WP1: Novel clinical trial methods and designs based on translation from animal to humans, research-based disease models

The global objective is to propose a methodological framework for accelerating drug development through mechanistic translational and bridging approaches, in order to refine and optimize animal experiments, gain information on PK/PD, and enable dose-finding and early selection for the Phase I/II clinical trials.

1. Build physiologically-based PK (PBPK) and statistical methods that provide results that are robust to model uncertainties to (1) predict clinical efficacy of antivirals and vaccines using the large amounts of preclinical data that have already been generated in COVID19 (2) develop a first-in- man exploratory clinical trial design using microdosing PET data

2. Develop early-phase clinical trial designs based on Bayesian adaptive approaches for exploration and down-selection among multiple potential regimens based on multivariate outcomes applied to vaccine development and drug resistant infections