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Suggested Citation:"Appendix B: Workshop Agenda." 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 B: Workshop Agenda." 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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Page 80
Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
Page 81
Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
Page 82
Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
Page 83
Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
Page 84
Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
Page 85
Suggested Citation:"Appendix B: Workshop Agenda." 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.
×
Page 86

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Appendix B Workshop Agenda Drug Research and Development for Adults Across the Older Age Span A Virtual Workshop August 5–6, 2020 Despite the widespread recognition of the “graying of America,” and the need for health care among older adults, there is a dearth of information about the appropriate use of drugs in this population. Older adults are vastly underrepresented in clinical trials. Yet older adults have higher rates of comorbidities and polypharmacy than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80+, can lead to significant differences in the pharmacokinetics and pharmacodynamics (PK/PD) of a given drug compared with the general population. There is a void in evidence-based information for making informed decisions on how to best optimize care for older adults, particularly those 80+. This public workshop will provide a venue for stakeholders to discuss the challenges and opportunities in drug research and development (R&D) for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding the clinical pharmacology for 65+ and 80+ populations. The workshop will feature invited presentations and discussions to: • Review the current landscape of drug R&D for 65+ and 80+ populations across public and private sectors; • Consider medication issues for older adult populations (e.g., dosage forms, adherence, polypharmacy, differences in PK/PD); • Explore methodologies that are currently used or could be implemented to study differences in pharmacology for older adult populations (e.g., minimal sampling); • Examine barriers to conducting clinical research for 65+ and 80+ populations (e.g., funding, data, comorbidity, polypharmacy, recruitment, access); and • Explore approaches to engage 65+ and 80+ populations in clinical research and strategies to generate evidence- based information on how to best optimize treatment for older adults. DAY 1: August 5, 2020 10:00 a.m. Welcome and opening remarks JAMES APPLEBY, Workshop Chair Chief Executive Officer The Gerontological Society of America SESSION I INCLUSION OF OLDER ADULTS IN CLINICAL TRIALS: AN EVOLVING LANDSCAPE Session Objectives: PREPUBLICATION COPY: UNCORRECTED PROOFS B-1

B-2 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN • Review the current landscape of drug R&D for 65+ and 80+ populations across public and private sectors; • Consider medication issues for older adult populations (e.g., dosage forms, adherence, polypharmacy, differences in PK/PD); and • Examine barriers to conducting clinical research for 65+ and 80+ populations (e.g., funding, data, comorbidity, polypharmacy, recruitment, access). 10:10 a.m. Introduction by session moderator JERRY GURWITZ Executive Director Meyers Primary Care Institute Division Chief of Geriatric Medicine University of Massachusetts Medical School 10:15 a.m. Knowledge gaps and issues unique to older adults ROSANNE M. LEIPZIG Professor of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Age-related changes that impact drug metabolism GEORGE A. KUCHEL Travelers Chair in Geriatrics and Gerontology, Professor of Medicine University of Connecticut Center on Aging Barriers to conducting clinical trials that include older adults NIH perspective MARIE A. BERNARD Deputy Director National Institute on Aging National Institutes of Health Industry perspective KATHERINE DAWSON Senior Vice President of the Therapeutics Development Group Biogen 11:00 a.m. Moderated panel discussion 11:30 a.m. BREAK SESSION II CONCOMITANT ILLNESS AND POLYPHARMACY: OVERCOMING KEY BARRIERS Session Objective: • Explore methodologies that are currently used or could be implemented to study differences in pharmacology for older adult populations (e.g., minimal sampling). PREPUBLICATION COPY: UNCORRECTED PROOFS

WORKSHOP AGENDA B-3 11:40 a.m. Opening remarks by panel moderator JONATHAN WATANABE Professor of Clinical Pharmacy, Associate Dean of Assessment and Quality University of California, Irvine, Samueli College of Health Sciences 11:45 a.m. Clinical trial considerations [Panel] Inclusion/exclusion criteria and trial design HEATHER ALLORE Professor of Medicine (Geriatrics) and Biostatistics Yale University Organ function criteria expansion STUART M. LICHTMAN Medical Oncologist Memorial Sloan Kettering Cancer Center FDA experience RAJESHWARI SRIDHARA Biostatistician Contractor Oncology Center of Excellence U.S. Food and Drug Administration Ethics perspective JASON KARLAWISH Professor of Medicine Perelman School of Medicine University of Pennsylvania 12:30 p.m. Moderated panel discussion 1:00 p.m. BREAK 1:20 p.m. Opening remarks by panel moderator ROBERT TEMPLE Deputy Center Director for Clinical Science Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration Alternative study approaches [Panel] Adaptive design SCOTT BERRY Cofounder and President Berry Consultants PREPUBLICATION COPY: UNCORRECTED PROOFS

B-4 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN Home-based clinical trials STEVEN R. CUMMINGS Executive Director S.F. Coordinating Center University of California, San Francisco Quantitative systems pharmacology models: Mechanistic science perspective CHRISTINA FRIEDRICH Chief Engineer Rosa & Co. Clinical trial simulation N. SETH BERRY Senior Director Decision Sciences Group IQVIA Real-world trials STEVEN CHEN Associate Dean for Clinical Affairs School of Pharmacy University of Southern California 2:20 p.m. Moderated panel discussion DAY 1 REFLECTIONS 2:50 p.m. Closing remarks JAMES APPLEBY, Workshop Chair Chief Executive Officer The Gerontological Society of America 3:00 p.m. ADJOURN WORKSHOP DAY 1 DAY 2: August 6, 2020 10:00 a.m. Welcome and overview of Day 1 JAMES APPLEBY, Workshop Chair Chief Executive Officer The Gerontological Society of America SESSION III THE ERA OF COVID-19 AND BEYOND Session Objectives: • Explore methodologies that are currently used or could be implemented to study differences in pharmacology for older adult populations (e.g., minimal sampling); and PREPUBLICATION COPY: UNCORRECTED PROOFS

WORKSHOP AGENDA B-5 • Explore approaches to engage 65+ and 80+ populations in clinical research and strategies to generate evidence-based information on how to best optimize treatment for older adults. 10:10 a.m. Opening remarks by panel moderator DEBORAH COLLYAR President Patient Advocates in Research 10:15 a.m. Older adult outreach and networking strategies JONATHAN TOBIN President/Chief Executive Officer, Clinical Directors Network Senior Epidemiologist, The Rockefeller University Center for Clinical & Translational Science Barbershop-based outreach programs: Case study CIANTEL BLYLER Clinical Research Pharmacist Cedars-Sinai Medical Center Patient perspective SUSAN STRONG Director of Patient Engagement Heart Valve Voice US Caregiver perspective LAUREL J. PRACHT Research Patient Advocate and Patient Representative National Cancer Institute Symptom Management and Health-Related Quality of Life Steering Committee Education for older adults and health care practitioners STEVEN ROTHSCHILD Professor and Chair Department of Family Medicine Rush Medical College 11:15 a.m. Moderated panel discussion 11:45 a.m. BREAK 12:00 p.m. Opening remarks by panel moderator, European perspective SVEN STEGEMANN Professor for Patient Centric Drug Development and Manufacturing Graz University of Technology PREPUBLICATION COPY: UNCORRECTED PROOFS

B-6 DRUG R&D FOR ADULTS ACROSS THE OLDER AGE SPAN Lessons learned from COVID-19 U.S. regulatory changes HARPREET SINGH Division Director (Acting) Division of Oncology 2 U.S. Food and Drug Administration Infectious disease perspective JOHN POWERS Professor of Clinical Medicine School of Medicine The George Washington University Telehealth/physician perspective ERIKA RAMSDALE Assistant Professor Medical Center University of Rochester Digitization of medicine ERIC TOPOL Founder and Director Scripps Research Translational Institute Patient perspective BEVERLY CANIN Patient Advocate Cancer and Aging Research Group 1:00 p.m. Moderated panel discussion 1:30 p.m. BREAK 1:45 p.m. Reflections: Looking forward to the future Session moderator JAMES APPLEBY, Workshop Chair Chief Executive Officer The Gerontological Society of America 1:50 p.m. AMY ABERNETHY Principal Deputy Commissioner Office of the Commissioner U.S. Food and Drug Administration ROBERT CALIFF PREPUBLICATION COPY: UNCORRECTED PROOFS

WORKSHOP AGENDA B-7 Head of Clinical Policy and Strategy Verily and Google Health MARIE A. BERNARD Deputy Director National Institute on Aging National Institutes of Health 2:20 p.m. Moderated panel discussion 2:50 p.m. Next steps JAMES APPLEBY, Workshop Chair Chief Executive Officer The Gerontological Society of America 3:00 p.m. ADJOURN WORKSHOP DAY 2 PREPUBLICATION COPY: UNCORRECTED PROOFS

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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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