Model-Informed Drug Development (MIDD) Applications in Advancing Patient Care

Model-Informed Drug Development (MIDD) can be a valuable tool to support drug development and advance patient care, especially in assessing benefit-risk of different dosing regimens, bridging between different routes of administration, or when considering dosing recommendations in specific situations not specifically evaluated in clinical trials. For example, by leveraging available clinical data to assess alternative dosing intervals, MIIDD approaches can potentially inform treatment options that reduce frequency or number of patients visits or inform handing of missed/interrupted dosing without the need of additional clinical trials.

In this webinar, we will discuss several case examples where MIDD approaches were used to support the approval of dosing regimens or dosing strategies not directly studied in clinical studies. Some of the specific examples will include use of MIDD approaches to guide dosing recommendations following dosing holidays for bispecific therapeutics and to guide dose selection during clinical development of an ocular implant designed to reduce patient treatment burden. Each of the examples will highlight the question that the MIDD approach was intended to answer, the role of the model in addressing the question, interactions between groups to achieve alignment on the approach and interpretation of the modeling, and overall outcome of the effort.