Executive Director, Medical Science Services Fortrea
Learning Labs have limited capacity and rooms will fill up quickly! Arrive early to ensure you can secure your spot.
Model-Informed Drug Development (MIDD) is a paradigm in which mathematical models and simulations are employed to optimize decision-making and accelerate the drug development process. In recent years, regulatory agencies have been shifting their stance on model-based approaches from one of acceptance to outright advocacy. For example, in 2023 the FDA formally instituted an MIDD paired meeting program following a very successful pilot. In a recent publication by Galluppi et al1, the authors surveyed 19 sponsor companies who participated in the pilot. The sponsor companies estimated that the paired meeting program saved them an average of 14 months of development time.
In this lunch and learn, we will introduce some of the key concepts and benefits of MIDD. We will also explain what Fortrea is doing to help our clients reap the rewards of the MIDD approach.
References: 1Galluppi 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.
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