There is a great need to understand the synergy between the areas of translational and regulatory science research as they pertain to microphysiological systems and their application in evaluating safety and efficacy for therapeutic indications for different disease areas. There has been much progress towards the experimental development of robust, scalable, and reproducible 3D cellular models, including spheroids, organoids, biofabricated tissues and microphysiological on chip systems, as assay platforms for preclinical drug testing.  However, there is a need for systematic physiological and pharmacological validation and benchmarking of the different 3D cellular models to establish their true clinical predictability and use for decision making in the drug discovery and development pipeline. This talk will focus on identifying these areas of synergy and focus on the development of microphysiological systems that are a best fit for different applications.