Danaher Corporation, a global science and technology innovator which recently acquired Abcam, has launched a strategic collaboration with Cincinnati Children’s Hospital Medical Center, with the goal of improving patient safety by addressing a leading cause of failure in clinical trials.
 
As part of the Danaher Beacons program, the multi-year collaboration aims to improve liver organoid technology as a drug toxicity screening solution for safeguarding patients, which could accelerate development of new therapies and potentially save billions of dollars in wasted research and development productivity each year.

Developing Better Liver Organoid Technology

More than 20% of clinical trials fail due to drug-induced liver injury (DILI)¹, leading to as much as $3 billion annually in lost effort². Widely used in vitro models for toxicity testing that rely on immortalized cell lines or primary cells frequently fall short in accurately predicting human responses such as DILI. Emerging alternatives, such as liver organoids – complex multicellular models that have been shown to be highly predictive of human responses – can offer a more physiologically complex and personalized replication of human biology, proving valuable in predicting individual patient reactions to drugs and therapeutic interventions.
 
However, liver organoids have not been adopted widely because they are challenging to manufacture consistently at large scale and are typically sourced from a small number of samples that represent a highly limited patient population. As a result, biotech and pharmaceutical companies often struggle to accurately predict the risk of DILI in preclinical stages of drug development – especially in genetically diverse human populations that are not adequately represented by current model systems.
 
Molecular Devices, a Danaher subsidiary and leading high-performance life science solutions provider, will build on a long-standing relationship with Cincinnati Children’s to lead the Beacon’s work. Molecular Devices is a pioneer of end-to-end solutions for organoid development, and recently launched the CellXpress.ai Automated Cell Culture System – an AI-enabled solution that automates demanding production schedules to produce reliable, reproducible, and streamlined organoids at scale.
 
The Cincinnati Children’s Center for Stem Cell & Organoid Medicine (CuSTOM)—a cross-departmental multi-disciplinary center of excellence leveraging advances in developmental biology and stem cell technologies to create complex, physiologically functioning human tissues—has been producing organoids using Molecular Devices technology since 2019.
 
William Blake, PhD, Chief Technology Officer, Human-Based R&D, Danaher, said: “Predictive, human-relevant drug safety testing is one of the most pressing needs to reduce clinical trial attrition. We are delighted to partner with Cincinnati Children’s with the goal of developing more streamlined, scalable, and genetically diverse liver organoid technology that could help get better, safer therapeutics to more patients faster.”

About the Collaboration

Collaborative project work will be performed in a facility known as the CuSTOM Accelerator (CA) lab that focuses on process, prototype development and de-risking proprietary technology to facilitate clinical translation and commercialization. Magdalena Kasendra, PhD, Director of Research and Development at CuSTOM and Takanori Takebe, MD, PhD, Director for Commercial Innovation at CuSTOM and an associate professor in the University of Cincinnati Department of Pediatrics, will co-lead the Beacon’s efforts.
 
Kasendra said: “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. The Beacon project is designed to adapt human liver organoids to align with industry standards and regulatory practices. This adaptation could facilitate their more accessible integration into drug discovery processes, addressing current gaps in predictive and equitable toxicity testing.”
 
Takebe remarked: “Our ongoing commitment to comprehending patient diversity and susceptibility to drug-related adverse events finds a synergistic match in our strategic collaboration with Danaher. This joint endeavor will bring together our collective expertise and aim to make strides in robust technology with the potential to impact countless patients waiting for safe new drugs.”
 
References:
^1. https://www.sciencedirect.com/science/article/pii/S0168827823000727
^2. https://nature.com/articles/s43856-022-00209-1