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Drug Research and Development for Adults Across the Older Age Span Proceedings of a Workshop (2021) / Chapter Skim
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Appendix B: Workshop Agenda
Pages 99-108

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From page 99...
... 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.
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From page 100...
... 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)
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From page 101...
... 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.
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From page 102...
... 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.
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From page 103...
... Food and Drug Administration Alternative study approaches (Panel) Adaptive design Scott Berry Co-founder and President Berry Consultants Home-based clinical trials Steven R
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From page 104...
... 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
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From page 105...
... 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.
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From page 106...
... 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.
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Key Terms

  • clinical trials
  • conducting clinical
  • minimal sampling
  • opening remarks
  • adult populations

  • adjourn workshop
  • workshop day
  • associate dean
  • panel moderator
  • clinical trial

  • session moderator
  • examine barriers
  • drug metabolism
  • function criteria
  • organ function

  • share lessons
  • james appleby
  • centric drug
  • landscape session
  • clinical pharmacy

  • dosage forms
  • explore barriers
  • clinical directors
  • directors network
  • study approaches

  • clinical affairs
  • criteria expansion
  • disease perspective
  • principal deputy
  • sloan kettering


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