Appendix D

Biographical Information

Edward Shortliffe, M.D., Ph.D. (Chair), is the chair emeritus and an adjunct professor of biomedical informatics at Columbia University. He serves as an adjunct professor of biomedical informatics at Arizona State University and is also an adjunct professor of population health sciences at Weill Cornell Medical College. He has served as the president and the chief executive officer of the American Medical Informatics Association, a professor in the School of Biomedical Informatics at the University of Texas Health Science Center in Houston, a professor of biomedical informatics at Arizona State University, a professor of basic medical sciences and a professor of medicine at the University of Arizona College of Medicine, and the founding dean of the Phoenix campus of the University of Arizona’s College of Medicine. He was the Rolf A. Scholdager Professor and the chair of the Department of Biomedical Informatics at the Columbia College of Physicians and Surgeons in New York City and a professor of medicine and computer science at Stanford University. He is a master of the American College of Physicians and was a member of that organization’s board of regents. He is the editor-in-chief of the Journal of Biomedical Informatics. A recipient of several awards including a research career development award from the National Library of Medicine, the Grace Murray Hopper Award of the Association for Computing Machinery, and the Morris F. Collen Award of the American College of Medical Informatics, he was also appointed as a Henry J. Kaiser Family Foundation Faculty Scholar in General Internal Medicine. His research interests include the broad range of issues related to integrated decision-support systems, their effective implementation, and the role of the

Internet in health care. He received an A.B. in applied mathematics from Harvard College and both a Ph.D. in medical information sciences and an M.D. from Stanford University. An elected member of the American Society for Clinical Investigation, the Association of American Physicians, and the American Clinical and Climatological Association, he has also been elected to fellowship in the American College of Medical Informatics and the American Association for Artificial Intelligence. He is a member of the National Academy of Medicine.

Julie Donohue, Ph.D., is the vice chair for research and the co-director of the Ph.D. program in the Department of Health Policy and Management in the Graduate School of Public Health at the University of Pittsburgh. She directs the Medicaid Research Center, which provides analytic support to Pennsylvania’s Medicaid program, and co-directs the Center for Pharmaceutical Policy and Prescribing. She conducts research on insurance coverage, financing, and delivery of health care with a focus on behavioral health care and pharmaceuticals. Her pharmaceutical policy work has informed both Medicare and Medicaid policy. Together with AcademyHealth, she recently launched the Medicaid Outcomes Distributed Research Network to support state Medicaid policy evaluations. She holds secondary appointments in the Clinical and Translational Science Institute and is a faculty affiliate in the Health Policy Institute. She earned a Ph.D. in health policy from Harvard University and completed a postdoctoral fellowship in pharmaceutical policy research at Harvard Medical School.

Anupam Jena, M.D., Ph.D., is the Ruth L. Newhouse Associate Professor of Health Care Policy at Harvard Medical School and a physician in the Department of Medicine at Massachusetts General Hospital. He is also a faculty research fellow at the National Bureau of Economic Research. His research involves several areas of health economics and policy, including the economics of physician behavior and the physician workforce, medical malpractice, the economics of health care productivity, and the economics of medical innovation. Dr. Jena provided compensated expert litigation consulting services in 2020 and 2021 to pharmaceutical companies including Merck, Genentech, Sanofi-Aventis, Janssen, and others through his affiliation with Analysis Group. Prior to his service on the committee, he was a consultant for pharmaceutical companies including Amgen, Eisai, and Otsuka through his affiliation with Precision Health Economics. He is a recipient of the Eugene Garfield Award from Research America for his work demonstrating the economic value of medical innovation in HIV/AIDS. He is a recipient of the National Institutes of Health’s Director’s Early Independence Award

to fund research on the physician determinants of health care spending, quality, and patient outcomes and the International Society for Pharmacoeconomics and Outcomes Research New Investigator Award. He received his M.D. and Ph.D. in economics from the University of Chicago. He completed his residency in internal medicine at Massachusetts General Hospital. He served on the National Academies of Sciences, Engineering, and Medicine ad hoc Committee on Diagnostic Error in Health Care.¹

Tracy Lieu, M.D., M.P.H., is the director of the Division of Research at Kaiser Permanente Northern California. She leads a department of 600 people who conduct studies in clinical effectiveness, delivery science, and epidemiology to benefit Kaiser Permanente members and society at large. She is also a practicing pediatrician who has led internationally recognized research in vaccine safety and policy and childhood asthma. Before her current role, she was a professor and a center director in the Department of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School. Her national roles have included membership on the U.S. Preventive Services Task Force and the Advisory Committee on Immunization Practices and the chair of the Health Services Organization and Delivery study section of the National Institutes of Health. She was elected to the National Academy of Medicine for her use of decision sciences and economic evaluation to inform health policy.

Gary Lyman, M.D., M.P.H., serves as a senior lead for health care quality and policy within the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center and as a professor of medicine, public health, and pharmacy at the University of Washington. He is a board-certified medical oncologist, hematologist, and public health researcher who focuses on comparative effectiveness, health technology assessment, and health services and outcomes research. He has served as an advisor to the U.S. Food and Drug Administration’s Oncologic Drug Advisory Committee, and has been active in the Alliance for Clinical Trials in Oncology (formerly Cancer and Leukemia Group B), the SWOG Cancer Research Network, and the Eastern Cooperative Oncology Group. He has served on the Breast Cancer Screening and Diagnosis Panel and the Growth Factors Panel for the National Comprehensive Cancer Network and chairs clinical practice guidelines for the American Society of Clinical

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¹ Anupam Jena’s biosketch has been updated since the release of this report to disclose compensated expert litigation consulting services to pharmaceutical companies during the course of the study and other consulting services to pharmaceutical companies before the start of the study.

Oncology (ASCO) and the American Society of Hematology. He was the chief of medicine at the Moffitt Cancer Center and Research Institute and a professor of medicine at the University of South Florida, the University of Rochester, and Duke University. Additionally, he holds leadership positions within ASCO as well as the SWOG Cancer Research Network, for which he serves as the executive officer for cancer care delivery, symptom management and quality of life research, and immunotherapy. Dr. Lyman made invited presentations in 2020 regarding the ASCO clinical practice guidelines for complications of cancer chemotherapy, the development of clinical pathways in oncology, and the work of the ASCO taskforce on biosimilars for which he received compensation from Jazz Pharmaceuticals, Merck Sharp & Dohme, Partner Therapeutics, Sandoz, and Seagen. He earned his M.D. from the State University of New York and an M.P.H. in biostatistics from the Harvard T.H. Chan School of Public Health and pursued postdoctoral training at the Roswell Park Cancer Center and Dana-Farber Cancer Institute.²

Kavita Patel, M.D., M.P.H., is a non-resident fellow at the Brookings Institution and a primary care physician in Washington, DC. She advises health care technology and services organizations through New Enterprise Associates. She is a member of the U.S. Department of Health and Human Services Physician Focused Payment Model Technical Advisory Committee. Previously, she consulted for biopharmaceutical companies, directed the health policy program at the New America Foundation, and served in the Obama administration as the director of policy for the Office of Intergovernmental Affairs and Public Engagement in the White House. She is a practicing physician with health care policy experience in the U.S. Senate Health, Education, Labor, and Pensions Committee, where she was the deputy staff director for health under Senator Edward Kennedy. She was selected as a young global leader by the World Economic Forum and is a Society of General Internal Medicine advisory board member for the National Commission on Physician Payment Reform. She received her M.P.H. from the University of California, Los Angeles, and her M.D. from the University of Texas Health Science Center.

Harold Paz, M.D., M.S., is the executive vice president and the chancellor for health affairs at The Ohio State University and the chief executive officer of The Ohio State Wexner Medical Center. Before joining Ohio State in June 2019, he was the executive vice president and the chief

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² Gary Lyman’s biosketch has been updated since the release of this report to disclose compensated invited presentations to pharmaceutical companies made during the course of the study.

medical officer at CVS Health/Aetna, where he led clinical strategy and policy at the intersection of all of Aetna’s domestic and global businesses. He reported to Aetna’s chairman and chief executive officer and was a member of its executive committee. He was also an adjunct professor of internal medicine at the Yale University School of Medicine. Prior to joining Aetna, he served as the president and the chief executive officer of the Penn State Hershey Health System and as the senior vice president for health affairs at The Pennsylvania State University and the dean of its College of Medicine for 8 years. Before his appointment at Penn State, he spent 11 years as the dean of the Robert Wood Johnson Medical School and the chief executive officer of the Robert Wood Johnson University Medical Group. He is a fellow of the American College of Physicians and the American College of Chest Physicians. He is currently on the board of Research America and the advisory board of United Surgical Partners International. He is the past chair of the board of directors of the Association of Academic Health Centers and a former board member of the Association of American Medical Colleges (AAMC) and chair of the AAMC council of deans. He has served on a number of corporate and scientific boards in the health care and biotechnology field. He received his bachelor’s degree from the University of Rochester, a master of science in life science engineering from Tufts University and his M.D. from the University of Rochester School of Medicine and Dentistry. He completed his residency at Northwestern University, where he served as the chief medical resident. He was a Eudowood Fellow in pulmonary and critical care medicine at Johns Hopkins University School of Medicine. In addition, he was a postdoctoral fellow in environmental health science at the Johns Hopkins University School of Hygiene and Public Health.

Deborah Schrag, M.D., is the chief of the Division of Population Sciences at the Dana-Farber Cancer Institute and a professor of medicine at Harvard Medical School in Boston, Massachusetts. Dr. Schrag is a health services researcher and a gastrointestinal medical oncologist with a focus on colorectal cancer. Her research focuses on improving the quality, effectiveness, and cost-effectiveness of cancer care delivery. She leads the Harvard Program in Cancer Care Delivery Research, is the principal investigator of several multi-center trials, and leads efforts to develop data standards to characterize outcomes of cancer treatment at population scale. She has performed foundational work in patient-reported outcomes and building phenomic data standards to systematically measure outcomes from electronic health records. Dr. Schrag is an associate editor of the Journal of the American Medical Association, a fellow of the American Society of Clinical Oncology and a former board director, a member of the National Academies of Sciences, Engineering, and Medicine’s National

Cancer Policy Forum, and an elected member of the American Association of Physicians.

Ya Chen Tina Shih, Ph.D., is a professor in the Department of Health Services Research and holds the Hubert L. and Olive Stringer Professorship for Cancer Treatment and Research at the University of Texas MD Anderson Cancer Center. She is also the chief of the Section of Cancer Economics and Policy in the Department of Health Services Research at the university. She applies methods of health economics, health services research, and pharmacoeconomics in medical research, in particular, cancer research. She studies the diffusion of new medical technologies among patients, providers, and geographic areas; examines the impact of new technologies on the outcomes and costs of cancer care; and conducts methodological research on the analysis of medical cost data. She is the associate editor of the Journal of the National Cancer Institute and is on the editorial boards of Value in Health, PharmacoEconomics, and JCO: Oncology Practice. She is a member of the American Cancer Society guidelines development workgroup and was a member of the National Cancer Policy Forum at the National Academies of Sciences, Engineering, and Medicine. She received her Ph.D. in economics from Stanford University.

Kenneth Silverman, M.S., is the director of packaging technology in global technical operations at AstraZeneca. He manages a team of engineers responsible for commercializing innovative, standardized, sustainable commercial package systems for protein-based therapeutics, including monoclonal antibodies, antibody drug conjugates, mRNA, DNA, enzymes, gene therapy, and cell therapy. He entered biopharmaceutical research and development over two decades ago as a lab manager for developing packaging systems for new protein-based therapeutics at Schering–Plough. He moved into medical device research and development at Merck Research Laboratories focusing on design control methodologies to assess and mitigate risk and ensure optimal device packaging system development from prototype to a commercially scalable device design for biologics. In 2012 he moved out of research and development into technical operations at Bristol-Myers Squibb, where he developed packaging, scaled up manufacturing, and commercially launched immuno-oncology therapies including Opdivo, Yervoy, and Empliciti. At Bristol-Myers Squibb, he advanced from principal engineer to associate director where he harmonized and standardized Bristol-Myers Squibb’s global packaging footprint for biologics. Mr. Silverman Joined AstraZeneca in January 2018 and he is responsible for all biological packaging from late-stage new molecular entities to commercialized products including Imfinzi, Fasenra,

and Lumoxiti. He is currently responsible for ensuring an uninterrupted supply of protein-based therapeutics with a focus on optimal package design, excellence in manufacturing, harmonization, interchangeability, sustainability, and simplicity. He is the single patent holder for a senior-friendly single-dose dispensing package (WO2009149267). He received his master’s degree and bachelor of science degree in packaging science from the Rochester Institute of Technology.

Holly Taylor, Ph.D., M.P.H., is a research bioethicist in the Department of Bioethics in the Clinical Center at the National Institutes of Health. She is a social scientist by training and has 20 years of experience conducting quantitative and qualitative research in the field of research ethics. Until 2019 she was an associate professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and core faculty of the Berman Institute of Bioethics. She has served on institutional review boards at the Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins University School of Medicine as well as in the government and private sector. Her primary interests are research ethics, local implementation of federal policy relevant to human subject research, and qualitative research methods. She earned a Ph.D. in bioethics and health policy from the Department of Health Policy and Management and Johns Hopkins Bloomberg School of Public Health, an M.P.H. from the University of Michigan School of Public Health, and a B.A. in human biology from Stanford University.

Jonathan Watanabe, Pharm.D., Ph.D., is a professor of clinical pharmacy and the associate dean of assessment and quality at the University of California (UC), Irvine, School of Pharmacy and Pharmaceutical Sciences. He was previously an associate professor of clinical pharmacy in the Skaggs School of Pharmacy and Pharmaceutical Sciences at UC San Diego. His research at UC San Diego focuses on pharmaceutical economic policy and health outcomes to improve health at the population level by examining how to improve medication-related health outcomes, particularly for the elderly and underserved populations. He served as an investigator and a fellowship director for the San Diego Geriatrics Workforce Enhancement Program. He is a clinical consultant for the Program of All-Inclusive Care for the Elderly (PACE) Clinic in San Diego, California. He was the inaugural recipient of the University of Washington/Allergan Global Health Economics and Outcomes Research Fellowship. He serves the California state legislature as a faculty content expert for the California Health Benefits Review Program and was a member of the advisory group on pain assessment and management standards for long-term care organizations for The Joint Commission. He is a board-certified geriatric

pharmacist. He received a B.S. in zoology from the University of Washington, a Pharm.D. from the University of Southern California, and an M.S. and a Ph.D. from the University of Washington. He was the recipient of the third National Academy of Medicine (NAM) fellowship in pharmacy and is currently an inaugural scholar in the NAM Emerging Leaders in Health and Medicine program.

Alastair Wood, M.B., Ch.B., is an emeritus professor of medicine and an emeritus professor of pharmacology at Vanderbilt University. Previously he was the assistant vice chancellor for clinical research and the associate dean of Vanderbilt Medical School. He has served as a professor of medicine and pharmacology at Weill Cornell Medical College in New York and has served on a number of editorial boards. He was a member of the New England Journal of Medicine editorial board, served as the drug therapy editor of the New England Journal of Medicine, and was on the editorial board of the British Journal of Clinical Pharmacology and The Scientist. He has previously served on the editorial boards of Clinical Pharmacology and Therapeutics and Biopharmaceutics and Drug Disposition. He authored the chapter in Harrison’s Principles of Internal Medicine on adverse drug reactions from the 9th through the 15th edition. He received his medical degree from St Andrews University and Dundee Medical School in Scotland. He is a member of the National Academy of Medicine.

K. Robin Yabroff, Ph.D., is an epidemiologist and the senior scientific director of health services research at the American Cancer Society. She also serves as an adjunct associate professor in the Department of Medicine at Johns Hopkins University and an adjunct professor in the Department of Health Policy and Management in the Rollins School of Public Health at Emory University. Prior to joining the Surveillance and Health Services Research Program at the American Cancer Society, she held positions within the Office of Health Policy of the Assistant Secretary for Planning and Evaluation in the U.S. Department of Health and Human Services, in the Health Services and Economics Branch of the National Cancer Institute, and in the faculty of the Lombardi Cancer Center at Georgetown University. She is an associate editor for the Journal of the National Cancer Institute, a founding member of the editorial board of the Journal of Cancer Survivorship, and a member of the editorial board of the Journal of Oncology Practice. She served as a guest editor for the Medical Care journal supplement, Health Care Costing: Data, Methods, Future Directions, and the Journal of the National Cancer Institute journal supplement Comparing Cancer Care and Economic Outcomes Across Health Systems: Challenges and Opportunities. She holds an M.B.A. from

the University of Rochester and her Ph.D. in epidemiology from the Johns Hopkins Bloomberg School of Public Health.

Since the release of this report, it was determined that two members of the committee had financial conflicts of interest during the course of the study that had not been fully disclosed.

Dr. Anupum Jena provided compensated expert litigation consulting services in 2020 and 2021 to pharmaceutical companies including Merck, Genentech, Sanofi-Aventis, Janssen, and others through his affiliation with Analysis Group. Although these cases did not directly involve discarded drugs, because the recommendations of the study could be viewed as having a direct impact on the financial interests of some of these companies, the National Academies have concluded that Dr. Jena had a financial conflict of interest during the course of the study.

Dr. Gary Lyman made invited presentations in 2020 regarding the American Society of Clinical Oncology (ASCO) clinical practice guidelines for complications of cancer chemotherapy, the development of clinical pathways in oncology, and the work of the ASCO taskforce on biosimilars for which he received compensation from Jazz Pharmaceuticals, Merck Sharp & Dohme, Partner Therapeutics, Sandoz, and Seagen. Although the topics of these presentations were not directly related to the specific questions addressed by the committee, because the recommendations of the study could be viewed as having a direct impact on the financial interests of some of these companies, the National Academies have concluded that Dr. Lyman had a financial conflict of interest during the course of the study.

STAFF

Francis Kwadwo Amankwah, M.P.H., is a program officer in the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine. He is the project lead on the National Academies study on the implications of discarded drugs resulting from weight-based dosing of medications contained in single-dose vials. He recently led a workshop that examined the role of the National Institutes of Health in drug development innovation and its impact on patient access. His portfolio of work at the National Academies has included providing research and analytical support in the development of the consensus study reports Guiding Cancer Control: A Path to Transformation; Making Medicines Affordable: A National Imperative; Preventing Bullying Through Science, Policy, and Practice; and Promoting the Educational Success of Children and Youth Learning English: Promising Futures. For his work at the National Academies, he has received the Mount Everest and the Fineberg Impact staff

achievement awards from the Health and Medicine Division. He earned his M.P.H. and a graduate certificate in global planning and international development from Virginia Tech. He was raised in Ghana and earned his B.S. in agricultural science from the Kwame Nkrumah University of Science and Technology.

Alexandra (Allie) Andrada, M.A., is an associate program officer in the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine, working on the consensus study on the implication of discarded weight-based drugs. Prior to joining the National Academies, she served as a lead research scientist supporting the Defense Health Board and the Defense Health Agency by producing technical reports on various public health topics affecting the military, such as child abuse and neglect and low-volume, high-risk surgical procedures throughout the Military Health System. She also has experience in survey research and design, program evaluation, guiding cognitive interviews, and conducting quantitative analyses focusing on military families, behavioral health, and at-risk youth. She earned her M.A. in experimental/biological psychology with a concentration in neuropsychology from American University and her B.S. in psychology and criminal justice from Virginia Commonwealth University.

Annalee Gonzales is an administrative assistant with the Board on Health Care Services and the National Cancer Policy Forum at the National Academies of Sciences, Engineering, and Medicine. She previously served as a senior program assistant for two reports from the National Academies on peer victimization and bullying and on fostering school success for English and dual-language learners. Prior to joining the National Academies she worked as an editorial and administrative coordinator at the National Association for Bilingual Education. She earned her B.A. in communication from Trinity University.

Tracy A. Lustig, D.P.M., M.P.H., is a senior program officer with the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine. Dr. Lustig was trained in podiatric medicine and surgery and spent several years in private practice. In 1999 she was awarded a congressional fellowship with the American Association for the Advancement of Science and spent 1 year working in the office of Ron Wyden of the U.S. Senate. She joined the National Academies in 2004. Much of her work has focused on the health care workforce and the aging of the U.S. population. She was the study director for consensus studies on the geriatrics workforce, oral health, ovarian cancer research, and social isolation and loneliness in older adults. She also

directed workshops on the allied health workforce, the use of telehealth to serve rural populations, assistive technologies, hearing loss, and artificial intelligence. In 2009 she staffed a National Academies–wide initiative on the “Grand Challenges of an Aging Society” and subsequently helped to launch the Forum on Aging, Disability, and Independence, which she currently directs. She has a doctor of podiatric medicine degree from Temple University and an M.P.H. with a concentration in health policy from The George Washington University.

Sharyl J. Nass, Ph.D., serves as the senior director of the Board on Health Care Services and the director of the National Cancer Policy Forum at the National Academies of Sciences, Engineering, and Medicine. The National Academies provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. To enable the best possible care for all patients, the board undertakes scholarly analysis of the organization, financing, effectiveness, workforce, and delivery of health care, with emphasis on quality, cost, and accessibility. The cancer forum examines policy issues pertaining to the entire continuum of cancer research and care. For two decades, Dr. Nass has worked on a broad range of health and science policy topics that include the quality and safety of health care and clinical trials, developing technologies for precision medicine, and strategies for large-scale biomedical science. She has a Ph.D. in cell biology from Georgetown University and undertook postdoctoral training at the Johns Hopkins University School of Medicine as well as a research fellowship at the Max Planck Institute in Germany. She also holds a B.S. and an M.S. from the University of Wisconsin–Madison. She has been the recipient of the Cecil Medal for Excellence in Health Policy Research, a distinguished service award from the National Academies, and the Institute of Medicine staff team achievement award (as team leader).

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