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Specific Populations
Symposia

Symposium 16: New Perspectives on Drug Evaluation in Older Adults

Tuesday, September 10, 2024
1:30 PM – 3:00 PM ET
Location:Grand Ballroom D
CE: 1.5

Target Audience:

The target audience for this Symposium is preclinical and clinical pharmacologists, pharmacokinetic/pharmacodynamic specialists, drug metabolism scientists, regulatory and pharma employees and general medical practitioners.



Description:

Aging is accompanied by physiological changes which alter the functional reserve capacity of many biological systems and therefore the ability to cope with possible ensuing pathological alterations. These modifications determine the frailty phenotype of the elderly, who accumulate medical conditions and often require polypharmacy. Nevertheless, inclusion of older patients in clinical trials is scare and a strategy to implement the evaluation of new drugs on geriatric population is needed, also because it will constitute about one quarter of the population in industrialized countries by 2060. This Symposium will provide an insight of the determinant of biological aging (the so-called aging clocks) and how to study and predict them through the novel tools and biomarkers provided by the “omics” revolution. Understanding the changes in biochemistry, physiology, immunology and nutritional status of the elderly is a key point to assess the efficacy and safety of medications in geriatric population. In fact, both pharmacokinetic (PK) and pharmacodynamic (PD) differences exist between younger and older adults, who are moreover characterized by a great interindividual variability because of their chronic health conditions and multiple medications themselves. As paradigmatic examples of this issue, warnings and drawbacks for antipsychotic and mood disorder drug prescriptions in the elderly will be discussed. Finally, how regulatory organizations and other stakeholders could tackle the problem will be examined, identifying major gaps and potential solutions for new drug evaluation in older adults and helping the design of focused clinical trials.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Analyze the so-far recognized determinants of biological aging and of the frailty phenotype;
  • Identify the unique pharmacokinetic/pharmacodynamic properties in the elderly and the need of therapeutic appropriateness in geriatric patients though paradigmatic examples;
  • Analyze the identified gaps and the potential solutions for new drugs evaluation in older patients.

Presentations:

  • Presentation of Speakers & Panel Discussion

    Co-Chair & Faculty: Manjunath Amit Pai, PharmD – Univ of Michigan

  • The Clinical Pharmacology of CNS-active Drugs in the Elderly: Warnings & Drawbacks

    Co-Chair & Faculty: Federica Ferrari, MD, MSc, PhD – Univ of Pavia - IRCCS Mondino Fdtn

  • Measuring Biological Aging: No Longer a Dream

    Faculty: Luigi Ferrucci, MD, PhD – National Inst of Health

  • Advancing Drug Evaluation in Older Adults: Regulatory Considerations

    Faculty: Rajanikanth Madabushi, PhD – US Food & Drug Administration

  • Discussion, Questions & Answers, Learner Feedback & Evaluations