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Collaboration to Develop Liver Organoids for Drug Toxicity Screening

The CuSTOM Accelerator Lab at Cincinnati Children’s will lead a multi-year collaborative project as part of the Danaher Corporation’s “Beacons” program to further develop human liver organoid technology as a tool for preclinical testing of prospective new medications to reduce the risk of drug-induced liver injury during clinical trials.

Danaher announced the collaboration Feb. 5, 2024. Read the Danaher announcement.

Magdalena Kasendra, PhD, director of research and development at CuSTOM, and Takanori Takebe, MD, PhD, director for commercial innovation at CuSTOM, will lead the Beacons project at Cincinnati Children’s.

A mission to improve clinical trial outcomes

Over the years, many clinical trials of seemingly promising therapies have ended in costly failures because animal models and other lab techniques could not consistently predict whether a new drug would cause liver injury among clinical trial participants. Emerging organoid technology may help address this challenge.

“The recent modification in FDA regulations, eliminating the mandatory testing of therapies on animals before commencing clinical trials, has created opportunities for the widespread adoption of alternative methods,” Kasendra says.

Takebe adds: “This joint endeavor will bring together our collective expertise to make strides in robust technology with the potential to impact countless patients waiting for safe new drugs.”

The new project also aims to enhance diversity and inclusion at the earliest stages of drug development.

“In addition to Caucasians, our new drug toxicity screening platform will incorporate cells from donors representing diverse ethnic backgrounds, including Asians and African Americans,” Kasendra says. “This will help address the longstanding underrepresentation of these communities in clinical trials and preclinical research.”

What is the CuSTOM Accelerator?

The CuSTOM Accelerator Lab is a part of the larger Center for Stem Cell and Organoid Medicine (CuSTOM) at Cincinnati Children’s. While scientists at CuSTOM continue the wide-ranging basic research needed to develop increasingly sophisticated organoids, the accelerator lab works to scale up biotech business applications.

“The CuSTOM Accelerator provides a runway to develop, manufacture and deliver innovative stem cell and organoid-based research tools,” says CuSTOM’s director, Aaron Zorn, PhD.

Generous gifts from the Farmer Family Foundation have provided major support to help launch the Accelerator Lab, including a $5 million challenge grant awarded in April 2023.

Cincinnati Children’s has five years to match the gift with investments from other donors. Contributions can be made at Give Now: CuSTOM or by contacting James Cleetus at 513-636-1166 or james.cleetus@cchmc.org.

Read more about organoid science at Cincinnati Children’s.