Appendix D

Biosketches

COMMITTEE MEMBERS

Donald R. Mattison, M.D. (Chair), was appointed Chief Medical Officer of Risk Sciences International in 2012. Dr. Mattison also serves as Associate Director of the McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa, Research Fellow of the International Prevention Research Institute, and member of the QuarterWatch Team, Institute for Safe Medication Practice. He has held academic, clinical, and research appointments, including Senior Advisor to the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Medical Director of the March of Dimes, Dean of the Graduate School of Public Health at the University of Pittsburgh, Professor of Obstetrics and Gynecology and Interdisciplinary Toxicology at the University of Arkansas for Medical Sciences, and Director of Human Risk Assessment at the U.S. Food and Drug Administration National Center for Toxicological Research. Dr. Mattison earned a B.A. (chemistry and mathematics) from Augsburg College in Minneapolis, Minnesota; an M.S. (chemistry) from the Massachusetts Institute of Technology in Cambridge, Massachusetts; and an M.D. from the Vagelos College of Physicians and Surgeons, Columbia University, New York. His clinical training in Obstetrics and Gynecology was at the Sloane Hospital for Women in the Columbia Presbyterian Medical Center in New York. His training in pharmacology and toxicology was at the National Institutes of Health in Bethesda, Maryland. He has published more than 250 peer-reviewed publications, as well as edited more than 10 monographs and books. In 1997, he was elected a Fellow of the American Association for the

Advancement of Science; in 1999, a Fellow of The New York Academy of Medicine; and in 2000, a member of the National Academy of Medicine. In 2005 he became a Distinguished Alumni of Augsburg College and in 2009 a Fellow of the Royal Society of Medicine.

Ruth M. Parker, M.D. (Vice Chair), is Professor of Medicine and Pediatrics at the Emory University School of Medicine and holds a secondary appointment at the Emory University School of Public Health in the Division of Epidemiology. Dr. Parker’s primary research interests and activities have been in the area of medical education and health services of underserved populations. She has been actively involved in medical education and faculty development since joining the medical school faculty. For more than two decades, Dr. Parker has focused extensively on health care issues of underserved populations, particularly health literacy. She was a principal investigator in the Robert Wood Johnson Foundation Literacy in Health Study and helped create a widely used measurement tool to quantify patients’ ability to read and understand health information (TOFHLA, the Test Of Functional Health Literacy in Adults). She has authored numerous papers on health literacy and co-edited the complete bibliography of medicine on health literacy for the National Library of Medicine. She coauthored the most widely used definition of health literacy, which was used in Healthy People 2010 and Healthy People 2020 and is currently used by the National Academies and by the National Institutes of Health. Dr. Parker currently serves as consultant and advisor to numerous federal agencies, professional societies, and members of industry on their initiatives related to health literacy. Dr. Parker attended Davidson College and received her medical training at the University of North Carolina at Chapel Hill. She completed her residency and chief residency at the Strong Memorial Hospital in Rochester, New York, and her fellowship as a Robert Wood Johnson Foundation Clinical Scholar at the University of Pennsylvania. She holds board certification in both internal medicine and pediatrics.

Lesley H. Curtis, Ph.D., is Professor and Chair of Population Health Sciences and Interim Director of the Duke Clinical Research Institute at Duke University. Dr. Curtis is a health services researcher who oversees a portfolio of projects that use observational data to address questions related to clinical and comparative effectiveness, pharmacoepidemiology, health care delivery, and epidemiological trends across a broad array of clinical conditions and clinical care settings. The Duke Clinical Research Institute has a number of professional connections with pharmaceutical companies, but it has not conducted trials on bioidentical hormone replacement therapy products. An expert in the use of Medicare claims data for health services and clinical outcomes research, she has led the linkage of Medicare claims

with several large clinical registries and epidemiological cohort studies including the Framingham Heart Study and the Cardiovascular Health Study. She leads the Distributed Research Network Operations Center for the Patient-Centered Outcomes Research Institute’s National Clinical Research Network (PCORnet), working with health systems and patient networks to develop a harmonized data infrastructure for robust observational and interventional research.

Susan S. Ellenberg, Ph.D., is Professor of Biostatistics, Medical Ethics, and Health Policy at the University of Pennsylvania Perelman School of Medicine. Prior to joining Penn in 2004, Dr. Ellenberg held leadership positions at the National Institutes of Health and the U.S. Food and Drug Administration (FDA). Due to her appointment to FDA’s Endocrinologic and Metabolic Advisory Committee, Dr. Ellenberg holds a Special Government Employee status. Her research interests have focused on issues in the design, conduct, and analysis of clinical trials, and on assessment of medical product safety. Particular areas of interest include efficient trial designs, interim monitoring, and the operation of data monitoring committees, evaluation of surrogate endpoints, ethical issues in clinical research, and special issues in trials of cancer and AIDS therapies, and of vaccines. In her work, Dr. Ellenberg works closely with several pharmaceutical companies, including Merck, Bristol-Myers Squibb, and Marinus Pharmaceuticals. She is Associate Editor of Clinical Trials and the Journal of the National Cancer Institute. Dr. Ellenberg is a Fellow of the American Statistical Association, the American Association for the Advancement of Science (AAAS), and the Society for Clinical Trials, and an elected member of the International Statistical Institute. She has served as President of the Society for Clinical Trials and the Eastern North American Region of the International Biometric Society, and has chaired the Statistics Section of AAAS and the Board of Trustees for the National Institute of Statistical Sciences. The second edition of her book on clinical trials data monitoring committees, co-authored with Thomas Fleming (University of Washington) and David DeMets (University of Wisconsin), released in January 2019.

Jennifer Fishman, Ph.D., is Associate Professor in the Biomedical Ethics Unit and the Department of the Social Studies of Medicine at McGill University. Dr. Fishman is a sociologist of science, technology, and medicine. She uses empirical qualitative methods to describe and analyze the emergence of new medical knowledge and technologies, from the early stages of development to their integration into clinical practice and dissemination to clinicians and patients. Often referred to as “empirical ethics,” she analyzes the oft unexamined and presumptive ethics and values within new scientific enterprises and how these affect research trajectories, technological

diffusion and commercialization, and ultimately patients and consumers. She has studied new pharmaceutical drug development and advertising, antiaging science and medicine, direct-to-consumer genetic risk susceptibility testing, end-of-life medical decisions, prenatal genetic carrier testing panels, and the promise of personalized genomic medicine. In 2015, she coauthored the academic paper titled “Bioidentical Hormones, Menopausal Women, and the Lure of the ‘Natural’ in US Antiaging Medicine.” Dr. Fishman received her Ph.D. in sociology at the University of California, San Francisco, and her B.A. at the University of California, Berkeley.

Adel H. Karara, Ph.D., FCP, is Professor of Pharmaceutical Sciences at University of Maryland, Eastern Shore (UMES), where he teaches in the areas of pharmaceutics, biopharmaceutics, and pharmacokinetics. Prior to joining UMES, he held senior positions in the pharmaceutical industry. His research had been primarily in the female health care area working on the pharmacokinetics/dynamics of combination hormone treatments. As Senior Clinical Pharmacologist at Roche, he had the responsibility for guiding the selection of early drug discovery compounds, due diligence projects, and design of clinical pharmacology development programs for several metabolic drug candidates. Before joining Roche, he was Director at Berlex where he provided new drug application support for Yasmin, ClimaraPro, Menostar, and Angeliq. At Novartis, he provided support for Starlix, Lescol, and Neoral. Within these positions, Dr. Karara was largely responsible for the clinical pharmacological characterization of hormone products in clinical trials (specifically oral contraceptive/birth control products), data interpretation, and quality support. Dr. Karara was a tenured faculty at the University of Louisiana where he mentored three Ph.D. and two M.S. students and won the Researcher of the Year award. Dr. Karara is a charter member of the American Association of Pharmaceutical Scientists (AAPS), participated in teaching short courses, and served on abstract screening committees. Dr. Karara was elected to serve as Chair of the Clinical Pharmacology and Translational Medicine Section of AAPS. He has 39 peer-reviewed publications and was invited speaker at several clinical pharmacology forums. He served on Pharmaceutical Research and Manufacturers of America, Clinical Pharmacology Technical Group, where he led the exploratory Investigational New Drug survey initiative. Dr. Karara currently serves on the U.S. Food and Drug Administration Pharmaceutical Science and Clinical Pharmacology Advisory Committee for oncology drugs. Dr. Karara is a Fellow of the American College of Clinical Pharmacology and serves on the editorial board of the Journal of Clinical Pharmacology.

Aaron S. Kesselheim, M.D., J.D., M.P.H., is Professor of Medicine at the Harvard Medical School (HMS) and a faculty member in the Division

of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital (BWH). He is board certified in internal medicine, and serves as a primary care physician at the Phyllis Jen Center for Primary Care at BWH. Within the division, Dr. Kesselheim created and leads the Program on Regulation, Therapeutics, And Law, an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. His research has concentrated on the interaction of law and public health related to drug discovery, testing, and regulatory approval, using a combination of quantitative and qualitative research tools and normative study. As the author of more than 350 publications in the peer-reviewed medical and health policy literatures, Dr. Kesselheim was recently recognized as the second most-cited health law scholar in Web of Science from 2013 to 2017. He has testified before Congress a half-dozen times on pharmaceutical policy, medical device regulation, generic drugs, and modernizing clinical trials; is a member of the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Advisory Committee; and served on a National Academies of Sciences, Engineering, and Medicine consensus study committee on addressing the opioid epidemic. Dr. Kesselheim is a core faculty member at the HMS Center for Bioethics, where he co-teaches a course on health policy, law, and bioethics and organizes a popular monthly policy and ethics seminar series. Dr. Kesselheim also serves as the Irving S. Ribicoff Visiting Associate Professor of Law at Yale Law School, where he teaches a yearly course on FDA law. He serves on the Perspectives Advisory Board of the New England Journal of Medicine and is Editor-in-Chief of the Journal of Law, Medicine & Ethics.

Robert B. MacArthur, Pharm.D., M.S., is currently Pharmacy Director at The Rockefeller University Hospital, and a member of the Hospital Senior Staff, Institutional Review Board, and Clinical Translational Science Review Committee. He is also President of Orphan Drug Services, Inc., which provides drug development and statistics services to pharmaceutical companies and academic researchers. For more than 30 years Dr. MacArthur has been continuously engaged in the fields of commercial drug development, clinical research, and research/hospital pharmacy practice. His work experience includes large pharma (Sandoz, Novartis), small/mid pharma (Systems Medicines, CTI, Aeson Therapeutics, Cancer Prevention Pharmaceuticals, others), commercial phase 1 units (LAB, Inc.), Good Manufacturing Practice–compliant drug production (investigational and commercial), and academia (The Rockefeller University, Columbia University, New York State Psychiatric Institute). In academia, as a Research and Hospital Pharmacy Director for more than 20 years, his work has enabled

and supported many hundreds of studies, and includes collaborating with many physician scientists. This includes compounding novel oral and injectable products for first-in-human/phase I/II/III studies, and distribution of study medications and supplies to research clinics in more than 30 countries. In 2003, Dr. MacArthur received a commendation from the National Institutes of Health (NIH) for his support of the ACCORD Clinical Trial. On behalf of clinical trial sponsors and investigators, Dr. MacArthur has worked with and presented to the U.S. Food and Drug Administration, European Medicines Agency, NIH, the National Cancer Institute, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, patient groups, Contract Research Organizations, Contract Development and Manufacturing Organizations, and others, always with the objective of moving a promising medication along the critical path toward regulatory approval. Over this time he has contributed to the development of many hundreds of human medicines, leading to multiple drug approvals in the United States and Europe.

José Manautou, Ph.D., is Professor of Toxicology and Interim Head of the Department of Pharmaceutical Sciences at the University of Connecticut. He was selected to serve on the National Advisory Environmental Health Sciences Council (NAEHSC), part of the National Institute of Environmental Health Sciences (NIEHS) in 2017. He has also served on the Board of Scientific Counselors within NIEHS. He is a world-renowned expert in acetaminophen hepatoxicity. Given his expertise, he is currently a member of the U.S. Food and Drug Administration’s Nonprescription Drugs Advisory Committee. Dr. Manautou received his undergraduate degree in pharmacy from the University of Puerto Rico and his Ph.D. in pharmacology and toxicology from Purdue University. He came to the University of Connecticut as a postdoctoral researcher in 1992, working with pioneering toxicologist Professor Emeritus Steven Cohen. He was named a tenure track Assistant Professor in Toxicology in 1995, and received tenure and promotion to Associate Professor in 2001.

Nancy King Reame, Ph.D., M.S.N., is the Mary Lindsay Professor Emerita of Health Promotion and Risk Reduction in the School of Nursing at Columbia University in New York City. From 2005 to 2015, she directed the Pilot Studies Resource of the Irving Institute for Clinical and Translational Research in the College of Physicians and Surgeons and was Director of the Ph.D. program in Nursing. From 1980 to 2005, she held faculty posts at the University of Michigan in the School of Nursing and the Department of Obstetrics-Gynecology in the School of Medicine. Dr. Reame’s research is focused on the effect of reproductive neuroendocrinology on women’s health across the life span. Current studies include the role of menopause on

cognition and HIV symptoms, and the effect of endometriosis on menstrual cycle phenotypes. A member of the National Academy of Medicine, Dr. Reame is a women’s health advocate, having served on the advisory committee to the National Institutes of Health’s Women’s Health Initiative, and as advisor for many years to the Boston Women’s Health Book Collective for the iconic book, Our Bodies, Ourselves. She is certified as a menopause clinician and served as a past member of the Board of Trustees for the North American Menopause Society (NAMS); however, did not serve as a co-author or reviewer for NAMS’s recently released position statement on bioidentical hormone replacement therapy products. Dr. Reame received her undergraduate degree in nursing from Michigan State University, a master’s degree as a clinical nurse specialist from Wayne State University College of Nursing, and a Ph.D. in physiology from the Wayne State University School of Medicine, with postdoctoral training in reproductive endocrinology at the University of Michigan School of Medicine.

David R. Rubinow, M.D., is the Meymandi Professor and Chair of the Department of Psychiatry at the University of North Carolina (UNC) at Chapel Hill’s School of Medicine. Prior to being recruited to UNC, he was Clinical Director of the National Institute of Mental Health (NIMH) and Chief of the Behavioral Endocrinology Branch of NIMH. His research interests focus on neurobehavioral effects of gonadal steroids and how genetic variation contributes to differential behavioral response to changes in steroid signaling. Research methods used include administration of hormone superagonists and receptor blockers to manipulate the menstrual cycle and identify the central effects of gonadal steroids in isolation. These studies have demonstrated that, unlike mood disorders accompanying endocrinopathies, reproductive endocrine-related mood disorders represent abnormal responses to normal hormonal signals. Dr. Rubinow has professional and financial interests in Sage Therapeutics, a pharmaceutical company that primarily manufactures and distributes medications to treat central nervous system disorders (e.g., depression). Current National Institutes of Health (NIH)-funded studies include investigations of continuous oral contraceptive administration in menstrual cycle-related mood disorders, estradiol effects on cardiovascular risk and mood dysregulation during perimenopause, and biomarkers of postpartum depression. Additionally, the UNC Women’s Mood Disorders Program, which he directs, has the first and only NIH training fellowship in Women’s Mood Disorders. On the basis of his research, he was inducted into the National Academy of Medicine in 2012. He received his B.A. from the University of Michigan in 1970 and his M.D. from the University of Connecticut Health Center in 1975.

Rulla Tamimi, Sc.D., is an interim Assistant Professor of Population Health Sciences and interim Assistant Professor of Epidemiology in Pathology and Laboratory Medicine at Weill Cornell Medicine. Formally, an Associate Professor of Medicine at the Harvard Medical School. Dr. Tamimi aims to better understand breast cancer risk by incorporating biospecimens and molecular tools in epidemiologic studies. She and her team have led research on breast cancer, including work on lifestyle risk factors, biomarkers, genetics, and gene expression. She studies intermediate markers of breast cancer risk including benign breast disease and mammographic density as an approach to better understand early-life influences on breast cancer risk. Working with computer scientists, she and her group are identifying additional mammographic imaging features that predict risk of breast cancer. By leveraging molecular tools and intermediate markers of risk, Dr. Tamimi hopes to shed new light on our understanding of risk factors of breast cancer with the goal of identifying strategies for breast cancer prevention and improved risk assessment. She received her M.S. and Sc.D. from the Harvard T.H. Chan School of Public Health.

STAFF

Leigh Miles Jackson, Ph.D. (Study Director), is a Senior Program Officer on the Board on Health Sciences Policy (HSP) and serves as Study Director for two U.S. Food and Drug Administration (FDA)-sponsored consensus studies related to compounded drug product—one that focuses on the utility of treating patients with compounded bioidentical hormone therapy and another that focuses on the safety and effectiveness of compounded topical pain creams. Prior to her work on HSP, Dr. Jackson served on the Board on Higher Education and Workforce, where she directed the consensus study report Minority Serving Institutions: America’s Underutilized Resource for Strengthening the STEM Workforce. Prior to this, Dr. Jackson worked in the Health and Medicine Division and directed the consensus study reports The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research and Advancing the Power of Economic Evidence to Inform Investments in Children, Youth, and Families. Prior to joining the National Academies, she was a developmental psychopathology and neurogenomics research fellow at Vanderbilt University, where she investigated the role of chronic sleep disturbance and specific epigenetic modifications on the health outcomes of adolescents. Dr. Jackson has a bachelor’s degree in chemistry from Wake Forest University and a Ph.D. in molecular and systems pharmacology from Emory University.

Jennifer Hinners, M.D., M.P.H., is a Program Officer on the Board on Health Sciences Policy on the Forum on Drug Discovery, Development,

and Translation. Prior to the National Academies, she consulted as a biomedical writer and additionally managed technical and marketing writing for QIAGEN’s product portfolios in infectious disease, tuberculosis, transplant, and sexual and reproductive health. Earlier research for the World Health Organization’s (WHO’s) HIV Department resulted in two systematic literature reviews that were used to inform the 2013 WHO guidelines for HIV and adolescents.

Elizabeth Townsend, M.P.H., is an Associate Program Officer with the Board on Health Sciences Policy (HSP). Prior to joining HSP, Ms. Townsend served as a staff member on several consensus study reports for the Division of Behavioral and Social Sciences and Education, including A Roadmap to Reducing Child Poverty, The Promise of Adolescence: Realizing Opportunity for All Youth, and A Decadal Survey of the Social and Behavioral Sciences: A Research Agenda for Advancing Intelligence Analysis. Before her work at the National Academies, Ms. Townsend managed a youth suicide prevention program for the State of Maine. She holds a B.S. from Radford University and an M.P.H. from the University of Alabama at Birmingham.

Andrew March, M.P.H., is a Research Associate participating in his first two studies at the National Academies for two U.S. Food and Drug Administration–sponsored consensus study reports on compounded pharmaceuticals. He comes to the Board on Health Sciences Policy after completing his master’s in public health at the Universitat Pompeu Fabra in Barcelona. Mr. March received his bachelor’s degree in biology and Spanish from Roanoke College. His previous research experience includes sickness absence trends in working women and health care access in migrant populations.

Justin Jones, M.A., is a Senior Program Assistant for the Board on Health Sciences Policy. He has a bachelor’s degree in history from the University of Maryland and a master’s in sociology from the University of Glasgow. His previous research experience focused on racial disparities within the LGBT community of Scotland and the gender pay gap among Scottish universities. Prior to working at the National Academies, he worked with several science, technology, engineering, and mathematics focused organizations including the National Science Foundation and the Association of American Medical Colleges.

Andrew M. Pope, Ph.D., is the Senior Director of the Board on Health Sciences Policy (HSP). He has a Ph.D. in physiology and biochemistry from the University of Maryland and has been a member of the National Academies of Sciences, Engineering, and Medicine staff since 1982 and the Health

and Medicine Division (HMD) staff since 1989. His primary interests are science policy, biomedical ethics, and environmental and occupational influences on human health. During his tenure at the National Academies, Dr. Pope has directed numerous studies on topics that range from injury control, disability prevention, biologic markers to the protection of human subjects of research, National Institutes of Health priority-setting processes, organ procurement and transplantation policy, and the role of science and technology in countering terrorism. Since 1998, Dr. Pope has served as Director of HSP, which oversees and guides a program of activities that is intended to encourage and sustain the continuous vigor of the basic biomedical and clinical research enterprises needed to ensure and improve the health and resilience of the public. Ongoing activities include the Forums on Neuroscience and Nervous System Disorders, Genomics, Drug Discovery and Development, and Medical and Public Health Preparedness for Catastrophic Events. Dr. Pope is the recipient of HMD’s Cecil Award and the National Academy of Sciences President’s Special Achievement Award.

CONSULTANT

Joe Alper, M.S., has been a science writer and technology analyst for more than 40 years. He played a central role in planning and establishing the National Cancer Institute’s (NCI’s) Alliance for Nanotechnology in Cancer and Physical Sciences-Oncology Centers programs, as well as the National Institute of Mental Health’s Decade of the Brain initiative, and has written numerous policy documents for the President’s Council of Advisors on Science and Technology; the National Academies of Sciences, Engineering, and Medicine; NCI; and the National Institutes of Health, as well as many other foundations, including the National Black Deaf Associates, and federal agencies. He has also served as a contributing correspondent for Science, Nature Biotechnology, and Self magazines, and has written for a variety of publications, including The Atlantic Monthly, Harper’s, The New York Times, The Washington Post, and National Geographic, work for which he received numerous national writing awards. Sandwiched between his years as a magazine writer and science and health care policy writer, Mr. Alper was Senior Director of corporate communication and strategic planning for a publicly traded biotechnology company in Boulder, Colorado. He graduated from the University of Illinois at Urbana-Champaign with a B.S. in chemistry and received M.S. degrees in both biochemistry and agricultural journalism from the University of Wisconsin–Madison. He also completed graduate coursework in architecture and conservation biology at the University of Minnesota and photography at the Maryland Institute College of Art.