Charles River Leverages Virtual Control Groups in GLP Studies

Charles River Leverages Virtual Control Groups in GLP Studies

Collaboration highlights ongoing commitment to industry modernization and the highest animal welfare standards

Charles River Laboratories International, Inc. (NYSE: CRL) today announced that its Virtual Control Group (VCG) database and methodology, aimed at reducing animal use, will be used in an upcoming Good Laboratory Practice (GLP)-compliant study for Ipsen. This collaboration highlights Charles River's and Ipsen's dedication and commitment to championing the 3Rs (Replacement, Reduction, and Refinement of animal use in research) while upholding the highest scientific standards. Charles River's VCG program operates under the Alternative Methods Advancement Project™ (AMAP™), an initiative aimed at minimizing animal use in research whenever scientifically appropriate.

"This partnership exemplifies Charles River's scientific leadership and commitment to modernizing our company and the industry," said Dr. Namandjé N. Bumpus, Chief Scientific and Innovation Officer, Charles River. "By advancing VCGs, we are driving innovation for safety studies and reducing animal use where scientifically appropriate."

By combining toxicology and regulatory expertise, historical control data, advanced statistical methods, and AI-powered analytics, VCGs can digitally replace a portion of concurrent control animals in safety studies. This approach lessens reliance on animal use while enhancing data clarity, offering a modern, ethical, and scientifically robust solution for developers seeking efficient decision-making. Charles River will supply VCG data to Ipsen to facilitate prospective analysis of general toxicology endpoints.

Advancing Virtual Control Groups

Virtual Control Groups may be able to impact study timelines, enhance data quality, and meet evolving regulatory expectations for the 3Rs.

  • Up to 12% reduction in animal use where scientifically appropriate, without compromising regulatory-grade rigor
  • Greater statistical power, particularly for detecting rare spontaneous findings that may otherwise obscure study outcomes
  • More consistent interpretation, leveraging large, curated historical datasets to contextualize unexpected results

As Charles River continues to advance innovative approaches through AMAP, collaborations like this demonstrate how science, technology, and expertise can work together to reduce animal use while maintaining the rigorous standards required to bring new therapies to patients.

About the Alternative Methods Advancement Project (AMAP)
The Alternative Methods Advancement Project (AMAP) is a Charles River-led initiative dedicated to developing New Approach Methodologies (NAMs) and exploring innovative scientific and technological solutions aimed at reducing reliance on traditional animal testing. As we enter the next frontier of drug development, AMAP enables strategic, purpose-driven investment to shape a future in which more patients can access the treatments and medicines they need safely, swiftly, and successfully. AMAP is supported by our global, cross-functional Scientific Advisory Board led by Dr. Namandjé N. Bumpus.

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 .

Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com

Charles River Media Contact:
Amy Cianciaruso
Corporate Senior Vice President,
Chief Communications Officer
781.222.6168
amy.cianciaruso@crl.com

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