Institute for Computational Medicine Seminar: Model-Informed Drug Development: Past, Present and Future
Who can attend?
Qi Liu, a senior science advisor in the Office of Clinical Pharmacology at the Food and Drug Administration, will give a talk entitled " Model-Informed Drug Development: Past, Present and Future" as an Institute for Computational Medicine Seminar.
Liu, who facilitates regulatory research, innovation, and collaboration in addition to providing scientific leadership for the regulatory review, will discuss Model‐informed drug development (MIDD), referring to the application of a wide range of quantitative models, which integrate the information about patient characteristics, diseases, and drug effect, to inform drug development and facilitate regulatory decision making. MIDD was formally recognized in Prescription Drug User Fee Act VI, although broadly speaking it has been applied to streamline drug development programs for decades. The regulatory applications of MIDD can be broadly classified into four categories: dose optimization, supportive evidence for efficacy, clinical trial design, and informing policy. In recent years, emerging areas such as more mechanistic models (e.g., quantitative systems pharmacology), neural network models, and real‐world data/evidence are gaining attention, and could possibly expand the scope of MIDD.
Please attend the event by joining the webcast. To view live captioning of this seminar, open this link on a split-screen or a second device.
Who can attend?