Bernard Lo, M.D. (Chair), is currently president of The Greenwall Foundation. Previously, Dr. Lo was professor of medicine and director of the Program in Medical Ethics at the University of California, San Francisco (UCSF). Currently, he is co-chair of the Standards Working Group of the California Institute of Regenerative Medicine, which recommends regulations for stem cell research funded by the state of California. Dr. Lo serves on the board of directors of the Association for the Accreditation of Human Research Protection Programs and on the Medical Advisory Panel of Blue Cross Blue Shield. Formerly, he was a member of the National Bioethics Advisory Commission under President Clinton, the National Institutes of Health (NIH) Recombinant DNA Advisory Committee and the Ethics Subcommittee, and the Advisory Committee to the director of the Centers for Disease Control and Prevention. He served on a number of Data and Safety Monitoring Committees at NIH for HIV prevention and treatments, diabetes prevention, and oxygen treatment in chronic obstructive pulmonary disease. A member of the Institute of Medicine (IOM), Dr. Lo served on the IOM Council and chaired the Board on Health Sciences Policy. He chaired IOM committees on conflicts of interest in medicine and on confidentiality in health services research and has been a member of several other IOM committees. He currently is a member of the Board on Life Sciences of the National Academy of Sciences. Dr. Lo and his colleagues have published about 200 peer-reviewed articles on ethical issues concerning decision making near the end of life, stem cell research, research with human participants and its oversight, the doctor–patient relationship, conflicts of interest, HIV infection, and public health. With colleagues on the UCSF Stem Cell Research Oversight
Committee, he has written articles on ethical issues in the procurement of embryos for research, oversight of stem cell lines derived in other institutions, informed consent for future research, and prohibiting the use of induced pluripotent stem cells for reproductive cloning. Dr. Lo is the author of Resolving Ethical Dilemmas: A Guide for Clinicians (5th ed., 2013) and of Ethical Issues in Clinical Research (2010). At UCSF, he directed medical student teaching in ethics, chaired the hospital ethics committee, and served as an attending physician on the medicine inpatient service. He was co-director of the Policy and Ethics Core of the Center for AIDS Prevention Studies. He continues to serve as the primary care physician for a panel of general internal medicine patients.
Timothy Coetzee, Ph.D., is Chief Advocacy, Services, and Research Officer of the National Multiple Sclerosis (MS) Society and is responsible for the society’s research program, which funds more than 375 academic and commercial research projects around the world. Most recently, he served as president of Fast Forward, a venture philanthropy project of the National Multiple Sclerosis Society, where he was responsible for the society’s strategic funding of biotechnology and pharmaceutical companies, as well as partnerships with the financial and business communities. Prior to Fast Forward, Dr. Coetzee led the society’s translational research initiatives on nervous system repair and protection in multiple sclerosis. He is a member of the Institute of Medicine’s Forum on Neuroscience and Nervous System Disorders and serves on the board of directors of the American Society of Experimental Neurotherapeutics. He also chairs the Integration Panel for the MS Research Program of the Department of Defense’s Congressionally Directed Medical Research Program. Dr. Coetzee received his Ph.D. in molecular biology from Albany Medical College in 1993 and has since been involved in the field of multiple sclerosis research. He has been with the National MS Society since fall 2000.
David L. DeMets, Ph.D., is currently the Max Halperin Professor of Biostatistics and founder/former chair of the Department of Biostatistics and Medical Informatics at the University of Wisconsin (UW)–Madison. Since receiving his Ph.D. in 1970 from the University of Minnesota, he has been very active in the design, conduct, and analysis of clinical trials in several disease areas. Following a postdoctoral appointment at the National Institutes of Health (NIH) (1970-1972), he spent 10 years (1972-1982) at the National Heart, Lung, and Blood Institute at NIH,
where he became chief of the Biostatistics Research Branch. He has coauthored four texts on the topic of clinical trial design, interim monitoring, and analyses. Dr. DeMets is a recognized international leader in statistical research and methods for the analysis of clinical trials. He has collaborated in the development of statistical methods for the sequential analysis of outcome data and the design of clinical trials. He has extensive national and international clinical trial experience and has served on and chaired numerous NIH and industry-sponsored Data Safety and Monitoring Committees for clinical trials in diverse disciplines. He served on the Board of Scientific Counselors of the National Cancer Institute and Board of Directors of the American Statistical Association, as well as serving as president of the Society for Clinical Trials and president of the Eastern North American Region of the Biometric Society. He is a fellow of the American Statistical Association, the International Statistics Institute, the Society of Clinical Trials, the American Medical Informatics Association, and the American Association for the Advancement of Science. Dr. DeMets has served on the Human Subjects Committee (1982-1987) and on the following UW committees since 1990: Ad Hoc Committee on Conflict of Interest (1992-1993); Tenure Track Promotions Committee (1995-1998); and Biomedical Industry Relations Committee (1996-1998). In addition, he has served on the search committees for the UW Cancer Center Director (1994-1997); Associate Dean for Research (Chair) (1995-1996); Associate Dean for Administration (Chair) (1995-1996); Section of Cardiology Chief (1998-1999); and Preventive Medicine Chair (1999-2000). His graduate school committees include the Committee on Training Research Ethics (Chair) (1993-1996; 1998-2000); the Health Sciences Information Technology Committee (1999-2003); and the University Conflict of Interest Committee (2010-present).
Jeffrey M. Drazen, M.D., joined the New England Journal of Medicine (NEJM) as editor-in-chief in July 2000. At NEJM, Dr. Drazen’s responsibilities include oversight of all editorial content and policies. His editorial background includes service as an associate editor or editorial board member for the Journal of Clinical Investigation, the American Journal of Respiratory Cell and Molecular Biology, and the American Journal of Medicine. A specialist in pulmonology, Dr. Drazen maintains an active research program. Dr. Drazen has published more than 300 articles on topics such as lung physiology and the mechanisms involved in asthma. In 1999, he delivered the Amberson Lecture, the major
research address at the annual meeting of the American Thoracic Society. In 2000, he received the Chadwick Medal from the Massachusetts Thoracic Society for his contributions to the study of lung disease. Dr. Drazen is the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, professor of physiology at the Harvard School of Public Health, and a senior physician at Brigham and Women’s Hospital. In 2003, he was elected as a member of the Institute of Medicine. Dr. Drazen has served on numerous committees for the National Institutes of Health, including the Respiratory and Applied Physiology Study Section; the Lung Biology and Pathology Study Section; the Pulmonary Disease Advisory Council; the National Heart, Lung, and Blood Institute (NHLBI) Advisory Council; the Public Access Working Group; and the NHLBI Division of Lung Disease Executive Planning Committee. He has also served on the Department of Veterans Affairs National Research Advisory Committee. He currently serves on the Global Initiative for Asthma Science Committee and the World Health Organization’s Scientific Advisory Group on Clinical Trials Registration and co-chairs the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation. Dr. Drazen earned his bachelor’s degree and graduated summa cum laude from Tufts University. He received his medical degree from Harvard Medical School and completed his internship and residency at Peter Bent Brigham Hospital in Boston. Dr. Drazen has received honorary degrees from the University of Ferrara, Italy, and the National and Kapodistrian University of Athens, Greece.
Steven N. Goodman, M.D., M.H.S., Ph.D., is associate dean for clinical and translational research and professor of medicine and health policy and research at Stanford University School of Medicine. Before joining Stanford in 2011, Dr. Goodman was professor of oncology in the division of biostatistics of the Johns Hopkins Kimmel Cancer Center, with appointments in the departments of pediatrics, biostatistics, and epidemiology in the Johns Hopkins Schools of Medicine and Public Health. He was also on the core faculties of the Johns Hopkins Center for Clinical Trials, Berman Bioethics Institute, Graduate Training Program in Clinical Investigation, and co-directed the epidemiology doctoral program. He is the editor of Clinical Trials: Journal of the Society for Clinical Trials and has been the statistical and associate editor of the Annals of Internal Medicine since 1987. He served on the Institute of Medicine’s Committee to Review the Health Effects in Vietnam
Veterans of Exposure to Herbicides: Second Biennial Update; Committee to Review the Evidence Regarding the Link between Exposure to Agent Orange and Diabetes; Immunization Safety Review Committee; Committee on Alternatives to the Daubert Standards; and Committee on Treatment of Post-Traumatic Stress Disorder in Veterans. Dr. Goodman also served on the Surgeon General’s committee to write the 2004 report on the Health Consequences of Smoking. He is a scientific advisor to the Medical Advisory Panel of the National Blue Cross Blue Shield Technology Evaluation Center and was appointed to the Methodology Committee of the Patient-Centered Outcomes Research Institute. Dr. Goodman received a B.A. from Harvard University and an M.D. from New York University, trained in pediatrics at Washington University in St. Louis, and received an M.H.S. in biostatistics and a Ph.D. in epidemiology from Johns Hopkins University. He writes and teaches on evidence evaluation and inferential, methodologic, and ethical issues in epidemiology and clinical research.
Patricia A. King, J.D., has expertise in the study of law, medicine, ethics, and public policy. She is an adjunct professor in the Department of Health Policy and Management, School of Hygiene and Public Health, at Johns Hopkins University. She is the co-author of Cases and Materials on Law, Science and Medicine. She teaches family law courses and offers a seminar in bioethics and the law. She is a member of the American Law Institute and the Institute of Medicine and a fellow of the Hastings Center. Her work in the field of bioethics has included service on the Health, Education and Welfare-Advisory Recombinant DNA Advisory Committee; the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research; the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; and the Ethics, Legal and Social Issues Working Group of the Human Genome Project. Ms. King is a former member of the Harvard Corporation and a trustee emeritus of Wheaton College in Massachusetts. Her professional experience before joining the Law Center faculty in 1973 was primarily in the civil rights field; she was the deputy director of the Office of Civil Rights and a special assistant to the chairman of the Equal Employment Opportunity Commission. She also served as a deputy assistant attorney general in the Civil Division of the Department of Justice.
Trudie Lang, Ph.D., is a clinical trials research methodologist with specific expertise in capacity development and trial operations in low-resource settings. She currently leads the Global Health Network (GHN) at the University of Oxford, which is a forum to help clinical researchers with trial design, methods, interpretation of regulations, and general operations. GHN conducts methodology research to identify the real barriers and issues involved in noncommercial trials, with the aim of developing best-practice guidelines. Dr. Lang has worked in the field of clinical trials for 20 years and has experienced the benefit of working in the pharmaceutical industry, the World Health Organization, and in academia. Ten years managing trials in industry gave Dr. Lang strong capabilities in leading teams, regulations, managing complex projects, and conducting effective strategic planning and taught her the rigors of designing and operating clinical trials in varied settings. At Oxford, she has further developed her expertise in the design, operation, and methodology of running trials in developing countries. Dr. Lang set up a clinical trial facility in Kenya with a strong focus on developing local research skills and engagement. More recently, she devised and set up Global Health Trials (www.globalhealthtrials.org). This is an online, research-led facility to support and guide research teams and is being used by more than 85,000 researchers. This evolved into GHN (www.theglobalhealthnetwork.org), a virtual science park that hosts 15 international collaborations across varied diseases areas—all aiming to support research by sharing knowledge, research tools, and methods.
Deven McGraw, J.D., M.P.H., L.L.M., is the director of the Health Privacy Project at the Center for Democracy and Technology (CDT). The project is focused on developing and promoting workable privacy and security protections for electronic personal health information. Ms. McGraw is active in efforts to advance the adoption and implementation of health information technology (HIT) and electronic health information exchange to improve health care. She was one of three persons appointed by Kathleen Sebelius, the Secretary of the U.S. Department of Health & Human Services (HHS), to serve on the Health Information Technology Policy Committee, a federal advisory committee established in the American Recovery and Reinvestment Act of 2009. She has chaired that committee’s Privacy and Security Workgroup since 2010 and also serves on its Information Exchange and Meaningful Use Workgroups. In addition, she served on two key workgroups of the American Health Information Community, the federal advisory body established by HHS
in the George W. Bush Administration to develop recommendations on how to facilitate use of HIT to improve health. She also serves on the executive committee of the Clinical Trials Transformation Initiative, the steering committee of the Electronic Data Methods Forum, and the leadership council of the eHealth Initiative. Ms. McGraw has a strong background in health care policy. Prior to joining CDT, Ms. McGraw was the chief operating officer of the National Partnership for Women & Families, providing strategic direction and oversight for all of the organization’s core program areas, including the promotion of initiatives to improve health care quality. Ms. McGraw also was an associate in the public policy group at Patton Boggs, LLP, and in the health care group at Ropes & Gray. She also served as deputy legal counsel to the Governor of Massachusetts and taught in the Federal Legislation Clinic at the Georgetown University Law Center. Ms. McGraw graduated magna cum laude from the University of Maryland, College Park. She earned her J.D., magna cum laude, and her L.L.M. from Georgetown University Law Center and was executive editor of the Georgetown Law Journal. She also has an M.P.H. from the Johns Hopkins School of Hygiene and Public Health.
Elizabeth G. Nabel, M.D., has served as president of Harvard University–affiliated Brigham and Women’s Hospital (BWH) since 2010. A cardiologist and distinguished biomedical researcher, Dr. Nabel is professor of medicine at Harvard Medical School. She brings a unique perspective to health care based on her experience as a physician, research scientist, academic medicine leader, and wellness advocate. At BWH, she led development of a comprehensive strategic plan that defines a new model of medicine characterized by cross-disciplinary collaboration, patient-inclusive care, and innovation. Initiatives include a new translational medical facility, patient-centered intensive care unit care, and a $1 billion campaign to advance innovation, patient care, and community health. Dr. Nabel has a long record of advocacy for health and broadening access to care. As director of the National Heart, Lung, and Blood Institute (NHLBI) from 2005 to 2009, she leveraged the $3 billion research portfolio to establish pioneering scientific programs in genomics, stem cells, and translational research. One of Dr. Nabel’s signature advocacy efforts was the Red Dress Heart Truth campaign, which raises heart awareness in women through innovative partnerships. Throughout her career, Nabel has been a champion for global health. At NHLBI, she established Centers of Excellence in developing countries to
combat cardiovascular and lung diseases. At BWH, she helped create a national teaching hospital in Haiti and is advancing training for clinicians in underresourced countries. An accomplished physician-scientist, Dr. Nabel’s work on the molecular genetics of cardiovascular diseases has produced 17 patents and more than 250 scientific publications. Her colleagues elected her to the American Academy of the Arts and Sciences and the Institute of Medicine, and she is a fellow of the American Association for the Advancement of Science. Dr. Nabel’s honors include the Willem Einthoven Award from Leiden University in the Netherlands; two Distinguished Achievement Awards from the American Heart Association; and six honorary doctorates. A native of St. Paul, Minnesota, Dr. Nabel attended Weill Cornell Medical College and completed her cardiology training at BWH.
Arti K. Rai, J.D., Elvin R. Latty Professor of Law at Duke University School of Law, is an internationally recognized expert in intellectual property (IP) law, administrative law, and health policy. Ms. Rai has also taught at the Harvard University, Yale University, and University of Pennsylvania law schools. Ms. Rai’s research on IP law and policy in biotechnology, pharmaceuticals, and software has been funded by the National Institutes of Health, the Kauffman Foundation, and the Woodrow Wilson Center. She has published more than 50 articles, essays, and book chapters on IP law, administrative law, and health policy. Her publications have appeared in both peer-reviewed journals and law reviews, including Science, the New England Journal of Medicine, the Journal of Legal Studies, Nature Biotechnology, and the Columbia, Georgetown, and Northwestern university law reviews. She is the editor of Intellectual Property Law and Biotechnology: Critical Concepts (Edward Elgar, 2011), the co-author of a 2012 Kauffman Foundation monograph on cost-effective health care innovation, and the co-author of a casebook on law and the mental health system. From 2009 to 2010, Ms. Rai served as the administrator of the Office of External Affairs at the U.S. Patent and Trademark Office (USPTO). As external affairs administrator, she led policy analysis of the patent reform legislation that ultimately became the America Invents Act and worked to establish USPTO’s Office of the Chief Economist. Prior to that time, she had served on President-Elect Obama’s transition team reviewing USPTO. Prior to entering academia, Ms. Rai clerked for the Honorable Marilyn Hall Patel of the U.S. District Court for the Northern District of California; was a litigation associate at Jenner & Block (doing patent
litigation as well as other litigation); and was a litigator at the Federal Programs Branch of the U.S. Department of Justice’s Civil Division. Ms. Rai regularly testifies before Congress and relevant administrative bodies on IP law and policy issues and advises federal agencies on IP policy issues raised by the research that they fund. She is a member of the National Advisory Council for Human Genome Research and of an Expert Advisory Council to the Defense Advanced Projects Research Agency. She is a public member of the Administrative Conference of the United States, a member of the American Law Institute, and co-chair of the IP Committee of the Administrative Law Section of the American Bar Association. In 2011, Ms. Rai won the World Technology Network Award for Law. She graduated from Harvard College, magna cum laude, with a B.A. in biochemistry and history, attended Harvard Medical School for the 1987-1988 academic year, and received her J.D., cum laude, from Harvard Law School in 1991.
Ida Sim, Ph.D., is professor of medicine, co-director of biomedical informatics at the University of California, San Francisco, Clinical and Translational Sciences Institute, and co-founder of Open mHealth, a nonprofit organization that is breaking down barriers to mobile health app and data integration through an open software architecture. Her primary research work is on knowledge-based technologies for evidence-based practice, especially in the ontological representation of clinical trials for data sharing and scientific computation. In 2005, Dr. Sim was the founding project coordinator of the World Health Organization’s International Clinical Trials Registry Platform, where she led the establishment of the first global policy on clinical trial registration, including the development of the Trial Registration Data Set, the common 20-item dataset that all registers worldwide adhere to. She has also published on clinical trial reporting bias, new models of scientific e-publication of clinical research, and other policies and practices of trial reporting and registration. In other work, Dr. Sim co-founded Open mHealth (http://openmhealth.org), a nonprofit to build an open-source way for the mobile health (mHealth) ecosystem to share data, methods, and software to maximize the potential of mHealth to improve individual and population health. Dr. Sim was a member of the National Research Council Comittee on Computational Technology for Effective Health Care. She serves on the editorial board of the Journal of Biomedical Informatics and is on the advisory board for PLoS One. She is a recipient of the United States Presidential Early Career Award for Scientists and
Engineers, a fellow of the American College of Medical Informatics, and a member of the American Society for Clinical Investigation. She is also a practicing primary care physician.
Sharon Terry, M.A., is president and CEO of Genetic Alliance, a network of more than 10,000 organizations, of which 1,200 are disease advocacy organizations. Genetic Alliance enables individuals, families, and communities to reclaim their health and become full participants in translational research and services. She is the founding CEO of PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE). As co-discoverer of the gene associated with PXE, she holds the patent for ABCC6 to act as its steward and has assigned her rights to the foundation. She developed a diagnostic test and conducts clinical trials. She is the author of 120 peer-reviewed papers, of which 30 are PXE clinical studies. Ms. Terry is also a co-founder of the Genetic Alliance Registry and Biobank. In her focus at the forefront of consumer participation in genetics research, services, and policy, she serves in a leadership role on many of the major international and national organizations, including the Institute of Medicine (IOM) Science and Policy Board, the IOM Roundtable on Translating Genomic-Based Research for Health, the PubMed Central National Advisory Committee, and the International Rare Disease Research Consortium Executive Committee, and as founding president of EspeRare Foundation. She is on the editorial boards of several journals. She was instrumental in the passage of the Genetic Information Nondiscrimination Act. In 2005, she received an honorary doctorate from Iona College for her work in community engagement; the first Patient Service Award from the University of North Carolina Institute for Pharmacogenomics and Individualized Therapy in 2007; the Research!America Distinguished Organization Advocacy Award in 2009; and the Clinical Research Forum and Foundation’s Annual Award for Leadership in Public Advocacy in 2011. In 2012, she became an honorary professor of Hebei United University in Tangshan, China, and also received the Facing Our Risk of Cancer Empowered Spirit of Empowerment Advocacy Award. She was named one of the Food and Drug Administration’s “30 Heroes for the Thirtieth Anniversary of the Orphan Drug Act” in 2013. She is an Ashoka Fellow.
Joanne Waldstreicher, M.D., is chief medical officer, Johnson & Johnson. In this role, she has oversight for epidemiology and safety of all
Johnson & Johnson products worldwide across all sectors, including pharmaceuticals, devices, and consumer products. In addition, she also plays a leadership role for internal and external partnerships and collaborations, including development of the corporate science, technology, regulatory, and government policies. Dr. Waldstreicher also chairs the Pharmaceuticals R&D Development Committee, which reviews all late-stage development programs in the pharmaceutical pipeline. Dr. Waldstreicher’s prior role was as chief medical officer of the pharmaceutical sector and head of Asia Pacific Medical Sciences, responsible for medical safety, Asia research and development, epidemiology, adaptive design strategy, pediatrics, established products, and small molecule clinical pharmacology. Prior to that role, she was head of Global Drug Development for the Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) CNS/Internal Medicine business unit. In this role, she was responsible for late-stage development spanning the areas of psychiatry, neurology, pain, infectious disease, cardiovascular medicine, urology, metabolism, and other emerging areas. Prior to joining J&JPRD in 2002, Dr. Waldstreicher was head of the endocrinology and metabolism clinical research group at Merck Research Laboratories and responsible for overseeing clinical development programs in atherosclerosis, obesity, diabetes, urology, dermatology, and oncology. During that time, she received numerous distinctions, including the Merck Research Laboratory Key Innovator Award. Dr. Waldstreicher received the Jonas Salk and Belle Zeller scholarships from the City University of New York and graduated summa cum laude from Brooklyn College and cum laude from Harvard Medical School. She completed her fellowship in endocrinology and metabolism at Massachusetts General Hospital, has won numerous awards and scholarships, and has authored numerous papers and abstracts.
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