Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation

Abstract

This document was developed to enable greater consistency in the practice, application, and documentation of Model-Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of "good practice" recommendations are assembled here in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of this white paper are 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.

Figure 1

Range of application types spanning discovery, development, regulatory assessment, and life‐cycle management. The Shading indicates areas for which we have presented case studies which can be found in the supplemental material.

Figure 2

Model Informed Drug Discovery and Development (MID3): genesis of terminology.

Figure 3

MID3: a quantitative framework for prediction and extrapolation centered on knowledge and inference generated from integrated models of compound, mechanism, and disease level data aimed at improving the quality, efficiency, and cost‐effectiveness of decision‐making. The colored boxes represent essential components of the “Learn and Confirm Cycle”. The arrows represent processes that link these components.