Company maintains focus on driving forward New Approach Methodologies to enhance safety and efficacy testing

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the creation of a global, cross-functional Scientific Advisory Board, led by Dr. Namandjé N. Bumpus, to guide the Company’s strategic focus on New Approach Methodologies (NAMs). NAMs are non-clinical tools that enhance the predictability of efficacy and safety in the development of therapeutics and chemical substances, aiming to reduce reliance on animal testing.

Charles River has a proven track record of pioneering initiatives that minimize animal use in research through the 3Rs (Replacement, Refinement, and Reduction) and has made substantial strategic investments in advancing alternative technologies. The Scientific Advisory Board incorporates Charles River’s industry-leading experts in animal welfare, science, technology, operations, and regulatory affairs, and will continue to advance science in this area.

“Our industry is at an inflection point where science and technology are intersecting to accelerate the pace of drug discovery and development. Charles River is poised to lead the development and regulatory validation of NAMs that can be integrated into programs across our vast client network,” said Birgit Girshick, Corporate Executive Vice President and Chief Operating Officer, Charles River. “We are excited to have premier internal and external expertise driving our strategy with a science-first approach.”

Deep Commitment to Scientific Expertise

The Scientific Advisory Board is an interdisciplinary, global collaboration between Charles River’s leading scientists. The Board is focused on embedding NAMs technologies and compatible testing platforms across therapeutic, preventive, and chemical substances. This includes:

• In vitro models, such as human cell-based assays, organoids, and organ-on-a-chip systems that replicate human tissue responses​
• In silico techniques, including computational toxicology, machine learning-based predictive modeling, and virtual screening to simulate biological interactions​
• In chemico methods, such as direct peptide reactivity assays (DPRA) and oxidative stress response assays that assess chemical reactivity without the use of live cells or animals

Girshick added: “Patient safety and regulatory acceptance will dictate the pace of industry adoption. While much work remains before emerging tools and alternative methods can be consistently and widely adopted, we are well-positioned to lead the path forward and view this as a long-term opportunity for Charles River.”

Leveraging Expertise to Drive Innovation

In her role leading Charles River’s Scientific Advisory Board, Dr. Bumpus will provide strategic guidance in advancing the Company’s comprehensive commercial and regulatory strategy to advance NAMs in the biopharmaceutical industry.

Dr. Bumpus joined the Food and Drug Administration in August 2022 as Chief Scientist and later served as the agency’s Principal Deputy Commissioner until December 2024. Before joining the FDA, Dr. Bumpus was a Professor and Director of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. Dr. Bumpus is a past president of the American Society for Pharmacology and Experimental Therapeutics, a fellow of the American Association for the Advancement of Science, and a member of the National Academy of Medicine.

“Charles River is uniquely positioned to foster both innovation and adoption of NAMs across the industry,” said Dr. Bumpus. “Not only are they actively developing NAMs and integrating advanced technologies with extensive scientific expertise, but they also understand the challenges clients face regarding regulatory acceptance. This combination is powerful and will enable Charles River to strategically and broadly partner in supporting the validation and integration of NAMs into drug discovery and development.”

Charles River has honed this expertise over decades, having already implemented a wide variety of NAMs into its ongoing drug discovery and development programs. These deployed examples include:

• Endosafe ® Trillium®: A recombinant bacterial endotoxin test that reduces reliance on horseshoe crab-derived limulus amoebocyte lysate (LAL)
• In Vitro Skin Sensitization Assays: A non-animal alternative that provides insight into skin reactions following chemical exposure
• Virtual Control Groups: Offers potential reduction of animals used in nonclinical safety studies by leveraging historical control data from previous, standardized studies, rather than conducting an on-study control group
• Logica®: An integrated, multidisciplinary in silico tool that integrates artificial intelligence with traditional bench science to optimize discovery and development
• Next-Generation Sequencing (NGS): An animal-free alternative for pathogen testing as well as genetic characterization of cell lines and drug substances/products produced under GMP conditions. NGS services replace conventional methods with faster, lower-risk, animal-free alternatives in biologics testing

The Scientific Advisory Board aims to develop a scalable approach for NAMs regulatory acceptance and implementation, advancing the goal of providing safe, effective treatments to patients.

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.

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NAMs are non-clinical tools that enhance the predictability of efficacy and safety in the development of therapeutics and chemical substances, aiming to reduce reliance on animal testing.