Preclinical, Clinical and Translational Sciences
Mindy Magee, PharmD (she/her/hers)
Vice President
Clinical Pharmacology Modeling & Simulation, Infectious Diseases and Vaccines, Precision Medicine, GlaxoSmithKline
Collegeville, Pennsylvania
Vaishali Sahasrabudhe, PhD (she/her/hers)
Clinical Pharmacology Therapeutic Area Head for Internal Medicine
Pfizer Inc.
Groton, Connecticut
Vaccine development, while analogous to drug development in many aspects, has unique challenges. These challenges stem from complex cascades of immunological mechanisms and multi-component nature of a vaccine dose (modality, antigen, adjuvant, and regimen). This session will explain such complexities while illustrating the opportunities in optimizing immunogenicity-reactogenicity profiles, de-risking and accelerating vaccine development by employing a clinical pharmacology-based modeling and simulation framework. Concepts and applications of embedding Model Informed Vaccine Development (MIVD) will be discussed.