A glimpse into the future of model-informed drug discovery and development

This publication provides a forward-looking overview of the evolution and expanding role of Model-Informed Drug Development (MIDD) across modern drug discovery, clinical development, and regulatory science. It highlights how approaches including pharmacometrics, population pharmacokinetics, exposure-response modeling, physiologically based pharmacokinetics (PBPK), quantitative systems pharmacology (QSP), model-based meta-analysis (MBMA), and precision dosing are increasingly integrated with real-world evidence, artificial intelligence, machine learning, and advanced mechanistic modeling to inform decisions across the development lifecycle. Drawing on applications in oncology, infectious diseases, special populations, and global regulatory settings, the publication demonstrates how MIDD can support dose selection, trial optimization, benefit-risk assessment, regulatory decision-making, and individualized therapy. Collectively, the work positions MIDD as an increasingly multidisciplinary and systems-level framework for improving the efficiency, precision, and evidence base of drug development as therapies and development challenges become more complex.