From Models to Medicines: A Narrative History and Regulatory Perspective on the Translational Impact of...

Model-informed drug development (MIDD) has grown from a constellation of methodological advances to a profound reorientation of how evidence is generated, evaluated, integrated, and leveraged in both drug development and regulatory decision-making. Over decades, pharmaco-statistical modeling and simulation (M&S) have moved from supplemental analyses toward shared frameworks for quantitative and mechanistic reasoning on questions as diverse as clinical trial planning, effectiveness and drug safety risk assessment, and therapeutic optimization. This perspective traces that evolution and argues that MIDD's translational promise lies not only in ever-increasing technical sophistication, but in its capacity to reshape how we talk about how medicines are developed, evaluated, and optimized for patients.