aimed at preventing the inheritance of genetic diseases. Such research activities include research cloning, stem cell research, and preimplantation genetic diagnosis. Before joining Johns Hopkins, he was a member of the faculty of George Mason University’s School of Public Policy. Dr. Furger received an MS in electrical engineering in 1982 and a PhD in environmental sciences in 1992 from the Federal Institute of Technology in Zurich. Fred H. Gage, PhD, (NAS) is a professor in the Laboratory of Genetics at the Salk Institute in La Jolla, California, and a professor of neuroscience at the University of California, San Diego. Dr. Gage received his undergraduate degree from the University of Florida and a PhD from Johns Hopkins University and is known for his discovery of structural and functional plasticity in the adult mammalian brain. His research focuses on the development of strategies to induce recovery of function after central nervous system damage and on the unexpected plasticity and adaptability that remain throughout the life of all mammals. His work may lead to methods of replacing brain tissue lost to stroke or Alzheimer’s disease and repairing spinal cords damaged by trauma. Dr. Gage’s laboratory showed that, contrary to years of dogma, human beings are capable of growing new nerve cells throughout life. Dr. Gage is a past president of the Society for Neuroscience. Among the awards

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Guidelines for Human Embryonic Stem Cell Research he has received are the Charles A. Dana Award for Pioneering Achievements in Health and Education (1993), the Christopher Reeve Research Medal (1997), and the Max Planck Research Prize (1999). David Garbers, PhD, is professor of pharmacology at the University of Texas Southwestern Medical Center in Dallas, Texas, and director of the Cecil H. and Ida Green Center for Reproductive Biology Sciences. He is also a Howard Hughes Medical Institute investigator. His laboratory explores how cells communicate with each other, particularly the mechanisms by which mammalian sperm detect signals from the egg. His research includes the development of technology to produce germ cells in vitro and to understand the mechanisms by which the mammalian egg is capable of reprogramming a somatic cell nucleus. He is a member of the American Academy of Arts and Sciences and has served on the editorial boards of various scientific journals, including the Journal of Biological Chemistry, Biology of Reproduction, and Biochemical Journal and Endocrine Reviews. Dr. Garbers received his bachelor’s, master’s, and PhD degrees in science from the University of Wisconsin. In 2001, he received the Endocrine Society’s Edwin B. Astwood award. Robert A Goldstein, MD, PhD, is the chief scientific officer of the Juvenile Diabetes Research Foundation International, where he is responsible for developing and guiding the research agenda. Before joining the foundation in 1997, he was director of the Division of Allergy, Immunology and Transplantation at the National Institute of Allergy and Infectious Diseases. He received his undergraduate degree from Brandeis University, his MD from Jefferson Medical College, his PhD in microbiology and immunology from George Washington University, and an MBA from the Stern School of Business, New York University. He recently testified before Congress on stem cell research. Henry T. Greely, JD, is the Deane F. and Kate Edelman Johnson Professor of Law and a professor, by courtesy, of genetics at Stanford University. He specializes in legal and social issues arising from advances in the biological sciences and in health law and policy. He has written on genetic testing, human cloning, the ethics of human genetics research, legal issues in neuroscience, and policy issues in the health care financing system. He directs the Stanford Center for Law and the Biosciences, chairs the steering committee of the Stanford University Center for Biomedical Ethics, and co-directs the Stanford Program on Genomics, Ethics, and Society. Dr. Greely graduated from Stanford in 1974 and from Yale Law School in 1977. He joined the Stanford faculty in 1985. Carl Gulbrandsen, PhD, JD, is the managing director of the Wisconsin Alumni Research Foundation (WARF) at the University of Wisconsin, Madison. He received his undergraduate degree from St. Olaf College in Northfield, Minnesota, a PhD in physiology from the University of Wisconsin, Madison, and a JD degree

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Guidelines for Human Embryonic Stem Cell Research from the University of Wisconsin Law School. In 1992, after 9 years of private practice law focusing on intellectual property rights, Dr. Gulbrandsen joined Madison, WI companies Lunar Corporation and Bone Care International, Inc. as general counsel. He joined WARF in October 1997 as director of patents and licensing and in 2000 he became the managing director. He is a member of the Association of University Technology Managers, the Licensing Executive Society, the American Intellectual Property Law Association, the Wisconsin State Bar, and the American Bar Association. He is also a director of the WiCell Research Institute, the Cornell Research Foundation, and the Wisconsin Biotechnology Association. Dan Hausman, PhD, is Herbert A. Simon Professor in the Department of Philosophy of the University of Wisconsin. After graduating from Harvard in 1969, where he studied biochemistry and then English history and literature, he taught public school in New York City and received a Master of Arts in Teaching from New York University. He then received a BA in philosophy from Cambridge University and a PhD from Columbia University in 1978. His dissertation (later published as Capital, Profits and Prices) addressed questions in the philosophy of science raised by economics, and a large portion of his research has focused on economic methodology. Partly as a result of editing the journal Economics and Philosophy (in 1984-1994, jointly with Michael McPherson), he has worked on issues in ethics and economics and foundational questions concerning the nature of rationality. His interest in economic methodology has led to a long and continuing research interest concerning the nature of causation. Brigid Hogan, PhD, (IOM) is the George Barth Geller Professor and chair of the Department of Cell Biology, Duke University Medical Center. Before joining Duke, Dr. Hogan was a Howard Hughes Medical Institute investigator and Hortense B. Ingram Professor in the Department of Cell Biology at Vanderbilt University Medical Center. Dr. Hogan earned her PhD in biochemistry at the University of Cambridge. She was then a postdoctoral fellow in the Department of Biology at MIT. Before moving to the United States in 1988, Dr. Hogan was head of the Molecular Embryology Laboratory at the National Institute for Medical Research in London. Her research focuses on the genetic control of embryonic development and morphogenesis, using the mouse as a model system. Her laboratory developed methods for deriving mouse pluripotent embryonic germ cell lines. She was co-chair for science of the 1994 National Institutes of Health Human Embryo Research Panel and a member of the National Academies Panel on Scientific and Medical Aspects of Human Cloning. In the past few years, Dr. Hogan has been elected to the Royal Society of London, the American Academy of Arts and Sciences, and the Institute of Medicine. William Hurlbut, MD, is a physician and consulting professor in the Program on Human Biology at Stanford University, where he has cotaught integrative courses

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Guidelines for Human Embryonic Stem Cell Research with Luca Cavelli-Sforza on human genetic diversity and with Nobelist Baruch Blumberg on epidemics, evolution, and ethics. Dr. Hurlbut’s main interests involve ethical issues associated with advancing biotechnology and neuroscience and the integration of philosophy of biology with Christian theology. His recent work has focused on the evolutionary origins of religious, spiritual, and moral awareness. In 2002, Dr. Hurlbut was appointed to the President’s Council on Bioethics. He is a member of the Chemical and Biological Warfare working group of Stanford’s Center for Security and International Cooperation. Dr. Hurlbut received his MD from Stanford and later conducted theological studies at Stanford and the Institute Catholique, Paris. His recent writings include From Biology to Biography: The Science of the Human Person, a chapter in Blankenhorn, D., Benson, I.T. and O’Hara, M. (eds.) Who are We?: Essays on the Nature of the Human Person (in press, 2004). Rudolf Jaenisch, MD, (NAS) is a founding member of the Whitehead Institute and professor of biology at the Massachusetts Institute of Technology. Born in Germany, he received his MD from the University of Munich in 1967 and was a postdoctoral fellow first at the Max Planck Institute for Biochemistry, Munich, and then at Princeton University. After a period as a visiting fellow at the Institute for Cancer Research in Philadelphia, Dr. Jaenisch joined the Salk Institute in La Jolla, California, where he remained from 1972 to 1977, rising from assistant to associate research professor. In 1977 he returned to Germany, where until 1984 (when he joined the Whitehead Institute) he was head of the Department of Tumor Virology at the Heinrich Pette Institute for Experimental Virology and Immunology at the University of Hamburg. Dr. Jaenisch is a pioneer in transgenic science (making mouse models of human disease) whose methods have been used to explore the role of DNA modification, genomic imprinting, and X chromosome inactivation, which are important topics in the study of cancer, developmental processes, and neurological and connective tissue disorders. Dr. Jaenisch has made major contributions to the study of genomic reprogramming that occurs during nuclear cloning. In addition to receiving many awards for his work, he was elected to the U.S. National Academy of Sciences in 2003. Bruce Jennings, MA, is senior research scholar at the Hastings Center. From 1991 through 1999, he served as the Center’s executive vice president. He has directed several research projects on the care of the dying, health policy, chronic illness and long-term care, and ethical issues in human genetics. He served as associate director of a project that produced the widely cited and influential Guidelines on the Termination of Life-Sustaining Treatment and the Care of the Dying. With Mildred Z. Solomon of the Education Development Center in Newton, Massachusetts, he is cofounder of the Decisions Near the End of Life Program, a hospital-based educational program for physicians and other health professionals that has been used in over 200 hospitals in 30 states. Mr. Jennings has served as a consultant to several

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Guidelines for Human Embryonic Stem Cell Research government and private organizations, including the American Hospital Association, the Education Development Center, the Robert Wood Johnson Foundation, the New York Academy of Medicine, the Prudential Foundation, and Eli Lilly and Company. He serves on the boards of directors of such organizations as the National Hospice and Palliative Care Organization, American Health Decisions, the American Association of Bioethics (1994-1997), and the Association of Politics and the Life Sciences. Mr. Jennings also serves on bioethics advisory committees for the Alzheimer’s Association, the Episcopal Church of the United States, and the National Hospice and Palliative Care Organization. In addition to his work with the Hastings Center, Mr. Jennings teaches at the Yale University School of Medicine in the Department of Epidemiology and Public Health. Leon Kass, MD, PhD, is Hertog Fellow in Social Thought at the American Enterprise Institute and is the Addie Clark Harding Professor at the College and the Committee on Social Thought at the University of Chicago (on leave of absence). He earned his BS and MD degrees at the University of Chicago (1958 and1962) and his PhD in biochemistry at Harvard (1967). After conducting molecular biology research at the National Institutes of Health while serving in the U.S. Public Health Service, Dr. Kass turned to the ethical and philosophical issues raised by biomedical advances and, more recently, to broader moral and cultural issues. From 1970 to 1972, Dr. Kass served as executive secretary of the Committee on the Life Sciences and Social Policy of the National Research Council, whose report Assessing Biomedical Technologies provided one of the first overviews of the emerging moral and social questions posed by biomedical advance. He taught at St. John’s College, Annapolis, MD, and served as Joseph P. Kennedy Sr. Research Professor in Bioethics at the Kennedy Institute of Ethics at Georgetown University before returning in 1976 to the University of Chicago. His widely reprinted essays on biomedical ethics have dealt with issues raised by in vitro fertilization, cloning, genetic screening and genetic technology, organ transplantation, aging research, euthanasia and assisted suicide, and the moral nature of the medical profession. In 2001, Dr. Kass was appointed by President Bush to chair the President’s Council on Bioethics. Michael Malinowski, JD, is the Ernest and Iris Eldred Professor of Law, and associate director of the Program in Law, Science, and Public Health at the Paul M. Hebert Law Center at Louisiana State University. He is cofounder of the Program in Law, Medicine, and BioScience and chair of the Health and Human Services Committee of the American Bar Association (ABA). He is a member of the ABA President’s Special Committee on Bioethics, Phi Beta Kappa, and Oxford University’s 21st Century Trust. In 1999-2000, Dr. Malinowski was a SmithKline Beecham Distinguished Fellow in Law and Genetics at the Center for the Study of Law, Science and Technology and a visiting professor of law at the Arizona State University College of Law. Previously, he was counsel to the law firm of Foley, Hoag & Eliot LLP in Boston, where his practice focused on biotechnology and health care.

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Guidelines for Human Embryonic Stem Cell Research He received a BA from Tufts University and a JD from Yale Law School. After law school, he clerked for a year for the Honorable Emilio M. Garza and a year for the Honorable Carolyn Dineen King, both federal appellate judges on the U.S. Court of Appeals for the Fifth Circuit. While clerking for Judge King, he was an adjunct professor of law in the Health Law Institute at the University of Houston Law Center. Dr. Malinowski has served as a member of the Special Committee on Genetic Information Policy of the Commonwealth of Massachusetts; the Grant Advisory Committee for the Ethical, Legal, and Social Issues Joint Working Group for the Human Genome Project; and the Biotechnology Industry Organization’s Bioethics Committee and Working Group on Biomedical Information. He has published extensively on the commercialization of biotechnology and related health care issues, including a recent piece, “Choosing the Genetic Makeup of Children: Our Eugenics Past, Present, and Future?” (36 Connecticut L. Rev. 125-224, 2003), and lectured on these topics throughout the United States, Europe, and Canada. Anne McLaren, DBE, PhD, FRS, is a principal research associate at the Wellcome Trust/Cancer Research UK Gurdon Institute at the University of Cambridge and a member of the European Molecular Biology Organization (EMBO). Before joining the Institute in 1992, she spent 19 years as director of the Medical Research Council’s Mammalian Development Unit in London. For the previous 15 years, she worked for the Agriculture Research Council in C. H. Waddington’s Institute of Animal Genetics in Edinburgh. Dr. McLaren’s research interests include developmental biology, reproductive biology, and genetics, including molecular genetics. Her primary model is the laboratory mouse and she is working on the development of mouse primordial germ cells and the pluripotent stem cells derived from them. Dr. McLaren was a member of the UK government’s Warnock Committee on Human Fertilisation and Embryology and until the end of 2001 was a member of the UK Human Fertilisation and Embryology Authority, which regulates in vitro fertilization and human embryo research in the UK. She chaired the Scientific and Technical Advisory Group of the World Health Organization’s Human Reproduction Programme and was a member of the Nuffield Foundation’s Bioethics Council. She is a member of the European Group on Ethics, which advises the European Commission on social and ethical implications of new technologies. Dr. McLaren, who completed her undergraduate and graduate work at Oxford University, was elected a fellow of the Royal Society in 1975 and she has served as the Society’s Foreign Secretary and Vice-President. She is a founding member of Academia Europaea and of the recently established Academy of Medical Sciences. In 2002, she was awarded (jointly with A. K. Tarkowski) the Japan Prize for Developmental Biology. Alison Murdoch, MD, FRCOG, is a consultant gynecologist and professor of reproductive medicine and the head of the Newcastle Fertility Centre for Life of the International Centre for Life at Newcastle University. Dr. Murdoch received her

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Guidelines for Human Embryonic Stem Cell Research BSc in medical science from Edinburgh University in 1972, followed by an MBChB (Bachelor of Medicine, Bachelor of Surgery) in 1975, an MD degree in 1987, and an FRCOG (Fellow of the Royal College of Obstetricians and Gynecologists) in 2001. Dr. Murdoch has been a speaker at such prestigious events as the International Conference on IVF in Chennai in 2001, the Stem Cell Research BFS/RCOG Ethics Meeting in 2002, and the Indian Medical Association Conference in Mangalore in September 2002. She was a guest lecturer at the medical staff rounds at Hammersmith Hospital in February 2003, a speaker at the British Council Symposium at the International Centre for Life in March 2003, the Updates in Infertility Conference in Florida in 2004, and she was the Keynote speaker at the British Congress of Obstetrics and Gynecology in Glasgow in 2004. In addition to her work at the Fertility Centre for Life, Dr. Murdoch is the chair of the British Fertility Society, an inspector for the Human Fertilisation and Embryology Authority, and a member of a panel that gave evidence to the House of Lords Select Committee on Stem Cell Research. Catherine Racowsky, PhD, is the director of Assisted Reproductive Technologies (ART) Laboratory in the Department of Obstetrics, Gynecology and Reproductive Biology at the Center for Reproductive Medicine, Brigham and Women’s Hospital. She is also an associate professor at Harvard University. Dr. Racowsky received her BA from the University of Oxford and her PhD from the University of Cambridge. Before joining Harvard and Brigham and Women’s, her academic appointments included the University of Arizona Department of Animal Sciences, Department of Physiology, and Center of Toxicology. She served as the director of research in the Department of Obstetrics, Gynecology and Reproductive Biology in the College of Medicine at the University of Arizona and also director of the ART Laboratory. She is a full member of the Canadian Andrology and Fertility Society. From 1997 through 2001, she was a Member of the Reproductive Toxicology Editorial Board. She received the 2000 Partners Healthcare Excellence Award in Leadership and Innovation. Her research focuses on the effects of caffeine and smoking on human fertility. She has recently spoken at such diverse places as the Jones Institute in Norfolk, Virginia, on the topic “Embryo Selection: Can It Be Improved?” and the Taiwanese Society for Reproductive Medicine in Taipei, Taiwan, on the topics “Quality Management of the IVF Laboratory” and “Embryo Selection and Its Impact on How Many Embryos to Transfer.” Martin Raff, MD, (NAS) is a professor in the Department of Biology of the Medical Research Council MRC Laboratory for Molecular and Cell Biology at University College London. He received his BSc and MD from McGill University. He then pursued residencies in medicine at the Royal Victoria Hospital in Montreal and in neurology at Massachusetts General Hospital in Boston. Dr. Raff completed his postdoctoral training in immunology at the National Institute for Medical Research in London, after which he moved to University College London and has been a

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Guidelines for Human Embryonic Stem Cell Research professor of biology since 1979. He is a Fellow of the Royal Society and of Academia Europaea, a foreign member of the American Academy of Arts and Sciences, and past president of the British Society of Cell Biology. His research interests span immunology, cell biology, and developmental neurobiology. Using the retina and optic nerve as model systems, he discovered that animal cells live, grow, differentiate, or proliferate depending on a combination of cell-cell interactions and cell-intrinsic programs. Dr. Raff is a foreign associate of the U.S. National Academy of Sciences. Davor Solter, MD, PhD, is the director and a member of the Max Planck Institute of Immunobiology. He is also a senior staff scientist at the Jackson Laboratory in Bar Harbor, Maine, and an adjunct professor at the Wistar Institute in Philadelphia. Dr. Solter received his MSc, MD, and PhD from the University of Zagreb. He serves as a member of numerous editorial and advisory boards and is the European editor of Genes and Development. He is a member of the American Academy of Arts and Sciences, the European Molecular Biology Organization, and Academia Europea. In 1998, he received the March of Dimes Prize in Developmental Biology for pioneering the concept of imprinting, and in 1999, he was distinguished as a J. W. Jenkinson Memorial Lecturer at Oxford University. Dr. Solter has contributed to many fields of mammalian developmental biology, including the differentiation of germ layers, the role of cell surface molecules in regulating early development, the biology and genetics of teratocarcinoma, the biology of embryonic stem cells, and imprinting and cloning. His current research focuses on genetic and molecular control of genome reprogramming and of activation of the embryonic genome. LeRoy Walters, PhD, is the Joseph P. Kennedy, Sr. Professor of Christian Ethics at the Kennedy Institute of Ethics, Georgetown University, and a professor of philosophy at Georgetown. He is coauthor with Julie Gage Palmer of The Ethics of Human Gene Therapy (1997), coeditor with Tom L. Beauchamp of an anthology titled Contemporary Issues in Bioethics (6th ed., 2003) and coeditor with Tamar Joy Kahn and Doris M. Goldstein of the annual Bibliography of Bioethics (1975-present). From 1965 through 1967, he studied at the University of Heidelberg and the Free University of Berlin. In 1971, he received his PhD from Yale University. Since 1999, Dr. Walters has had an active interest in human embryonic stem cell research. He served as a consultant to the National Bioethics Advisory Committee in 1999 and discussed ethical issues in human embryonic stem cell research at a National Academy of Sciences workshop in June 2001. In August 2001, he was consulted by President Bush on public policies for stem cell research. His most recent article, published in the March 2004 issue of the Kennedy Institute of Ethics Journal, was “Human Embryonic Stem Cell Research: An Intercultural Perspective.”

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Guidelines for Human Embryonic Stem Cell Research Irving L. Weissman, MD, PhD, (NAS, IOM) is the Karel and Avice Bekhuis Professor of Cancer Biology and professor of pathology and developmental biology at Stanford University. He is cofounder and director of StemCells, Inc., a company focused on adult stem cell biology. Dr. Weissman’s research interests encompass developmental biology, self-renewal, homing, and functions of the cells that make up the blood-forming and immune systems. His main focus for the last several years has been the purification, biology, transplantation, and evolution of stem cells. The isolation of mouse hematopoietic stem cells (HSC) in his laboratory was followed by the isolation of human HSCs by Dr. Weissman and his colleagues at SyStemix, Inc., of which he was a founder. Purified human HSCs have been successfully used to provide cancer-free autologous stem cell transplants for patients receiving otherwise lethal chemotherapy and radiotherapy for cancer. His laboratory has gone on to identify the stages of development between stem cells and mature blood cells. Dr. Weissman is the recipient of several awards, including the Leukemia Society of America de Villier’s International Achievement Award, the E. Donnall Thomas Prize from the American Society of Hematology, and the Montana Conservationist of the Year Award. Michael J. Werner is chief of policy for the Biotechnology Industry Organization (BIO), overseeing all policy development, legislative, regulatory, bioethics, and legal department activities. Before becoming chief of policy, Mr. Werner was BIO’s vice president of bioethics. In that capacity, he led BIO’s efforts to develop policies, programs, and activities that promote responsible and ethical uses of biotechnology. His work has explored a variety of bioethics issues, including, confidentiality of medical information, use of genetic information, gene therapy, cloning, stem cell research, xenotransplantation, protection of human subjects in research, and global health. Mr. Werner has over 17 years of experience in health law and policy in Washington, DC. Before joining BIO, he spent 6 years as counsel for legislation and policy for the American College of Physicians-American Society of Internal Medicine, performing legal analysis, policy development, and congressional and regulatory advocacy on a variety of issues, including end of life care, Medicare reform, liability reform, and integration and delivery system re-structuring. Mr. Werner also served as a senior health adviser to US Senate Majority Leader George Mitchell and as senior adviser to Maryland Governor William Donald Schaefer. Laurie Zoloth, PhD, is professor of medical ethics and humanities and of religion at the Feinberg School of Medicine of Northwestern University. Her research projects include work on emerging issues in medical and research genetics, ethical issues in stem cell research, and distributive justice in health care. Dr. Zoloth chairs the Howard Hughes Medical Institute’s Bioethics Advisory Board and served as president of the American Society for Bioethics and Humanities in 2001. She is a member of numerous advisory boards including, the National Aeronautics and Space Administration National Advisory Council; the Executive Committee of the

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Guidelines for Human Embryonic Stem Cell Research International Society for Stem Cell Research; the American Association of the Advancement of Science’s (AAAS) Dialogue on Science, Ethics and Religion; the Geron Ethics Advisory Board; the Data Safety Monitoring Board for the National Institutes of Health International AIDS Clinical Trials Group; the AAAS Working Group on Human Germ-Line Interventions and on Stem Cell Research; and the Ethics Section of the American Academy of Religion. In 1999, she was invited to give testimony to the National Bioethics Advisory Board on Jewish philosophy and stem cell research. In 2001, she was named principal investigator for the International Project on Judaism and Genetics, cosponsored by the AAAS and supported by the Haas Foundation and the Greenwall Foundation. Dr. Zoloth received a BA in Women’s Studies and History from the University of California at Berkeley, a BSN from the State University of New York, an MA in English from San Francisco State University, and an MA in Jewish studies and PhD in social ethics from the Graduate Theological Union in Berkeley. Leonard I. Zon, MD, is professor of pediatrics and a Howard Hughes Medical Institute investigator at Children’s Hospital in Boston. He received a BS in chemistry and natural sciences from Muhlenberg College and an MD from Jefferson Medical College. He did an internal medicine residency at New England Deaconess Hospital and a fellowship in medical oncology at Dana-Farber Cancer Institute. His postdoctoral research was in the laboratory of Stuart Orkin. Dr. Zon’s research focuses on the zebrafish, a new genetic and developmental model system for understanding blood formation. His laboratory has characterized over 26 mutant groups that can live with decreased blood or no blood at all. Several of them represent models of human disease. Dr. Zon is the president of the International Society for Stem Cell Research.

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