Animal testing has long been at the forefront of drug and cosmetic development. Rats and various species of monkeys, including rhesus macaques, have undergone some of the most invasive forms of testing. However, researchers are increasingly questioning whether animal testing is effective enough and whether it can accurately predict how the human body will respond.
Researchers at the University of Rochester are investigating an alternative method using tissue chips, or “organs-on-a-chip,” designed to mimic human biology and predict dangerous reactions before experimental treatments move into human trials.
The research team is part of the University of Rochester’s Translational Center for Barrier Microphysiological Systems (TraCe-bMPS), and its technology was recently accepted into the U.S. Food and Drug Administration’s (FDA) Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program, which evaluates promising new tools for drug development.
“We’re excited the FDA sees value in developing tissue chips, and we will work hard to go through the remaining steps to ensure the research community can more widely leverage this technology for drug discovery,” said Joan Adamo, director of regulatory support services at URochester Medicine’s Clinical & Translational Science Institute, in a statement.
However, acceptance into the FDA’s ISTAND program does not mean the chip has been approved for routine drug testing. Instead, it provides researchers with an opportunity to work with regulators toward developing a system that is useful and reliable for drug testing and development.
The system uses modular, mass-producible µSiM tissue chips containing ultrathin membranes and human cells. Sensors incorporated into the chips can monitor inflammatory signals in real time, allowing researchers to observe biological responses. Among the dangerous reactions researchers hope to predict are cytokine release syndrome (CRS), a potentially severe inflammatory response, and immune effector cell-associated neurotoxicity syndrome (ICANS), in which immune activity can damage the nervous system.
“The goal is to predict these toxicities from human cells on a chip, before a drug ever reaches a patient, and to do it without relying on animal models that have repeatedly failed to predict CRS in people,” says center director James McGrath.
McGrath, a professor of biomedical engineering, and the research team hope to determine whether these toxicities can be predicted using human cells on a chip rather than relying on animal models, which have historically struggled to accurately predict CRS in humans.
The next steps include submitting a plan addressing clinical considerations, timelines, data-sharing procedures, and statistical methods for evaluating the technology. If the system ultimately receives FDA qualification, pharmaceutical companies could potentially use the chip technology to generate human-relevant data for inclusion in new drug applications.
The development comes as U.S. regulators accelerate efforts to reduce reliance on animal testing. The FDA Modernization Act 2.0, passed in 2022, helped open the door to new possibilities in drug testing.
The chip system remains an emerging technology, but if eventually adopted on a wider scale, it could help scientists detect dangerous reactions earlier while reducing the number of animals used in experimental drug testing.
Chrissy Newton is a PR professional and the founder of VOCAB Communications. She currently appears on The Discovery Channel and Max and hosts the Rebelliously Curious podcast, which can be found on YouTube and on all audio podcast streaming platforms. Follow her on X: @ChrissyNewton, Instagram: @BeingChrissyNewton, and chrissynewton.com. To contact Chrissy with a story, please email chrissy @ thedebrief.org.