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.
×
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.
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.
×
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:
- Review the current landscape of drug R&D for 65+ and 80+ populations across the 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).
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.
×
| 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 | |
| National Institutes of Health perspective | |
| Marie A. Bernard | |
| Deputy Director | |
| National Institute on Aging | |
| National Institutes of Health | |
| Industry perspective | |
| Katherine Dawson | |
| Senior Vice President | |
| Therapeutics Development Group | |
| Biogen | |
| 11:00 a.m. | Moderated panel discussion |
| 11:30 a.m. | BREAK |
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.
×
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).
| 11:40 a.m. | Opening remarks by panel moderator |
| Jonathan Watanabe | |
| Professor of Clinical Pharmacy and Associate Dean of Assessment and Quality | |
| Samueli College of Health Sciences | |
| University of California, Irvine | |
| 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 | |
| U.S. Food and Drug Administration 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 |
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.
×
| 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 | |
| Co-founder and President | |
| Berry Consultants | |
| 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
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.
×
| 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
- 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 and Chief Executive Officer | |
| Clinical Directors Network | |
| Senior Epidemiologist | |
| Center for Clinical & Translational Science | |
| The Rockefeller University | |
| Barbershop-based outreach programs: Case study | |
| Ciantel Blyler | |
| Clinical Research Pharmacist | |
| Cedars-Sinai Medical Center |
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.
×
| Patient perspective | |
| Susan Strong | |
| Director of Patient Engagement | |
| Heart Valve Voice US | |
| Caregiver perspective | |
| Laurel J. Pracht | |
| Research Patient Advocate and Patient Representative | |
| Symptom Management and Health-Related Quality of Life Steering Committee | |
| National Cancer Institute | |
| 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 | |
| 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 |
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.
×
| 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 |
REFLECTIONS: LOOKING FORWARD TO THE FUTURE
| 1:45 p.m. | 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 | |
| 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 |
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.
×
| 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 |
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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