The older population (65 years and over) is currently the fastest growing age group in the US and this trend will continue for the next several decades. Aging is a complex and multi-dimensional process that is affected by many individual intrinsic and extrinsic factors. Consequently, there is a wide range of variability among the older individuals, in which some are fit with very few ailments, while others are frail with multiple organ dysfunctions. Nevertheless, overall older individuals have higher disease burden compared to younger adults and are the major users of medications. Marketing approval of a new drug should be based upon evidence of the safety and effectiveness in the intended target patient population, yet older patients are often excluded from clinical trials, even for the drugs that have high utility in this age group. Extrapolation of clinical results from younger individuals to older patients does not provide adequate benefit/risk estimation for drugs under investigation and a frequent need of dose adjustment in older patients from initially approved doses testifies the current lack of adequate clinical data for the older population. Considering significant age-dependent changes in physiology, pharmacology and psychiatric functions, better pharmacokinetic and pharmacodynamic understanding of this age population is essential. In this symposium, recent progress will be discussed on the patho/physiology of aging, cognitive dysfunctions, regulatory and industry perspectives on clinical drug development for older patients, and key clinical pharmacology considerations. The objectives is to learn the normal and diseased aging process, clinical parameters particularly pertinent to older patients, and improved clinical development strategy to allow a provision of evidence-based, patient-individualized treatment to patients in need.
Networking reception to follow.
|Student / Postdoc / Fellow Member
|Student / Postdoc / Fellow Nonmember