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New Approach Methodology (NAMs) Strategies

Transform your drug development with NAMs Strategy & Regulatory Support

How Certara helps you integrate NAMs into drug development

While New Approach Methodologies hold promises to reduce animal use in drug development, regulatory concerns still persist. These include questions about global regulatory acceptance, the translatability of NAMs for human risk assessment, and the short-term impact on cost and timelines until broader validation is achieved.

Certara’s regulatory and drug development experts partner with companies to assess, design, and implement best-fit NAM strategies tailored to their specific development programs. Our approach combines deep regulatory insight, scientific rigor, and cross-functional expertise to deliver strategies that accelerate development while supporting global regulatory alignment.

The Certara difference

Certara clients also benefit from access to industry-leading tools, including the Simcyp Simulator™—the most widely adopted platform for PBPK modeling—and validated mAb QSP models, to further support NAM-based strategies.

Benefits of working with us:

Innovation underpinned by compliance

Transition to NAMs with innovative strategies anchored in an understanding of regulatory expectations.

Global perspective

Tailor NAM strategies for a seamless global approach, regardless of the regional nuances or differences in regulations.

Expert-driven efficiency

Partner with a multidisciplinary team of industry veterans ready to refine, align, and accelerate your drug development efforts.

联系我们

Learn how Certara can help you design a future-ready NAM strategy—contact us to get started.

实力积淀:依托 25 年行业经验及获全球监管机构认可的生物模拟平台,制定前瞻性开发策略
监管信心:以真实世界数据、先进建模与已验证新方法学为支撑,制定符合 FDA 路线图的替代动物实验策略
加速成功:通过更快速、更经济的临床前路径,打造抗风险管线,获取高质量证据与竞争优势


常见问题解答

What are New Approach Methodology (NAMs) Strategies and why are they important in drug development?

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.

How does Certara help companies integrate NAMs into their development programs?

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.

What does a NAM Development Plan from Certara include?

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.

How does Certara support regulatory discussions around NAMs?

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.

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