The NIH microphysiological systems program: developing in vitro tools for safety and efficacy in drug development.

Approximately 30% of drugs have failed in human clinical trials due to adverse reactions despite promising pre-clinical studies, and another 60% fail due to lack of efficacy. One of the major causes in the high attrition rate is the poor predictive value of current preclinical models used in drug development despite promising pre-clinical studies in 2-D cell culture and animal models. Microphysiological Systems or Tissue Chips are bioengineered microfluidic cell culture systems seeded with primary or stem cells that mimic the histoarchitecture, mechanics and physiological response of functional units of organs and organ systems. These platforms are useful tools for predictive toxicology and efficacy assessments of candidate therapeutics. Implementation of tissue chips in drug development requires effective partnerships with stakeholders, such as regulatory agencies, pharmaceutical companies, patient groups, and other government agencies. Tissue chips are also finding utility in studies in precision medicine, environmental exposures, reproduction and development, infectious diseases, microbiome and countermeasures agents. Published by Elsevier Ltd.