New Approach Methodologies

New Approach Methodologies (NAMs) are tools that improve the predictability of the efficacy and/or safety of a therapeutic or chemical substance in humans and reduce and/or replace animal testing.

At Charles River, we are committed to leading the industry in the adoption and validation of NAMs and over the past decade, we have made significant strategic progress in this area. Through strategic integration of NAMs and collaborative partnerships, we are fostering innovation that enables the creation of next-generation tools and approaches. These solutions not only elevate the quality of nonclinical programs but also support the global shift toward more ethical, sustainable, and scientifically robust research practices.

Our implementation strategy focuses on embedding NAMs technologies and compatible testing platforms across both:

• Therapeutic and preventive substances, encompassing all drug modalities within traditional and emerging areas of drug discovery and development
• Chemical substances, including non-therapeutic compounds such as agrochemicals (currently tested) and cosmetics

This includes:

1. In vitro models, such as human cell-based assays, organoids, and organ-on-a-chip systems that replicate human tissue responses
2. In silico techniques like computational toxicology, machine learning-based predictive modeling, and virtual screening to simulate biological interactions
3. 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

Contract research organizations (CROs) like Charles River play a pivotal role in advancing new approach methods by evaluating and validating new models, embedding them into drug development strategies, and ensuring they meet evolving regulatory expectations. We provide the scientific expertise, infrastructure, and flexible platforms needed to apply NAMs effectively—either alongside or as new alternative methods to animal testing—helping clients make confident, data-driven decisions and accelerate their development timelines.

NAMs are essential to the future of drug discovery and development. They enable more predictive, human-relevant data generation, reduce reliance on animal models, and support ethical research practices. New alternative methods also have the potential to identify toxicities earlier, improve clinical translation, and streamline the regulatory path, ultimately helping to bring safer, more effective therapies to patients faster because every moment matters.

Our leadership in new approach methods is built on deep scientific expertise, a broad portfolio of non-GLP and GLP-compliant methodologies, and a commitment to innovation. We’ve developed a strong foundation of in vitro, in silico, in chemico, and human-relevant models that are actively used across the drug development lifecycle.

What sets us apart is our ability to translate scientific innovation into practical, scalable solutions. We work closely with regulators, academia, and industry to ensure NAMs are not only scientifically sound but also aligned with evolving standards—helping shape the future of safety assessment and therapeutic development.

To further strengthen this leadership, we have established a Scientific Advisory Board comprised of industry-leading experts in animal welfare, science, technology, operations, and regulatory affairs. This board guides our strategic direction in NAMs, ensuring that our approach remains at the forefront of responsible innovation and supports the development and adoption of alternatives to animal testing that uphold scientific integrity and patient safety.

While NAMs offer significant potential, the industry is not yet able to fully replace traditional animal models. Key challenges include the need for robust scientific validation, broader regulatory acceptance, and the development of standardized methodologies. Successfully integrating new alternative methods into existing drug development workflows also requires strategic planning, cross-functional collaboration, and a clear understanding of their appropriate applications and limitations.

Through initiatives like AMAP, Charles River is actively working to overcome these barriers—driving innovation, building confidence, and advancing the responsible adoption of new approach methods across the industry.