A University of Washington–Mount Sinai School of Medicine research team has reached a major milestone in its effort to modernize how new medicines are evaluated for safety. The collaborative Translational Centers for Microphysiological Systems (TraCE)-MPS group—co-led at UW by Dr. Ed Kelly and Dr. Cathy Yeung from the School of Pharmacy—has been accepted into the FDA’s ISTAND program, a competitive pathway for validating cutting-edge tools that could one day transform drug development.
Their focus: qualifying a “kidney-on-a-chip” as a reliable way to predict kidney injury and understand how the kidney processes medicines—long before a drug ever reaches human trials.
A Human-Relevant Tool Designed to Improve Safety
Drug-induced kidney injury remains one of the major safety challenges in developing new medications. Traditional approaches often rely on animal testing, which does not always accurately predict human responses. The kidney-on-a-chip, however, recreates part of the human kidney’s structure and function using real human kidney cells.
“The UW kidney chip is a credit card–sized device that models part of the human kidney using live cells,” said Dr. Yeung. “It allows scientists to predict if a new drug might cause kidney damage without having to test the drug in lots of animals or humans.”
This system lets researchers directly compare how a new drug behaves relative to similar drugs known to cause kidney injury, helping FDA reviewers make quicker, better-informed decisions about whether a drug is ready for human studies or requires additional testing.
Supporting the 3Rs: Reduce, Refine, Replace
A key advantage of the kidney-on-a-chip is its alignment with the global 3Rs principle in toxicology—Reduce, Refine, and Replace animal experimentation.
“The UW kidney chip directly supports the 3Rs,” said Dr. Kelly. “It uses cells derived from kidneys that were not viable for transplant, reducing the need for animal studies while providing more human-relevant information about drug safety.”
This approach is fully consistent with the FDA Modernization Act 2.0, which encourages the use of “new approach methodologies” (NAMs) like organ chips and organoids to bring more human-predictive tools into drug development.
Beyond Safety: A Tool With Broad Future Uses
While predicting kidney injury is the primary focus of FDA qualification, the chip has additional applications.
“We’ve also used the kidney chip to estimate kidney clearance—how quickly the kidney removes drugs from the body,” said Dr. Yeung. “In the future, we believe it will help determine optimal dosing for both healthy individuals and people with kidney disease.”
These capabilities could support safer prescribing, clearer dosing guidance, and more individualized treatment strategies.
A Nationally Significant Collaboration
The TraCE MPS project brings together expertise across institutions. At the University of Washington, investigators from the School of Pharmacy (Kelly, Yeung) and School of Medicine (Freedman) work closely with colleagues at the Icahn School of Medicine at Mount Sinai (Himmelfarb).
The UW Pharmacy team is leading the FDA qualification work for assessing nephrotoxicity and estimating kidney clearance, while UW collaborators Beno Freedman and Ying Zheng are advancing qualification of a kidney organoid model for polycystic kidney disease drug development.
As of November 2025, this team is only the second TraCE group in the nation to advance to the Qualification Plan phase of the ISTAND process.
A Potential Turning Point for Drug Development
If successful, the kidney-on-a-chip could become an integrated, FDA-qualified tool used routinely by pharmaceutical companies:
- Faster decision-making: Regulators could more quickly evaluate the safety of new drugs entering human studies.
- Better patient protection: Human-derived tissues offer more accurate predictions of kidney injury.
- Reduced reliance on animal testing: The chip provides meaningful, human-relevant data that aligns with ethical and scientific goals.
- More efficient drug development: Improved early safety insights can help promising medications reach patients sooner.
“Our aim is simple,” said Dr. Kelly. “We want to make drug development faster, safer, and more human-centered. If the kidney chip becomes part of the drug development process, it could benefit patients everywhere.”
The TraCE-MPS team’s progress represents a significant step toward that future—one where innovative human-based technologies help ensure that lifesaving treatments reach the public both more safely and more swiftly.