Preclinical Development – Biomolecular
2019 PharmSci 360
The design, translation, and optimal development of new drugs is a process fraught with challenges for which quantitative strategies exist to enhance understanding, mitigate risk, and provide predictive guidance. Modeling approaches can be used to better integrate disparate data and pathway understanding to develop a quantitative rationale for the optimization of assets, preclinical-to-clinical translation, and dose expansion decisions. Here, we give a brief introduction to mechanistically-based modeling strategies that may be used to help with the development of new therapies. We will motivate the session with an introduction to critical issues of import to the design of bispecific antibodies, modeling in vitro assays to better assess the properties of assets pre-clinically, considerations for modeling and translating animal models, and finally additional insights that can be provided by QSP platforms.