The National Institutes of Health (NIH) recently awarded kidney disease researchers at UW $7.3 million in the form of a federal grant. Money from the grant will be used to continue research into drug-development systems that minimize the use of animals in medication development.
Drugs that go into clinical trials have a failure rate of 90%. Dr. Edward Kelly, associate professor at the UW School of Pharmacy, attributed a significant part of that failure rate to unanticipated toxicity in drugs. Currently, the prediction of drug safety before clinical trials is based on animal testing, however Kelly said that rodents do not make good predictors for humans.
For over a decade, the NIH has been funding a chips initiative at UW through the National Center for Advancing Translational Sciences (NCATS) to create kidney physiological micro-systems that better indicate drug induced injury to the kidney.
When the Food and Drug Administration (FDA) Modernization Act 2.0 was passed in 2022, the project transitioned to get FDA qualification. Part of the act states that, along with animal testing, novel alternate methods have to be used before drugs go to clinical trials.
“This new grant from NCATS is going to fund us to qualify, which is a regulatory term to show robustness and reproducibility of our kidney chip and kidney organoid systems in certain contexts of use,” Kelly said. “These contexts of use include drug-induced injury, disease modeling, as well as physiologically based pharmacokinetic modeling. In other words, how long does the drug stay in your body? How’s it eliminated?”
Silico, computer-based modeling, is another component of the FDA act that the project is following. The researchers have been able to use the kidney chip data and Silico modeling of kidney drug clearance to predict human outcomes. Historically, to test computer models, tests were done with animals, but the kidney chips represent a bridge between Silico modeling and clinical testing.
A challenge that the team has faced in creating the kidney chips is that the simple matrix in which the cells for the chips are grown are not ideal. Currently, there are two chemical engineering undergraduate students working on optimizing the matrices, which Kelly sees as a training opportunity and a way of making a better system.
The system is currently robust, but according to Kelly, there is always room for improvement as the FDA standard for qualification is much higher than what is needed for an academic publication.
Reach contributing writer Nameek Chowdhury at [email protected]. X: @ChowdhuryNameek
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