NIH Funding of Human Organs-on-Chips Essential to Replacing Unreliable Animal Tests

The National Institutes of Health (NIH) recently awarded 13 investigators around the country two-year grants totaling about $15 million per year to further develop tissue chips to model certain human diseases, including rheumatoid arthritis, kidney disease, flu infection, neurodegenerative diseases, heart conditions, and even rare genetic disorders. This Tissue Chip for Disease Modeling and Efficacy Testing initiative serves as the first phase of a five-year program to support new research tools for modeling human diseases in the laboratory and testing the effectiveness of new therapies. This exciting announcement is a sign of dramatic change in the way we study human diseases, and a promising sign of continued progress.

These tissue chips or organs-on-chips are miniature platforms support living cells or tissues in a 3-D architecture to mimic the complex biological interconnections and interactions within human organs or systems. They promise to yield more human-relevant results while reducing and replacing the use of animals in research and toxicological testing. They may also be utilized one day to personalize medicine by allowing an individual patient’s responses to drugs to be tested prior to administration. The goals of the Tissue Chip for Disease Modeling and Efficacy Testing initiative include:

• Developing tissue chips as human-relevant disease models using cells derived from humans, including stem cells and primary human tissues
• Determining the disease relevance of these models by verifying key experimental features in pilot tests.
• Testing the ability of these models to measure the effectiveness of candidate drugs

Upon successful completion of the first phase, the awarded investigators will partner with pharmaceutical companies to develop a plan to use these models for testing the safety and efficacy of candidate drugs.

The Tissue Chip for Disease Modeling and Efficacy Testing initiative is part of a continuing effort by the National Center for Advancing Translational Sciences (NCATS) at the NIH to support this promising area of research. In 2012, NCATS partnered with the Defense Advanced Research Projects Agency (DARPA) and the Food and Drug Administration (FDA) to launch the Tissue Chip for Drug Screening program to develop tissue chips to mimic human organ systems and to integrate them to form a human body-on-a-chip. Over the last five years, NIH and DARPA awarded about $70 million of research funding to support this program.

Up to 95 percent of drug candidates fail in human clinical trials due to lack of efficacy or safety. Having better predictive models for testing candidate drugs is not only essential for avoiding major drug failures or disasters in humans but also to avoid missing out on potentially helpful treatment for humans that have been erroneously labeled as ineffective or toxic in animal tests. Given that animal experiments are unreliable predictors of drug responses in humans, developing tissue chips as human-relevant models for drug testing is essential to replacing the costly and unreliable animal tests.  "The goal is for these tissue chips to provide more accurate platforms to understand diseases, and to be more predictive of the human response to drugs than current research models, thereby improving the success rate of candidate drugs in human clinical trials," said NCATS director Christopher P. Austin, M.D.

Unfortunately, this timely announcement comes the same month that the National Institute for Environmental Health Sciences (NIEHS) announced available grants for developing “animals-on-chips.” They’re funding work to create miniature dog, rat, or monkey organs because drugs are currently tested in these animals, and they hope to compare the results of the animal-organs-on-chips to results from animal tests. This approach is a distraction from what we really need, and what our government should be funding—models that give us information on how humans react to drugs. The $2 million they are offering would be better spent on human cell and tissue models.