Associated Scientific Director, Clinical Pharmacology and Pharmacometrics Moderna Therapeutics Mahwah, New Jersey
mRNA modalities have provided unique challenges and opportunities for the application of model informed drug development (MIDD) in the overall drug development process. Three MIDD case examples from our experience with the COVID vaccine, infectious diseases, and oncology will be presented to highlight these challenges and opportunities in an effort to highlight the diversity of MIDD applications across various stages of development.
Learning Objectives:
Upon completion, participants will be able to compare and contrast IS/ID modeling to PK/PD modeling
Upon completion, participants will be able to understand how IS/ID modeling can be used to define dosing strategies in mRNA vaccine clinical trials
Upon completion, participants will be able to summarize how IS/ID modeling was used to drive COVID mRNA vaccine dosing strategies in pediatrics
Upon completion, participants will be able to describe how mRNA MIDD can be used to support regulatory filings in unique development scenarios
Upon completion, participants will gain an appreciation for the wide variety of applications of MIDD in mRNA vaccine development.
