Appendix D
Participant Biographies
Joseph Arvai, Ph.D., is Professor and Svare Chair in Applied Decision Research, Department of Geography, Institute for Sustainable Energy, Environment, and Economy, University of Calgary. His departmental homes are the Department of Geography, and the Institute for Sustainable Energy, Environment, and Economy. Dr. Arvai is also a Senior Researcher at Decision Research in Eugene, Oregon, and an Adjunct Professor in Engineering and Public Policy at Carnegie Mellon University. Dr. Arvai is an internationally recognized expert in the risk and decisions sciences; his research focuses on advancing our understanding of how people process information and make decisions, both as individuals and in groups. A second objective of his research is to develop and test decision support tools that can be used by people to improve decision quality across a wide range of environmental, social, and economic contexts; these include energy transitions, climate change, international development, space exploration, food security, health promotion, business and finance, and the protection of ecosystem services. Dr. Arvai’s current research in these areas is supported by grants from the Canada School of Energy and Environment, the National Science Foundation, Carbon Management Canada, and the International Development Research Centre of Canada. In addition to Dr. Arvai’s academic work, he is a member of the U.S. Environmental Protection Agency’s Science Advisory Board, and a member of the U.S. National Academy of Sciences’ (NAS’s) Board on Environmental Change and Society. Dr. Arvai has also received several awards for his work. He was a recipient of the Chauncey Starr Award, which each year honors
the individual age 40 or under who has made exceptional contributions to the field of risk and decision analysis. In 2011, he was named an Aldo Leopold Leadership Fellow by the Woods Institute for the Environment at Stanford University.
Kimby Barton, M.Sc., is Director, Bureau of Cardiology, Allergy and Neurological Sciences, Health Canada. Ms. Barton joined Health Canada in 2002 with the Marketed Pharmaceuticals and Medical Devices Bureau of the Marketed Health Products Directorate (MHPD). At MHPD, she was involved with development of methodologies for signal prioritization and signal assessment, and participated in a number of policy initiatives, including modernization of the Food and Drugs Act, as well as development of a Health Product Vigilance Framework. Ms. Barton has been the Director of the Bureau of Cardiology, Allergy and Neurological Sciences, in the Therapeutic Products Directorate, the group responsible for market authorization of drugs in these fields, since September 2009.
Carmen Bozic, M.D., is Senior Vice President, Clinical and Safety Sciences, Biogen Idec. Her department is responsible for managing clinical development, safety, and risk management, as well as preclinical safety for all products in the preapproval and postapproval phases within Biogen Idec’s therapeutic focus areas of Neurology, Immunology, and Hematology. She has more than 15 years of industry experience overseeing clinical development programs, filings and launches in multiple therapeutic areas, and addressing complex issues in drug safety and benefit–risk management. Dr. Bozic led the development of the risk management plan for Tysabri (natalizumab) and presented on this topic at an FDA Advisory Committee. She has also served as a non-voting industry representative to the FDA’s Risk Communication Advisory Committee. She received an M.D. and did her residency in Internal Medicine at McGill University in Montreal, Canada; completed a Fellowship in Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital in Boston; and was an Associate Physician at Beth Israel Deaconess Medical Center and Harvard Medical School before joining the biopharmaceutical industry. Dr. Bozic is a frequent lecturer and speaker on benefit–risk and other drug development topics nationally and internationally.
Baruch Fischhoff, Ph.D., M.A., is Howard Heinz University Professor, Department of Social and Decision Sciences, Department of Engineering and Public Policy, Carnegie Mellon University, where he heads the Decision Sciences major. A graduate of the Detroit Public Schools, he holds a B.S. in Mathematics and Psychology from Wayne State University and an M.A. and Ph.D. in Psychology from the Hebrew University of Jerusalem.
He is a member of the Institute of Medicine of The National Academies and is a past President of the Society for Judgment and Decision Making and of the Society for Risk Analysis. He chaired the FDA Risk Communication Advisory Committee and the National Research Council (NRC) Committee on Behavioral and Social Science Research to Improve Intelligence Analysis for National Security; he currently co-chairs the NRC Committee on Future Research Goals and Directions for Foundational Science in Cybersecurity. He was a member of the Eugene, Oregon, Commission on the Rights of Women, the Department of Homeland Security Science and Technology Advisory Committee, and the Environmental Protection Agency Scientific Advisory Board, where he chaired the Homeland Security Advisory Committee. He has written or edited several books: Acceptable Risk (1981), A Two-State Solution in the Middle East: Prospects and Possibilities (1993), Preference Elicitation (1999), Risk Communication: The Mental Models Approach (2001), Communicating Risks and Benefits: An Evidence-Based User’s Guide (2011), Intelligence Analysis: Behavioral and Social Science Foundations (2011), Judgment and Decision Making (2011), Risk: A Very Short Introduction (2011), Risk Analysis and Human Behavior (2011), and Counting Civilian Casualties (2013).
Robert Fox, M.D., is Staff Neurologist, Mellen Center for Multiple Sclerosis and Vice-Chair for Research of the Neurological Institute, Cleveland Clinic. He received his M.D. from Johns Hopkins University, neurology training at the University of Pennsylvania, a master’s degree in Clinical Research from Case Western Reserve University, and multiple sclerosis (MS) fellowship training at Cleveland Clinic. Dr. Fox’s current research interests focus on clinical trials in MS, innovative magnetic resonance imaging, techniques to evaluate tissue recovery after injury and the effects of MS treatments, as well as MS patient decision making and tolerance to risk. He serves as an advisor for many clinical trials, including the Principal Investigator of the National Institutes of Health (NIH)-funded Phase II SPRINT-MS trial of ibudilast in progressive MS. In addition, he serves as the Managing Director of the NARCOMS MS Patient Registry, which currently follows more than 13,000 MS patients. Dr. Fox serves as a member of various advisory and review committees for the National MS Society and NIH, the General Advisory Council for the Cleveland Clinic Clinical Research Unit, and the Editorial Board of Neurology and Multiple Sclerosis Journal, and as a consultant to the pharmaceutical industry.
Patrick J. Frey, M.P.P., is the Director of the Office of Program and Strategic Analysis in the CDER at FDA. This office is deeply involved in numerous aspects of CDER’s business, including the implementation and evaluation of significant CDER programs such as the PDUFA, Generic Drugs User
Fee Act (GDUFA), and Biosimilar User Fee Act of 2012 (BsUFA) programs, performance analysis and reporting of the user fee programs, economic analysis with respect to CDER’s external stakeholder environment, lean management approaches to CDER’s regulatory operations, and developing structured approaches to CDER’s regulatory decision making. Before joining CDER, Mr. Frey was a Research Chemist at Merck & Co., Inc., in West Point, Pennsylvania, where he supported various drug development programs from the pre-Investigational New Drug phase through market launch. Mr. Frey received his B.S. in Chemistry from the University of Pittsburgh, and a master’s in Public Policy from the Gerald R. Ford School of Public Policy at the University of Michigan.
Joel Greenhouse, Ph.D., M.P.H., is Professor of Statistics, Carnegie Mellon University, and Adjunct Professor of Psychiatry and Epidemiology at the University of Pittsburgh. He is a Fellow of the American Statistical Association and of the American Association for the Advancement of Science, and an elected Member of the International Statistical Institute. Professor Greenhouse has been a member of the NAS’s Committee on National Statistics, the IOM’s Committee on the Assessment of Family Violence Interventions, and the NRC panel on Statistical Issues for Research in the Combination of Information. He is an editor in chief for the journal Statistics in Medicine, and is a past editor of the Institute of Mathematical Statistics’ Lecture Notes and Monograph Series. His research interests include applied Bayesian methods, methods for the analysis of data from longitudinal and observational studies, and methods for clinical trials. Professor Greenhouse is also interested in issues related to the use of research synthesis in practice, especially as it is used to synthesize evidence for scientific discovery and for making policy.
Tarek A. Hammad, M.D., Ph.D., M.Sc., M.S., FISPE, has recently joined Merck & Co., Inc., as an Executive Director in the Department of Epidemiology. Prior to joining Merck & Co., Inc. he was the Deputy Division Director of FDA’s Division of Epidemiology located in the Office of Surveillance and Epidemiology (OSE) in CDER. In 2000, he joined the Divisions of Neurology and Psychiatry Drug Products in CDER as a drug safety Medical Reviewer and served as an active member of a multidisciplinary team that had overall responsibility for pre- and postmarketing safety evaluation of neurology and psychiatry drugs in the Divisions. Subsequently, in 2004, Dr. Hammad joined OSE as a Senior Medical Epidemiologist to work on large electronic medical records and insurance claims databases assessing postmarketing safety issues. He served as the Analytic Epidemiology Team Leader (2004) and as the Associate Director of Epidemiology (2008) in the same Division. Dr. Hammad has authored
more than 60 peer-reviewed publications and made many presentations in various scientific conferences and other settings. He also holds several academic appointments, spanning various medical disciplines.
Ralph I. Horwitz, M.D., MACP, is Senior Vice President for Clinical Sciences Evaluation at GlaxoSmithKline, and Harold H. Hines, Jr. Professor Emeritus of Medicine and Epidemiology at Yale University. Dr. Horwitz trained in Internal Medicine at institutions (Royal Victoria Hospital of McGill University and the Massachusetts General Hospital) where science and clinical medicine were connected effortlessly. These experiences as a resident unleashed a deep interest in clinical research training, which he pursued as a Fellow in the Robert Wood Johnson Foundation Clinical Scholars Program at Yale under the direction of Alvan R. Feinstein. He joined the Yale faculty in 1978 and remained there for 25 years as Co-Director of the Clinical Scholars Program and later as Chair of the Department of Medicine. Dr. Horwitz’s research has focused on the application of quantitative methods in design and analysis to the strategies of clinical care. Before joining GlaxoSmithKline, Dr. Horwitz was Chair of Medicine at Stanford University and Dean of Case Western Reserve Medical School. He is an elected member of the IOM, the American Society for Clinical Investigation, the American Epidemiological Society, and the Association of American Physicians (he was President in 2010). He was a member of the Advisory Committee to the NIH Director (under both Elias Zerhouni and Francis Collins). He currently serves on the scientific advisory board of IMEDS (Innovation in Medical Evidence Development and Surveillance) of the Reagan-Udall Foundation. Dr. Horwitz served on the American Board of Internal Medicine and was Chair in 2003. He is a Master of the American College of Physicians.
Alice Hughes, M.D., is the Deputy Director for Safety of the Division of Neurology at FDA’s CDER. She oversees the identification, assessment, and management of postmarketing safety issues for drugs for neurological indications. Dr. Hughes joined FDA 11 years ago as a Medical Officer Safety Reviewer and subsequently was the leader of the division’s safety group prior to assuming her current position. She has been extensively involved in the review of, and regulatory actions pertaining to, safety issues associated with (Tysabri) natalizumab, notably PML. She was the safety reviewer for Biogen’s application for resumed marketing of Tysabri subject to a special restricted distribution program, which was approved in 2006. Dr. Hughes received a B.A. from Princeton University and an M.D. from the Mount Sinai School of Medicine prior to completing a residency in Internal Medicine at the Duke University Medical Center. She was a Morris Fishbein Fellow in Medical Editing at the Journal of the
American Medical Association before joining FDA. Dr. Hughes is Board Certified in Internal Medicine by the American Board of Internal Medicine.
Gavin Huntley-Fenner, Ph.D., is a Human Factors and Safety Consultant at Huntley-Fenner Advisors. He has a unique problem-solving skill set and communication style developed over more than 15 years as a researcher, author, educator, and business consultant. He regularly provides consumer product hazard analyses and has served as an expert witness for matters relating to risk perception, instruction manuals, warnings, labeling, safety and human development, human reaction time, and decision making. Dr. Huntley-Fenner is an educator and certified Continuing Legal Education provider, as well as a published author. Dr. Huntley-Fenner’s consulting and forensic projects have involved a wide variety of types of products and situations, including consumer products, professional tools, medical devices, and human behavior in a variety of environments, including homes, schools, workplaces, and daytime and nighttime outdoor contexts. Dr. Huntley-Fenner’s research employs a range of tools, including literature reviews, incident database analyses, statistics, experimental design, hazard and risk analyses, and specific human behavioral research methods such as surveys and human subjects testing. Recent research has focused on the impact of risk perception and design on product safety, an analysis of online consumer reviews for child safety–related content, a review of the effectiveness of auditory and visual warnings at railroad grade crossings, and a study on the impact of environmental signs on perceived risk. Dr. Huntley-Fenner’s peer-reviewed and invited publications include “ANSI Z535.6 and Conspicuity: A Test of the New State of the Art Format for Instructional Manuals” (Proceedings of the Human Factors and Ergonomics Society) and “How will the Searchable Consumer Products Safety Incident Database Improve Product Safety” (Analysis and Perspective, Product Safety and Liability Reporter). Dr. Huntley-Fenner has been invited to speak at national and international scientific and non-scientific gatherings on topics ranging from basic and applied research to forensic consulting and to education. He is a member of the FDA Risk Communication Advisory Committee and he served as a member of California’s Statewide Committee on Autism and Education. Prior to focusing full-time as a human factors consultant, Dr. Huntley-Fenner was a business consultant at McKinsey & Company. He began his professional career as an Assistant Professor at the University of California, Irvine (UCI). While on the UCI faculty, Dr. Huntley-Fenner’s National Science Foundation (NSF)-supported research focused on problem solving, language processing and language development, cognitive development, and normal and abnormal brain development. Since 2005,
Dr. Huntley-Fenner has served as a Governing Board Member of the Irvine Unified School District.
John P. A. Ioannidis, M.D., D.Sc., holds the C. F. Rehnborg Professor in Disease Prevention, Stanford University, and is Professor of Health Research and Policy, and Director of the Stanford Prevention Research Center (SPRC), Stanford University School of Medicine, Professor of Statistics (by courtesy) at Stanford University School of Humanities and Sciences, and Director of the Meta-Research Innovation Center at Stanford (METRICS). From 1999 until 2010, he chaired the Department of Hygiene and Epidemiology at the School of Medicine, University of Ioannina in Greece, as a tenured professor since 2003. He graduated in the top rank of his class from the School of Medicine, University of Athens, in 1990 and also received a doctorate in Biopathology from the same institution. He trained at Harvard and Tufts, specializing in Internal Medicine and Infectious Diseases, and then held positions at NIH, Johns Hopkins University School of Medicine, and Tufts University School of Medicine. He has been Adjunct Professor of Medicine at Tufts, Adjunct Professor of Epidemiology at the Harvard School of Public Health, and Visiting Professor of Epidemiology and Biostatistics at Imperial College London. Dr. Ioannidis is a member of the executive board of the Human Genome Epidemiology Network, senior advisor on knowledge integration at the National Cancer Institute, and has served as President of the Society for Research Synthesis Methodology, and as a member of the editorial boards of 30 leading international journals. He has received several awards, including the European Award for Excellence in Clinical Science for 2007, and was inducted in the Association of American Physicians in 2009 and in the European Academy of Cancer Sciences in 2010.
John Jenkins, M.D., is currently the Director, Office of New Drugs, CDER, FDA. Dr. Jenkins received his undergraduate degree in Biology from East Tennessee State University in 1979 and his M.D. from the University of Tennessee at Memphis in 1983. He completed his postgraduate medical training in internal medicine, pulmonary disease, and critical care medicine at Virginia Commonwealth University/Medical College of Virginia from 1983 until 1988. Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. Following completion of his medical training, Dr. Jenkins joined the faculty of Medical College of Virginia as an Assistant Professor of Pulmonary and Critical Care Medicine and as a Staff Physician at the Hunter Holmes McGuire Veterans Administration Medical Center in Richmond. Dr. Jenkins joined FDA as a Medical Officer in the Division of Oncology and Pulmonary Drug Products in 1992. He subsequently served as Pul-
monary Medical Group Leader and Acting Division Director before being appointed as Director of the newly created Division of Pulmonary Drug Products in 1995. Dr. Jenkins became the Director of the Office of Drug Evaluation II in 1999 and served in that position until he was appointed to his current position in January 2002.
Michaela Kiernan, Ph.D., is a Senior Research Scientist at the SPRC at the Stanford University School of Medicine. She received her Ph.D. in Social/Health Psychology from Yale University. Funded by NIH and the American Heart Association (AHA), Dr. Kiernan’s research focuses on testing behavioral interventions that promote long-term lifestyle changes and weight management among subgroups at risk, as well as developing methodological and statistical approaches that improve the design, delivery, and analysis of randomized clinical trials. The latter includes developing and testing recruitment and retention strategies for ethnic minorities and other underserved subgroups. Dr. Kiernan reviewed for the AHA Western States Affiliate Behavioral Science, Epidemiology, and Prevention Review Committee (2000–2003) and was a standing member of the NIH Psychosocial Risk and Disease Prevention Study Section (2009–2012). In 2002 and 2007, she was awarded the SPRC/Department of Medicine Divisional Teaching Award, and, in 2009, the Stanford University Postdoctoral Association Excellence in Mentoring Award.
Joyce Korvick, M.D., M.P.H., is currently the Deputy Director for Safety in the Division of Gastroenterology and Inborn Error Products, Office of Drug Evaluation III, CDER, FDA. In addition, she has extensive experience as a primary medical reviewer evaluating benefit–risk, having worked in several Divisions within CDER over the past 20 years. In her role as Deputy Director, she was intimately involved in the reintroduction of Lotronex to the market. Over the past several years, she has been involved in numerous benefit–risk assessments for gastroenterological therapies. Dr. Korvick is trained in Internal Medicine, as well as Infectious Diseases. She is a Fellow of the Infectious Diseases Society of America. Previously she worked for the NIH in the Division of AIDS developing the clinical trials for AIDS: ACTG and CPCRA. During that period, she served as a member of the NIH institutional review board. Her academic experience includes Assistant Professor of Medicine at the University of Kentucky, Lexington, where she was the Chair of the Infection Control Board. She has published numerous papers, and has served as a peer reviewer for several medical journals. Dr. Korvick’s extensive clinical trials and regulatory experience gives her a unique perspective on benefit–risk and drug development.
Lisa LaVange, Ph.D., is Director of the Office of Biostatistics in the Office of Translational Sciences, CDER, FDA. She assumed this position in September 2011, and as Director, oversees approximately 170 statistical reviewers and staff members involved in the development and application of statistical methodology for drug regulation. Prior to joining FDA, Dr. LaVange was Professor and Director of the Collaborative Studies Coordinating Center in the Department of Biostatistics, Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. As Center Director, she served as Principal Investigator of the coordinating centers for several large-scale multicenter studies. Before joining academia, Dr. LaVange spent 10 years in the pharmaceutical industry, serving as vice president for a small pharmaceutical company and for a large, global contract research organization. Dr. LaVange is a Fellow of the American Statistical Association and served as President of the Eastern North American Region of the International Biometric Society (2007). She is co-editor of the Journal of Pharmaceutical Statistics and editor in chief of the ASA-SIAM book series. Her research areas include methods for the design and analysis of clinical trials and complex sample survey data. She taught graduate courses at University of North Carolina in the areas of clinical trials, statistical consulting, and statistical leadership.
Robyn Lim, Ph.D., is Senior Science Advisor with the Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada, bringing technical and review-related perspectives to the development of Canada’s modernized drug regulatory system since the project’s inception in late 2005. In this capacity, Dr. Lim developed the benefit–risk–based evidence standard and concepts for market authorization and benefit–harm–uncertainty management for the new Canadian drug regulatory framework and has presented these and related issues at a variety of international meetings since 2007. Prior to joining the modernization team, Dr. Lim was a Health Canada clinical and non-clinical safety and effectiveness reviewer (with the Therapeutic Products Directorate, since 1996) and assessed drug submissions across product lifecycle (clinical trial applications, pre- and postmarket drug submissions) and other drug issues, primarily in the fields of analgesia, anesthesia, neurology, and psychiatry. Dr. Lim has participated on Health Canada intra- and inter-Directorate working groups, such as Good Review Practices (and developed TPD’s Good Review Guiding Principles) and Adaptive Trial Design and at Departmental Expert Advisory Committee meetings. She was also nominated and served on the U.S. Pharmacopeia Neurology Expert Committee (2000–2005). Since 2007, Dr. Lim has participated in a number of international public–private endeavors focused on benefit–risk–uncertainty science. Dr. Lim has received Health Canada Awards
for Excellence in Risk Management (2001) and for Creativity and Innovation (2007) for her review work and as part of the modernization team, respectively. In 2012, Dr. Lim also received an honor from the editors of the Journal of Pharmacoepidemiology and Drug Safety for best peer reviewer performance. Dr. Lim received bachelor’s and master’s degrees from the Biochemistry Department, Queen’s University at Kingston, Ontario, Canada, and a doctorate in Molecular Neurophysiology from the Physiological Laboratory, University of Cambridge, United Kingdom, and Trinity College, Cambridge, United Kingdom.
David R. Mandel, M.Sc., Ph.D., is Senior Scientist, Socio-Cognitive Systems, Defence Research and Development Canada (DRDC), Toronto Research Centre. He earned a B.A. in Psychology from Concordia University and M.A. and Ph.D. in Psychology from University of British Columbia. He was a Social Sciences and Humanities Research Council Postdoctoral Fellow at Stanford University. He held academic positions as a Senior Lecturer at University of Herfordshire and, later, as a tenured Associate Professor at University of Victoria. He is currently a senior defence scientist in the Sensemaking and Decision Group of the Socio-Cognitive Systems Section at DRDC’s Toronto Research Centre. He is also Adjunct Professor of Psychology at York University. His research examines the coherence and accuracy of human judgment and decision making under conditions of uncertainty. He has served as a scientific advisor to such organizations as the NAS, NIH, Office of the Director of National Intelligence, U.S. Department of Defense, and NATO. His books include The Psychology of Counterfactual Thinking and Neuroscience of Decision Making.
Charles F. Manski, Ph.D., has been Board of Trustees Professor in Economics at Northwestern University since 1997. He previously was a faculty member at the University of Wisconsin–Madison, the Hebrew University of Jerusalem, and Carnegie Mellon University. He received his B.S. and Ph.D. in Economics from Massachusetts Institute of Technology in 1970 and 1973. Dr. Manski’s research spans econometrics, judgement and decision, and the analysis of social policy. He is author of Public Policy in an Uncertain World (Harvard, 2013), Identification for Prediction and Decision (Harvard, 2007), Social Choice with Partial Knowledge of Treatment Response (Princeton, 2005), Partial Identification of Probability Distributions (Springer, 2003), Identification Problems in the Social Sciences (Harvard, 1995), and Analog Estimation Methods in Econometrics (Chapman & Hall, 1988); co-author of College Choice in America (Harvard, 1983); and co-editor of Evaluating Welfare and Training Programs (Harvard, 1992) and Structural Analysis of Discrete Data with Econometric Applications (MIT, 1981). He has served as
Director of the Institute for Research on Poverty and as Chair of the Board of Overseers of the Panel Study of Income Dynamics. Editorial service includes terms as editor of the Journal of Human Resources, co-editor of the Econometric Society Monograph Series, member of the Editorial Board of the Annual Review of Economics, and associate editor of the Annals of Applied Statistics, Econometrica, Journal of Economic Perspectives, Journal of the American Statistical Association, and Transportation Science. Service at the NRC includes being Chair of the Committee on Data and Research for Policy on Illegal Drugs and a member of the Report Review Committee, the Committee on Law and Justice, the Board on Mathematical Sciences and their Applications, the Committee on National Statistics, and the Commission on Behavioral and Social Sciences and Education. Dr. Manski is an elected member of the NAS, and an elected Fellow of the Econometric Society, the American Academy of Arts and Sciences, and the American Association for the Advancement of Science.
Kimberly McCleary is Director of Strategic Initiatives at FasterCures, a center of the Milken Institute determined to remove barriers to medical progress. At FasterCures, Ms. McCleary leads the charge on key programmatic areas, including FDA and how it evaluates risk and benefit for patients, and medical innovation and how we determine value and reimbursement. Prior to joining FasterCures’ staff, she was President and CEO of the CFIDS Association of America from 1991 to 2013. She earned a reputation as an articulate patient advocate, a keen policy strategist, a diplomatic bridge builder, and a dedicated servant leader. She has worked with leaders throughout the executive and legislative branches to develop, implement, and oversee effective policy. Ms. McCleary helped found the Chronic Pain Research Alliance and joined with other leaders and Pfizer to establish the Campaign to End Women’s Pain in 2010. She led the Partnering to End Pain project selected by Sanofi U.S. as a finalist in the 2012 Collaborate/Activate Innovation Challenge. She has participated in every opportunity organized by FDA to shape its Patient-Focused Drug Development Initiative (PFDDI), including a range of consultations leading up the first of the 20 PFDDI workshops focused on chronic fatigue syndrome and myalgic encephalopathy held in April 2013. With leaders in the narcolepsy community, Ms. McCleary helped design and launch the Unite Narcolepsy initiative to educate, engage, and empower narcolepsy patients and their advocates to participate effectively in the PFDDI meeting held in September 2013. She is a graduate of the University of North Carolina at Chapel Hill.
Timothy McDaniels, Ph.D., M.A., is Professor, Faculty of Science, Institute of Resources and Environment, University of British Columbia. Dr.
McDaniels received his Ph.D. from Carnegie Mellon University. He is a specialist in decision sciences and policy analysis, particularly in managing environmental and technology-related societal risks. His current research focuses on climate change adaptation in linked human/ecological systems. Dr. McDaniels is a professor appointed in two graduate interdisciplinary programs at the University of British Columbia. He served as the Director of the Institute for Resources, Environment and Sustainability, and also as the interim Principal of the College for Interdisciplinary Studies. He also has served on expert panels for the NAS, NOAA, the Environmental Protection Agency, Health Canada, and other organizations. He has participated in advisory roles for several Canadian inquiries and panels regarding risk issues. He was a co-investigator in the Climate and Energy Decision Making Center at Carnegie Mellon University in Pittsburgh. In 2008, he was appointed to the NAS Committee on the Human Dimensions of Global Change. He served as the Decision Sciences area editor of the journal Risk Analysis for 8 years, and is a Fellow of the Society for Risk Analysis.
M. Granger Morgan, Ph.D., M.S., is Professor and Head of the Department of Engineering and Public Policy, Carnegie Mellon University, where he is also University and Lord Chair Professor in Engineering. In addition, he holds academic appointments in the Department of Electrical and Computer Engineering and in the H. John Heinz III College. His research addresses problems in science, technology, and public policy, with a particular focus on energy, environmental systems, climate change, and risk analysis. Much of his work has involved the development and demonstration of methods to characterize and treat uncertainty in quantitative policy analysis. At Carnegie Mellon, Dr. Morgan directs the NSF Center for Climate and Energy Decision Making (www.cedmcenter.org). He is also Director of the campus-wide Wilton E. Scott Institute for Energy Innovation (www.cmu.edu/energy). Dr. Morgan serves as Chair of the Scientific and Technical Council for the International Risk Governance Council. He is a Member of the NAS, and a Fellow of the American Association for the Advancement of Science, the Institute of Electrical and Electronics Engineers, and the Society for Risk Analysis. He holds a B.A. from Harvard College, where he concentrated in Physics, an M.S. in Astronomy and Space Science from Cornell University, and a Ph.D. from the Department of Applied Physics and Information Sciences at the University of California, San Diego.
Theresa Mullin, Ph.D., is Director, Office of Strategic Programs, CDER, FDA. As Director of the CDER Office of Strategic Programs, Dr. Mullin
leads CDER strategic planning and directs the CDER international program, business informatics, drug data standards, and program and strategic analysis. This includes leading FDA development of a drug benefit–risk assessment framework, and Patient-Focused Drug Development initiative. In addition, Dr. Mullin heads the FDA delegation to International Conference on Harmonization (ICH), leading the U.S. discussion of the future of ICH. She served as the FDA lead negotiator for the 2012 reauthorization of the PDUFA providing an estimated $700 million in annual fee revenues. She also served as lead negotiator for new user fees for biosimilar biological products authorized under the Biologics Price Competition and Innovation Act of 2009. Prior to joining CDER in 2007, Dr. Mullin was Assistant Commissioner for Planning in the FDA Office of Commissioner, where she led FDA user fee negotiations with the pharmaceutical industry for both the 2007 and the 2002 reauthorizations of PDUFA. Since joining FDA, Dr. Mullin has received a number of awards, including the Senior Executive Service Presidential Rank Award for Distinguished Service in 2011 and Presidential Rank Award for Meritorious Service in 2006, as well as the FDA Commissioner’s Award of Excellence. Prior to work at FDA, Dr. Mullin was a Senior Manager with The Lewin Group, specializing in health care consulting, and Principal Scientist at Decision Science Consortium, specializing in decision research and analysis. Dr. Mullin received her B.A. magna cum laude in Economics from Boston College and Ph.D. in Public Policy Analysis from Carnegie Mellon University.
Mary H. Parks, M.D., is currently the Deputy Director in the Office of Drug Evaluation II, Office of New Drugs, CDER, FDA, which oversees therapies developed in the Division of Metabolism and Endocrinology Products, Division of Anesthesia, Analgesia, and Addiction Products, and Division of Pulmonary, Allergy, and Rheumatology Products. Dr. Parks is a board-certified endocrinologist and internist and received her medical training and degree from Tufts University Medical School and Georgetown University School and Medical Center. She joined FDA as a Medical Officer in 1998 in the Division of Metabolism and Endocrinology Products, where she served as Division Director from 2006 through 2013.
Francesco Pignatti, M.D., is Head of Oncology, Hematology, Diagnostics Section, Scientific and Regulatory Management Department, Human Medicines Evaluation Division, EMA. Dr. Pignatti earned his M.D. at the University of Rome La Sapienza. In 1995 he became Research Fellow at the EORTC Data Center, Brussels, Belgium, where he was involved in numerous activities, including clinical trial design, conduct, analysis, and reporting. In 1997 he became Medical Advisor for the Gastrointestinal
Tract Cancer Cooperative Group and Brain Tumor Cooperative Group. In 1997 he obtained an M.S. in Biostatistics from the University of Limbourg, Belgium. In 1999 he joined the EMA in London. Since 2009, he has held the position of Head of Oncology, Haematology, and Diagnostics in the Human Medicines Evaluation Division.
Jennifer R. Pippins, M.D., M.P.H., is a Medical Officer in the Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, CDER, FDA. Dr. Pippins attended Harvard College and Harvard Medical School, and completed a combined internal medicine–pediatrics internship and residency at the Harvard Combined Med/Peds Program. After completing residency, she was a General Internal Medicine Research Fellow at Brigham and Women’s Hospital, where she focused on health disparities. She left Boston and relocated in the Washington, DC, area, first as an AcademyHealth Health Policy Fellow at the National Center for Health Statistics, and subsequently as a Medical Officer with FDA, in what is now the Division of Pulmonary, Allergy, and Rheumatology Drugs within FDA’s CDER/Office of New Drugs.
Robert E. Ratner, M.D., FACP, FACE, is Chief Scientific and Medical Officer for the American Diabetes Association, where he provides leadership and oversight of scientific and medical activities, including research, clinical affairs, program recognition and certification, medical information, and professional education. In this capacity, he oversees the Association’s support of a broad range of professional education activities and the development of the Association’s Clinical Practice Recommendations, clinical consensus reports, and expert opinions. Prior to joining the American Diabetes Association, Dr. Ratner was a Professor of Medicine at Georgetown University Medical School and Senior Research Scientist at the MedStar Health Research Institute in Washington, DC. In 2012 he completed a sabbatical as a Robert Wood Johnson Foundation Health Policy Fellow, having served as the study director for the IOM Comparative Effectiveness Research Priorities Committee, and as a program examiner for health reform in the Health Division of the U.S. Office of Management and Budget. He received his M.D. from Baylor College of Medicine, where he also completed his Internal Medicine training. He underwent Fellowship training in Endocrinology and Metabolism at Harvard Medical School and the Joslin Diabetes Center in Boston. Dr. Ratner recently completed 6 years of service on the Steering Committee of the National Diabetes Education Program, representing the American Diabetes Association. He has served on the Board of Directors of the National Certification Board for Diabetes Education and the American Association of Dia-
betes Educators, and is past President of the Washington Area Affiliate of the American Diabetes Association. His research interests include diabetes therapeutics and complications, with an emphasis on translational efforts from controlled trials into community-based practice. He is the author of more than 120 original scientific articles and 20 book chapters.
Sebastian Schneeweiss, M.D., Sc.D., is Professor of Medicine and Epidemiology at Harvard Medical School and Vice Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics of the Department of Medicine, Brigham and Women’s Hospital. He is Principal Investigator (PI) of the Harvard-Brigham Drug Safety Research Center funded by FDA/CDER, and Methods Lead of the FDA Mini-Sentinel program. His research is funded by multiple grants from NIH, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, and FDA and focuses on the comparative effectiveness and safety of biopharmaceuticals and analytic methods to improve the validity of epidemiologic studies using complex health care databases, particularly for newly marketed medical products. His work is published in high-ranking journals. Dr. Schneeweiss is past President of the International Society for Pharmacoepidemiology and is Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology. He is voting consultant to the FDA Drug Safety and Risk Management Advisory Committee and member of the Methods Committee of the Patient-Centered Outcomes Research Institute. He received his medical training at the University of Munich Medical School and his doctoral degree in Pharmacoepidemiology from Harvard University.
Lisa M. Schwartz, M.D., M.S., is Professor, Departments of Medicine and Community & Family Medicine, Dartmouth Medical School, and Co-Director, Center for Medicine and the Media, at The Dartmouth Institute for Health Policy and Clinical Practice. Dr. Schwartz graduated from New York University School of Medicine and completed internal medicine residency at the New York University/Bellevue Hospital program in New York City. She received an M.S. at the Center for the Evaluative Clinical Sciences at Dartmouth. She is the Co-Director of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice, and former co-Director of the VA Outcomes Group (White River Junction, Vermont). Together with Dr. Steven Woloshin, she has worked to improve communication of medical evidence to physicians, journalists, and the public (specifically focusing on screening, prescription drugs, and statistics). She is a co-author of two books: Know Your Chances and Overdi-
agnosed; she is an occasional columnist for the British Medical Journal, and her essays have appeared in The New York Times and The Washington Post.
Paul J. Seligman, M.D., M.P.H., is currently Executive Director for U.S. Regulatory Policy at Amgen Inc. Prior to joining Amgen in 2012, he had a public health career of nearly 30 years in the federal government. At FDA he served as the Director of FDA’s Latin America Regional Office, as Associate Director for Safety Policy and Communication in CDER, and as the Director of the Office of Pharmacoepidemiology and Statistical Science. Before joining FDA in July 2001, Dr. Seligman served for 7 years as the Deputy Assistant Secretary for Health Studies at the U.S. Department of Energy. He began his Public Health Service (PHS) career in 1983 at the Centers for Disease Control and Prevention (CDC) as an Epidemic Intelligence Service Officer. He completed a primary care internal medicine residency at The Cambridge Hospital in Cambridge, Massachusetts, prior to joining CDC. From 1974 to 1976, he was a Peace Corps volunteer in Kenya. Dr. Seligman holds an M.D. from the University of California, Davis, an M.P.H. in Industrial Health from the University of Michigan, and a B.S. in Chemistry from Yale University. He is Board Certified in Internal Medicine, Occupational Medicine, and Public Health, and General Preventive Medicine. He is a retired Commissioned Officer from PHS, having attained the rank of Rear Admiral.
Cynthia Sitcov is a Patient Representative & Voting Member of the FDA Central and Peripheral Systems Advisory Committee. Ms. Sitcov attended the State University of New York at Buffalo. She is an executive recruiter specializing in attorney recruitment. She was diagnosed with MS in 1975. For the past 5 years, she has served as a patient representative on FDA’s Peripheral and Central Nervous System Advisory Committee as a voting member. The committees she has participated in include the review of the following MS drugs: Tysabri, Gilenya, Ampyra, and most recently Lemtrada. She has appeared on panels for the National MS Society, NAS, and FDA.
Brian L. Strom, M.D., M.P.H., is the recently appointed Inaugural Chancellor of Rutgers Biomedical and Health Sciences (RBHS) and the Executive Vice President for Health Affairs at Rutgers University. RBHS has nine schools and five centers/institutes, and includes academic, patient care, and research facilities. These are most of the units of the former University of Medicine and Dentistry of New Jersey (UMDNJ), now dissolved, several Rutgers University units with health-related missions, and two research units historically co-managed by Rutgers and UMDNJ. The integration of these entities is designed to create a single organization that
will lead to new models for clinical care and community service, educate the next generation of health care providers using health care team approaches, and conduct research. Dr. Strom was formerly the Executive Vice Dean of Institutional Affairs, Founding Chair of the Department of Biostatistics and Epidemiology, Founding Director of the Center for Clinical Epidemiology and Biostatistics, and Founding Director of the Graduate Program in Epidemiology and Biostatistics, all at the Perelman School of Medicine of the University of Pennsylvania (Penn). Dr. Strom earned a B.S. in Molecular Biophysics and Biochemistry from Yale University and an M.D. from the Johns Hopkins University School of Medicine in 1975. He was an intern and resident in Internal Medicine and an NIH Fellow in Clinical Pharmacology at the University of California, San Francisco. He simultaneously earned an M.P.H. in Epidemiology at the University of California, Berkeley. He has been on the faculty of the Penn School of Medicine since 1980. The Center for Clinical Epidemiology and Biostatistics (CCEB) that he created at Penn includes more than 550 faculty, research and support staff, and trainees. At the time Dr. Strom stepped down, CCEB research received nearly $49 million/year in extramural support. Its total budget was approximately $67 million. Although Dr. Strom’s interests span many areas of clinical epidemiology, his major research interest is in the field of pharmacoepidemiology, that is, the application of epidemiologic methods to the study of drug use and effects. He is recognized as a founder of this field and for his pioneer work in using large automated databases for research. He is editor of the field’s major text (now in its fifth edition) and editor in chief for Pharmacoepidemiology and Drug Safety, the official journal of the International Society for Pharmacoepidemiology. As one of many specific contributions, his research was pivotal in prompting the American Heart Association and American Dental Association to reverse 50 years of guidelines, and recommend against use of antibiotics to prevent infective endocarditis, instead of recommending for this widespread practice. In addition to writing more than 580 papers, and 14 books, he has been PI for more than 275 grants, including more than $115 million in direct costs alone. Dr. Strom has been invited to give more than 400 talks outside his local area, including presentations as the keynote speaker for numerous international meetings. He has been a consultant to NIH, FDA, CDC, U.S. Pharmacopeia, Association of American Medical Colleges, Joint Commission on the Accreditation of Healthcare Organizations, foreign governments, most major pharmaceutical manufacturers, and many law firms. Dr. Strom is also a nationally recognized leader in clinical research training. At the Perelman School of Medicine, Dr. Strom developed graduate training programs in epidemiology and biostatistics. More than 625 clinicians have been trained or are in training through the largest of these training programs, which leads to a Master of
Science in Clinical Epidemiology degree. All but approximately 65 former trainees in this program have appointments in academic or other research institutions. Dr. Strom was PI or Co-PI of 11 different NIH-funded clinical epidemiology trainees. The NIH training grants (T32, D43, K12, and K30) supported the clinical epidemiology trainees in many different specialties and subspecialties. Dr. Strom has also been the primary mentor for more than 40 clinical research trainees, former and current, and numerous junior faculty members. Internationally, Dr. Strom was a key contributor to the conceptualization and planning that led to the development of the International Clinical Epidemiology Network (INCLEN), created in 1979 with support provided by the Rockefeller Foundation to provide clinical research training to clinicians from selected developing country sites. Penn was an INCLEN founding member and one of five training centers. INCLEN Phase I, from 1979 through 1995, resulted in the establishment of 26 clinical epidemiology units in Africa, India, Latin America, and Southeast Asia. The Penn training program alone, led by Dr. Strom, trained 63 INCLEN trainees. Dr. Strom was a member of the Board of Regents of the American College of Physicians, the Board of Directors of the American Society for Clinical Pharmacology and Therapeutics, and the Board of Directors for the American College of Epidemiology, and is currently a member of the Board of Directors for the Association for Patient-Oriented Research. He was previously President of the International Society for Pharmacoepidemiology and the Association for Clinical Research Training. Dr. Strom was on the Drug Utilization Review Committee and the Gerontology Committee of the U.S. Pharmacopoeia, served on the Drug Safety and Risk Management Advisory Committee for FDA, chaired the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, chaired the IOM Committee on Smallpox Vaccine Program Implementation, chaired the IOM Committee to Review NIOSH’s Traumatic Injury Program, chaired the IOM Committee on the Consequences of Reducing Sodium in the Population, was a member of the IOM Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program, and was a member of the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Dr. Strom is a member of the American Epidemiology Society, and is one of a handful of clinical epidemiologists ever elected to the American Society of Clinical Investigation and American Association of Physicians. He has also been an elected member of the IOM of the NAS since 2001. Dr. Strom received the 2003 Rawls-Palmer Progress in Medicine Award from the American Society for Clinical Pharmacology and Therapeutics, the Naomi M. Kanof Clinical Investigator Award of the Society for Investigative Dermatology, the George S. Pepper Professorship of Public Health and Preventive Medicine, and in 2006 he received the Sustained Scientific Excellence Award
from the International Society for Pharmacoepidemiology. In addition, Dr. Strom was named the 2008 recipient of the John Phillips Memorial Award for Outstanding Work in Clinical Medicine. This award is from the American College of Physicians (ACP) and is considered to be one of the highest awards in Internal Medicine. Dr. Strom also received the 2013 Association for Clinical and Translational Science/American Federation for Medical Research National Award for Career Achievement and Contribution to Clinical and Translational Science for translation from clinical use into public benefit and policy. Penn awards that Dr. Strom received include the Class of 1992 Class Teaching Award and the Samuel Martin Health Evaluation Sciences Research Award. Dr. Strom received the 2004 Christian R. and Mary F. Lindback Award, the university’s most prestigious teaching award, in recognition of the contribution he has made in his career to clinical research teaching.
Robert Temple, M.D., is Deputy Director for Clinical Science and Acting Deputy Director, Office of Drug Evaluation I, CDRE, FDA. Dr. Temple received his M.D. from the New York University School of Medicine. In 1972, he joined CDER as a review Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products. In his current position, Dr. Temple oversees ODE-1, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. Dr. Temple has a longstanding interest in the design and conduct of clinical trials and has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose–response, and trials using “enrichment” designs. He also has a longstanding interest in hepatotoxicity of drugs, having participated in the first detailed FDA–NIH-outside discussion of the subject in 1978.
Steven Woloshin, M.D., M.S., is Professor, Departments of Medicine and Community & Family Medicine, Dartmouth Medical School, and Co-Director, Center for Medicine and the Media, at The Dartmouth Institute for Health Policy and Clinical Practice. Dr. Woloshin graduated from Boston University School of Medicine and completed an internal medicine residency at the New York University/Bellevue Hospital program in New York City. He received an M.S. at the Center for the Evaluative Clinical Sciences at Dartmouth. He is the Co-Director of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice, and former Co-Director of the VA Outcomes Group (White River Junction, Vermont). Together with Dr. Lisa M. Schwartz, he has worked to improve communication of medical evidence to physicians, journalists,
and the public (specifically focusing on screening, prescription drugs, and statistics). He is a co-author of two books: Know Your Chances and Overdi agnosed; he is an occasional columnist for the British Medical Journal, and his essays have appeared in The New York Times and The Washington Post.
Janet Woodcock, M.D., is Director, CDER, FDA. Dr. Woodcock joined FDA in 1986, assuming the leadership of CDER in May 1994. Prior to joining CDER, she served as Acting Deputy Center Director of the Center for Biologics Evaluation and Research (1990–1992) and Director of the Office of Therapeutics Research and Review (1992–1994), where she oversaw approval of the first biotechnology-based treatments for MS and cystic fibrosis. From 2004 to 2008, Dr. Woodcock provided support to FDA’s Commissioner, serving as Deputy Commissioner for Operations and Chief Medical Officer. During her tenure at FDA, Dr. Woodcock’s achievements have been substantial. Under her leadership, CDER has streamlined review processes for new and generic drugs while improving standards for quality, safety, and effectiveness. The submission of marketing applications and adverse events reports and the review of submissions in FDA have been transitioned to electronic formats. CDER’s regulatory decision-making processes have also been streamlined, making decisions more open and transparent. CDER’s regulatory procedures and policies are publicly available—scores of technical guidances describing FDA’s thinking on regulatory standards have been issued. Many CDER processes are carried out with an unprecedented degree of participation on the part of consumer and patient representatives. An extensive CDER website hosts a myriad of helpful information on drug approvals, safety issues, and other critical information targeting consumers, patients, health care practitioners, regulated industry, and other audiences. Highlights of selected recent accomplishments include negotiations of the 2012 GDUFA, which will speed access to safe and effective generic drugs to the public and reduce costs to industry, and the PDUFA V to support timely evaluation and approval of new drugs. PDUFA V has a particular emphasis on patient-focused drug development. In 2011 and 2012, Dr. Woodcock launched multiple efforts to support development of new therapies for rare and neglected diseases and new antibacterial therapies. She oversaw the implementation of innovative policies to foster adaptive trial designs (2010) and trial enrichment strategies (2012) and encouraged the qualification of new drug development tools (2010) to help speed drug development and evaluation. Following enactment in March 2010 of the Patient Protection and Affordable Care Act (Affordable Care Act), Dr. Woodcock developed and launched the biosimilars effort to create an abbreviated licensure pathway for biological products, then worked on negotiating the BsUFA to support approval using this new pathway.
Dr. Woodcock continues to lead FDA’s Pharmaceutical Quality for the 21st Century initiative, to modernize pharmaceutical manufacturing, and the Safe Use/Safety First initiatives, which are critical to managing drug safety throughout the drug lifecycle and ensuring frequent and clear communications to the public about the risks and benefits of drugs. As Acting Deputy Commissioner for Operations, in 2004, Dr. Woodcock led the Critical Path Initiative, which continues to encourage and foster the development of new and better tools to support medical product research so that drug, device, and biologics development is more predictable and more informative. As Deputy Commissioner and Chief Medical Officer, Dr. Woodcock launched the Sentinel Initiative with the goal of building a new active surveillance system to augment FDA’s existing adverse events monitoring systems. The resulting Mini-Sentinel pilot program, now used to assess safety signals, can access data on more than 130,000 people. As Director of CDER, Dr. Woodcock maintains contact with a variety of diverse constituencies, including the clinical and scientific communities, members of Congress and the administration, the national media, patient and consumer advocacy groups, the international drug regulatory community, regulated industry, and representatives of federal and state agencies. She frequently appears in or is quoted by the national media and has testified repeatedly before Congress. Dr. Woodcock has earned numerous awards, most recently, the Arthritis Foundation’s Floyd B. Odlum Making a Difference Award and the Luminary Award from the Personalized Medicine World Conference. She has been the recipient of the Presidential Rank Meritorious Executive Award and three Health and Human Services Secretary’s Distinguished Service Awards, among many others. She has authored more than 60 publications. Dr. Woodcock received her M.D. from Northwestern University Medical School, following an undergraduate degree in Chemistry from Bucknell University.
Deborah A. Zarin, M.D., is Director, ClinicalTrials.gov, National Library of Medicine, NIH. In this capacity, Dr. Zarin oversees the development and operation of an international registry and results reporting system for clinical trials, and the corresponding implementation of legal and other trial reporting policies. Dr. Zarin’s recent research has been on the quality of trial reporting, as well as issues in the design and analysis of clinical trials. Previous positions held by Dr. Zarin include the Director, Technology Assessment Program, at the Agency for Healthcare Research and Quality, and the Director of the Practice Guidelines program at the American Psychiatric Association. In these positions, Dr. Zarin conducted systematic reviews and related analyses in support of evidence-based clinical and policy recommendations. Dr. Zarin’s academic interests are in the area of evidence-based clinical and policy decision making, as
well as clinical trial conduct, analysis, and reporting. She is the author of more than 70 peer-reviewed articles. Dr. Zarin graduated from Stanford University and received her doctorate in medicine from Harvard Medical School. She completed a clinical decision-making fellowship, a pediatric internship, and is Board Certified in General Psychiatry, as well as in Child and Adolescent Psychiatry.
