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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Suggested Citation:"Appendix C: Speaker Biosketches." National Academies of Sciences, Engineering, and Medicine. 2021. Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25998.
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Appendix C Speaker Biosketches AMY ABERNETHY, M.D., PH.D., is an oncologist and internationally recognized clinical data expert and clinical researcher. As the principal deputy commissioner of food and drugs, Dr. Abernethy helps oversee the U.S. Food and Drug Administrations (FDA’s) day-to day functioning and directs special and high-priority cross-cutting initiatives that impact the regulation of drugs, medical devices, tobacco, and food. As acting chief information officer, she oversees FDA’s data and technical vision, and its execution. She has held multiple executive roles at Flatiron Health and was professor of medicine at Duke University School of Medicine, where she ran the Center for Learning Health Care and the Duke Cancer Care Research Program. Dr. Abernethy received her M.D. at Duke University, where she did her internal medicine residency, served as chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University and B.A. from the University of Pennsylvania, and is boarded in palliative medicine. HEATHER ALLORE, PH.D., focuses on issues related to the design and analysis of trials and studies of multifactorial geriatric health conditions, especially among persons with Alzheimer’s disease and related dementia. Several projects focus on health disparities of older adults. She developed a subdiscipline of biostatistics that focuses on training and methodological development in geriatrics called “Gerontologic Biostatistics.” This discipline trains biostatisticians in conducting collaborative research with clinical investigators in geriatrics and gerontology and provides the basis for the development of new statistical methodologies. JAMES APPLEBY, SC.D. (HON.), M.P.H., is the chief executive officer of The Gerontological Society of America (GSA), the nation’s largest interdisciplinary organization devoted to research, education, and practice in the field of aging. The Society works to advance innovation in aging and disseminate information among scientists, clinicians, policy makers, and the public. He is leading the Society’s current initiative to “reframe aging” in America by fostering accurate narratives of aging to replace the outdated “conventional wisdom” that dominates public understanding. The 5,500-member Society is advancing major initiatives related to improving adult immunization rates, detecting cognitive impairment earlier, improving oral health, and demonstrating the impact of the longevity economy. Dr. Appleby also is serving a 4-year term on the National Advisory Council on Aging after being appointed by the U.S. Secretary for Health and Human Services. Prior to joining GSA, he had a 17-year career with the American Pharmacists Association (APhA), where he served in a variety of roles before being appointed chief operating officer. Before joining APhA, he was on faculty at the Philadelphia College of Pharmacy and Science (PCPS). Dr. Appleby holds a B.S. in pharmacy from PCPS and an M.P.H. PREPUBLICATION COPY: UNCORRECTED PROOFS C-1

C-2 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN from Temple University. He has been awarded an honorary Doctor of Science degree from the University of the Sciences in Philadelphia. MARIE A. BERNARD, M.D., serves as deputy director of the National Institute on Aging (NIA) at the National Institutes of Health (NIH). As NIA’s senior geriatrician, she serves as the principal advisor to the NIA director, working closely with the director in overseeing approximately $3.1 billion in aging and Alzheimer’s disease research conducted and supported annually by the Institute. She co-chairs two new Department of Health and Human Services Healthy People 2020 objectives: (1) older adults and (2) dementias, including Alzheimer’s disease. Within NIH she co-chairs the Inclusion Governance Committee, which oversees inclusion in clinical research by sex/gender, race/ethnicity, and age, including pediatric and older adult subjects. She has been recognized for her leadership in geriatrics by receipt in the Clark Tibbitts Award from the Academy for Gerontology in Higher Education (2013), and the Donald P. Kent Award from the Gerontological Society of America (2014). Until 2008 she was the endowed professor and founding chairperson of the Donald W. Reynolds Department of Geriatric Medicine at the University of Oklahoma College of Medicine (the third department of geriatrics in the United States), and associate chief of staff for geriatrics and extended care at the Oklahoma City Veterans Affairs Medical Center. She has held numerous national leadership roles, including chair of the Clinical Medicine Section of the Gerontological Society of America, chair of the U.S. Department of Veterans Affairs National Research Advisory Committee, board member of the American Geriatrics Society, president of the Academy for Gerontology in Higher Education, and president of the Association of Directors of Geriatric Academic Programs. She has lectured and published widely in her area of research, nutrition and function in older populations, as well as topics related to geriatric education. She received her undergraduate education at Bryn Mawr College and her M.D. from the University of Pennsylvania. She trained in internal medicine at Temple University Hospital in Philadelphia, Pennsylvania, where she also served as chief resident. She has received additional training through the AAMC Health Services Research Institute, the Geriatric Education Center of Pennsylvania, and the Wharton School Executive Development program. N. SETH BERRY, PHARM.D., is a senior director in the Decision Sciences group at IQVIA. He obtained his Pharm.D. from the University of Missouri–Kansas City, School of Pharmacy. He completed a 2-year postdoctoral pharmacokinetic/pharmacodynamics (PK/PD)fellowship with the University of North Carolina, and a 2-year pharmacometrics fellowship with the Center for Drug Development Science at Georgetown University. Since joining IQVIA (formerly Quintiles) in 2004, Dr. Berry’s research has focused primarily on performing population (PK/PD) modeling and clinical trial simulations to optimize dose selection and study design. His work also centers on the development of precision dosing applications for individualizing pharmacotherapy, building high-performance computing solutions, and authoring R packages for non-linear mixed effects modeling. Dr. Berry has numerous publications and presentations in the pharmacometrics discipline, while also mentoring students, fellows, and colleagues through various workshops and training seminars. SCOTT BERRY, M.S., PH.D., is president and a senior statistical scientist at Berry Consultants, LLC. He earned his M.S. and Ph.D. in statistics from Carnegie Mellon University and was an assistant professor at Texas A&M University before cofounding Berry Consultants in 2000. He PREPUBLICATION COPY: UNCORRECTED PROOFS

BIOSKETCHES C-3 has led Berry Consultants to be widely regarded as the premier Bayesian consulting company in the world. Since 2000, he has been involved in the design of hundreds of Bayesian adaptive clinical trials of pharmaceuticals and medical devices and has become an opinion leader in the field of Bayesian adaptive clinical trials. Some of these trials have been groundbreaking trial designs, setting new standards for innovation and flexibility in trial design. These include the trials supporting the first fully Bayesian approval by the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (Pravastatin–aspirin combination) and the statistical design for TIME Magazine’s #2 Medical Breakthrough of 2007 (Veridex’s GeneSearch BLN Assay). CIANTEL BLYLER, PHARM.D., CHC, is a clinical research pharmacist at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Blyler earned a Doctor of Pharmacy degree from the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill and completed her clinical work at Duke University Health System. After graduation she worked as a clinical pharmacist at Senior PharmAssist, a non-profit based in Durham, North Carolina, where she provided free medication therapy management services to low-income, dual-eligible geriatric patients as part of an initiative with Community Care of North Carolina. Upon moving to the West Coast, she managed an independent specialty pharmacy in Beverly Hills, California, before joining Cedars-Sinai in 2016. There she served as one of two full-time clinical research pharmacists on a National Heart, Lung, and Blood Institute-funded randomized trial that investigated a novel community-based approach to treat hypertension in African-American male patients. The trial involved pharmacists, barbers, and physicians. The highly successful intervention was recognized by the Clinical Research Forum as the Top Research Achievement of the Year. Dr. Blyler has spoken about this work at multiple national meetings, including ASN Kidney Week (2019), American Heart Association (AHA) Hypertension Sessions (2018), and the National Medical Association meeting (2016). She is a co-author on articles in the New England Journal of Medicine, Circulation, and The Journal of the American Heart Association and has been covered in TIME Magazine, The Washington Post, and CNN. She is a certified hypertension clinician and a member of the Target BP advisory board, a collaboration between the American Medical Association and AHA. Her professional interests include health disparities research, community-based practice, cardiology, and geriatrics. ROBERT CALIFF, M.D., MACC, is the head of clinical policy and strategy for Verily Life Sciences and Google Health for Verily and Google Health. Prior to this Dr. Califf was the vice chancellor for health data science for the Duke University School of Medicine; director of Duke Forge, Duke’s center for health data science; and the Donald F. Fortin, M.D., Professor of Cardiology. He served as deputy commissioner for medical products and tobacco in the U.S. Food and Drug Administration from 2015 to 2016, and as commissioner of food and drugs from 2016 to2017. A nationally and internationally recognized leader in cardiovascular medicine, health outcomes research, health care quality, and clinical research, Dr. Califf is a graduate of the Duke University School of Medicine. Dr. Califf was the founding director of the Duke Clinical Research Institute and is one of the most frequently cited authors in biomedical science. BEVERLY CANIN, a breast cancer survivor, is a former member of the board of directors of Breast Cancer Action, a national organization dedicated to inspiring and compelling societal changes necessary to end the breast cancer epidemic; president of Breast Cancer Options, a PREPUBLICATION COPY: UNCORRECTED PROOFS

C-4 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN grassroots support, education, and advocacy organization serving six counties in the Hudson Valley; patient advocate member of the Cancer and Aging Research Group, seeking to improve cancer care for older adults with cancer; and chair of Stakeholders for Care in Oncology and Research for our Elders (SCOREboard), a patient and caregiver advisory group STEVEN CHEN, PHARM.D., FASHP, FCSHP, FNAP, is an associate professor and associate dean for clinical affairs at the University of Southern California (USC) School of Pharmacy and the William A. Heeres and Josephine A. Heeres Chair in Community Pharmacy. He received his Pharm.D. from USC and completed a USC-affiliated residency in 1990. Before joining the faculty at USC in 1998, he was a quality assurance pharmacist and clinical pharmacy coordinator at the Department of Veterans Affairs. Dr. Chen has received honorary fellowships from the California Society of Health-System Pharmacists (CSHP), the American Society of Health- System Pharmacists (ASHP), and the National Association of Practitioners. He is a member of research and practice teams that have been awarded the Best Practices Award from ASHP twice (2002 and 2008), the American Pharmacists Association Pinnacle Award (2007), and the American Association of Colleges of Pharmacy Inaugural Community Transformative Award (2009). He received the USC School of Pharmacy Outstanding Alumnus of the Year Award and the American Pharmacists Association Pinnacle Award for individual career achievement in 2013. In 2015, he received the American Heart Association Multicultural Initiatives Award, the Schweitzer Fellowship Leadership Award, and the CSHP Innovator Award. He was recognized by the Centers for Medicare and Medicaid Services in 2016 for his collaboration with The Partnership for Public Service that contributed to 87,000 lives saved, 2.1 million fewer patient harms, and $19.8 billion in cost savings. In 2017, Dr. Chen received a third Pinnacle Award through his partnership with the Center for Medicare & Medicaid Innovation, and in 2018, he received the Pharmacist of the Year Award from CSHP. Dr. Chen has received multiple teaching awards from USC students and residents. DEBORAH COLLYAR has been a leader in cancer patient advocacy since 1991, using successful business, leadership, information technology, and communication skills to bridge research gaps among science, medical providers, and patients. Her patient advocacy work encompasses many diseases, programs, and policies at grassroots, national, and international levels. She also provides guidance to organizations, institutions, universities, cancer centers, non-profits, government agencies, companies, and most importantly, to patients. Ms. Collyar founded the PAIR international network, helped initiate the National Cancer Institute (NCI) SPORE program, and served as program director for their Patient Advocate Research Team (PART) Program. She also started patient advocacy in many cooperative groups and cancer centers, and has helped plan national and international biobanks. She has also served on many committees and boards, including: the NCI Experimental Therapeutics (NExT) program, and Board of Scientific Counselors; Princeton Physical Sciences in Oncology Center; Agency for Healthcare Research and Quality Comparative Effectiveness Research Stakeholder Council; as chair of the CALGB Committee on Advocacy, Research Communication, Ethics, and Disparities (CARE); and as vice chair of the Alliance for Clinical Trials in Oncology (Alliance) Publications Committee. She and her husband have survived three cancers. STEVEN R. CUMMINGS, M.D., is a professor of medicine, epidemiology, and biostatistics Emeritus at the University of California, San Francisco (UCSF), and executive director of the PREPUBLICATION COPY: UNCORRECTED PROOFS

BIOSKETCHES C-5 San Francisco Coordinating Center. He designed and led numerous clinical trials, including pivotal trials of therapies for U.S. Food and Drug Administration approvals. He co-founded the UCSF Clinical Research Training Program and is a co-author of Designing Clinical Research (Williams and Wilkins). He is an expert in clinical research on aging, leading several large studies of the biological basis of human aging and biomarkers of aging outcomes and has served on the National Institute on Aging’s (NIA’s) National Advisory Council on Aging. He has more than 600 publications and was elected to the National Academy of Medicine for his accomplishments in clinical research. Dr. Cummings is also a pioneer in “direct-to-participant” AKA “Virtual” AKA home-based clinical trials and interactive e-consent. Pertinent to this conference, Dr. Cummings leads the NIA-funded TOPAZ trial, a randomized trial of an IV treatment for osteoporosis in patients age 65 or older with Parkinson’s disease, that is being conducted entirely from patients’ homes. KATHERINE DAWSON, M.D., senior vice president, Therapeutics Development Group, started at Biogen in 2004 from Massachusetts General Hospital, where she trained and was an attending physician in the Neuromuscular Group. During her initial 9 years in clinical development, she worked on Tysabri, Avonex, and Plegridy, and brought Tecfidera through Phase 3 trials and approval in the United States and European Union. For the next 4 years, she worked on the Medical Affairs leadership team, first as vice president (VP), Global Medical Neurology, and then VP, US Medical. In June Dr. Dawson transitioned back to Development and her current role. She received her M.D. from Albert Einstein College of Medicine in New York. She is currently chair of the Biogen Foundation, our nonprofit organization. CHRISTINA FRIEDRICH, PH.D., brings more than 17 years of leadership expertise in applying mathematical models of biologic/physiologic systems for overcoming development challenges faced by pharmaceutical and consumer product companies. At Rosa (and previously at Entelos, Inc.), she has developed significant experience in the fields of diabetes, blood disorders, central nervous system disorders, oncology, immune oncology, rheumatoid arthritis, respiratory diseases, skin diseases, gastrointestinal disorders, and other immune system dysfunctions and inflammatory processes. While at Rosa, Dr. Friedrich developed and published the first peer- reviewed journal article on the qualification of mechanistic mathematical models. Before Rosa, she was the director of core product development at Entelos, Inc., the first-generation leader in PhysioPD-style models. She has spearheaded numerous modeling methodologies and contributed to foundational patents, including on the use of virtual patients and populations to explore biological variability and uncertainty, and on the identification of biomarkers. She completed her B.S. at the Massachusetts Institute of Technology and her Ph.D. in management science and engineering at Stanford University. JASON KARLAWISH, M.D., is a physician and writer. He is a professor of medicine, medical ethics and health policy as well as neurology at Penn and cares for patients at the Penn Memory Center, which he co-directs. His research focuses on issues at the intersections of bioethics, aging, and the neurosciences. He leads the Penn Program for Precision Medicine for the Brain (P3MB). He has investigated the development and translation of Alzheimer’s disease treatments and biomarker-based diagnostics, informed consent, quality of life, research and treatment decision making, and voting by persons with cognitive impairment and residents of long-term PREPUBLICATION COPY: UNCORRECTED PROOFS

C-6 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN care facilities. P3MB has developed standards for Alzheimer’s disease biomarker disclosure and investigated the clinical impacts of this knowledge on persons and their families. GEORGE A. KUCHEL, M.D., FRCP, is a professor of medicine, Travelers Chair, and director of the University of Connecticut Center on Aging. This center brings together clinicians, educators, clinical investigators, basic scientists, and researchers conducting health outcome/population studies who are all committed to the discovery of strategies for promoting independence and health in old age. Dr. Kuchel’s research, funded by the National Institutes of Health and other agencies, is focused on precision gerontology, an approach designed to help older adults remain healthy and independent in a manner that is both individualized and guided by mechanisms. To that end, his work focused on potentially targetable pathways contributing to functional declines involving host defense, mobility, continence, and cognition. ROSANNE M. LEIPZIG, M.D., PH.D., is an internationally recognized leader in the field of geriatrics and has received numerous awards for her work, including the American College of Physicians Richard and Hinda Rosenthal Foundation Award, Joy McCann Scholar, Dennis W. Jahnigen Memorial Award from the American Geriatrics Society (2008), Brookdale National Fellowship in Geriatric Medicine, and the Paula Ettelbrick Community Service Award from Services & Advocacy for GLBT Elders (2014). She also received the Jacobi Medallion, one of the highest honors from the Mount Sinai Health System (2016). She is the editor-in-chief of Focus on Healthy Aging, a monthly newsletter. Dr. Leipzig has published more than 100 articles and published two groundbreaking books on geriatrics. During her career as a doctor, she has been named as one of the Best Doctors in America (Woodward/White, Inc.), Best Doctors in the New York Metro Area (The Castle Connolly Guide), America’s Top Physicians (Consumers’ Research Council of America), a New York Times SuperDoc, and one of New York Magazine’s Top Doctors for Geriatric Medicine. She has appeared on The Today Show, CBS Evening News, CBS Sunday Morning, CNN, and AARP Webinars, and has been published in TIME Magazine, The New York Times, The Wall Street Journal, Bottom Line Health, AARP The Magazine, and American Medical News, among others. Dr. Leipzig is currently writing a book about what to expect as during the aging process. STUART M. LICHTMAN, M.D., is an attending physician and member, Memorial Hospital for Cancer and Allied Diseases; member, Memorial Sloan Kettering Cancer Center; and professor of medicine, Weill Cornell Medical College. He is a member of the 65+ Clinical Geriatrics Program and Gynecologic Oncology Disease Management Team at the Center. He has been on the Board of Directors and treasurer of SIOG since 2010 and has participated in multiple task forces (Chemotherapy, as chair; Geriatric Assessment; Renal Dysfunction; Lymphoma; and Oral Chemotherapy). He was also U.S. national representative and scientific chair of the 2011 meeting. He has been a participant in the Alliance for Clinical Trials in Oncology (formerly CALGB) as a member of the Pharmacology and Experimental Therapeutics Committee (1990- 2008) and the Cancer in the Elderly Committee (1995-present). His work also included the Scientific Advisory Board of the Geriatric Oncology Consortium, the Elderly Taskforce of the Gynecologic Oncology Group, Cancer and Aging Research Group and the NCCN Guidelines Taskforce for the treatment, Evaluation of Older Women with Breast Cancer, editorial board of the Journal of Geriatric Oncology, External Advisory Board of the University of Iowa Cancer Center, Governing Board Cancer, and the Kidney International Network. He has been a member PREPUBLICATION COPY: UNCORRECTED PROOFS

BIOSKETCHES C-7 of the American Society of Clinical Oncology (ASCO) since 1988 and has been an active participant by serving on the Clinical Practice Committee, Scientific Program Committee, and Geriatric Oncology Special Interest Group. He has been an invited speaker at Educational Sessions, ASCO University, and ASCO Post and a faculty member of the ASCO/AACR Vail Clinical Trials workshop for five sessions on the topic of special populations. LAUREL J. PRACHT represents the patient perspective as protocols evolve into research concepts through her membership in a nationwide cooperative group. As lead patient advocate for a cancer prevention clinical trial, she assisted with the accrual of participants and direct support of the trial. As a member of the National Cancer Institute Symptom Management and Health- Related Quality of Life Steering Committee, her goal in reviewing concepts is to include suggested shared decision-making materials and adverse events to ensure patient-centeredness is a central goal of research. As a Patient-Centered Outcomes Research Institute (PCORI) Ambassador, Ms. Pracht participated in a site visit to the Zuni Nation in Zuni, New Mexico, for an ongoing clinical trial. There, she reviewed a paper that was later published in a scientific journal. She became a PCORI Ambassador after cycling off the inaugural Patient Engagement Advisory Panel and anticipates that she will remain involved in the Ambassador program. Ms. Pracht received her B.S. at the University of Nebraska. She has also received Research Advocacy Network Symposium advocate training, and the American Society of Clinical Oncology Patient Advocate Training. JOHN POWERS, M.D., is the senior medical scientist at Leidos Biomedical Research in support of the Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, and an associate clinical professor of medicine at The George Washington University School of Medicine in Washington, DC. His’ research interests are in clinical trials in a variety of infectious diseases, with a focus on research methodology and patient-centered outcomes, and measuring the safety and effectiveness of medical interventions. Dr. Powers also has a research interest in antimicrobial resistance and appropriate antimicrobial use. He was the co-chair of the U.S. Inter-Agency Task Force on Antimicrobial Resistance and is a member of the World Health Organization Advisory Group on Integrated Surveillance of Antimicrobial Resistance. He received medical training in internal medicine at Temple University School of Medicine and subspecialty training in infectious diseases at the University of Virginia. ERIKA RAMSDALE, M.D., is a dual-trained and board-certified geriatrician and oncologist at the University of Rochester Wilmot Cancer Institute. Her research involves the development and implementation of care delivery interventions to decrease polypharmacy in older adults with cancer. She has authored multiple peer-reviewed articles about polypharmacy and association with adverse outcomes within this population, and she is currently studying the role of virtual, pharmacist-led “deprescribing” interventions for these patients. She also has interest and expertise in the role of information technology in the care of older adults with cancer, including the development of digital approaches to remotely capture patient-reported data. She received her B.S. and M.D. from the University of Kansas; she completed her residency and fellowships in Hematology/Oncology and Geriatric Medicine at the University of Chicago. She is a current graduate student at the Goergen Institute for Data Science at the University of Rochester. PREPUBLICATION COPY: UNCORRECTED PROOFS

C-8 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN STEVEN ROTHSCHILD, M.D., is a family physician, educator, and researcher in the Departments of Preventive Medicine and Family Medicine at Rush University. In addition to a 30-year clinical career focused on providing primary medical care to the medically underserved, he is an established researcher focusing on health services research, chronic illness self-management, and community- and team-based approaches to addressing health disparities. As an expert in community-based participatory research, he has been an invited faculty member for the National Institutes of Health Summer Institute on Design and Conduct of Randomized Clinical Trials involving behavioral interventions, sponsored by the Office of Behavioral and Social Sciences Research. As a faculty member at Rush, he has been recognized by students for his teaching excellence and humanism. He is also the co-convener of Rush’s interprofessionalism interest group, bringing together over 30 clinicians and faculty from across the Medical Center to improve team-based education, research, and patient care. Dr. Rothschild serves on the Chicago Board of Health, the advisory committee for the Albert Schweitzer Fellowship Program, and the Health and Medicine Policy Research Group, where he is vice president. HARPREET SINGH, M.D., is a medical oncologist at the U.S. Food and Drug Administration (FDA) with an emphasis on cancer in older adults. She continues to see patients in a prostate cancer multidisciplinary clinic at the National Cancer Institute (NCI). She is native of Los Angeles and graduated from the University of California, San Diego, before completing her M.D. at the University of Southern California Keck School of Medicine. She completed her internal medicine residency and geriatrics fellowship at the Los Angeles County + University of Southern California Medical Center. She then went on to NCI for a fellowship in medical oncology. She focused on tumor immunology and biology, including cancer vaccines and immunotherapy clinical trials. Dr. Singh joined FDA as a medical officer in 2015, where she quickly established herself as a leader in geriatric oncology. RAJESHWARI SRIDHARA, PH.D., is director of the Division of Biometrics V in the Office of Biostatistics, which supports the Office of Hematology Oncology Products in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). Dr. Sridhara has contributed to the understanding of statistical issues unique to the area of oncology disease, such as evaluation and analysis of time to disease progression. Her research interests include evaluation of surrogate markers and design of clinical trials. She has organized, chaired, and given invited presentations at several workshops, and has worked on regulatory guidance documents across multiple disciplines. She has published extensively in refereed journals and presented at national and international conferences. She is an elected fellow of the American Statistical Association. Prior to joining FDA, Dr. Sridhara was a project statistician for the AIDS vaccine evaluation group at EMMES Corporation, and was an assistant professor at the University of Maryland Cancer Center. SUSAN STRONG, M.A., works with local organizations, including CU, as an Entrepreneur in Residence; SAGE in Boulder and Fort Collins, Colorado, helping early-stage companies connect with teams of expert advisors; mentoring women-led companies with MergeLane; and as an Innosphere program manager helping with start-up and scale-up. She is the principal of The Strong Group, a high-technology consulting firm focusing on business development, sales and marketing, and market research. She has served in marketing executive positions at public and private companies, including Agilent Technologies, Dionex, Dharmacon, GeneData, and PREPUBLICATION COPY: UNCORRECTED PROOFS

BIOSKETCHES C-9 Genomica. She advises the SJSU Master’s in Biotechnology program. Her degrees are from Penn State (B.S. in chemistry) and University of North Carolina at Chapel Hill (M.S. in analytical chemistry). ROBERT TEMPLE, M.D., serves as the Center for Drug Evaluation and Research’s (CDER’s) deputy center director for clinical science and senior advisor in the immediate office of the Office of New Drugs (OND). As the senior advisor, he is a consultant to the OND director and other U.S. Food and Drug Administration officials on matters related to clinical program objectives. Dr. Temple received his M.D. from the New York University School of Medicine in 1967. In 1972, he joined CDER as a 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. Before becoming senior advisor in OND, Dr. Temple was the acting deputy director of OND’s Office of Drug Evaluation-I (ODE-I), which is responsible for the regulation of cardiovascular and renal, neurology, and psychiatry drug products. He served in this capacity for more than 23 years—since the office’s establishment in 1995. JONATHAN TOBIN, PH.D., FACE, FAHA, is the president/chief executive officer of Clinical Directors Network Inc. and codirector of community-engaged research at The Rockefeller University Center for Clinical and Translational Science. He teaches the fundamentals of getting started in collaborative community-based research to a live audience of family health center clinicians. A board-certified epidemiologist, Dr. Tobin leads the audience through the key concepts and importance of translational research, the basic epidemiological skills necessary for the development and understanding and interpretation of community-based research, and how epidemiological measures relate to clinical research and clinical practice. Topics covered include measures of morbidity and mortality (prevalence and incidence), causal inference, data collection methods, validity, reliability, and working with human subjects. He closes with a practical exercise that assists with conceptualizing and developing research aims and questions. ERIC TOPOL, M.D., is a professor in the Department of Molecular Medicine, is an executive vice president at Scripps Research, and is the founder and director of the Scripps Research Translational Institute (previously Scripps Translational Science Institute). His work melds genomics, big data, and both information technologies and digital health technologies to advance the promise of personalized medicine. In 2016, the National Institutes of Health awarded Dr. Topol a $207 million grant to lead a significant part of the All of Us Research Program, a long- term research endeavor aimed at understanding how a person’s genetics, environment, and lifestyle can guide approaches to preventing or treating disease. Dr. Topol has published more than 1,100 peer-reviewed articles, and his more than 200,000 citations place him among the top 10 most cited researchers in medicine as measured by Thomson Reuters’ Institute for Scientific Information. Widely viewed as one of the most influential physician leaders in the country, Dr. Topol is the author of two best-selling books on the future of medicine: The Creative Destruction of Medicine and The Patient Will See You Now. His next book, Deep Medicine, focused on artificial intelligence, will be published in 2019. JONATHAN WATANABE, PHARM.D., PH.D., M.S., seeks to determine factors that jeopardize appropriate medication use. Dr. Watanabe practices in senior care pharmacy and focuses on outcomes in older adults and residents of extended care facilities. He has completed PREPUBLICATION COPY: UNCORRECTED PROOFS

C-10 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN investigations on (1) the role of adherence on surrogate markers for chronic conditions; (2) the effect of copayment and copayment pricing on adherence; (3) the impact of polypharmacy on adherence; (4) the role of pharmacy benefit on health services; and (5) the methods used in health services research applying large national data. Collaborating with an interdisciplinary care team, Professor Watanabe initiated longitudinal assessments of outcomes in postacute care settings and characterized those at risk for poor adherence and compromised health outcomes in veterans with chronic diseases. He has served as an invited speaker at several international forums devoted to improving care for seniors in long- term care settings and provided presentations on pharmacy benefit and evaluation at the National Academy of Sciences. He currently trains students, postdocs, and practitioners in multiple disciplines in clinical research and postacute care. Professor Watanabe is a clinical consultant for the Program of All-inclusive Care for the Elderly (PACE) Clinic in San Diego, California, and the Villa Pomerado Skilled Nursing Facility in Poway, CA. He is an investigator on the Health Resources and Services Administration-funded San Diego Geriatrics Workforce Enhancement Program Grant. Dr. Watanabe was the inaugural recipient of the University of Washington/Allergan Health Economics and Outcomes Research Fellowship. He serves as the advisor for the Academy of Managed Care Pharmacy student chapter. Dr. Watanabe serves the California State Legislature as a faculty content expert for the California Health Benefits Review Program. He serves as a member of the advisory group on pain assessment and management standards for long-term care organizations for The Joint Commission. He was a contributing author to the Making Medicines Affordable consensus report from the National Academies of Sciences, Engineering, and Medicine. He is a board-certified geriatric pharmacist. PREPUBLICATION COPY: UNCORRECTED PROOFS

Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop Get This Book
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There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population.

On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.

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