- Danaher Beacon for Preclinical Drug Safety seeks to address
major cause of failure in clinical trials
- Program will leverage automated liver organoid technology
for drug toxicity screening
- Aims to expand genetic diversity of screening, accelerate
therapy development, and help ensure patient safety
WASHINGTON, Feb. 5, 2024
/PRNewswire/ -- Danaher Corporation (NYSE: DHR), a global
science and technology innovator, today 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.
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."
Collaborative project work will be performed in a
state-of-the-art 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 said: "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."
The collaboration with Cincinnati Children's is the latest
addition to the Danaher Beacons program, which funds product-driven
pioneering scientific research with globally recognized academic
investigators. The ultimate objective of this program is to develop
innovative technologies and applications that can improve human
health, with focus areas in genomic medicines, precision
diagnostics, next-generation biomanufacturing, human systems and
data sciences.
ABOUT DANAHER
Danaher is a leading global life sciences and diagnostics
innovator, committed to accelerating the power of science and
technology to improve human health. Our businesses partner closely
with customers to solve many of the most important health
challenges impacting patients around the world. Danaher's advanced
science and technology – and proven ability to innovate – help
enable faster, more accurate diagnoses and help reduce the time and
cost needed to sustainably discover, develop and deliver
life-changing therapies. Focused on scientific excellence,
innovation and continuous improvement, our approximately 63,000
associates worldwide help ensure that Danaher is improving quality
of life for billions of people today, while setting the foundation
for a healthier, more sustainable tomorrow. Explore more at
www.danaher.com.
ABOUT CINCINNATI CHILDREN'S
HOSPITAL MEDICAL CENTER
Cincinnati Children's ranks #1 in the nation in U.S. News &
World Report's 2023-24 listing of Best Children's Hospitals. In
addition, Cincinnati Children's was recognized as one of America's
Most Innovative Companies by Fortune in 2023 – and ranks the
highest of any children's hospital in the nation. Cincinnati
Children's also was recognized by Forbes as one of America's Best
Employers for Diversity for 2023, and the only children's hospital
recognized in the Top 20 by DiversityInc. Established in 1883,
Cincinnati Children's is a nonprofit academic health system that is
internationally recognized for improving child health and
transforming delivery of care through research, education, and
innovation. Nearly one-third of the more than 18,000 employees are
engaged in research, and Cincinnati Children's is one of the top
recipients of pediatric research grants from the National
Institutes of Health.
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Sources:
-
https://www.sciencedirect.com/science/article/pii/S0168827823000727
- https://nature.com/articles/s43856-022-00209-1
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SOURCE Danaher Corporation