What is model-informed drug development (MIDD), and why is it so critical to informing the development of safer and more effective new drugs?
Upon watching this video, you will uncover ways to leverage model-informed drug development (MIDD) to maximize the value of your data. You will also learn how to successfully extrapolate beyond your observed data—so you can explore the therapeutic possibilities of your asset.
Our experts present on how regulators leverage and apply MIDD and will explain how MIDD has accelerated drug development programs through the optimization of dosing regimens, trial designs, and other key development decisions. In some cases, MIDD has even been used to completely obviate the need for some clinical studies.
MIDD: Smoothing the Road to Approval and Beyond
The regulatory landscape is rapidly evolving regarding regulators’ acceptance, even advocacy, of modeling and simulations approaches. Recent examples of this progression include FDA’s Project Optimus and the FDA Modernization Act—both of which have significantly expanded the opportunities to apply MIDD strategies. In this segment, Dr. Krithika Shetty will provide an overview of recent regulatory trends, illustrating how MIDD can help you capitalize on them.
Clinical Pharmacometrics: Your Key to Maximizing the Value of Clinical Trial Data
Pharmacometrics (PMx) is a methodology whereby drug development data is described and interpreted quantitatively using mathematical models. Among the most common applications of PMx are population PK meta-analyses, which have become a de rigueur component of NDA submission packages. Yet, the value of PMx extends far beyond “tick-the-box” regulatory requirements. In this presentation, Dr. Mirjam Trame will explain why the full potential of pharmacometrics is only realized when applied to strategic decision-making regarding treatment and trial design optimization.