Abstract

The NIH Microphysiological Systems Program: Tissue Chips for Tools for Drug Development and Precision Medicine

Danilo Tagle, Associate Director for Special Initiatives, National Institutes of Health

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. A number of these failures can be attributed to poor predictability of human response from animal and 2D in vitro models currently being used in drug development. To address this challenges in drug development, the NIH Tissue Chips or Microphysiological Systems program is developing alternative innovative approaches for more predictive readouts of toxicity or efficacy of candidate drugs. Tissue chips are bioengineered 3D microfluidic platforms utilizing chip technology and human-derived cells and tissues that are intended to mimic tissue cytoarchitecture and functional units of human organs and systems. In addition toxicity studies in drug development, these microfabricated devices are also being used to model various human diseases for assessment of efficacy of candidate therapeutics. A more recent program is the development of “clinical trials on chips” to inform clinical trial design and implementation, and for studies in precision medicine. Presentation will provide a program update and future directions towards widespread use of tissue chip technologies in partnerships with various stakeholders.