Abstract:
Quantitative modeling has become a critical approach in preclinical, translational, and clinical drug development. Quantitative pharmacology is being used to inform decisions such as choice of target, drug modality & properties, preclinical study design, and clinical dose/regimen, indication, and patient selection. Indeed regulatory agencies have been increasing encouraging and reporting the use of model-informed drug development to support health authority discussions and applicaitons. This talk will give a general overview of the use of mathematical modeling in preclinical and clinical pharmacology followed by a deeper look into varied applications of mechanistic and systems pharmacology in specific throughout the development pipeline. Finally we will also consider future directions for mechanistic and systems pharmacology in the context of the evolution of large data and artificial intelligence.