New Approach Methodology (NAMs) Strategies

NAMs refer to innovative, science-driven approaches—such as in vitro, in silico, and real-world evidence models—that aim to reduce or replace the use of animals in drug development. These methods can improve the relevance and translatability of nonclinical findings to humans. While promising, NAMs raise questions about regulatory acceptance and scientific validity. Certara helps navigate these challenges with tailored, evidence-based strategies.

Certara works with clients to assess their current program, understand regulatory pathways, and design a fit-for-purpose NAM strategy. This includes program analysis, a detailed NAM development plan, and full support for regulatory engagement. Our team of toxicology, regulatory, clinical pharmacology, and modeling experts builds a customized roadmap to support both scientific objectives and Agency alignment.

The NAM Development Plan is a comprehensive, weight-of-evidence-based roadmap that combines multiple types of data—in vitro, in vivo, in silico, and real-world evidence. It outlines study designs, supporting justifications, literature reviews, and a regulatory strategy tailored to global requirements. This plan supports regulatory discussions and guides implementation throughout the development process.

Certara provides end-to-end support for regulatory engagement, from drafting meeting requests and briefing documents to attending meetings and responding to Agency feedback. We adapt the NAM strategy based on regulatory input and offer implementation support for NAM studies. Clients also gain access to powerful tools like the Simcyp Simulator® and mAb QSP models to enhance their NAM approach.