Biopharmaceutics Focus Group – Meeting report from “Physiologically Based Pharmacokinetic Modelling (PBBM) – Best Scientific Practices to Define Drug Product Performance: Latest Regulatory and Industry Perspectives”
28 May 2026
The APS Biopharmaceutics Focus Group are pleased to share that the meeting report from the 2-day meeting on “Physiologically Based Pharmacokinetic Modelling (PBBM) – Best Scientific Practices to Define Drug Product Performance: Latest Regulatory and Industry Perspectives” and hosted by MHRA in London, UK is now available ((Physiologically Based Biopharmaceutics Modelling—Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report)). Around 80 scientists from industrial, academic, regulatory, and software companies came together to discuss the latest developments in PBBM and to debate key topics relevant to the establishment of best practices and improved implementation. Case study presentations which were previously shared at an earlier M-CERSI meeting were reviewed again but this time from the perspective of the model developer. Breakout sessions were an important part of the agenda and provided time to debate aspects of model build, verification and suitability for the context of use.
The manuscript captures both the presentations and the discussions during the breakout sessions. Although significant progress has been made with the use of PBBM over the last 10 years, there is a need to continue the conversations and build an understanding between Industry and Regulators on how models can be used effectively to support drug product development.
This manuscript took much longer to complete than we had initially anticipated but I’d like to thank all the author group for their patience and contributions to the meeting report. It is important that we document the progress in the implementation of PBBM via meetings like this as it helps frame the discussions which are yet to come and are needed to consolidate accepted best practice for all involved in this area.