Authors of two recent publications independently estimated that utilization of model-informed drug development (MIDD) approaches save an average of 10-14 months of R&D cycle time¹ ,² per development program—equating to an estimated $140-196M in recouped sales revenue per asset³.

Companies can no longer afford to overlook MIDD approaches. In this webinar hosted by Fortrea, industry experts Dr. Liang Zhao, Jill Fiedler-Kelly, Mark Lovern, and John Mondick will discuss the history of MIDD and examine its current state-of-the-art application. They will also mark the next stage in the MIDD revolution: the emergence of model-integrated evidence (MIE).

With MIE, validated modeling approaches are being used to generate decision-grade evidence for regulatory approvals, as a supplement to, or in some cases, a substitute for clinical data. As such, MIE has the potential to address many of the challenges currently facing the pharmaceutical industry: dependence on large, inefficient clinical study designs, inclusion of under-served populations, and rare disease drug development, to name a few.

This is a can’t miss opportunity to hear four leading experts discuss the next evolution for our industry. Register now to save your seat.

References:

1. Galluppi GR, Brar S, Caro L, et al. Industrial Perspective on the Benefits Realized From the FDA’s Model-Informed Drug Development Paired Meeting Pilot Program. Clin Pharmacol Ther. 2021;110(5):1172-1175. doi:10.1002/cpt.2265.

2. Sahasrabudhe V, Nicholas T, Nucci G, Musante CJ, Corrigan B. Impact of Model-Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost. Clin Pharmacol Ther. 2025 Aug;118(2):378-385. doi: 10.1002/cpt.3636. Epub 2025 Mar 26. PMID: 40135941; PMCID: PMC12272314.

3. Smith ZP, DiMasi JA, Getz KA. New Estimates on the Cost of a Delay Day in Drug Development. Ther Innov Regul Sci. 2024 Sep;58(5):855-862. doi: 10.1007/s43441-024-00667-w. Epub 2024 May 21. PMID: 38773058.

Presenters: 

• Dr. Liang Zhao,
• Jill Fiedler-Kelly
• Mark Lovern
• John Mondick