Translational in vitro research: integrating 3D drug discovery and development processes into the drug development pipeline

•Identification of the need to harmonize validation criteria for 3D tissue models for preclinical drug discovery.•A translational capacity model is proposed based on quantitative equivalency measures of selected responses of 3D in vitro and in vivo models.•There is a need to establish a diversity of compounds to measure efficacy and toxicity in 3D in vitro models using quantitative equivalency measures.•Consortiums of academic, industrial and government scientists to identify and harmonize validation criteria for the rapidly developing 3D tissue models provides an ideal venue to enable harmonization validation criteria. As we witness steady progress towards the development of robust, scalable, and reproducible 3D tissue models for preclinical drug testing, there is a need for systematic physiological and pharmacological validation and benchmarking. Ongoing and future studies should generate evidence as to whether 3D tissue models are more predictive, help reduce the risk of failure rate, and can be used for decision making in the drug discovery and development pipeline. Here, we discuss the importance of harmonizing the validation of these models based on throughput capacity and physiological complexity as a requirement to establish their true translational capacity. We also outline our strategy for a novel 3D-tailored holistic drug discovery concept rather than piecemeal integration of 3D models into the current process.