Featured Speaker - Karthik Venkatakrishnan

Opportunities for Quantitative Clinical Pharmacology from Translational to Global Drug Development

This presentation will discuss opportunities for quantitative clinical pharmacology in dosage optimization and the enablement of appropriately inclusive global drug development. Case studies will illustrate the application of mechanism-informed translational and clinical PK/PD modeling and simulation in driving dose selection decisions in oncology drug development. The critical role of clinical pharmacology and pharmacometrics in translating principles of ICH E5 and E17 into ethnically and globally inclusive drug development strategies will be illustrated using representative examples. Finally, the speaker will reflect on the importance of a Totality of Evidence approach, Purpose-Orientation and Trust as mindset/ behavioral enablers.