The number of successful drug development projects has been stagnant for decades despite major breakthroughs in chemistry, molecular biology and genomics. Unreliable translatability of preclinical in vitro and in vivo models has been identified as the cause of most failure. Organotypic and microphysiological culture of primary human cells has emerged as a set of promising tools for preclinical drug development to narrow this translation gap. In this talk I will provide an overview of our recent efforts in developing 3D human tissue cultures and microfluidic models for both efficacy and safety assessments. In addition, the talk will present recent use cases where the use of such organotypic cultures has had direct impacts on market authorizations.

Keywords: 3D human tissue models; translational pharmacology; precision drug development