Modeling and simulation is a proven and regulatory-accepted scientific approach used to inform crucial drug development decisions.
While patients vary dramatically in their epidemiologic and epigenetic factors, drugs are still designed as “one-size-fits-all.” Failing to consider interindividual variability results in drugs having sub-optimal risk-benefit profiles. Moreover, clinical trials alone simply cannot address all potential clinical scenarios or address “untestable” scenarios involving sensitive patient populations.
The future of drug development is virtualized and personalized. Modeling and simulation integrates computer-aided mathematical simulation with biological science to inform drug development and labels. This approach will also enable the dream of precision medicine to become a reality.
This article provides a compilation of insights from the experts discussing the role that modeling and simulation will play in modernizing drug development, clinical research, and patient care.