New Age Elderly: Are We Prepared for the Future of Aging?

Session Description

The elderly population is projected to increase to 88 million in the US by 2050 and to exceed the number of children by 2040 globally. In 2018, the US population of the 75-84 year group (15.4 million) was 20 times larger than in 1900. 85 and older elderly are predicted to be more than double from 2008 to 2040 (6.5 million to 14.4 million). Older people are considered a “special population” because they are more vulnerable to adverse drug effects than younger adults, potentially due to decreased organ function, comorbidity and polypharmacy. However, data on safety and efficacy of medication use in the elderly who are 75 years and older are sparse. They are generally excluded in clinical trials due to polypharmacy, complex pathophysiology and decreased organ function. Experts agree that drug dosing regimens used in younger adults are unlikely to adequately inform drug prescribing for the aging population, especially for those at the middle and oldest end of the age span. Collectively, a critical gap remains regarding the safety and effectiveness of medication use in this special population. This knowledge gap is particularly problematic because the new age elderly (≥75 years) might be prone to more severe manifestations of side effects due to comorbidities with polypharmacy. Additionally, current knowledge is focused on typical old adults, not those who are 75 years and older. Several questions are unclear such as how do comorbidities impact on drug’s disposition; are there pharmacokinetic difference between youngest-old, middle-old, and oldest-old patients; what is the effect of age on the expression and activities of phase II enzymes and transporters. This innovative interactive session will define problems and gaps and provide potential strategies to address those challenges in the new era, which can foster research in the community to provide the right dosing to this special population.

Learning Objectives

1. Upon completion, participants will be able to identify the scientific, clinical practice and regulatory challenges of studying older adults (≥ 75 years).

2. Upon completion, participants will be able to understand underlying mechanisms and modeling tools that may help develop strategies and foster research to address knowledge gaps, drug development, regulatory, and clinical practice challenges we face.

Session Schedule

1:15 PM - 1:20 PM ET
Introduction
Zhu Zhou, PhD

1:20 PM - 1:31 PM ET
The Future is Now: Medication Evaluation for Older Adults
Janice Schwartz, MD

1:31 PM - 1:38 PM ET
An Industrial Clinical Pharmacologists View of Developing Drugs to be Used in the Elderly
Jack Cook, PhD

1:38 PM - 1:50 PM ET
Model Informed Drug Development: New Age Helping Old Age
Oliver Hatley, PhD

1:50 PM - 1:58 PM ET
Evaluation of Older Adults in Drug Development: What Can FDA Do?
Shiew-Mei Huang, PhD

1:58 PM - 2:15 PM ET
Live Q&A and Panel Discussion
All Speakers