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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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B

Speaker Biographical Sketches

María de Jesús Medina Arellano, Ph.D., LL.M., is a qualified lawyer who graduated from the University of Nayarit, Mexico, in 2004. After finishing her degree she decided to move to Mexico City to continue her studies in the philosophy of law. In January 2008 she graduated with the equivalent of an M.Phil. (with honors) from the Postgraduate Law Division at the National Autonomous University of Mexico. During her postgraduate degree work she focused on the new paradigm of health law and human rights in Mexico. In December 2008 she was recognized with the Young Academic Talent of the Year award granted by the Nayarit Government in Mexico. She obtained her Ph.D. in bioethics and medical jurisprudence (with honors) in July 2012, from the School of Law/Institute for Science, Ethics and Innovation in the University of Manchester. She is currently studying the regulation of stem cell research in developing countries (Mexico as a case study) under the supervision of Dr. John Harris, Dr. David Gurnham, and Dr. Sarah Devaney.

Paolo Bianco, M.D., is a professor and director of anatomic pathology and chief of the Stem Cell Lab in the Department of Molecular Medicine, Sapienza University of Rome and Umberto I University Hospital, Rome. His specific areas of expertise are skeletal diseases and the biology and clinical use of skeletal stem cells (also known as mesenchymal stem cells). He has contributed extensively in these fields.

Timothy Caulfield, LL.M., is a Canada research chair in health law and policy and a professor in the Faculty of Law and the School of Public Health at the University of Alberta. He was the research director of the Health Law Institute at the University of Alberta from 1993 to 2011 and

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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is now leading the Faculty of Law’s Health Law and Science Policy Group. Over the past several years he has been involved in a variety of interdisciplinary research endeavors that have led to his publishing more than 250 articles and book chapters. He is a health senior scholar with the Alberta Heritage Foundation for Medical Research and the principal investigator for a number of large interdisciplinary projects that explore the ethical, legal, and health policy issues associated with a range of topics, including stem cell research, genetics, patient safety, the prevention of chronic disease, obesity policy, the commercialization of research, complementary and alternative medicine, and access to health care. Professor Caulfield is and has been involved with a number of national and international policy and research ethics committees, including the Canadian Biotechnology Advisory Committee, Genome Canada’s Science Advisory Committee, the Ethics and Public Policy Committee for International Society for Stem Cell Research (ISSCR), and the Federal Panel on Research Ethics. He is a fellow of the Royal Society of Canada and the Canadian Academy of Health Sciences. He writes frequently for the popular press on a range of health and science policy issues and is the author of The Cure for Everything: Untangling the Twisted Messages About Health, Fitness and Happiness (Penguin, 2012).

R. Alta Charo, J.D., is the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin at Madison, where she is on the faculty of the Law School and the Medical School’s Department of Medical History and Bioethics. She also serves on the faculty of the University of Wisconsin’s Master of Biotechnology Studies program and lectures in the Master of Public Health program of the Department of Population Health Sciences. Professor Charo served as a member of the Obama-Biden Transition Project, where she was a member of the Department of Health and Human Services review team, focusing her attention particularly on transition issues related to the National Institutes of Health (NIH), Food and Drug Administration (FDA), bioethics, stem cell policy, and women’s reproductive health. She was on leave for the 2009-2010 academic year to serve as a senior advisor in the Office of the Commissioner at FDA. Professor Charo serves on several expert advisory boards of organizations with an interest in stem cell research, including CuresNow, the Juvenile Diabetes Research Foundation, ISSCR, and WiCell, as well as on the advisory board to the Wisconsin Stem Cell Research Program. In 2005, she was appointed to the ethics standards working group of the California Institute for Regenerative Medicine (CIRM).

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Also in 2005, she helped to draft the National Academies’ Guidelines for Embryonic Stem Cell Research, and in 2006 she was appointed to co-chair the National Academies’ Human Embryonic Stem Cell Research Advisory Committee. In 1994, Professor Charo served on the NIH Human Embryo Research Panel, and from 1996-2001, she was a member of President Clinton’s National Bioethics Advisory Commission where she participated in drafting its reports on “Cloning Human Beings” (1997); “Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity” (1998); “Research Involving Human Biological Materials: Ethical Issues and Policy Guidance” (1999); “Ethical Issues in Human Stem Cell Research” (1999); “Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries” (2001); and “Ethical and Policy Issues in Research Involving Human Participants” (2001).

Ralph J. Cicerone, Ph.D., is the president of the National Academy of Sciences and Chair of the National Research Council. His research in atmospheric chemistry, climate change and energy has involved him in shaping science and environmental policy at the highest levels nationally and internationally. Dr. Cicerone has received a number of honorary degrees and many awards for his scientific work. Among the latter, the Franklin Institute recognized his fundamental contributions to the understanding of greenhouse gases and ozone depletion by selecting Dr. Cicerone as the 1999 laureate for the Bower Award and Prize for Achievement in Science. One of the most prestigious American awards in science, the Bower Award also recognized his public policy leadership in protecting the global environment. In 2001, he led a National Academy of Sciences study of the current state of climate change and its impact on the environment and human health, requested by President Bush. The American Geophysical Union awarded Dr. Cicerone its James B. Macelwane Award in 1979 for outstanding contributions to geophysics by a young scientist and its 2002 Roger Revelle Medal for outstanding research contributions to the understanding of Earth’s atmospheric processes, biogeochemical cycles, and other key elements of the climate system. In 2004, the World Cultural Council honored him with the Albert Einstein World Award in Science. In addition to the National Academy of Sciences, Dr. Cicerone is a member of the American Academy of Arts and Sciences, the American Philosophical Society, the Accademia Nazionale dei Lincei, the Russian Academy of Sciences, and the Korean Academy of Science and Technology. He has served as president of the

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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American Geophysical Union, the world’s largest society of earth scientists. Dr. Cicerone was educated at the Massachusetts Institute of Technology (B.S. in electrical engineering) and the University of Illinois at Champaign-Urbana (M.S., Ph.D. in electrical engineering, with a minor in physics). In his early career, he was a research scientist and held faculty positions in electrical and computer engineering at the University of Michigan. The Ralph J. Cicerone Distinguished University Professorship of Atmospheric Science was established there in his honor in 2007. In 1978, he joined the Scripps Institution of Oceanography at the University of California, San Diego as a research chemist. From 1980 to 1989, he was a senior scientist and director of the Atmospheric Chemistry Division at the National Center for Atmospheric Research in Boulder, Colorado. In 1989, he joined the University of California, Irvine, where he was founding chair of the Department of Earth System Science and was appointed the Daniel G. Aldrich Professor of Earth System Science. As Dean of the School of Physical Sciences from 1994 to 1998, he recruited outstanding faculty and strengthened the school’s curriculum and outreach programs. Immediately prior to his election as National Academy of Sciences president, Dr. Cicerone served as Chancellor of the University of California, Irvine from 1998 to 2005, a period marked by a rapid rise in the academic capabilities of the campus. His research has focused on atmospheric chemistry, the radiative forcing of climate change due to trace gases, and the sources of atmospheric methane, nitrous oxide and methyl halide gases.

I. Glenn Cohen, J.D., is one of the world’s leading experts on the intersection of bioethics (sometimes also called “medical ethics”) and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Professor Cohen has spoken at legal, medical, and industry conferences around the world and his work has been covered on PBS, National Public Radio, ABC, Mother Jones, The New York Times, The Boston Globe, and several other media venues. Professor Cohen’s current projects relate to reproduction/reproductive technology, research ethics, rationing in law and medicine, health policy, and to medical tourism—the travel of patients who are residents of one country, the “home country,” to another country, the “destination country,” for medical treatment. His past work has included projects on end-of-life decision-making, FDA regulation and commodification. He is the author of more than 50 articles and chapters, and his award-winning work has appeared in leading legal (including the Stanford, Cornell, and Southern California

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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law reviews), medical (including the New England Journal of Medicine, Journal of the American Medical Association), bioethics (including the American Journal of Bioethics, the Hastings Center Report) and public health (the American Journal of Public Health) journals, as well as Op-Eds in The New York Times and The Washington Post. Cohen is the editor of The Globalization of Health Care: Legal and Ethical Issues (Oxford University Press, 2013), and is currently writing Patients with Passports: Medical Tourism, Law, and Ethics (under contract, Oxford University Press) as well as working on three other books. Prior to becoming a professor he served as a law clerk to Judge Michael Boudin of the U.S. Court of Appeals for the First Circuit and as a lawyer for U.S. Department of Justice, Civil Division, Appellate Staff, where he handled litigation in the Courts of Appeals and (in conjunction with the Solicitor General’s Office) in the U.S. Supreme Court. In his spare time, he still litigates, most recently having authored an amicus brief that was submitted to the U.S. Supreme Court for leading gene scientist Eric Lander in Association of Molecular Pathology v. Myriad, concerning whether human genes are patent eligible subject matter, a brief that was extensively discussed by the Justices at oral argument. Cohen was selected as a Radcliffe Institute Fellow for the 2012-2013 year and by the Greenwall Foundation to receive a Faculty Scholar Award in Bioethics. He is currently one of the key co-investigators on a $100 million award over 10 years from the National Football League Players Association (NFLPA), known as the Harvard Integrated Program to Protect and Improve the Health of NFLPA Members.

George Daley, M.D., Ph.D., is the Samuel E. Lux IV Professor of Hematology/Oncology and director of the Stem Cell Transplantation Program at Children’s Hospital Boston. He is also professor of biological chemistry and molecular pharmacology and pediatrics at Harvard Medical School, an investigator of the Howard Hughes Medical Institute, associate director of the Children’s Stem Cell Program, founding member of the executive committee of the Harvard Stem Cell Institute, and past-president and current clerk of ISSCR. Dr. Daley seeks to translate insights in stem cell biology into improved therapies for genetic and malignant diseases. Important research contributions from his laboratory include the creation of customized stem cells to treat genetic immune deficiency in a mouse model (together with Rudolf Jaenisch), the differentiation of germ cells from embryonic stem cells (cited as a Top Ten Breakthrough by Science magazine in 2003), and the generation of dis-

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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ease-specific pluripotent stem cells by direct reprogramming of human fibroblasts (cited as Breakthrough of the Year in Science magazine in 2008). As a graduate student working with Nobel Prize winner David Baltimore, Dr. Daley demonstrated that the BCR/ABL oncogene induces chronic myeloid leukemia (CML) in a mouse model, which validated BCR/ABL as a target for drug blockade and encouraged the development of imatinib (Gleevec™; Novartis), a revolutionary magic-bullet chemotherapy that induces remissions in virtually every CML patient. Dr. Daley’s recent studies have clarified mechanisms of Gleevec resistance and informed novel combination chemotherapeutic regimens. Dr. Daley received his bachelor’s degree magna cum laude from Harvard University (1982), a Ph.D. in biology from the Massachusetts Institute of Technology (1989), and his M.D. from Harvard Medical School, where he was only the 12th individual in the school’s history to be awarded the degree summa cum laude (1991). He served as chief resident in internal medicine at the Massachusetts General Hospital (1994–1995) and is currently a staff physician in hematology/oncology at the Children’s Hospital and the Dana Farber Cancer Institute. He has been elected to the Institute of Medicine (IOM) of the National Academies, the American Society for Clinical Investigation, the American Association of Physicians, and the American Pediatric Societies, and he is a fellow of the American Academy of Arts and Sciences and the American Association for the Advancement of Science. Dr. Daley was an inaugural winner of the NIH Director’s Pioneer Award for highly innovative research and has received the Judson Daland Prize from the American Philosophical Society for achievement in patient-oriented research, the E. Mead Johnson Award from the American Pediatric Society for contributions to stem cell research, and the E. Donnall Thomas Prize of the American Society for Hematology for advances in human induced pluripotent stem cells.

Ellen Feigal, M.D., is senior vice president of research and development at CIRM. Prior to CIRM, Dr. Feigal was the executive medical director of global development at Amgen, an adjunct professor at the University of California, San Francisco (UCSF), and the founding director of the American Course on Drug Development and Regulatory Sciences, a collaborative effort with FDA, UCSF, and the European Center of Pharmaceutical Medicine, University of Basel, from 2008-2011. She was chief medical officer of Insys Therapeutics, director of medical devices and imaging at the Critical Path Institute, and vice president of clinical sciences/deputy scientific director of the Translational Genomics Research

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Institute from 2004-2008. From 1992-2004, she held senior positions at the National Cancer Institute’s (NCI) Division of Cancer Treatment and Diagnosis, most recently directing the Division from 2001 to 2004. Dr. Feigal earned a B.S. in biology and an M.S. in molecular biology/biochemistry from the University of California, Irvine; an M.D. from the University of California, Davis; completed her residency in internal medicine at Stanford University; and did a fellowship in hematology/oncology at UCSF. She was on faculty at UCSF and the University of California, San Diego before joining the NCI.

Harvey V. Fineberg, M.D., Ph.D., is president of the IOM. He served as Provost of Harvard University from 1997 to 2001, following thirteen years as Dean of the Harvard School of Public Health. He has devoted most of his academic career to the fields of health policy and medical decision making. His past research has focused on the process of policy development and implementation, assessment of medical technology, evaluation and use of vaccines, and dissemination of medical innovations. Dr. Fineberg helped found and served as president of the Society for Medical Decision Making and has been a consultant to the World Health Organization. At the IOM, he has chaired and served on a number of panels dealing with health policy issues, ranging from AIDS to new medical technology. He also served as a member of the Public Health Council of Massachusetts (1976-1979), as chairman of the Health Care Technology Study Section of the National Center for Health Services Research (1982-1985), and as president of the Association of Schools of Public Health (1995-1996). Dr. Fineberg is co-author of the books Clinical Decision Analysis, Innovators in Physician Education, and The Epidemic that Never Was, an analysis of the controversial federal immunization program against swine flu in 1976. He has co-edited several books on such diverse topics as AIDS prevention, vaccine safety, and understanding risk in society. He has also authored numerous articles published in professional journals. Dr. Fineberg is the recipient of several honorary degrees and the Stephen Smith Medal for Distinguished Contributions in Public Health from the New York Academy of Medicine. He earned his bachelor’s and doctoral degrees from Harvard University.

Toshio Miyata, M.D., is currently the executive director of the Health and Global Policy Institute. In 2010–2011, he was engaged in the early phase clinical trials activation program, when he was deputy director of the research and development division, health policy bureau in the Japa-

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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nese Ministry of Health, Labor, and Welfare. In 2012–2013, he worked on the reform of the pharmaceutical affairs law, when he was the deputy director of the evaluation and licensing division, pharmaceutical and food safety bureau in the ministry. In March 2011, he was involved with the restoration of Fukushima prefecture. Dr. Miyata served as the assistant professor of cardiac surgery in Osaka University Medical School. He completed a surgical internship at Osaka Koseinenkin Hospital and a residency in thoracic surgery at Osaka City General Hospital. He is a graduate of Osaka University Medical School. He received a B.A. degree in mechanical engineering from Waseda University.

Alan Petersen, Ph.D., is a professor of sociology at the School of Political and Social Inquiry, Monash University in Melbourne, Australia. His research interests span the sociology of health and medicine, science and technology studies, and gender studies. He has authored or edited 18 books and numerous articles in these fields, most recently on stem cell tourism, the sociology of bioethics, and the discourse of childhood obesity. His most recent books are The Politics of Bioethics (Routledge, 2011) and Aging Men, Masculinities and Modern Medicine (Routledge, 2013) (edited with Antje Kampf and Barbara Marshall).

Mike Phelan, B.S., is a serial entrepreneur who was the chief executive officer (CEO) and co-founder of SevOne, one of the fastest growing software companies in the world. He recently stepped down because he has MS. Mr. Phelan has advocated for patients’ rights to use their own stem cells for potential life-saving therapies.

Amy Comstock Rick, J.D., is CEO of Parkinson’s Action Network (PAN), a Washington, D.C.-based national Parkinson’s disease nonprofit advocating for better treatments and a cure. In this capacity, Ms. Rick works in partnership with other Parkinson’s organizations and PAN’s powerful grassroots network to educate the public and government leaders on better policies for research and an improved quality of life for people living with Parkinson’s. PAN serves as the voice of Parkinson’s on numerous public policy issues affecting the Parkinson’s community. In addition to continuing its work on NIH funding and research, the Parkinson’s community is now a powerful voice on many crucial issues including Parkinson’s specific programs at the Departments of Defense and Veteran’s Affairs and the Department of Health and Human Services, FDA drug approval issues, and the continuing

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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struggle to achieve research freedom for stem cell research. As CEO of PAN, Ms. Rick currently serves as an officer or board member with several national coalitions and councils. She is president of the Coalition for the Advancement of Medical Research (CAMR), the nation’s leading bipartisan pro-cures coalition. Comprising 100 nationally recognized patient organizations, universities, scientific societies, and foundations, CAMR’s advocacy and education outreach focuses on research toward developing better treatments and cures for individuals with life-threatening illnesses and disorders. She served as president of CAMR from 2008-2010 and has been a board member since 2004. She serves as Treasurer for the American Brain Coalition (ABC), a national non-profit organization comprising some of the United States’ leading professional neurological, psychological, and psychiatric associations and patient organizations. Together, they seek to advance the understanding of the functions of the brain and to reduce the burden of brain disorders through public advocacy. She has served on ABC’s Board of Directors since 2008. Ms. Rick also sits on the Board of Directors for the National Health Council (NHC), a national non-profit that brings together all segments of the health community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers. Ms. Rick is called upon frequently by the media and other organizations to speak about biomedical research and the importance of strong federal funding and policy support. She has testified before several congressional committees and subcommittees and in 2011 was honored as an Innovator by the Genetic Alliance for her work on the complex federal embryonic stem cell research policy. Prior to joining PAN, she served as the Senate-confirmed director of the U.S. Office of Government Ethics from 2000-2003 and served as associate counsel to the president in the White House Counsel’s Office from 1998-2000. Ms. Rick began her federal service as an attorney at the U.S. Department of Education in 1988, ending her tenure there in 1998 as Assistant General Counsel for Ethics. Ms. Rick began her professional career at the law firm of Beveridge & Diamond. She received a B.A. from Bard College and a J.D. from the University of Michigan.

Margaret Foster Riley, J.D., is a professor of law at the University of Virginia School of Law where she teaches in the areas of bioethics, food and drug law, health law, animal law, and public health law. She also has secondary appointments in the Department of Public Health Sciences at the University of Virginia School of Medicine and in the Batten School

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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of Leadership and Public Policy. She is a graduate of Duke University and Columbia University Law School. Her areas of interest include health institutions and reform, biomedical ethics and research, food and drug law, genomics, reproductive technologies, stem cell research, biotechnology, health disparities, and chronic disease.

Glenn L. Schattman, M.D., is a specialist in infertility and reproductive surgery. He is board certified in obstetrics and gynecology as well as in reproductive endocrinology and infertility. He currently holds the position of associate professor of reproductive medicine at the New York Presbyterian Hospital, Weill Cornell Medical College. He was the chair of the Practice Committee of the Society for Assisted Reproductive Technology, and he served as the society’s president in 2012.

Doug Sipp, B.A., is head of the Science Policy and Ethics Studies unit at the RIKEN Center for Developmental Biology in Kobe, Japan. His work focuses primarily on issues in the clinical application and commercialization of stem cell therapeutics, and the analysis of approaches to stem cell research and development in the Asia-Pacific region. His research and commentaries have been published in numerous high-profile journals including Science, Nature, Cell Stem Cell, Neuron, and Regenerative Medicine. He serves on the International Society for Cellular Therapy Presidential Task Force on the Use of Unproven Cellular Therapies, and was a member of the ISSCR Task Force on Unproven Stem Cell Treatments. He has also served on the ISSCR international, government affairs, website, and membership committees. He graduated from Rutgers University in 1991.

Gil Van Bokkelen, Ph.D., has served as CEO and chairman of Athersys, Inc., since August 2000. Dr. Van Bokkelen co-founded Athersys in October 1995 and served as CEO and director from Athersys’s founding to August 2000. Prior to May 2006, he also served as Athersys’s president. Dr. Van Bokkelen is chairman (ex officio) of the Alliance for Regenerative Medicine, a Washington, DC–based consortium of companies, patient advocacy groups, disease foundations, and clinical and research institutions that are committed to the advancement of the field of regenerative medicine. He is also the chairman of the board of governors for the National Center for Regenerative Medicine and serves on a number of other boards, including the Biotechnology Industry Organization’s ECS board of directors, the McGowan Institute for Regenerative Medi-

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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cine, and the Regenerative Medicine Foundation. He received his Ph.D. in genetics from Stanford University School of Medicine; his B.A. in economics from the University of California, Berkeley, and his B.A. in molecular biology from the University of California, Berkeley.

David Vladeck, J.D., LL.M., was a professor at the Georgetown University Law Center for 7 years before his appointment to head the Bureau of Consumer Protection. While at Georgetown, he served as the co-director of the Institute for Public Representation, leading the institute’s work in civil rights. He taught courses in federal courts, civil procedure, and government processes, and he co-directed the Institute for Public Representation, a legal clinic. Before joining the faculty of the Georgetown University Law Center, Vladeck spent nearly 30 years as a lawyer at the Public Citizen Litigation Group, the litigation arm of Public Citizen, an advocacy organization founded by Ralph Nader. He served as the group’s director for 10 years. While at the Public Citizen Litigation Group, Vladeck argued a number of cases in front of the U.S. Supreme Court, including cases about the First Amendment, civil rights, and labor law. He also argued more than 60 cases in front of federal courts of appeal and state courts of last resort. Vladeck received his B.A. from New York University in 1972 and graduated with a J.D. from Columbia Law School in 1976. He received an LL.M. degree from Georgetown in 1977.

John Wagner, M.D., is a professor of pediatrics, director of the Division of Hematology–Oncology and Blood and Marrow Transplantation and co-director of the Center for Translational Medicine at the University of Minnesota. He currently holds two endowed chairs: Hageboeck/Children’s Cancer Research Fund Chair in Pediatric Cancer Research and the University of Minnesota McKnight Presidential Chair in Hematology and Oncology. Dr. Wagner is internationally recognized as an expert in the field of stem cells and umbilical cord blood transplantation. He received his M.D. degree at Jefferson Medical College in 1981, completed his internship and residency in pediatrics at Duke University School of Medicine in 1984, and did a postdoctoral fellowship in hematology–oncology at the Johns Hopkins School of Medicine in 1987, where he remained until joining the faculty at the University of Minnesota in 1991. He is board certified in pediatrics and pediatric hematology/oncology.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Irving L. Weissman, M.D., is a professor of pathology and developmental biology at Stanford University, where he is the director of the Stanford Institute of Stem Cell Biology and Regenerative Medicine. Dr. Weissman was raised in Great Falls, Montana, and started his scientific career at the McLaughlin Research Institute there. He obtained his M.D. from Stanford University in 1965 after earning a B.S. from Montana State University in 1961. His research has since focused on hematopoietic stem cell biology. His awards include election to the National Academy of Sciences in 1989 and being named California Scientist of the Year in 2002. He has also received the 2008 Robert Koch Prize and the 2009 Lewis S. Rosenstiel Award for Distinguished Work in Basic Medical Science. He developed methods to identify stem cells and has extensively researched stem cells and progenitor cells. His research focus is the phylogeny and developmental biology of the cells that make up the blood-forming and immune systems. Dr. Weissman is widely recognized as the “father of hematopoiesis,” being the first to purify blood-forming stem cells in both mouse and humans. His work has contributed greatly to the understanding of how a single hematopoietic stem cell can give rise to different specialized blood cells. Dr. Weissman is also a leading expert in the field of cancer stem cells, where much of his work has shed light on the pathogenesis of multiple human malignancies. He is known also for transgenic research in which human brain cells were grown in mouse brains.

Qi Zhou, Ph.D., received a Ph.D. in physiology and embryology from Northeast Agriculture University, China, in 1996 with a dissertation titled “Nuclear Transfer and Serial Nuclear Transfer Research in Rabbit.” In 1997–1999, he held a postdoctoral and associate professor position in the Institute of Developmental Biology at CAS, and in 1999–2002 he was a postdoc and project leader within the group of J. P. Renard (developmental biology and reproduction, INRA, Jouy-en-Josas, France). In 2001, he was offered a 100-Talent Program position at the Institute of Zoology, CAS, where he is currently the director of State Key Laboratory of Reproductive Biology and vice director of Institute of Zoology, CAS. Professor Zhou studies the mechanisms of reprogramming, differentiation, and de-differentiation as well as cellular plasticity and totipotency of stem cells and somatic cells, with the goal of understanding the mechanisms of mammalian cloning and improving cloning efficiency as well as promoting the application of stem cells in regenerative medicine.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Page 73
Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
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Page 74
Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
×
Page 75
Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
×
Page 76
Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
×
Page 77
Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine and National Research Council. 2014. Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/18746.
×
Page 78
Next: Appendix C: Statement of Task »
Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings: Summary of a Joint Workshop by the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research Get This Book
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Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes, and spinal cord injury. Clinical trials of stem cell treatments are under way in countries around the world, but the evidence base to support the medical use of stem cells remains limited. Despite this paucity of clinical evidence, consumer demand for treatments using stem cells has risen, driven in part by a lack of available treatment options for debilitating diseases as well as direct-to-consumer advertising and public portrayals of stem cell-based treatments. Clinics that offer stem cell therapies for a wide range of diseases and conditions have been established throughout the world, both in newly industrialized countries such as China, India, and Mexico and in developed countries such as the United States and various European nations. Though these therapies are often promoted as being established and effective, they generally have not received stringent regulatory oversight and have not been tested with rigorous trials designed to determine their safety and likely benefits. In the absence of substantiated claims, the potential for harm to patients - as well as to the field of stem cell research in general - may outweigh the potential benefits.

To explore these issues, the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research held a workshop in November 2013. Stem Cell Therapies summarizes the workshop. Researchers, clinicians, patients, policy makers, and others from North America, Europe, and Asia met to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from treatments that are dangerous or ineffective or by steering them toward treatments that are effective. This report discusses the current environment in which patients are receiving unregulated stem cell offerings, focusing on the treatments being offered and their risks and benefits. The report considers the evidence base for clinical application of stem cell technologies and ways to assure the quality of stem cell offerings.

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