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Direct-to-Consumer Genetic Testing: Summary of a Workshop (2011)

Chapter: Appendix E: Planning Group Biographies

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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Appendix E
Planning Group Biographies

CO-CHAIRS

Frederick R. Anderson, Jr., B.A., (History of Science), University of North Carolina; BA (Jurisprudence), Oxford University; J.D., Harvard Law School, is a partner of the law firm of McKenna, Long & Aldridge LLP in Washington, D.C. He addresses “green” technologies (wind, solar, fuel cell, biofuels), legal strategies for bringing chemicals to market, a wide variety of Clean Air Act issues, risk assessment and management, greenhouse gas science and international negotiations, chemical regulation, FDA and EPA food contact and antimicrobial approvals, access to genetic information, and environmental aspects of international trade. Mr. Anderson is former Dean of the law school at American University, and was the first full-time President of the Environmental Law Institute. He was the first Editor-in-Chief of the Environmental Law Reporter and was Chairman of the American Bar Association’s Standing Committee on Environmental Law. He served on a 12-member Congressional study commission created by the Superfund legislation to examine toxic tort recovery for injury from hazardous substances. Mr. Anderson was a member of the Harvard Group on Risk Management and Reform and was chairman of the Advisory Working Group on Environmental Sanctions for the U.S. Sentencing Commission. He has been both a member of and a consultant to the Administrative Conference of the United States. In 1984 his analysis of the Superfund program resulted in the adoption by the Conference of a policy favoring negotiated solutions to disputes about waste site cleanup. He is also Chairman of the Board of the Institute for Governance and Sustainable Development and was chairman of the American Bar Association’s Commission on Inter-American Affairs. As chairman of the ABA’s Standing Committee

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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on Environmental Law, he played a key role in organizing international conferences in Europe and Canada on acid rain, and in Mexico City on environmental issues. He was the founding chair of the board of the Center for International Environmental Law, a position he held for 19 years. His book, NEPA in the Courts, went through several printings and was a Literary Guild selection. His book, Environmental Improvement through Economic Incentives, has been translated and widely used by governments and in universities. He has written numerous scholarly articles as well as other pieces. Mr. Anderson has served on several National Academies committees, including (1) Board on Atmospheric Sciences and Climate, (2) Commission on Life Sciences, (3) Board on Environmental Studies and Toxicology, (4) Committee on Industrial Competitiveness and Environmental Protection, (5) Committee to Review Risk Management in the DOE’s Environmental Remediation Program, (6) Panel on Integration of Socio-Economic Criteria into the Site Selection Process for a High-Level Radioactive Waste Repository, and (7) Committee on EPA Assessment Factors for Data Quality. He was a member of the National Academies’ planning committee that initiated the 1997 Academy Symposium on Science, Technology, and Law. He has been a member of the Committee on Science, Technology, and Law since its inception.


Barbara E. Bierer, M.D., is Senior Vice President for Research at the Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. Dr. Bierer, a graduate of Harvard Medical School, completed her internal medicine residency at the Massachusetts General Hospital and her hematology and medical oncology training at the Brigham and Women’s Hospital and the Dana-Farber Cancer Institute. Dr. Bierer maintained a research laboratory in the Department of Pediatric Oncology at Dana-Farber Cancer Institute and was appointed Director of Pediatric Stem Cell Transplantation at Dana-Farber Cancer Institute and Children’s Hospital in 1993. In 1997, she was named Chief of the Laboratory of Lymphocyte Biology at the National Heart, Lung and Blood Institute at the National Institutes of Health in Bethesda, MD. She served on the Scholars Committee of the Howard Hughes Medical Institute and on the Biomedical Research Training Program for Underrepresented Minorities at NHLBI, where she received the Director’s Award in 1999. She returned to the Dana-Farber Cancer Institute in July 2002 as Vice President of Patient Safety and Director of the Center for Patient Safety. In 2003, Dr. Bierer moved to the Brigham and Women’s Hospital to assume her cur-

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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rent position. In addition, in 2006, Dr. Bierer established the Center for Faculty Development and Diversity at the Brigham and Women’s Hospital and now serves as its first director.

Dr. Bierer’s laboratory research interests include mechanisms of T cell activation and of immunosuppression, interests that complement her clinical commitment to hematology. In addition to her academic responsibilities, Dr. Bierer was elected to the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP), serving as its President from 2003-2007, and was on the Board of Directors of the Federation of American Societies for Experimental Biology (FASEB). She was a member of the Medical and Scientific Advisory Board and, later, the Board of Directors of ViaCell, Inc. She is on the editorial boards of a number of journals including Current Protocols of Immunology. She is currently a member of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Clinical Research, on the National Academies’ Committee on Science, Technology and the Law, and on the Secretary’s Advisory Committee for Human Research Protections for which she serves as chair.

MEMBERS

Joseph Fraumeni, Jr., is a physician and cancer researcher. He received an A.B. from Harvard College, an M.D. from Duke University, and an M.Sc. in epidemiology from the Harvard School of Public Health. He completed his medical residency at Johns Hopkins Hospital and Memorial Sloan-Kettering Cancer Center, and received internal medicine board certification. He then joined the National Cancer Institute at the National Institutes of Health as a post-doctoral fellow, becoming founding Chief of the Environmental Epidemiology Branch in 1975, Director of the Epidemiology and Biostatistics Program in 1979, and currently Director of the Division of Cancer Epidemiology and Genetics since 1995.

Dr. Fraumeni has been recognized by numerous honors and awards for his research into the genetic and environmental determinants of cancer. Among them are the Abraham Lilienfeld Award from the American College of Epidemiology, John Snow Award from the American Public Health Association, James D. Bruce Award from the American College of Physicians, Nathan Davis Award from the American Medical Association, Charles S. Mott Prize (with F.P. Li) from the General Motors Cancer Research Foundation, Medal of Honor from the International

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Agency for Research on Cancer, and Lifetime Achievement Award from the American Association for Cancer Research. Dr. Fraumeni is an elected member of the National Academy of Sciences, the Institute of Medicine, and the Association of American Physicians. He has over 800 scientific publications, including several books on the causes and prevention of cancer.


Patricia Ganz is Professor of Health Services in the School of Public Health and Professor of Medicine in the David Geffen School of Medicine at UCLA, and Vice Chair of the Department of Health Services. She teaches Health Care Practices and Variations and Ethical Issues in Public Health. Dr. Ganz received her M.D. from the University of California, Los Angeles, School of Medicine in 1973, and completed post-doctoral training in internal medicine and medical oncology at the UCLA Medical Center. She has been on the faculty of the School of Medicine since 1977, and joined the faculty of the School of Public Health in 1992. Dr. Ganz has devoted the past 25 years to the study of quality-of-life outcomes in cancer and other chronic diseases. She is a leader in the integration of quality-of-life assessment in clinical trials. She has conducted federally funded research for over two decades, and has led several large clinical intervention trials in breast cancer. Her current research focuses on the late effects of cancer treatment, and improving the quality of care for cancer survivors. In 2006, she received funding from the Lance Armstrong Foundation to establish the UCLA-LIVESTRONG Survivorship Center of Excellence, whose mission is to facilitate improvements in the quality of life and quality of care of cancer survivors in the Los Angeles region and wherever they may reside. Dr. Ganz is also the Director of the Division of Cancer Prevention and Control Research of the Jonsson Comprehensive Cancer Center at UCLA, and leads a large research group that applies the scientific disciplines of public health (epidemiology, health services, behavioral sciences, biostatistics) to research on the prevention, detection, treatment and supportive care of cancer. Dr. Ganz is Associate Editor of the Journal of Clinical Oncology and the Journal of the National Cancer Institute and is a member of the editorial board of the Cochrane Breast Cancer Group. In 1999 she was named an American Cancer Society Clinical Research Professor and in 2007 she became a member of the Institute of Medicine.


Mikhail Gishizky, Ph.D., has over 25 years experience in research and

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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development within the academic, biotechnology and pharmaceutical industry settings where he led efforts in the development of revolutionary signal transduction inhibitor drugs for the treatment of cancers and other diseases. Dr. Gishizky has been instrumental in establishing two biotechnology companies (SUGEN, Entelos) whose technology is helping to bring the promise of personalized medicine to the patient’s bedside. Most recently, as the Chief Scientific Officer at Entelos, Dr. Gishizky supervised the development of capabilities and scientific programs that employ computer simulation models to identify patient populations who would benefit most from new medicines and combination therapies. Use of these capabilities result in faster and more cost-effective drug development programs by helping drug developers predict patient responses prior to initiation of therapy, thus helping physicians optimize the beneficial outcome and minimize the risk to the patient. Dr. Gishizky has been a member of the Institute of Medicine Forum on Drug Discovery, Development and Translation since 2005. Earlier in his career, Dr. Gishizky held positions of increasing management responsibility at SUGEN, Pharmacia, and Pfizer (as Vice President and Research Zone Head), developing targeted therapies and signal transduction pathway analysis tools to identify patients most likely to respond to given therapies (e.g., Sutent, a leader in the class of signal transduction inhibitors marketed by Pfizer). Dr. Gishizky received his degree in Endocrinology at the University of California, San Francisco, where his work focused on defining the molecular mechanisms responsible for the development and progression of Diabetes Mellitus. Dr. Gishizky’s post-doctoral training and academic work focused on cancer biology and hematopoietic cell development. His research led to the development of in vitro systems and an animal model for human Chronic Myeloid Leukemia that was instrumental in the development of Gleevec. Dr. Gishizky has published extensively in the areas of Diabetes Mellitus and oncology research. During his tenure within the biotech/pharma industry Dr. Gishizky has led research efforts across a broad range of therapeutic areas including oncology, immunology, inflammation, and CNS and metabolic diseases.


Alberto Gutierrez, Ph.D., is the Director of U.S. Food and Drug Administration’s Office of In Vitro Diagnostic Device Evaluation and Safety. Dr. Gutierrez received a bachelor’s degree from Haverford College, and master and doctorate degrees in Chemistry from Princeton University. Dr. Gutierrez has over 10 years of experience in research in

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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the area of structural organic and organometallic chemistry. Dr. Gutierrez joined the FDA in 1992 as researcher and reviewer in FDA’s Center for Biologics Evaluation and Research working on vaccine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he joined the Office of In Vitro Diagnostic Device Evaluation and Safety as a scientific reviewer, becoming a Team leader for Toxicology in 2003, Director of the Division of Chemistry and Toxicology Devices in 2005, Deputy Director of the Office of In Vitro Diagnostic Devices in 2007 and Director in 2009.


Kathy Hudson is Chief of Staff to the Director of the National Institutes of Health. She is the founder of the Genetics and Public Policy Center at Johns Hopkins University. At the time of the workshop, Dr. Hudson was Director of the Genetics and Public Policy Center and an Associate Professor in the Berman Bioethics Institute, Institute of Genetic Medicine, and the Department of Pediatrics at Johns Hopkins University. The Genetics and Public Policy Center was established in April 2002 with a grant from The Pew Charitable Trusts. Dr. Hudson founded the Center to fill an important niche in the science policy landscape and to focus exclusively on public policy issues raised by advances in human genetics. She led the Center’s efforts to address legal, ethical, and policy issues related to human reproductive genetic technologies, genetic testing quality and oversight, and public engagement in genetic research. Prior to establishing the Center, Dr. Hudson served as Assistant Director of the National Human Genome Research Institute. She received her Ph.D. in molecular biology from the University of California, Berkeley.


Muin Khoury is the first director of the Centers for Disease Control and Prevention’s Office of Public Health Genomics. The Office was formed in 1997 to assess the impact of advances in human genetics and the Human Genome Project on public health and disease prevention. As the nation’s prevention agency, CDC’s mission is to protect the health and safety of people, to provide credible information to enhance health decisions, and to promote health through strong partnerships. CDC’s Office of Public Health Genomics serves as the national focus for integrating genomics into public health research and programs for disease prevention and health promotion. Dr. Khoury joined CDC as an Epidemic Intelligence Service Officer in 1980 in the Birth Defects and Genetic Diseases Branch, and as a medical epidemiologist in 1987. In

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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1990, he became Deputy Chief of the same Branch. In 1996, Dr. Khoury chaired a CDC-wide Task Force on Genetics and Disease Prevention and provided important leadership in outlining a plan delineating the future direction that CDC should take in this important area.

Dr. Khoury received his B.S. degree in Biology/Chemistry from the American University of Beirut, Lebanon and his medical degree and Pediatrics training from the same institution. He received a Ph.D. in Human Genetics/Genetic Epidemiology and training in Medical Genetics from Johns Hopkins University. Dr. Khoury is board certified in Medical Genetics.

Dr. Khoury has published extensively in the fields of genetic epidemiology and public health genetics. He is a member of many professional societies and serves on the editorial boards of several journals. Dr. Khoury also serves on several scientific, public health, and health policy national and international committees. He is an adjunct professor of Epidemiology at Emory’s School of Public Health and an associate in the Department of Epidemiology at Johns Hopkins University Bloomberg School of Public Health.


David Korn became Vice Provost for Research of Harvard University in November 2008. He is also Professor of Pathology at Harvard Medical School. Prior to that he was senior vice president for biomedical and health sciences research at the Association of American Medical Colleges in Washington, DC, a position he assumed on September 1, 1997. Dr. Korn served as Carl and Elizabeth Naumann Professor and Dean of the Stanford University School of Medicine from October 1984 to April 1995, and as Vice President of Stanford University from January 1986 to April 1995. Before that he had served as Professor and Chairman of the Department of Pathology at Stanford, and Chief of the Pathology Service at the Stanford University Hospital, since June 1968. Dr. Korn has been Chairman of the Stanford University Committee on Research; President of the American Association of Pathologists (now the American Society for Investigative Pathology). Dr. Korn was a founder and Chairman of the Board of Directors of the California Transplant Donor Network, one of the nation’s largest Organ Procurement Organizations. He is a member of the Institute of Medicine and a founder of the Clinical Research Roundtable. Dr. Korn served on the Boards of Directors of the Stanford University Hospital from October 1982 to April 1995, the Children’s Hospital at Stanford from October 1984 to its closure, and the Lucile Salter Packard Children’s Hospital at Stanford from October

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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1984 to April 1995. He was a member of the Board of Directors of the California Society of Pathologists from 1983-86. Since January 2010, Dr. Korn has been Co-chair of the National Academies’ Committee on Science, Technology, and Law. He has been a member of the committee since its inception in 1998.


Jonathan D. Moreno, Ph.D., (IOM) is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of History and Sociology of Science at Penn. He holds a courtesy appointment as Professor of Philosophy. He is also a Senior Fellow at the Center for American Progress in Washington, DC, where he edits the magazine Science Progress (www.scienceprogress.org). He was a member of President Barack Obama’s transition team for the Department of Health and Human Services. Dr. Moreno is an elected member of the Institute of Medicine/National Academy of Sciences and serves on numerous National Academies committees. In 2008 he was designated a National Associate of the National Research Council. He has served as a senior staff member for two presidential advisory commissions, and has given invited testimony for both houses of congress. He was an Andrew W. Mellon post doctoral fellow, holds an honorary doctorate from Hofstra University, and is a recipient of the Benjamin Rush Medal from the College of William and Mary Law School. Dr. Moreno has served as adviser to the Howard Hughes Medical Institute and the Bill and Melinda Gates Foundation, among many other organizations. Moreno is also a Faculty Affiliate of the Kennedy Institute of Ethics at Georgetown University and a Fellow of the Hastings Center and the New York Academy of Medicine. He is a past president of the American Society for Bioethics and Humanities. Publisher’s Weekly said that his most recent book, Science Next: Innovation for the Common Good (2009), “brings hope into focus with reports of innovation that will enhance lives.” His other books include Mind Wars: Brain Research and National Defense (2006), which the journal Nature called “fascinating and sometimes unsettling”; Undue Risk: Secret State Experiments on Humans (1999), described by the The New York Times as “an earnest and chilling account” and by the Journal of the American Medical Association as a “classic” in the literature on human experimentation; Ethical Guidelines for Innovative Surgery (2006); Is There an Ethicist in the House? (2005); In the Wake of Terror: Medicine and Morality in a Time of Crisis (2003); Ethical and Regulatory Aspects of Clinical Research (2003); Deciding Together: Bioethics and Moral Consensus (1995); Ethics in Clinical Practice (2000); and Arguing

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Euthanasia (1995). Moreno has published more than 300 papers, reviews and book chapters, and is a member of several editorial boards.

STAFF

Anne-Marie Mazza is Director of the Committee on Science, Technology and Law. She joined the National Academies in 1995. She has served as Senior Program Officer with both the Committee on Science, Engineering, and Public Policy and the Government-University-Industry Research Roundtable. In 1999 she was named the first director of the Committee on Science, Technology, and Law (CSTL), a newly created Program designed to foster communication and analysis among scientists, engineers, and members of the legal community. In 2007, she became the director of the Christine Mirzayan Science and Technology Graduate Policy Fellowship Program. Dr. Mazza has been the study director on numerous Academy reports including Science and Security in a Post 9-11 World, 2007; Reaping the Benefits of Genomic and Proteomic Research, 2005; Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues, 2004; Ensuring the Quality of Data Disseminated by the Federal Government, 2003; The Age of Expert Testimony: Science in the Courtroom, 2002; Issues for Science and Engineering Researchers in the Digital Age, 2001; and Observations on the President’s Fiscal Year 2000 Federal Science and Technology Budget, 1999. Between October 1999 and October 2000, she divided her time between CSTL and the White House Office of Science and Technology Policy, where she served as a Senior Policy Analyst responsible for issues associated with the government-university research partnership. Before joining the National Academies, Dr. Mazza was a Senior Consultant with Resource Planning Corporation. She received a B.A., M.A., and Ph.D. from The George Washington University.


Guruprasad Madhavan was a Program Officer for the Committee on Science, Technology, and Law, and the Committee on Science, Engineering, and Public Policy at the National Academies until November 2010. He was formerly a Christine Mirzayan Science and Technology Policy Fellow with the National Academies’ Board on Science, Technology, and Economic Policy. Madhavan received his B.E. (honors with distinction) in instrumentation and control engineering from the University of Madras (India), and M.S. in biomedical engineering from SUNY Stony Brook. Following his medical device industry experience as a

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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research scientist at AFx, Inc. and Guidant Corporation in California, Madhavan completed an M.B.A. in leadership and health care management and a Ph.D. in biomedical engineering at SUNY Binghamton. His doctoral research was focused on non-invasive and non-pharmacologic neuromuscular stimulation for enhancing lower limb circulation. Among other honors, Madhavan was chosen as an outstanding young scientist to attend the 2008 World Economic Forum’s Annual Meeting of the New Champions and as one of the 2009 New Faces of Engineering by the Engineers Week Foundation in the USA Today. He is also an elected member to the administrative council of the International Federation for Medical and Biological Engineering. Madhavan is a coeditor of Career Development in Bioengineering and Biotechnology (Springer) and Pathological Altruism (Oxford University Press).


Steven Kendall is Senior Program Associate for the Committee on Science, Technology, and Law. He is a Ph.D. candidate in the Department of the History of Art and Architecture at the University of California, Santa Barbara where he is completing a dissertation on 19th century British painting. Mr. Kendall received his M.A. in Victorian Art and Architecture at the University of London. Prior to joining The National Academies in 2007, he worked at the Smithsonian American Art Museum and The Huntington in San Marino, California.


Mary Fraker is a writer specializing in the intersection of emerging technologies and evolving public policy. She has written about financial institutions’ roles and responsibilities under the USA PATRIOT Act; the disposition of wastewater treatment residuals, including siting issues and renewable-energy production; and encryption, electronic signatures and authenticating identities on the Internet. In the biomedical arena, she has written annual reports for, among others: Human Genome Sciences, 1993 (the company’s first); Genetic Therapy Inc. (later acquired by Novartis), 1991 and 1992; and Life Technologies Inc., 1986 through 1990. From 1979 to 1991, Ms. Fraker held various marketing and communications positions at Life Technologies (formerly Bethesda Research Laboratories), writing journal advertisements, brochures and annual reports and managing the company’s DNA sequencing workshop program. Between 1991 and 1994, she audited the open meetings of the Human Genome Project’s ELSI (ethical, legal and social implications) Task Force and Insurance Working Group and served on the local (Washington, DC) steering committees of the Biotechnology Industry

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Organization (BIO) and the Association of Biotechnology Companies (one of BIO’s two predecessor organizations). Ms. Fraker holds bachelor and masters degrees, respectively, from Tufts University and Canada’s York University.


Adam C. Berger, Ph.D. is a Program Officer at the Board on Health Sciences Policy at the Institute of Medicine where his primary interest focuses on policy issues relating to translational medicine. Dr. Berger received his doctorate from Emory University in the Biochemistry, Cell and Developmental Biology Program studying the fatal childhood neurodegenerative disorder, Niemann Pick Disease Type C, and additionally performing genome wide screening for novel cellular targets of anti-cancer and anti-malarial drug compounds. Following a post-doctoral fellowship at the National Cancer Institute studying the immunological impact of altered cholesterol homeostasis, Dr. Berger joined the Institute of Medicine where he is currently directing the Roundtable on Translating Genomic-Based Research for Health. He is the recipient of the National Institutes of Health Fellows Award for Research Excellence and a Ruth L. Kirschstein National Research Service Award. Dr. Berger received his B.S. from The Ohio State University where he majored in Molecular Genetics.


Sally Cluchey (formerly Robinson) is a Research Associate with the Engelberg Center for Health Care Reform at The Brookings Institution. She is responsible for working with multiple stakeholders to develop the infrastructure, methods, and governance structure necessary to conduct active medical product safety surveillance and comparative effectiveness research.

Prior to joining Brookings she was a program officer with the Institute of Medicine (IOM) of the National Academy of Sciences. At IOM, Ms. Cluchey staffed multiple projects including the Committee on Comparative Effectiveness Research Prioritization, where she helped to write the report Initial Prioritizes for Comparative Effectiveness Research, and served for two years on the Forum on Drug Discovery, Development, and Translation. While working on the Forum, Ms. Cluchey was responsible for several key IOM initiatives involving the science of drug safety, FDA policy, funding models for drug development, and improving the clinical research process.

Prior to joining the IOM in 2006, she worked for the Walter Reed Army Institute of Research’s malaria vaccine development program, where she managed the manufacture, preclinical, and Phase I develop-

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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ment of multiple vaccine candidates, and coordinated regulatory submissions. Ms. Cluchey holds a Master of Science in Biomedical Science and Regulatory Compliance from Hood College and a Bachelor of Arts from Kenyon College.


Lyla M. Hernandez (until March 2010) was a Senior Program Officer with the Institute of Medicine for the past thirteen years. During that time she has been study director for projects related to Gulf War veterans’ health, public health, complementary and alternative medicine, genomics, and health status indicators. Reports from her most recently completed studies include Genes, Behavior, and the Social Environment: Moving Beyond the Nature/Nurture Debate, Training Physicians for Public Health Careers, and State of the USA Health Indicators. She is currently Staff Director of the Roundtable on Translating Genomic-Based Research for Health, Staff Director of the Roundtable on Health Literacy, and Study Director for the Committee on a National Surveillance System for Cardiovascular and Other Select Chronic Diseases. Prior to joining the IOM, Lyla was Director of the Pharmacy Intelligence Center of the American Pharmaceutical Association where she was responsible for identifying and conducting analyses of health care issues, national programs, and policies that affect pharmacy. She also served as Executive Director of the American Medical Peer Review Organization, the national trade association for organizations evaluating the utilization and quality of medical care. Lyla received her Masters of Public Health degree from the University of California at Berkeley and her Bachelor of Science in Education from the University of Illinois at Urbana.


Sharon Murphy joined the Institute of Medicine as a Scholar-in-Residence in October 2008, coming to DC from Texas where she was the inaugural Director of the Greehey Children’s Cancer Research Institute and Professor of Pediatrics at the University of Texas Health Science Center at San Antonio from 2002 to 2008. From 1988 to 2002, Dr. Murphy was Chief of the Division of Hematology/Oncology at Children’s Memorial Hospital in Chicago and Professor of Pediatrics at Northwestern University School of Medicine where she also led the program in pediatric oncology at the Robert H. Lurie Cancer Center. From 1974 to 1988, Dr. Murphy was on the faculty at St. Jude Children’s Research Hospital in Memphis. A pediatric oncologist and clinical cancer researcher, Dr. Murphy has devoted the past thirty-five years to improving cure rates for childhood cancer, particularly childhood lymphomas and leukemias.

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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She was chair of the Pediatric Oncology Group from 1993 to 2001. She has been recognized for her achievements by the Association of Community Cancer Centers (2001), the Distinguished Service Award for Scientific Leadership from the American Society of Clinical Oncology (2005) and the Distinguished Career Award from the American Society of Pediatric Hematology and Oncology (2009). The author of more than 220 original articles, reviews, and book chapters, Dr. Murphy has also served on numerous editorial boards, including Cancer Research, Clinical Cancer Research, and the Journal of Clinical Oncology. She has been a member of the Boards of Directors of the American Cancer Society, the American Association of Cancer Research, the American Society of Hematology, and the American Society of Clinical Oncology, and has been an advisor to NCI and FDA. She earned her bachelor’s of science degree from the University of Wisconsin (1965) and her medical degree, cum laude, from Harvard Medical School (1969). She completed postdoctoral training in pediatrics at the University of Colorado (1969-71) and in pediatric hematology and oncology at the University of Pennsylvania (1971-73).


Ann Reid was a Senior Program Officer for the Board on Life Sciences at the National Research Council until December 2009. She served as study director for a diverse set of reports including: The Ecological Impacts of Climate Change; The Role of Theory in Advancing 21st-Century Biology; The New Science of Metagenomics; Exploring the Role of Antiviral Drugs in Eradicating Polio; and Treating Infectious Diseases in a Microbial World. From 1989 to 2004 she was a research biologist at the Armed Forces Institute of Pathology where she applied the techniques of molecular biology to archival tissue samples. From 1995 to 2004 her research focused on the isolation and sequencing of the 1918 pandemic influenza virus from archived autopsy samples and lung samples from an Inuit victim who had been buried in permafrost. The genomic sequence of the virus was completed in 2004. The sequence has been used to try to determine why the 1918 epidemic was so severe, where the pandemic strain came from, and to test the effectiveness of influenza vaccines and antiviral drugs. Before turning to science she was a political analyst for the Japanese Embassy in Washington, DC, and the Organization for Economic Cooperation and Development in Paris. She holds a B.A. in environmental science from Simon’s Rock College, an M.A. from the Johns Hopkins School of Advanced International Studies and has published more than 30 papers and reviews, and 7 book chapters.

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Adam Schickedanz was a Christine Mirzayan Science and Technology Policy Fellow with the Institute of Medicine’s Board on Health Care Services in winter of 2009 and served as a member of the IOM staff for nearly a year. Mr. Schickedanz received his baccalaureate degree from Washington University in St. Louis and his M.D. from the University of California, San Francisco, in May of 2010. At UCSF, he developed a clinical focus in urban underserved patient care while advancing research interests in professionalism and cultural competency in medical education, novel approaches to clinician-patient communication in medical decision making (particularly at the end of life), and the intersections of education and health. At IOM, he contributed projects on value in cancer care, health consequences for the uninsured, continuing medical education, and health care data collection practices to improve quality of care and reduce health disparities. Mr. Schickedanz will pursue residency training in pediatrics.

Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Page 66
Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Page 67
Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Page 68
Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Page 69
Suggested Citation:"Appendix E: Planning Group Biographies." Institute of Medicine and National Research Council. 2011. Direct-to-Consumer Genetic Testing: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13021.
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Page 70
Next: Appendix F: Workshop Agenda »
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Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they offer demonstrate a public appetite for this information and where the future of genetics may be headed; they also demonstrate the need for serious discussion about the regulatory environment, patient privacy, and other policy implications of direct-to-consumer (DTC) genetic testing.

Rapid advances in genetic research already have begun to transform clinical practice and our understanding of disease progression. Existing research has revealed a genetic basis or component for numerous diseases, including Parkinson's disease, Alzheimer's disease, diabetes, heart disease, and several forms of cancer. The availability of the human genome sequence and the HapMap, plummeting costs of high-throughput screening, and increasingly sophisticated computational analyses have led to an explosion of discoveries of linkages between patterns of genetic variation and disease susceptibility. While this research is by no means a straight path toward better public health, improved knowledge of the genetic linkages has the potential to change fundamentally the way health professionals and public health practitioners approach the prevention and treatment of disease. Realizing this potential will require greater sophistication in the interpretation of genetic tests, new training for physicians and other diagnosticians, and new approaches to communicating findings to the public. As this rapidly growing field matures, all of these questions require attention from a variety of perspectives.

To discuss some of the foregoing issues, several units of the National Academies held a workshop on August 31 and September 1, 2009, to bring together a still-developing community of professionals from a variety of relevant disciplines, to educate the public and policy-makers about this emerging field, and to identify issues for future study. The meeting featured several invited presentations and discussions on the many technical, legal, policy, and ethical questions that such DTC testing raises, including: (1) overview of the current state of knowledge and the future research trajectory; (2) shared genes and emerging issues in privacy; (3) the regulatory framework; and (4) education of the public and the medical community.

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