Quantitative approaches to drug development

Peter Milligan is retiring after seven successful years as CEO of Pharmetheus, and the board has appointed Jonas Möller as his successor. Pharmetheus, founded in 2012, began its growth trajectory under the leadership of Peter Milligan, who became CEO in 2018. With his experience at companies like Pfizer and in-depth knowledge of the pharmacometrics field, he helped grow the company to a leading position, serving a diverse portfolio of pharmaceutical clients and contributing to drug development through its expertise in quantitative approaches.

Manual data collation from regulatory documents is a time-consuming bottleneck in drug development. In this recent publication in the inaugural issue of Quantitative Medicine, the authors explore the potential of using Large Language Models for this task.

This publication is a collaboration between pharma, consultancies and academia, and outlines a pivotal shift from Model-Informed Drug Development (MIDD) to Model-Integrated Evidence (MIE). In this emerging paradigm, rigorously validated computational models generate “digital evidence” that carries evidentiary weight comparable to empirical clinical data for regulatory purposes, including approvals, labeling, and lifecycle management. The vision is for MIE to be recognized as primary evidence of safety and effectiveness, accelerating R&D and improving treatment options for patients.

Traditional Visual Predictive Checks (VPCs) can fall short when applied to real-world data shaped by adaptive clinical decisions. This new CPT publication from InsightRX and Pharmetheus outlines why standard and prediction-corrected VPCs may mislead, and offers a path forward for more accurate pharmacometric modeling.