Senior Principal Scientist Certara UK Limited, Simcyp Division Sheffield, England, United Kingdom
The BEST resource documentation defines seven categories of biomarkers and identifying predictive biomarker to improve drug development performance and/or clinical outcome while is highly desirable it can be very challenging. Modelling and simulation tools such as Physiologically Based Pharmacokinetic (PBPK) and Quantitative Systems Pharmacology (QSP) models can be used to identify and assess predictive biomarkers for small molecules and for new modalities. The physiological nature of these models helps to integrate various processes related to biomarkers including their synthesis in plasma and other organs and their elimination as well as their interactions with other processes affecting drug disposition, effect, or side-effect. They can also help to identify current gaps in our knowledge regards specific biomarker. Specifically, PBPK models can be used to assess the performance of biomarkers especially for understanding metabolism- and transporter-mediated interactions. In this presentation a PBPK based framework for modelling endogenous biomarkers and few case studies are presented for small molecules. For the new modalities the four topics of the session presentations are introduced.
Learning Objectives:
To be able to define a BEST resource biomarker and a quailified biomarker.
To understand the workflow involved in developing, verifying, and applying a biomarker for small molecules within a PBPK framework.
To use biomarkers in the context of new modalities.