COVID-19 has changed the way we live our lives. It has also brought numerous challenges in drug development. For COVID-19 related drugs and vaccines, development timelines were shortened to months between initiation of non-clinical studies to FIH dosing to regulatory filing, which normally would take years in pre-pandemic development situations. Such timelines required more than a sense of urgency, and Clinical Pharmacology had to bring innovative strategies complemented with Model Informed Drug Development approaches to expedite regulatory submission of these dossiers. This presentation will focus on the clinical pharmacology strategies employed to accelerate the development of PAXLOVID.
Learning Objectives:
To illustrate how Model Informed Drug Development was utilized for key decisions in the development of PAXLOVID.
To provide examples of innovation and a culture of “lightspeed” in bringing a safe and effective oral anti-viral treatment for COVID-19.
To present clinical pharmacology data that supported the Emergency Use Authorization of PAXLOVID.
