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Charles River Laboratories Announces Development of Nonclinical Virtual Control Groups with Sanofi to Reduce the Use of Animals in Research

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Charles River Laboratories (NYSE: CRL) has announced a collaboration with Sanofi to develop Virtual Control Groups (VCGs) in nonclinical toxicology. This initiative aims to reduce the use of animals in research by replacing some control group animals with data-driven virtual counterparts created from historical datasets. Guided by Charles River’s Alternative Methods Advancement Project (AMAP), this collaboration leverages machine learning and extensive data to generate meaningful study results without the need for as many animal subjects. The project is a pioneering effort to apply VCGs, commonly used in clinical trials, to preclinical research, involving partnerships with regulatory and biopharmaceutical leaders. The initiative aims to advance sustainable science in toxicology studies.

Positive
  • Charles River's collaboration with Sanofi aims to reduce animal usage in research, promoting ethical practices.
  • Development of Virtual Control Groups (VCGs) leverages extensive historical datasets and machine learning.
  • The initiative is guided by the Alternative Methods Advancement Project (AMAP), enhancing its credibility.
  • The project involves partnerships with regulators and the biopharmaceutical industry, ensuring comprehensive support.
  • VCGs could offer meaningful study results, potentially setting new standards in nonclinical toxicology.
Negative
  • The application of VCGs to preclinical research is new and untested, presenting potential uncertainties.
  • Initial reliance on VCGs may face skepticism from stakeholders accustomed to traditional methods.
  • There could be regulatory hurdles in the adoption of VCGs for nonclinical toxicology studies.

Insights

Charles River Laboratories' collaboration with Sanofi to develop Virtual Control Groups (VCGs) is a strategic move that could have meaningful financial implications. By leveraging historical data and machine learning to create VCGs, Charles River can potentially reduce costs associated with nonclinical toxicology studies. Fewer animal control groups mean lower expenses for animal care, procurement and management. This initiative also aligns well with increasing regulatory and ethical demands for reducing animal use, which could improve the company's public image and attract more clients.

Moreover, the application of VCGs could lead to faster study timelines. Traditional control groups often lengthen study durations due to their larger animal requirements and complex logistics. Faster studies mean quicker time-to-market for new drugs, a critical factor in the highly competitive pharmaceutical sector. While the financial benefits are promising, investors should also consider the adoption risk. The acceptance of VCGs by regulators and the scientific community is not guaranteed and resistance could dampen the initiative's impact.

The introduction of Virtual Control Groups (VCGs) signifies an innovative application of machine learning and big data analytics in the field of toxicology. Machine learning models use historical data to predict control outcomes, which can be highly accurate if the dataset is comprehensive and well-maintained. The collaboration with Sanofi suggests that both companies are confident in the robustness of their data and the predictive capabilities of their algorithms.

However, investors should be aware of potential challenges. The accuracy of VCGs depends heavily on the quality and diversity of the historical data. Any biases or gaps in this data could lead to inaccurate predictions, impacting the validity of study results. Additionally, integrating such advanced technology into existing workflows might require significant time and resources. If successful, this initiative could set a new standard in preclinical research, making Charles River a pioneer in the field and offering a competitive edge.

From a market perspective, the collaboration between Charles River and Sanofi to develop Virtual Control Groups (VCGs) addresses a growing demand for ethical and sustainable research practices. This initiative aligns with the broader trend of reducing animal testing in scientific research, which is gaining traction due to increasing regulatory pressures and public scrutiny. Companies that lead in this area are likely to gain favor with both regulators and consumers.

Furthermore, VCGs could open new market opportunities for Charles River. If the technology proves effective, it may attract a wider range of biopharmaceutical clients who are keen to adopt more ethical research practices. This could result in increased market share and revenue. However, the market adoption rate will depend on the perceived effectiveness and reliability of VCGs. Success stories and endorsements from key industry players like Sanofi could accelerate market acceptance, but initial skepticism is likely, which may affect short-term revenue growth.

Through ongoing collaboration with Sanofi, Charles River will explore use of Virtual Control Groups in nonclinical toxicology

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) today announced the launch of its Virtual Control Groups (VCG) initiative with Sanofi. The companies are working together to reduce animal usage by replacing selected control group animals with selected matched virtual control animals developed using retrospective datasets. The VCG collaboration is a project guided by Charles River’s Alternative Methods Advancement Project (AMAP), an initiative focused on reducing the use of animals in research.

“Charles River is uniquely positioned to combine the science of toxicology with the power of machine learning to drive greater use of VCGs for nonclinical research across the industry,” said Shannon Parisotto, Corporate Executive Vice President, Global Discovery & Safety Assessment, Charles River. “We have an unmatched breadth of data, providing a powerful database of study parameters. By leveraging this historical information, we are able to reduce control group animals and provide clients with meaningful study results.”

A VCG is a data-driven, digital creation based on robust historical study data, parameters, and complex statistical methodology. VCGs are an established practice in some clinical trials, however the application to preclinical research is new. Charles River is partnering with internal and external stakeholders, including regulators and leaders from the biopharmaceutical industry to advance this research. Charles River and Sanofi are collaborating to pilot VCGs in nonclinical toxicology programs and explore their use.

“We are proud to work with Charles River on this important initiative,” said Philippe Detilleux, Global Head of Preclinical Safety, Sanofi. “We have an incredible opportunity to advance sustainable science by reducing our reliance on animal models, and VCGs are one way in which we are utilizing technology to make progress in this area.”

As more studies are designed using VCGs, with a myriad of industry partners, increased levels of data will support their refinement, making VCGs more suitable replacements for animals in research.

About the Alternative Methods Advancement Project (AMAP)
The Alternative Methods Advancement Project (AMAP) is a Charles River initiative dedicated to developing alternatives to reduce the use of animals in testing. As we enter the next frontier of drug development, AMAP will facilitate strategic and purposeful investing to lead the way toward a future where more patients receive needed treatments and medicines safely, swiftly, and successfully. In keeping with our commitment to the 4Rs, we are dedicated to pursuing scientific and technological innovations to explore new and exciting ways we can further reduce the use of animals in testing. The guidance of AMAP will help us align our investments, partnerships, product and service initiatives, and advocacy efforts as we focus on our goal of investing $300 million over the next five years to further enhance this critical mission and drive industry-wide adoption of alternatives.

About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

Investor Contact:

Todd Spencer

Corporate Vice President,

Investor Relations

781.222.6455

todd.spencer@crl.com

Media Contact:

Amy Cianciaruso

Corporate Vice President,

Chief Communications Officer

781.222.6168

amy.cianciaruso@crl.com

Source: Charles River Laboratories International, Inc.

FAQ

What is the focus of the collaboration between Charles River Laboratories and Sanofi?

The collaboration focuses on developing Virtual Control Groups (VCGs) in nonclinical toxicology to reduce the use of animals in research.

What are Virtual Control Groups (VCGs)?

VCGs are data-driven, digital creations based on historical study data and robust statistical methodology, aimed at replacing animal control groups in research.

How will the collaboration between Charles River Laboratories and Sanofi impact animal use in research?

The collaboration aims to reduce the reliance on animals by using VCGs, which could offer meaningful study results without as many animal subjects.

Who are the stakeholders involved in the VCG initiative with Charles River and Sanofi?

The stakeholders include regulators, biopharmaceutical leaders, and internal and external partners, ensuring comprehensive support for the initiative.

What is the Alternative Methods Advancement Project (AMAP) by Charles River?

AMAP is an initiative by Charles River focused on reducing the use of animals in research through alternative methods like VCGs.

Why is the application of VCGs to preclinical research significant?

The application of VCGs to preclinical research is significant because it represents a new, untested approach that could set new standards in nonclinical toxicology.

Charles River Laboratories International, Inc.

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