Appendix I

Biographical Sketches for Committee Members, Fellow, Consultants, and Staff

COMMITTEE

Debra A. Schwinn, M.D. (Chair), is a professor of anesthesiology, pharmacology, and biochemistry at the University of Iowa (UI). She served as the dean of the UI Carver College of Medicine (2012–2016), the associate vice president for medical affairs at UI (2016–2019), and is currently the president-elect of Palm Beach Atlantic University (2020). Dr. Schwinn is a member of the National Academy of Medicine and Association of American Physicians, the past chair of the Board of Trustees of the International Anesthesiology Research Foundation, and the past chair of the Sarnoff Cardiovascular Research Foundation Board of Directors. Her molecular pharmacology laboratory focused on mechanisms underlying alpha1adrenergic receptor regulation and modulation in cardiovascular disease, including the biological effects of genetic variants of these stress receptors. In parallel, over the past few decades, her clinical studies have focused on perioperative genomics, a relatively new field aimed at identifying genetic variants that predict increased risk for perioperative adverse events. Prior to moving to UI in 2012, Dr. Schwinn was a professor and the chair of anesthesiology and pain medicine, the Allan J. Treuer Endowed Professor in Anesthesiology, and an adjunct professor of pharmacology and genome sciences at the University of Washington in Seattle. Prior to that period, she spent her entire career at the Duke University Medical Center. Dr. Schwinn served for many years on the National Institutes of Health (NIH) National Institute of General Medical Sciences advisory council and the external advisory board for the NIH Pharmacogenomics Research Network.

Stephen Byrn, Ph.D., is the Charles B. Jordan Professor of Medicinal Chemistry in the Department of Industrial and Physical Pharmacy at Purdue University in West Lafayette, Indiana. Dr. Byrn set in motion the development of the field of solid state chemistry of drugs with his books, short courses, and papers on the subject, the first of which were first published in the mid-1970s. He has also educated more than 50 Ph.D. students and postdoctoral fellows and taught a wide range of courses at Purdue. Dr. Byrn has had numerous grants, including one of the first 13 National Institutes of Health Centers for AIDS Research. Dr. Byrn is the co-founder of Purdue’s graduate programs in regulatory and quality compliance. These programs now constitute the Biotechnology Innovation and Regulatory Science MS program. He is also the co-founder of the Purdue-Kilimanjaro School of Pharmacy Sustainable Medicines in Africa project in Moshi, Tanzania. Dr. Byrn has served as the chair of the Pharmaceutical Sciences Advisory Committee to the U.S. Food and Drug Administration and chaired several United States Pharmacopeia committees. Dr. Byrn is also the co-founder of Solid State Chemical Information, Inc. (SSCI), a cGMP research and information company. SSCI, Inc. is now owned by Albany Molecular Research Inc. Dr. Byrn has taught a range of courses and short courses involving medicinal chemistry, industrial pharmacy, physical pharmacy, and solid state chemistry. Dr. Byrn is an elected fellow of the American Association of Pharmaceutical Scientists (AAPS) and has received several awards for his research and entrepreneurial activities including the AAPS David Grant Award for Research Achievement and the AAPS Wurster award in pharmaceutics and formulation. Dr. Byrn also received the Purdue University Morrill Award.

Diana D. Cardenas, M.D., M.H.A., is a professor and the chair emeritus of the Department of Physical Medicine and Rehabilitation at the University of Miami Miller School of Medicine. She has years of experience with the Spinal Cord Injury (SCI) Model Systems, a program sponsored by the National Institute on Disability, Independent Living, and Rehabilitation Research, having served as the principal investigator (PI) of the SCI Model System in Seattle from 1990 to 2006, as well as for the South Florida SCI Model System (2011–2015). Her research focus is pain and other secondary conditions of SCI. She is the vice president of the Foundation for Physical Medicine and Rehabilitation, which fosters rehabilitation research. She was elected to the National Academy of Medicine in 2004. A 1969 graduate of The University of Texas at Austin, Dr. Cardenas earned her medical degree at The University of Texas Southwestern Medical School in Dallas in 1973. She completed her internship and residency in physical medicine and rehabilitation medicine at the University of Washington (UW) in 1976, and joined the UW faculty in 1981. She was the clinical director of the UW Medical Center’s Spinal Cord Injury Service, and director of the UW

Rehabilitation Medicine Spinal Cord Injury Clinic. In 2001 she earned a master’s degree in health administration from UW. In 2006 she was recruited to the University of Miami Miller School of Medicine as the founding chair of the Department of Physical Medicine and Rehabilitation where she served until her retirement in 2015. She continued to conduct research in pain as the co-PI of the South Florida SCI Model System until 2019. She is widely published and is the recipient of the 2020 American Spinal Injury Association Lifetime Achievement Award.

Barbara Insley Crouch, Pharm.D., is the executive director of the Utah Poison Control Center (UPCC). She has been the director of the UPCC since 1992. She holds a bachelor’s degree in pharmacy from the Philadelphia College of Pharmacy and Science, a master of science in public health from the University of Utah, and a doctor of pharmacy jointly administered by The University of Texas at Austin and The University of Texas Health Science Center at San Antonio. She completed a clinical toxicology fellowship at the University of Maryland School of Pharmacy and Maryland Poison Center. She held faculty positions at the University of California, San Francisco, School of Pharmacy and the Philadelphia College of Pharmacy and Science prior to joining the University of Utah in 1990. Her primary academic appointment is a professor (clinical) in the Department of Pharmacotherapy, College of Pharmacy. She established a 2-year fellowship in clinical and applied toxicology for doctor of pharmacy graduates. Her research interests include the epidemiology of poisonings and facilitation of communication to improve patient care.

Edmund J. Elder, Ph.D., R.Ph., is the director of the Zeeh Pharmaceutical Experiment Station in the School of Pharmacy at the University of Wisconsin–Madison (UW). Dr. Elder obtained 16 years of experience in the pharmaceutical and drug delivery industry prior to joining UW in 2006. As the director of the station, he is responsible for providing pharmaceutical and biopharmaceutical research and development support and educational programs for researchers, both on and off campus. Dr. Elder also serves as the scientific advisor to the U.S. Food and Drug Administration Regulated Research Oversight Committee in the UW Institute for Clinical and Translation Research (ICTR) and serves as the chemistry, manufacturing, and controls advisor for the ICTR Investigational New Drug/Investigational Device Exemption Consultation Service, which provides support for campus researchers pursuing regulatory filings related to their clinical research. Dr. Elder also holds appointments as an affiliate in the Pharmaceutical Sciences Division at the UW School of Pharmacy and is the course director for Biotechnology Operations in the MS in Biotechnology Program at the UW School of Medicine and Public Health.

John T. Farrar, M.D., Ph.D., has been involved in clinical research for more than 25 years, with a major focus on the study of the efficacy of pain therapeutics and on novel methodology in the design and execution of clinical trials. As a neurologist and a pharmacoepidemiologist, he has been involved in numerous studies including randomized controlled trials (RCTs), cohort studies, and methodologic studies of pain and associated symptoms such as fatigue, depression, and quality of life in clinical research and practice. His research has been funded by the National Institutes of Health, the U.S. Food and Drug Administration (FDA), private foundations, and industry sources. Currently, he is the principal investigator of an FDA-funded contract to use large datasets to study the relative efficacy of acute drug treatments for pain and the HEAL Initiative Early Phase Pain Investigation Clinical Network Clinical Specialty site. He also directs the evaluation component of the University of Pennsylvania’s current Clinical and Translational Science Award, and is a collaborator with the data coordinating center for the U54 multicenter Multidisciplinary Approach to the Study of Chronic Pelvic Pain study and the Hemodialysis Opioid Prescription Effort study. Nationally he has served as a member and the chair of the Anesthetic and Life Support Drugs Advisory Board for FDA, on the National Research Council Panel on Handling Missing Data in Clinical Trials, and on the Institute of Medicine Committee on Advancing Pain Research, Care, and Education. He also serves as an associate editor for the journal Pharmacoepidemiology and Drug Safety. At the University of Pennsylvania Perelman School of Medicine, he has co-directed the Biostatistical Analysis Center and the Master of Science in Clinical Epidemiology program for more than 10 years. In addition, he continues to see pain patients, predominately in a palliative care setting.

Carmen Green, M.D., is a tenured professor of anesthesiology with joint appointments in the Medical School’s Department of Obstetrics and Gynecology and the Department of Health Management and Policy in the School of Public Health at the University of Michigan. She was co-director for the Community Liaison Core and the director of the Healthier Black Elders Center for the Michigan Center for Urban African American Aging Research at the University of Michigan Institute for Social Research. Her research focuses on pain management outcomes, physician decision making, and access to care, and she has documented disparities due to age, race, gender, and class across the life span as well as disparities in hospital security being called for Black patients and their visitors. She has also found community-based structural barriers to health and pain care, including clear disparities in access to pain medication for Blacks, women, and low-income individuals with chronic pain. Her leadership in developing and diversifying the health professional pipeline includes service on faculty and

advisory boards for programs designed to achieve a critical mass of minorities and women in biomedical science. She has been selected for several fellowships focusing on aging, health care, and health policy, including the Robert Wood Johnson Health Policy Fellowship at the National Academies of Sciences, Engineering, and Medicine, where she worked as a health policy analyst on the U.S. Senate’s Health Education, Labor, and Pensions Committee and the Children and Families Subcommittee. She is an elected fellow of The New York Academy of Medicine, the Gerontological Society of America, and the Association of University Anesthesiologists. Her work has informed the policy agenda and she has provided expert testimony to state and federal entities.

Friedhelm Sandbrink, M.D., is the national program director for pain management within the Office of Specialty Care Services in the Veterans Health Administration (VHA). Dr. Sandbrink completed his residency in neurology at Georgetown University in Washington, DC, and a fellowship in clinical neurophysiology at the National Institutes of Health (NIH). He is board certified in neurology, clinical neurophysiology, and pain medicine. He is a clinical associate professor in neurology at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, and an assistant clinical professor of neurology at The George Washington University in Washington, DC. Dr. Sandbrink joined the U.S. Department of Veterans Affairs (VA) in 2001 and since then has been leading the comprehensive interdisciplinary Pain Management Program within the Neurology Department at the Washington VA Medical Center. He was appointed deputy national program director at the VHA in 2014. After serving in an acting capacity (since October 2016), he became the national program director for pain management in September 2018. He participates in many VHA and national pain management initiatives, and was involved in writing the Pain Management Best Practices Federal Inter-Agency Task Force Report in 2019 (by the U.S. Department of Health and Human Services) and the VA/U.S. Department of Defense Clinical Practice Guidelines for Opioid Therapy and for Low Back Pain.

Vinod P. Shah, Ph.D., joined NDA Partners as an expert consultant in 2016. He had 30 years of experience at the U.S. Food and Drug Administration (FDA), working in different divisions, until he retired as a senior research scientist in the Office of Pharmaceutical Sciences in 2005. During his career at FDA, he developed several regulatory guidances for industry in areas such as dissolution, SUPAC, bioanalysis, bioequivalence, biopharmaceutics, and topical drugs. In addition to his career at FDA, Dr. Shah worked at Sarabhai Chemicals, Baroda, India. He served as scientific secretary of the International Pharmaceutical Federation (FIP), as adjunct faculty at JSS

University, India, and an adjunct professor at the College of Pharmacy, University of Kentucky. Dr. Shah is a former Biopharmaceutics Expert Committee member of the United States Pharmacipeia (USP). He was the co-chair of USP’s Advisory Panel on Dosage Form Performance—Topical/Dermal, and Distinguished Pharmaceutical Scientist/Consultant at USP in Biopharmaceutics. He is a member of the steering committee of Non-Biological Complex Drugs (hosted at Lygature, The Netherlands), and the founder and chairman of the Society of Pharmaceutical Dissolution Science International. In addition, Dr. Shah was a board member of the Product Quality Research Institute from 2013 to 2017 and holds two honorary doctorates from Semmelweis University, Hungary, and the University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania. Dr. Shah was the president of the American Association of Pharmaceutical Scientists (2003). He is a recipient of FDA’s Distinguished Service Award, FIP’s Lifetime Achievement in Pharmaceutical Sciences Award, the American Association of Pharmaceutical Scientists’s (AAPS’s) Distinguished Pharmaceutical Scientist Award, AAPS’s Global Leader Award, and the Marquis Who’s Who Albert Nelson Marquis Lifetime Achievement Award.

Joyce S. Tsuji, Ph.D., DABT, FATS, is a board-certified toxicologist and a fellow of the Academy of Toxicological Sciences. She specializes in assessing exposure and risks associated with chemicals, and in communication of scientific issues. Dr. Tsuji has worked on projects in the United States and internationally for industry, trade associations, the U.S. Environmental Protection Agency (EPA) and state agencies, the U.S. Department of Justice, the Australian EPA, municipalities, and private citizens. Her experience includes toxicology and risk assessment related to a wide variety of chemicals in the environment, workplace, food, consumer and personal care products, pharmaceuticals, and medical devices. She has designed and directed dietary and environmental exposure studies and community programs involving health education and biomonitoring for populations potentially exposed to chemicals in the environment, including soil, water, and food-chain exposures. She has served on expert panels on toxicology and health risks issues for the National Academy of Sciences/National Research Council (including the Board on Environmental Studies and Toxicology), the Institute of Medicine, and federal and state agencies. Dr. Tsuji earned her B.S. in biological sciences from Stanford University, and a Ph.D. focused in environmental physiology from the Department of Zoology, University of Washington.

Carol S. Wood, Ph.D., is a distinguished staff scientist in the Environmental Science Division of Oak Ridge National Laboratory. She has more than 20 years of experience as a toxicologist, with extensive work performing risk assessments of inhalation/pulmonary and oral toxicity from exposure to

a variety of chemicals. Her past work has included developing acute exposure guideline levels and provisional advisory levels, in which health-based exposure levels are developed for priority toxic chemicals. These projects often used toxicokinetic data and physiologically based pharmacokinetic models for extrapolating animal toxicology data to humans. Dr. Wood is a past president of the American Board of Toxicology. She is certified in general toxicology by the American Board of Toxicology. She served on the National Academies of Sciences, Engineering, and Medicine’s Committee on the Review of Clinical Guidance for the Care of Health Conditions Identified by the Camp Lejeune Legislation, the Committee on Spacecraft Exposure Guidelines, and the Committee on Gulf War and Health: Volume 11 (Generational Health Effects of Serving in the Gulf War); she currently serves on the Committee on Toxicology. Dr. Wood received her M.S. in toxicology from Mississippi State University and her Ph.D. in toxicology from Oregon State University.

NATIONAL ACADEMY OF MEDICINE FELLOW

Dima Qato, Pharm.D., Ph.D., M.P.H., is an associate professor in the Department of Pharmacy Systems, Outcomes, and Policy and an affiliate in the Center for Pharmacoepidemiology and Pharmacoeconomic Research at the University of Illinois at Chicago (UIC), and the 2018 National Academy of Medicine Fellow in Pharmacy. Her research focuses on access and safe use of medications in vulnerable populations, including refugee and immigrant populations. She uses population-based methods to better understand the underlying mechanisms responsible for the use, underuse, and unsafe use of medications; how these patterns may influence health outcomes and health disparities; and what can be done from a community and policy perspective to address these growing public health problems. Her work focuses on the growing prevalence and impact of pharmacy deserts; the increasing and widespread use of polypharmacy and potentially harmful drug–drug interactions among people of all ages, including teens and the elderly; and the systems-level transformation needed to combat these trends that have received significant attention from national news outlets, care providers, and community-based advocacy groups. Dr. Qato earned a doctor of pharmacy degree from UIC, a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health, and a doctor of philosophy degree from the UIC School of Public Health.

CONSULTANTS

S. Narasimha Murthy, Ph.D., is a professor of pharmaceutics and drug delivery and the associate director of the Pii Center for Pharmaceutical

Technology at the University of Mississippi School of Pharmacy. Dr. Murthy is also the founder-director of a nonprofit research organization, Institute for Drug Delivery and Biomedical Research in Bangalore, India (http://www.IDBresearch.com). Transcutaneous drug delivery is one of the main areas of Dr. Murthy’s research. His research programs are funded by the National Institutes of Health, the U.S. Food and Drug Administration, and pharmaceutical companies. He has published more than 100 research papers and presented more than 200 scientific posters in various national and international scientific meetings. He has authored 2 books and more than 15 book chapters. He is serving on the editorial board of several journals including AAPS PharmSciTech, Drug Development and Industrial Pharmacy, and the Journal of Pharmaceutical Sciences. Dr. Murthy has received several awards such as the New Investigator award and Cumberland Researcher of the Year from the University of Mississippi, the Global Indus Technovator award from the Massachusetts Institute of Technology, the Endowed Chair for Research at Ohio Northern University, and he was inducted as a fellow of the American Association of Pharmaceutical Scientists in 2017. The American Association of Indian Pharmaceutical Scientists has also honored him with the Distinguished Scientist award.

Anna Nicholson, Ph.D., M.A., M.Phil., is the founder and lead writer of Doxastic, a science writing firm based in Chapel Hill, North Carolina. She founded Doxastic after completing graduate degrees and a postdoctoral fellowship in linguistics, philosophy, and cognitive science at Indiana University Bloomington, Trinity College Dublin, and University College Dublin. Doxastic supports clients seeking to disseminate the latest advances in research, translate knowledge into improved practice and better outcomes, and shape health policy toward broader access to care. For clients including the National Academies of Sciences, Engineering, and Medicine and the Harvard Medical School Center for Global Health Delivery, she has provided writing support for meeting proceedings and consensus studies spanning a range of pressing issues in global and public health. Recent areas of focus have included infectious disease threats, the opioid use disorder epidemic, community-based health care delivery systems, and medical and public health preparedness for disasters and emergencies.

NATIONAL ACADEMIES STAFF

Leigh Miles Jackson, Ph.D. (Study Director) is a senior program officer for the Health and Medicine Division’s Board on Health Sciences Policy (HSP) and serves as the study director for two U.S. Food and Drug Administration–sponsored consensus studies related to compounded drug products—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 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 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.

Claire Giammaria, M.P.H., is an associate program officer for the Health and Medicine Division’s Board on Health Sciences Policy (HSP). She has worked for HSP since 2010, during which time she has helped staff consensus studies, standing committees, roundtables, and forums on a variety of topics. Most recently, she was the lead on a stand-alone workshop on medical product shortages during disaster events. Prior to working for the National Academies, she worked for the American Civil Liberties Union on privacy and health care issues. She attended Grinnell College, where she majored in biology, and the University of Michigan, where she received her master in public health with a concentration in policy and genetics.

Andrew March, M.P.H., is a research associate for the Health and Medicine Division’s Board on Health Sciences Policy (HSP). He came to HSP after completing his master 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 Health and Medicine Division’s Board on Health Sciences Policy. He has a bachelor’s degree in history from the University of Maryland and a master’s degree in sociology from the University of Glasgow. His previous research experience focused on racial disparities within the lesbian, gay, bisexual, and transgender community of Scotland and the gender pay gap among Scottish universities. Prior to working at the National Academies, he worked

with several STEM-focused organizations, including the National Science Foundation and the American Association of Medical Colleges.

Andrew M. Pope, Ph.D., is the senior director of the Board on Health Sciences Policy. 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 of the Health and Medicine Division 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, and 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 the Board on Health Sciences Policy, 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 Forums on Neuroscience, Genomics, Drug Discovery and Development, and Medical and Public Health Preparedness for Catastrophic Events. Dr. Pope is the recipient of the Health and Medicine Division’s Cecil Award and the National Academy of Sciences President’s Special Achievement Award.