A large percentage of drug candidates fail at the clinical trial stage due to a lack of efficacy and unacceptable toxicity, primarily because the in vitro cell culture models and in vivo animal models commonly used in preclinical studies provide limited information about how a drug will affect human physiology. The need for more physiologically 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), based on engineered human tissue constructs. The MPS development process requires an initial assessment of viability and functionality, followed by an examination of the MPS response to various stimuli, including drugs, environmental toxins, and disease-related cues. These extensive development efforts take place mainly in the developer’s lab, and the reproducibility of the MPS results are rarely assessed by an independent research group or transferred to industry partners for use in drug development.

Although there is a need for more physiologically-relevant preclinical testing technologies, the transition of MPS technologies from academia to industry remains challenging. Successful transfer and deployment of MPS technologies requires quantitative characterization and validation of the systems, preferably by an independent and unbiased external testing facility. Translational Center of Tissue Chip Technologies (TC2T) has been established to bridge between academic research and development and industrial application of MPS technologies via providing unbiased testing and validation of MPS technologies.

TC2T takes a holistic and mechanistic approach—based on quantitative systems pharmacology (QSP)—that combines quantitative experimental biology, computational biology, and biostatistics to achieve unbiased characterization of these complex systems and translation of experimental insights to clinical outcomes. Our translational systems pharmacology team at MIT includes tissue engineers, experimentalists, and computational biologists and serves as the core of the testing center to identify adverse effects of pharmaceutical compounds and environmental toxin on human organs.

Importantly, researchers concerned about environmental exposures are faced with many of the same challenges as those in drug development. They need to know what is toxic and what is not so that decisions can be made about protection and remediation. The resources being developed by TC2T can ultimately be used for critical problems in environmental health.

For more information on TC2T please visit their website.