Abstract

Merging Human Microphysiological Systems with Quantitative Systems Pharmacology for In Vitro In Vivo Translation

Murat Cirit, CEO & Co-Founder, Javelin Biotech

A large percentage of drug candidates fail at the clinical trial stage due to a lack of efficacy and unacceptable toxicity, primarily because of translational gap between human physiology and preclinical models including both in vitro culture and animal models. This need for more human-physiology relevant in vitro systems for preclinical efficacy and toxicity testing has led to a major effort to develop “Microphysiological Systems (MPS)”, aka tissue chips (TC) or organs on chips (OOC), based on engineered human tissue constructs.

MPSs hold promise for improving therapeutic drug approval rates by providing more physiological, human-based, in vitro assays for preclinical drug development activities compared to traditional in vitro and animal models. The full impact of MPS technologies to bridge the gap preclinical and clinical gap will be realized only when robust approaches for in vitro–in vivo (MPS-to-human) translation are developed and utilized.