Drug Research and Development for Adults Across the Older Age Span: A Workshop

Workshop

Download PDF

Paperback - $36.00
Ebook - $29.69

Request an exam or desk copy

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.

Publication information

142 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-68568-0
ISBN Ebook: 0-309-68569-9
DOI: https://doi.org/10.17226/25998

Suggested citation

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.

Import this citation to:

James C. Appleby

James C. Appleby, BSPharm, MPH, ScD (Hon), 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the Society’s current initiative to “reframe aging” in America by fostering accurate narratives of aging to replace the outdated “conventional wisdom” that dominates public understanding.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, earlier detection of cognitive impairment, improving oral health, and demonstrating the impact of the longevity economy. Appleby also is currently serving a four-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). Appleby holds a bachelor of science degree in pharmacy from PCPS and a master of public health degree from Temple University. He has been awarded an honorary Doctor of Science degree from the University of the Sciences in Philadelphia.

Marie A. Bernard

Marie A. Bernard, MD serves as Deputy Director of the National Institute on Aging (NIA) at the National Institutes of Health. 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 – inclusive of 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 October 2008 she was the endowed professor and founding chairman of the Donald W. Reynolds Department of Geriatric Medicine at the University of Oklahoma College of Medicine (the third department of geriatrics in the U.S.), 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 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 related to geriatric education. She received her undergraduate education at Bryn Mawr College and her MD from University of Pennsylvania. She trained in internal medicine at Temple University Hospital in Philadelphia, PA, 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.

Barry S. Coller

Dr. Coller serves as Physician in Chief, Vice President for Medical Affairs and the David Rockefeller Professor at The Rockefeller University. An authority on the cardiovascular biology of integrins and TGF-beta, Dr. Coller is a member of the Institute of Medicine, the National Academy of Sciences and was founding president of the Society for Clinical and Translational Science. Dr. Coller is a pioneer in the discovery and development of monoclonal antibodies for use as human therapeutics. He played the central role in discovering the active component and mechanism of abciximab (ReoPro(R)), and he was a leader in its subsequent clinical development resulting in one of the first FDA approvals of and antibody medicine. He has been a Member of Scientific Advisory Board at Scholar Rock, Inc. since September 2014.

Deborah Collyar

Deborah Collyar has been a leader in cancer patient advocacy since 1991, utilizing successful business, leadership, IT and communication skills to bridge research gaps between science, medical providers and patients. Her patient advocacy work encompasses many diseases, programs and policies at grassroots, national and international levels. She also gives 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 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. Deborah 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 (PS-OC); AHRQ Comparative Effectiveness Research (CER) 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. Deborah and her husband have survived 3 cancers.

R. D. Harvey

R. Donald Harvey, PharmD, is Professor in the Department of Hematology and Medical Oncology with a joint appointment in the Department of Pharmacology and Chemical Biology at Emory University School of Medicine. A board certified oncology pharmacist, Dr. Harvey serves as director of Winship Cancer Institute's Phase I Clinical Trials Unit and as chair of the Data and Safety Monitoring Committee. He is a Fellow of the American College of Clinical Pharmacy and a Fellow of the Hematology/Oncology Pharmacy Association. Dr. Harvey has established an active clinical pharmacology research program in cancer at Emory with the goal of using pharmacokinetic, pharmacodynamic, and other tools to improve individualization of therapy and clinical outcomes. An active principal and co-investigator on multiple trials, he also consults on experimental design of preclinical and clinical studies with a focus on optimizing correlative measures. Dr. Harvey's research interests include the clinical application of pharmacokinetic, pharmacodynamic, and pharmacogenomic data to patient care. Specific areas of research interest include agent tolerability and disposition in renal and hepatic impairment, effects of novel immunotherapeutics on hepatic metabolism, and use of therapeutic drug monitoring for anticancer agents. He is also active nationally and internationally in several cancer and pharmacology professional organizations. Dr. Harvey is also a past President of the Hematology and Oncology Pharmacy Association, an international professional organization.

Alex London

Alex John London is the Clara L. West Professor of Ethics and Philosophy and Director of the Center for Ethics and Policy at Carnegie Mellon University. An elected Fellow of the Hastings Center, Professor London’s work focuses on ethical and policy issues surrounding the development and deployment of novel technologies in medicine, biotechnology and artificial intelligence, on methodological issues in theoretical and practical ethics, and on cross-national issues of justice and fairness. His papers have appeared in Mind, The Philosopher’s Imprint, Science, JAMA, The Lancet, The BMJ, PLoS Medicine, Statistics In Medicine, The Hastings Center Report, and numerous other journals and collections. He is also co-editor of Ethical Issues in Modern Medicine, one of the most widely used textbooks in medical ethics.

Miriam Mobley Smith

Dr. Mobley Smith received her BS in Pharmacy from the University of Michigan in 1978. She went on to earn her PharmD from the University of Illinois and completed a pharmacy practice residency at Sinai Hospital of Detroit. Dr. Mobley Smith is currently Interim Dean and Visiting Professor at Northeastern University Bouve' College of Health Sciences School of Pharmacy at Boston. She has held numerous leadership positions during her career, notably serving as the Director of Strategic Alliances for the Pharmacy Technician Certification Board in Washington, D.C. She spent twelve years as a clinical faculty member and eventually the Director of Experiential Education at the University of Illinois at Chicago College of Pharmacy. Dr. Mobley Smith spent eight years at the Chicago State University College of Pharmacy, ultimately servings as Dean until her departure in 2015. She has also served leadership positions in numerous professional pharmacy organizations. She was chair for the American Association of Colleges of Pharmacy Professional Affairs Committee, vice-chair of the Illinois State Board of Pharmacy, chair of the American Society of Health-System Pharmacists Council on Education and Workforce Development, a member of the Institute of Medicine Committee on the Future Healthcare Workforce for Older Americans, Pharmacy Workforce Center, Inc., Technical Advisory Panel, and on the Professional Examination Service Board of Directors. Dr. Mobley Smith has received numerous grants, professional and civic awards, including recognition as a 2013 Fellow of the American Society of Health-System Pharmacists, the 2012 National Pharmaceutical Association’s Chauncey I. Cooper Award in recognition of sustained and distinguished professional service, and the 2013 Illinois Pharmacists Association Pharmacist of the Year.

David B. Reuben

Dr. Reuben is Director, Multicampus Program in Geriatrics Medicine and Gerontology and Chief, Division of Geriatrics at the University of California, Los Angeles (UCLA) Center for Health Sciences. He is the Archstone Foundation Chair and Professor at the David Geffen School of Medicine at UCLA and Director of the UCLA Claude D. Pepper Older Americans Independence Center and the UCLA Alzheimer's and Dementia Care program. Dr. Reuben sustains professional interests in clinical care, education, research and administrative aspects of geriatrics, maintaining a clinical primary care practice of frail older persons and attending on inpatient and geriatric psychiatry units at UCLA. His bibliography includes more than 220 peer-reviewed publications in medical journals, 39 books and numerous chapters. Dr. Reuben is lead author of the widely distributed book, Geriatrics at Your Fingertips. Dr. Reuben is a past President of the American Geriatrics Society and the Association of Directors of Geriatric Academic Programs. He served for 11 years on the Geriatrics Test Writing Committee for the American Board of Internal Medicine (ABIM) and for 8 years on the ABIM's Board of Directors, including as Chair from 2010-2011.

Research Interests: Health services delivery to older persons; Functional assessment; Predictors of survival and functional impairment; Alzheimer's and Dementia Care; Falls. Technical Research Interests: Clinical and social epidemiology; Health services research, including economics; Interventional and behavioral research; Measurement. Past President of the American Geriatrics Society; Past President of Directors of Geriatric Academic Programs (ADGAP); Past Chair of the Board of Directors of the American Board of Internal Medicine; Chief, Division of Geriatrics Medicine at UCLA.

Mark Rogge

Mark Rogge, PhD, FCP serves as Global Head of Quantitative Translational Science at Takeda Pharmaceuticals, International. He oversees all discovery and development modeling & simulation, clinical pharmacology, imaging, and Bioanalytical Sciences. In this role and throughout his career he has promoted the application of advanced modeling & simulation to pharmacokinetic and pharmacologic processes in the preclinical and clinical realms, and applied these principles to both efficacy and to safety. His work has encompassed small molecules, glycoproteins, antisense constructs, and most recently, gene/cellular therapy. Mark has given numerous plenary presentations related to drug development at scientific and regulatory conferences; he has more than 80 peer-reviewed publications and invited presentations at scientific symposia. He is Past Chair of the AAPS PPDM Section, Past Chair of BIO’s Safety and Pharmacokinetics scientific advisory section and Past Chair of the Clinical Pharmacology Leadership Group for the International Consortium for Innovation and Quality in Pharmaceutical Development. Mark completed his undergraduate studies at the University of Wisconsin, where he is a Citation of Merit recipient, and completed his graduate work at the University of Michigan.

Janice Schwartz

Janice B. Schwartz, MD, is a board-certified internist and cardiologist with a distinguished record of leadership and research in clinical pharmacology and geriatric medicine. She received her medical degree from Tulane University School of Medicine and completed an internship in internal medicine at LAC/USC Medical Center and internal medicine residency training at Cedar Sinai Medical Center, Los Angeles. She began cardiology training at Cedar Sinai followed by a combined clinical and research cardiology fellowship at Stanford University, where she focused on evaluation of new cardiovascular drugs in clinical populations. She began her faculty career in the Department of Medicine at Baylor College of Medicine in the Divisions of Cardiology and Clinical Pharmacology. She has been an active member of cardiology, clinical pharmacology and geriatric professional societies, including serving as President of the Society for Geriatric Cardiology and Vice President of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), past member of the Board of Directors and a former member of the ASCPT Editorial Board. She has served on NIH peer review committees for more than sixteen years during her career and served on the Advisory Panel on Geriatrics, USP Pharmacopeial Convention, Inc., and on the Institute of Medicine’s Committee on Pharmacokinetics and Drug Interactions in the Elderly.
Dr. Schwartz’s research has focused on understanding drug responses to medications and especially factors leading to altered drug responses in older people. She has utilized laboratory and clinical investigations to investigate changes in cardiovascular function and rhythm, the autonomic system, and drug pharmacokinetics and pharmacodynamics in models of healthy aging and in patient populations including the frail elderly. Her work has improved the understanding of age and disease-related effects that can lead to improved use of therapeutic medications. She has also elucidated gender differences in drug metabolism and responses that are especially pertinent in the clinical care of patients. Working within both the research and clinical worlds has provided the opportunity to translate research findings into clinical practice and to train and mentor others. Her goal of improving medication therapy for older patients has also led to efforts beyond research in the form of contributing to textbooks for health care professionals, creating on-line educational content for health care professionals, and writing on medication and health- related issues in the lay press.

Robert Temple

Dr. Robert Temple serves as 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, Bob is a consultant to the OND director and other FDA officials on matters related to clinical program objectives. Dr. Temple received his medical degree 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.
Dr. Temple has a long-standing interest in the design and conduct of clinical trials. He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation and active control trials, trials to evaluate dose-response, and trials using “enrichment” designs. He has been involved in the development of many International Conference on Harmonization (ICH) guidelines and numerous FDA guidances, including ones on study enrichment and on issues related to the design and interpretation of non-inferiority studies.

Jonathan Watanabe

Jonathan Watanabe, PharmD, Ph.D., BCGP, is professor of clinical pharmacy and Associate Director and Founding Associate Dean of Assessment and Quality at the University of California Irvine Samueli College of Health Sciences and National Academy of Medicine Emerging Leader in Health and Medicine Scholar. He was a contributor to the National Academy of Sciences, Engineering, and Medicine (NASEM) Making Medicines Affordable: A National Imperative consensus report and is a current member of the NASEM ad hoc committee on Implications of Discarded Weight-Based Drugs. Dr. Watanabe employs real-world data to develop policy solutions to improve patient care, augment population health, and reduce medical costs. Watanabe focuses on improving access to evidence-driven medication use and pharmacist-directed patient care. He serves as an advisor to the California Health Benefits Review Program for the California State Legislature. His research on safe and effective medication use has been cited in enacted legislation efforts. He served as an investigator, faculty, and fellowship director for the federal Health Resources and Services Administration funded San Diego Geriatrics Workforce Enhancement Program and is a current investigator for the California Tobacco-related Disease Research Program. Dr. Watanabe was the inaugural recipient of the University of Washington/Allergan Global Health Economics and Outcomes Research Fellowship. He is an advisor to the Joint Commission on pain management and assessment standards in long-term care and to the California Health Benefits Review Program for the California Legislature. He currently serves as a Distinguished Fellow for the not-for-profit Get the Medications Right Institute. He received his BS from the University of Washington (UW). He received a doctor of pharmacy (PharmD) from the University of Southern California. He received an MS and PhD from the UW Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute. He is a Board-Certified Geriatric Pharmacist (BCGP).

Barbara Zarowitz

Dr. Zarowitz previously served as vice president for pharmacy care management at Henry Ford Health System; vice president and chief clinical office at Omnicare, Inc; chief clinical officer for long-term care at CVS Health; and adjunct professor of pharmacy practice at the College of Pharmacy and Health Sciences, Wayne State University and the University of Michigan. She created clinical programs for Omnicare, Inc., subsequently a CVS Health Company, and developed strategies and tactics to manage drug utilization, including disease management and formulary management to optimize clinical outcomes. Omnicare provided pharmacy care for 1.4 million older adults living in long-term care facilities. Her expertise has been chronicled through attainment of board certification in pharmacotherapy (BCPS) and geriatric pharmacotherapy (BCGP). She has been recognized as a fellow of the Society of Critical Care Medicine, American College of Clinical Pharmacy, and the American Society of Consultant Pharmacists. Over her career she has published 10 book chapters; 125 peer-reviewed articles and over 120 abstracts, editorials, letters and columns. Dr. Zarowitz is a frequent speaker at national research and society meetings. She has received 11 leadership, research, teaching and practice awards, including the 2015 George F. Archambault Award for outstanding contributions to consultant and senior care pharmacy.

Log In

Sign in to access your saved publications, downloads, and email preferences.

Former MyNAP users: You'll need to reset your password on your first login to MyAcademies. Click "Forgot password" below to receive a reset link via email. Having trouble? Visit our FAQ page to contact support.

Members of the National Academy of Sciences, National Academy of Engineering, or National Academy of Medicine should log in through their respective Academy portals.

Email (required)
Password (required)

Don't have an account?

Register

Email (required)
New password (required)
Retype password (required) Password must be at least 8 characters
I accept the terms of use
terms of use

Thank You

Thank you for creating a MyAcademies account!

Enjoy free access to thousands of National Academies' publications, a 10% discount off every purchase, and build your personal library.

Forgot Password

Enter the email address for your MyAcademies (formerly MyNAP) account to receive password reset instructions.

Reset Requested

We sent password reset instructions to your email . Follow the link in that email to create a new password. Didn't receive it? Check your spam folder or contact us for assistance.

Reset Password

New password (required)
Retype password (required) Password must be at least 8 characters

Reset Password

Your password has been reset.

Log In

Verify email

Verify Your Email Address

We sent a verification link to your email. Please check your inbox (and spam folder) and follow the link to verify your email address. If you did not receive the email, you can request a new verification link below

Subscribe

First Name
Last Name
Email (required)
I agree to receive emails from the National Academies (required)

We respect your privacy and will never share your information.

Drug Research and Development for Adults Across the Older Age Span: A Workshop

Featured publication

Description

Contributors

Committee

Sponsors

Staff

Parent projects

Board on Health Sciences Policy

National Cancer Policy Forum

Forum on Drug Discovery, Development, and Translation

Forum on Aging, Disability, and Independence

Major units and sub-units

Contact

Contact us

Provide feedback

More like this

National Forum on Nature-Based Solutions

Future pathways for the BGC Argo program: A Workshop

Prevention of and Response to Sexual Harassment in Higher Education: Tools for Department Chairs and Principal Investigators: A Workshop

Strengthening Southeast Asian Academia and Industry Biotechnology and Biomanufacturing Safety and Security - A Workshop

Future pathways for the BGC Argo program: A Workshop

Review of the draft United by Nature assessment

Health Care Financing to Improve Availability of Affordable Contraception: Identifying Promising Practices

Review of Methods in the Report on Carcinogens Handbook

Exploring Relevant Policy Domains — Housing Policy and Population Health: A Workshop

Publication information

Suggested citation

My Academies

Drug Research and Development for Adults Across the Older Age Span: A Workshop

Dropdown items

Featured publication

Drug Research and Development for Adults Across the Older Age Span: Proceedings of a Workshop

Description

Contributors

Committee

Sponsors

Staff

Parent projects

Board on Health Sciences Policy

National Cancer Policy Forum

Forum on Drug Discovery, Development, and Translation

Forum on Aging, Disability, and Independence

Major units and sub-units

Contact

Contact us

Provide feedback

More like this

National Forum on Nature-Based Solutions

Future pathways for the BGC Argo program: A Workshop

Prevention of and Response to Sexual Harassment in Higher Education: Tools for Department Chairs and Principal Investigators: A Workshop

Strengthening Southeast Asian Academia and Industry Biotechnology and Biomanufacturing Safety and Security - A Workshop

Future pathways for the BGC Argo program: A Workshop

Review of the draft United by Nature assessment

Health Care Financing to Improve Availability of Affordable Contraception: Identifying Promising Practices

Review of Methods in the Report on Carcinogens Handbook

Exploring Relevant Policy Domains — Housing Policy and Population Health: A Workshop