New Approach Methodologies (NAMs) in Drug Development

New Approach Methodologies (NAMs) Aim to Minimize Animal Testing

In April 2025, the U.S. Food and Drug Administration (FDA), working alongside the National Institutes of Health (NIH), issued new guidance on New Approach Methodologies (NAMs)—a set of innovative technologies designed to evaluate safety and efficacy without relying solely on traditional animal testing. Together, these changes mark a pivotal shift for the biotech and pharmaceutical industries.

Table of Contents

• New Approach Methodologies (NAMs) Aim to Minimize Animal Testing
• What Are New Approach Methodologies (NAMs)?
• Incorporating NAMs Into Study Programs
• Emerging NAM Technologies to Watch
• How Thermo Fisher Scientific Supports Customers
• FAQ: Common Questions About NAMs
• Resources & Next Steps

These developments also reinforce the principle of the “3Rs” in research—Replace, Reduce, and Refine:

• Replace animal use where possible with scientifically valid non-animal methodologies
• Reduce the number of animals needed by adopting more efficient approaches
• Refine practices to minimize stress and improve animal welfare when animal use is still necessary

The 3Rs have long-guided regulatory and ethical thinking in preclinical testing and now provide a foundation for understanding why NAMs are central to the industry’s future.

Mark Powers, VP of R&D, Cell Biology at Thermo Fisher, highlights: “For researchers beginning their NAM journey, it’s not always about jumping straight to organoids or organ-on-a-chip. It’s about choosing the right model for the question at hand. And often, that can start with a well-designed cell culture system that’s easier to adopt and scale.”

What Are New Approach Methodologies (NAMs)?

New Approach Methodologies (NAMs) are innovative scientific approaches (including in vitro, in silico, and in chemico tools) that are used to evaluate the safety, efficacy, or risk of drugs and chemicals without relying solely on traditional animal testing. NAMs are designed to provide human-relevant, reliable, and reproducible data to support regulatory decisions and advance drug development (see FDA and OECD).

NAMs encompass a range of scientific tools, including:

• 2D & 3D cell culture and organoids
• Organs-on-a-chip
• Computational toxicology models
• In chemico methods such as protein assays for irritancy
• Omics approaches (genomics, proteomics, metabolomics)

As Powers explains: “NAMs allow us to study human biology directly, instead of transposing animal results.”

Incorporating NAMs Into Study Programs

Transitioning from animal studies to NAMs is best approached incrementally. Powers notes: “It’s not practical to say we’ll suddenly switch from animal models to NAMs. The practical way is to start small, using NAMs alongside animal studies, then build evidence. Regulators are open, but engagement with FDA early is key.”

Emerging NAM Technologies to Watch

Several NAM technologies are poised to reshape preclinical testing, including:

• Organs-on-chips: miniature in vitro systems that mimic organ function
• Patient-derived organoids: enabling precision culture
• AI/ML analytics: integrating complex datasets and predictions

How Thermo Fisher Scientific Supports Customers

Thermo Fisher is exceptionally positioned to support NAM adoption with extensive tools and specialist experience/knowledge. Powers explains: “We have all the building blocks—cells, media, growth factors, assay systems. We can customize solutions, and our R&D scientists are excited to engage with both new and experienced users.”

Mary Scanlan, Executive Director of Strategic Scientific Collaboration at Thermo Fisher, added: “[In clinical research services], we are rapidly evolving to position ourselves to be the partner that helps customers bridge gaps in [NAM] expertise and capability [for preclinical studies].”

To further discuss how we can support your NAMs strategy, please contact us.

FAQ: Common Questions About NAMs

To learn more about how Thermo Fisher can support your NAMs journey, visit our website.

Or to discuss how we can support your NAMs strategy, please contact us.

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Resources & Next Steps

Explore further:

• FDA NAMs Resource Hub
• FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies
• NIH NAMs Announcement
• EMA Ethical Use of Animals Guidance
• OECD NAM Validation Portal
• Understanding the 3Rs Framework

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