TUCSON, Ariz., March 23, 2026 — Critical Path Institute® (C-Path) announced today that the Society of Toxicology (SOT) has awarded the 2026 Toxicological Sciences Paper of the Year to a landmark study on liver safety biomarkers authored by C-Path researchers and their long-time collaborators. Titled “Serum Glutamate Dehydrogenase Activity Enables Sensitive and Specific Diagnosis of Hepatocellular Injury in Humans,” the winning publication details the validation of glutamate dehydrogenase (GLDH) as a superior precision medicine tool for detecting drug-induced liver injury.
Addressing a critical gap in patient safety, the award-winning research solves a longstanding unmet need in drug development. Patients with underlying muscle impairments often face misdiagnosis or exclusion from necessary clinical trials because standard liver injury markers are unreliable in their specific cases. By establishing GLDH as a specific and sensitive alternative, the team has provided drug developers a way to monitor patient safety with unprecedented accuracy.
“Receiving this award marks the culmination of a deep and strategic partnership that has spanned more than a decade,” said C-Path CEO Klaus
Romero, M.D., M.S., FCP. “Jiri Aubrecht is an outstanding partner scientist that has championed this project since the earliest days of the Predictive Safety Testing Consortium. SOT’s recognition of him and our own dedicated team, including John-Michael Sauer, Ph.D., Katrina Peron, M.S., RAC, and Nicholas King, M.S., affirms the power of collaborative science. Our collaborators have successfully delivered a tool that puts industry-leading safety technologies directly into the hands of drug developers.”
Selected from all articles published in “Toxicological Sciences” over the past year, the paper stood out for its impact on the field. It demonstrates how consortium-based data sharing can generate the regulatory-grade evidence needed to advance novel biomarkers.
“Our goal with this research was to validate a precision instrument and put it directly into the hands of drug developers,” said Jiri Aubrecht, Ph.D., Pharm.D., lead author and long-time C-Path collaborator. “Using GLDH supercharges the development workflow by reducing the false signals that often derail trials for neuromuscular diseases. This paper provides the definitive evidence the scientific community needs to innovate with confidence.”
SOT will present the award at its 2026 Annual Meeting in San Diego this week.
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 56% funded by the FDA/HHS, totaling $23,740,424, and 44% funded by non-government source(s), totaling $18,881,611. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
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