Presenter
Lanyan (Lucy) Fang, PhD
Deputy Division Director
Division of Quantitative Methods and Modeling (DQMM)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Lucy Fang introduces the Model Master File (MMF) concept, explaining how modeling and simulation (M&S) can make drug development more efficient, especially for generic drugs where utilization has been less than for new drug development. The FDA’s Office of Generic Drugs is actively promoting the use of M&S, including through the Model Integrated Evidence (MIE) pilot program, launched in October 2023, which serves as a dedicated platform for enhanced scientific communication on MIE approaches. The MMF concept allows for models to be shared and reused, leveraging the established Type 5 Drug Master File regulatory mechanism. An MMF is defined as a set of information and data for an in silico quantitative model or modeling platform, supported by sufficient verification and validation, and can include various model types like PBPK, CFD, PPK, and mechanistic IV-IVC. Sharing models through MMFs offers significant benefits, including increased efficiency and consistency for regulatory agencies and reduced time, effort, and costs for industry, boosting confidence in using M&S for complex generic products. This initiative aims to improve regulatory efficiency and consistency for the large volume of generic drug applications and reduce the risk associated with incorporating innovative modeling approaches. The initiative officially kicked off with a Federal Register notice in January.