How Regulatory-Ready is Model-Informed Drug Development?

Can we truly trust mathematical models to shape the future of medicine? In this episode, we explore the fascinating world of Model-Informed Drug Development (MIDD)—a game-changing approach that blends cutting-edge simulations with real-world data to revolutionise how drugs are developed and approved.

With the new ICH M15 Guideline, the global pharmaceutical landscape is moving towards a harmonised framework that ensures credibility, consistency, and trust in MIDD evidence. But how do these models hold up under scrutiny? And what does this mean for patient safety, regulatory decision-making, and the future of innovation in healthcare?

Join us for an engaging discussion on the science, risks, and rewards of MIDD, and discover how this transformative approach is reshaping the way medicines are brought to life.

 

Marshall S, Ahamadi M, Chien J, Iwata D, Farkas P, Filipe A, Frey N, Greene E, Kawai N, Li J, Lippert J, Musuamba Tshinanu F, Manolis E, Peterson MC, Sarem S, Shebley M, Tegenge M, Tsai CH, Tu CL, Otsubo Y, Wei J, Zhang L, Zhu H, Karlsson KE. Model-Informed Drug Development: Steps Toward Harmonized Guidance. Clin Pharmacol Ther. 2023 Nov;114(5):954-959. doi: 10.1002/cpt.3006.