The appropriate selection of vaccine dose, regimen and adjuvant is a fundamental challenge in balancing vaccine immunogenicity and reactogenicity. Model-informed drug development (MIDD) techniques have the potential to address such critical uncertainties in vaccine discovery and development. We will discuss recent applications of MIDD in our group towards informing key clinical trial design parameters, as well as highlight opportunities to advance the utility of MIDD in accelerating and de-risking pivotal development decisions for vaccines.
Learning Objectives:
Understand how state-of-the-art pharmacometrics and mechanistic modeling techniques can inform key decisions across the development pipeline for novel vaccines.
Identify potential opportunities for advancing applicability and acceptance of MIDD techniques for vaccine development