KEYNOTE LECTURE - Industry presentation: practical application of the ICH M15 guideline approach for assessing MIDD Evidence
Nicolas Frey (1), Scott Marshall (2) and Joerg Lippert (3)
(1) Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland, (2) Clinical Pharmacology Modelling and Simulation, Asia & Lifecycle Management, GSK, Stevenage, England, United Kingdom. (3) Model-Informed Drug Development, Research & Development Pharmaceuticals, Bayer AG, Leverkusen, Germany
Objectives: To illustrate the application of the ICH M15 guideline for assessing MIDD evidence
Overview/Description of presentation: The ICH M15 guideline introduces a standardized approach to assessing MIDD evidence, enhancing transparency and consistency. It provides a structured framework for documenting, justifying, and evaluating model risk, model impact, and the appropriateness of model-based approaches across different stages of drug development. All relevant information is consolidated into an assessment table, facilitating streamlined regulatory interactions. This presentation will offer a practical, example-driven guide to effectively using this assessment approach. Each element will be explained in the context of its role in evaluating MIDD evidence, along with the level of detail regulators expect from sponsors throughout the drug development lifecycle.