The National Institutes of Health is collaborating with the Defense Advanced Research Projects Agency and Food and Drug Administration to create miniature 3D models of living organs and tissues on microchips to test drug safety and efficacy more accurately and less costly than current methods.

The aim of these models is to predict whether a candidate drug, vaccine or biologic agent is safe or toxic in humans. According to NIH, more than 30 percent of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in animal models. The problem with traditional animal models is that they do not accurately mimic human physiology. However, these “organs-on-chips” could potentially eliminate toxic and/or ineffective drugs earlier development, thereby saving time and money.  

“Predicting toxicity or adverse events is one of the major reasons that drugs fail in development,” testified Christopher Austin, M.D., director of NIH’s National Center for Advancing Translational Sciences (NCATS), before a Senate Health, Education, Labor, and Pensions Committee hearing on medical innovation held April 28. “We’re tackling this in multiple ways, one of which is through the Tissue Chip for Drug Screening program.”

These bioengineered “human tissue chips” contain living cells and are designed to model the complex structure and biological functions of specific human organs, such as the lungs, liver and heart. Composed of clear flexible polymer that contain hollow microfluidic channels lined by human cells, these transparent microchips provide a window into the inner workings of human organs.

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“The chip that I have with me today represents a kidney,” Austin told lawmakers. “NCATS is building on its initial phase in which there were 10 different organs, the kidney among them, and we’re now funding projects to link these organs together, with the eventual goal within the next four or five years of having 10 organs on a chip—a human on a chip, if you will.”

Ultimately, these organ-specific chips will be integrated into a full system to mimic whole body physiology and used to model disease, as well as to predict whether a drug, vaccine or biologic agent would be effective—or toxic—in humans. The effects will be measured within and across various organs and tissues by which a drug is introduced into the human body, such as the liver and digestive system, as well as the drug’s effectiveness in the organ or tissue it targets, such as the kidney or heart.

Austin also said that personalized chips could be potentially created for individual patients mimicking their unique mechanical and biochemical behaviors. “This is a research project at this point,” he added. “It’s made much more rapid headway than I anticipated, but it is very much in the testing/validation stage now with a lot more work to go.”     

The mission of NCATS, established in 2011 and the newest of NIH’s 27 institutes and centers, is to accelerate translation of basic research discoveries into new drugs and devices so that new treatments and cures for disease can be delivered to patients faster than current methods.

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