The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies to maximize the efficacy of a drug as well as the safety and tolerability.
Quantitative Systems Pharmacology (QSP) modeling describes the mechanism of action (MOA) of a drug and mechanistically translates in vitro and preclinical PK and PD data to patients by accounting for known differences among these systems. It can also be used to bridge different populations by accounting for known differences between different populations. In general, QSP is a powerful tool to understand and predict therapeutic and toxic effects of drugs before clinical data is available or when clinical data is sparse and can therefore be applied to the rational selection of clinical dosing regimens in oncology, which is the main aim of Project Optimus.
In this webinar, our experts discuss:
- Case study examples of QSP applications for Project Optimus
- How QSP modelers and clinical pharmacologists can collaborate to ensure successful applications of QSP
- Current status of QSP adoption and the FDA’s perspective on QSP