{"id":33974,"date":"2025-12-03T12:03:07","date_gmt":"2025-12-03T20:03:07","guid":{"rendered":"https:\/\/sop.washington.edu\/?p=33974"},"modified":"2025-12-03T13:51:25","modified_gmt":"2025-12-03T21:51:25","slug":"uw-mt-sinai-team-advances-kidney-on-a-chip-toward-fda-qualification-opening-a-new-era-for-safer-faster-drug-development","status":"publish","type":"post","link":"https:\/\/staff.washington.edu\/twentzel\/wordpress\/uw-mt-sinai-team-advances-kidney-on-a-chip-toward-fda-qualification-opening-a-new-era-for-safer-faster-drug-development\/","title":{"rendered":"UW\u2013Mt. Sinai Team Advances \u201cKidney-on-a-Chip\u201d Toward FDA Qualification, Opening a New Era for Safer, Faster Drug Development"},"content":{"rendered":"
\"Cathy
Cathy Yeung and Ed Kelly <\/figcaption><\/figure>\n

A University of Washington\u2013Mount 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\u2014co-led at UW by Dr. Ed Kelly<\/strong> and Dr. Cathy Yeung<\/strong> from the School of Pharmacy\u2014has been accepted into the FDA\u2019s ISTAND program, a competitive pathway for validating cutting-edge tools that could one day transform drug development.<\/p>\n

Their focus: qualifying a \u201ckidney-on-a-chip\u201d<\/strong> as a reliable way to predict kidney injury and understand how the kidney processes medicines\u2014long before a drug ever reaches human trials.<\/p>\n

A Human-Relevant Tool Designed to Improve Safety<\/strong><\/p>\n

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\u2019s structure and function using real human kidney cells.<\/p>\n

\u201cThe UW kidney chip is a credit card\u2013sized device that models part of the human kidney using live cells,\u201d said Dr. Yeung<\/strong>. \u201cIt allows scientists to predict if a new drug might cause kidney damage without having to test the drug in lots of animals or humans.\u201d<\/p>\n

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.<\/p>\n

Supporting the 3Rs: Reduce, Refine, Replace<\/strong><\/p>\n

A key advantage of the kidney-on-a-chip is its alignment with the global 3Rs<\/strong> principle in toxicology\u2014Reduce, Refine, and Replace<\/strong> animal experimentation.<\/p>\n

\u201cThe UW kidney chip directly supports the 3Rs,\u201d said Dr. Kelly<\/strong>. \u201cIt 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.\u201d<\/p>\n

This approach is fully consistent with the FDA Modernization Act 2.0<\/strong>, which encourages the use of \u201cnew approach methodologies\u201d (NAMs) like organ chips and organoids to bring more human-predictive tools into drug development.<\/p>\n

Beyond Safety: A Tool With Broad Future Uses<\/strong><\/p>\n

While predicting kidney injury is the primary focus of FDA qualification, the chip has additional applications.<\/p>\n

\u201cWe\u2019ve also used the kidney chip to estimate kidney clearance\u2014how quickly the kidney removes drugs from the body,\u201d said Dr. Yeung<\/strong>. \u201cIn the future, we believe it will help determine optimal dosing for both healthy individuals and people with kidney disease.\u201d<\/p>\n

These capabilities could support safer prescribing, clearer dosing guidance, and more individualized treatment strategies.<\/p>\n

A Nationally Significant Collaboration<\/strong><\/p>\n

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).<\/p>\n

The UW Pharmacy team is leading the FDA qualification work for assessing nephrotoxicity and estimating kidney clearance, while UW collaborators Beno Freedman <\/strong>and Ying Zheng<\/strong> are advancing qualification of a kidney organoid model for polycystic kidney disease drug development.<\/p>\n

As of November 2025, this team is only the second TraCE group in the nation<\/strong> to advance to the Qualification Plan phase of the ISTAND process.<\/p>\n

A Potential Turning Point for Drug Development<\/strong><\/p>\n

If successful, the kidney-on-a-chip could become an integrated, FDA-qualified tool used routinely by pharmaceutical companies:<\/p>\n