ICH M15 is creating a common framework for how model-informed evidence is planned, evaluated, and communicated across drug development, and raising the bar for MIDD readiness industry-wide. But preparing for the guideline requires more than understanding new regulatory expectations. It requires organizations to think differently about how quantitative evidence informs decisions.
This executive brief explores how pharmaceutical and biotech organizations can strengthen Model-Informed Drug Development (MIDD) readiness and turn quantitative evidence into a more strategic driver of development and regulatory decision-making. Building this kind of MIDD readiness starts with treating your model-informed drug development strategy as a core part of regulatory planning, not an afterthought — and it depends on strong MIDD governance to keep evidence generation consistent across programs.
What you’ll learn about building MIDD readiness
Download the executive brief to learn:
- What ICH M15 means for MIDD and development strategy
- How to build decision-ready model-informed evidence
- What leading organizations do differently to strengthen MIDD readiness
- How to assess your organization’s ICH M15 readiness
- Practical steps for MIDD implementation and MIDD governance across development programs
Author and scientific contributors:
Erika Brooks, Paul Matthias Diderichsen, Eva Berglund, Masoud Jamei, Rik de Greef, Fran Brown, Karen Rowland Yeo, Piet van der Graaf
Looking for the technical side — how to apply the ICH M15 model credibility framework itself? See our companion guide, Guided by Evidence: Implementing the ICH M15 Guideline for MIDD.
