Clinical Pharmacology – Biomolecular

Session: Rapid Fire: COVID Pandemic and Beyond: Role of Clinical Pharmacology in Development of Non-COVID and COVID Drugs (BM)

Clinical Pharmacology in COVID-19 Drug Development: Remaining Agile During a Public Health Emergency

Monday, October 17, 2022

3:00 PM – 3:15 PM ET

Location: 152

Rapid Fire Speaker(s)

Kellie S. Reynolds, PharmD

Division Director
Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, OTS, CDER, FDA
Silver Spring, Maryland

Handouts

Drug development during a public health emergency, such as an infectious disease outbreak, is challenging. Decisions about development of therapeutics must balance the urgent need for treatments with the importance of a thorough evaluation of safety and efficacy. A number of available tools can guide an agile process as scientific knowledge accumulates and the clinical setting evolves. Key principles of clinical pharmacology – the right drug at the right dose for each patient – remain foundational during such emergencies.

This presentation will address several tools that assisted the response to the COVID-19 public health emergency. Two examples will be provided.

Learning Objectives:

name drug development challenges faced during a public health emergency
describe three tools that assisted drug development during the COVID-19 public health emergency
describe two examples that illustrate how the tools have been used to respond to the COVID-19 public health emergency