The global COVID-19 pandemic created many challenges at Merck, including ensuring employee safety, global drug supplies, and maintaining ongoing investigational drug trials. In a setting of a global health crisis, the ability to continue to drive decisions to move research forward was important. The field of pharmacometrics uses modeling and simulation (M&S) approaches to describe and quantify the mechanistic basis of disease and pharmacologic interventions and this approach allows for an integrated interpretation of available data. In this presentation, the theme that pandemic drove an increased willingness to make decisions based on M&S results will be explored through 3 case studies: 1) Expansion of treatment regimen (dose and dosing frequency) options for Keytruda<sup>TM</sup> (pembrolizumab, an anti PD-1 monoclonal antibody) to include an every 6 week regimen established based on extensive modeling and simulation analyses; 2) Model-based dose selection for the Phase 3 evaluation of molnupiravir (an orally administered ribonucleoside prodrug of β-D-N4-hydroxycytidine with sub-micromolar potency against SARS-CoV-2) in the treatment of COVID-19 in adults; and 3) Use of model-based meta-analysis to integrate and interpret literature data on the relationship between antibody titer and protection for early decision-making in vaccines programs, such as go / no-go and dose-level / regimen decisions.

Lessons from the pandemic at Merck: Enhanced use of modeling and simulation to drive decisions

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.