Mathematical biosciences research is increasingly used to drive decisions that are made during the drug discovery and development process. Underscoring this impact, the U.S. Food and Drug Administration has a goal of integrating model-informed drug development (MIDD) into more drug applications and advancing the use of MIDD, under the 2017 Prescription Drug User Fee Amendments act. This goal aims to develop information that cannot or would not be generated experimentally.
We will discuss the typical scientific questions encountered during the development of therapeutic agents. To illustrate the breadth of mathematical approaches that can be employed to address these questions, the mathematical models used during the development of a novel glucose-responsive insulin will be presented.