Model-informed drug development (MIDD)
Meghal Mistry
General Manager | Business Development & Strategy Lead for Biosimilars, Vaccines, and Novel Assets | Driving Growth, Innovation, Licensing and Strategic Partnerships
USFDA has just published a briefing document on the topic of "Strategies, approaches, and challenges in model-informed drug development (MIDD)" as part of the advisory meeting on March 15, 2017 with the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The advancing of Model-Informed Drug Development is part of PDUFA VI : performance and procedural goals for fiscal years 2018 through 2022 as indicated in slide below.
Even an EMA workgroup has published a collection of "good practice" recommendations in a recent article in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of the white paper were to: i) inform company decision makers how the strategic integration of MID3 can benefit R&D efficiency; ii) provide MID3 analysts with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide regulatory authorities with substrate to develop MID3 related and/or MID3 enabled guidelines
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4809625/
As the use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. FDA has arrange for an Advisory committee to discuss strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug’s lifecycle. During the afternoon session, the committee will discuss mechanistic model-informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be discussed as an example. The agenda and briefing material links are as follows,
Agenda : https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM546149.pdf
Advisory Meeting Briefing Material: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM544838.pdf