Polymer chip models may improve drug testing

By Greg Cima
Published on
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Translucent polymer chip models, about the size of a AA battery, could provide drug candidate safety data with greater speed and accuracy than from testing in animals and cells.

Federal drug authorities will help develop and test those chips over the next few years, starting with those designed to mimic a human liver and animal livers.

Food and Drug Administration officials announced in April plans to evaluate tissue chips—also known as organs-on-chips—produced by one company, Emulate. FDA information indicates the chips could be used to test the effects of candidate pharmaceuticals and biologics as well as pathogens, biological hazards, cosmetics, and dietary supplements. Future tests could involve chip models for kidneys, lungs, and intestines.

An Emulate organ chip that is used as a liver model (Courtesy of Emulate)

An announcement from Emulate indicates that, in the agreement, FDA officials will evaluate and qualify use of Emulate’s organs-on-chips technology for toxicological testing in product evaluations. The studies will use Emulate’s chips, instruments, and software, which the company claims create a predictive model with more precision and detail than other preclinical testing methods, including cell culture– and animal-based testing.

“In the collaboration, FDA and Emulate researchers will initially use Emulate’s Liver-Chip from multiple species (Human Liver-Chip, Dog Liver-Chip, and Rat Liver-Chip), to conduct studies to assess the cross-species differences in toxicology data between humans and animal species,” the Emulate announcement states.

The FDA and National Institutes of Health have been funding tissue chip research since at least 2010, when they awarded money to Harvard University for development of a heart-lung tissue chip model for drug safety and efficacy testing, NIH information states. The NIH National Center for Advancing Translational Sciences has been working since 2012 with other NIH entities, the Defense Advanced Research Projects Agency, the FDA, and pharmaceutical companies on the Tissue Chip for Drug Screening program. The program is intended to develop platforms that can support living human tissues and cells, model the structure and function of human organs, and combine those models into an integrated system that can mimic complex functions of a human body.

NIH information indicates the chip models of organs should be faster and more effective in evaluating safety of a candidate drug, vaccine, or biologic agent. Geoff Spencer, a spokesman for the NIH translational sciences center, said the research supported through the center has shown great promise, but predicting how much difference the chip models could make would be premature.

Information he provided indicates about 90 percent of candidate drugs fail during human clinical trials because 30 percent are unsafe, and 60 percent are ineffective.

In October 2016, the center also announced $6 million in awards to establish three tissue chip testing centers. Investigators at the Massachusetts Institute of Technology and Texas A&M University plan to validate tissue chip platforms, and recipients at the University of Pittsburgh will establish a tissue chip database for each organ platform, NIH information states.

Another announcement from October 2016 indicates the center had allocated $13.5 million toward research using tissue chips to create human disease models that could be used to evaluate candidate drugs. The models would help scientists assess biomarkers, bioavailability, efficacy, and toxicity of candidate therapeutics prior to clinical trials, NIH information states.

And the center has partnered with the Center for the Advancement of Science in Space to refine tissue chip technology for biomedical research at the International Space Station, where the chips could be used to study effects of reduced gravity.