Leveraging Model Master Files from a Technology Company Perspective: Facilitating Quantitative Medicine in Regulatory Frameworks.

Abstract

Model Master Files (MMFs) offer a much needed approach to integrating computational modelling into drug development and regulatory frameworks, supporting the growth of quantitative medicine. By acting as confidential repositories for validated models, MMFs enable streamlined submissions, model reuse, and context-specific reviews while safeguarding intellectual property. For technology companies (such as software providers), MMFs provide a structured pathway to engage with the FDA, align innovations with regulatory standards, and expand the use of models across diverse applications. A challenge with the current framework is the need to provide the same validation and verification information to multiple drug companies each time the submit an application. With an MMF in place, drug companies can refer to this same document which the technology provider can add to over time. However, challenges persist, including limited direct interaction with the FDA outside (A)NDA submissions and the need for consistent model validation and version management. Addressing these issues through enhanced collaboration and clear guidelines will maximize the potential of MMFs, fostering broader adoption of modelling and simulation in drug development and advancing personalized medicine.