Seventeen National Institutes of Health (NIH) grants are aimed at creating 3-D chips with living cells and tissues that accurately model the structure and function of human organs such as the lung, liver and heart. Once developed, these tissue chips will be tested with compounds known to be safe or toxic in humans to help identify the most reliable drug safety signals — ultimately advancing research to help predict the safety of potential drugs in a faster, more cost-effective way. The initiative marks the first interagency collaboration launched by the NIH's recently created National Center for Advancing Translational Sciences (NCATS).
Tissue chips merge techniques from the computer industry with modern tissue engineering by combining miniature models of living organ tissues on a transparent microchip. Ranging in size from a quarter to a house key, the chips are lined with living cells and contain features designed to replicate the complex biological functions of specific organs.
NIH's newly funded Tissue Chip for Drug Screening initiative is the result of collaborations that focus the resources and ingenuity of the NIH, Defense Advanced Research Projects Agency (DARPA) and U.S. Food and Drug Administration. NIH's Common Fund and National Institute of Neurological Disorders and Stroke led the trans-NIH efforts to establish the program. The NIH plans to commit up to $70 million over five years for the program.
“Serious adverse effects and toxicity are major obstacles in the drug development process,” said Thomas R. Insel, M.D., NCATS acting director. “With innovative tools and methodologies, such as those developed by the tissue chip programme, we may be able to accelerate the process by which we identify compounds likely to be safe in humans, saving time and money, and ultimately increasing the quality and number of therapies available for patients.”
More than 30 per cent of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in animal models. Tissue chips, which are a newer human cell-based approach, may enable scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies.
“The tissue chip programme aims to improve drug development for a multitude of different diseases, and will also provide fundamental knowledge about biology that is relevant to multiple scientific disciplines,” said James M. Anderson, M.D., Ph.D., director of the Division of Program Coordination, Planning, and Strategic Initiatives that guides the NIH Common Fund's programs. “The transformative potential of this program, along with its interdisciplinary nature, make this an excellent example of the type of high-impact research supported by the Common Fund.”
The NIH and DARPA programmes will be coordinated closely. For example, DARPA has entered into cooperative agreements with two of the NIH recipients, the Wyss Institute at Harvard University and MIT, to develop engineering platforms capable of integrating 10 or more organ systems. The FDA will help explore how this new technology might be utilized to assess drug safety, prior to approval for first-in-human studies.
In total, 15 NIH institutes and centers are assisting in the coordination of this programme.
The National Center for Advancing Translational Sciences (NCATS) aims to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.
The NIH Common Fund supports goal-driven, research networks in which investigators generate data to solve technological problems, and/or otherwise pilot resources and tools that will be stimulatory to the broader research community. The research products of Common Fund programs are expected to catalyze disease-specific research supported by the NIH Institutes and Centers.