NAMs

New Approach Methodologies (NAMs) Frequently Asked Questions

• What are new approach methodologies?

  New approach methodologies (NAMs) are laboratory, computational, or integrated methods that generate biological evidence without relying exclusively on traditional animal models. Examples include human cell-based assays, organoids, advanced tissue models, chemical-based tests, computational models, and combinations of these approaches.

• Are NAMs the same as alternatives to animal testing?

  Not exactly. Animal-testing alternatives focus on replacing, reducing, or refining the use of animals. NAMs are a broader category centered on useful, often human-relevant evidence. NAMs may replace an animal study, complement it, or strengthen how a research program is designed.

• Do NAMs have to be completely animal-free?

  No. Whether NAMs must be animal-free depends on the definition and intended use. Some workflows use animal-derived matrices, antibodies, sera, or reference data while reducing reliance on intact animals. Researchers should report these inputs clearly and align them with project goals.

• Why are NAMs receiving so much attention?

  NAMs can provide human-relevant mechanistic data while improving speed, scalability, and early decision-making. They may reduce animal use and address species differences that limit translation. Regulatory initiatives and demand for reproducible human-based models are accelerating development, validation, and adoption.

• Are 3D cell cultures considered NAMs?

  Yes, when used within a defined, fit-for-purpose workflow. 3D cell cultures can serve as in vitro NAMs by modeling human biology, disease, toxicity, or treatment response. Its value depends on biological relevance, technical performance, reproducibility, and the decision it supports.

• Are spheroids and organoids considered NAMs?

  They can be. Spheroids and organoids may function as NAMs when they address a defined question and produce reliable, interpretable evidence. The label reflects how the model is used and qualified, not simply its shape or complexity.

• What’s the difference between organoids, spheroids, and advanced tissue models?

  Spheroids are multicellular aggregates formed largely through cell-cell adhesion. Organoids usually develop from stem or progenitor cells and self-organize into tissue-like structures. Advanced tissue models are engineered platforms that may add flow, mechanical forces, tissue interfaces, sensors, or linked organ functions.

• Why are 3D models often used in NAMs workflows?

  Compared with flat monolayers, 3D models can better reproduce tissue architecture, cellular interactions, polarity and oxygen, nutrient, and drug gradients. These features can reveal responses that 2D cultures miss and improve the relevance of mechanistic, toxicity, and efficacy studies.

• Does using a 3D model automatically make a workflow NAMs-ready?

  No. A 3D cell culture system increases biological complexity, but NAMs readiness also requires a clear context of use, relevant endpoints, controlled inputs, predefined quality criteria, repeatable performance, and transparent reporting. A model is not decision-ready if its results cannot be interpreted or reproduced.

• Are all NAMs accepted by regulators?

  No. Regulatory acceptance is method-, endpoint-, product-, and context-specific. A regulator may accept NAMs for one decision but not another or consider them within a weight-of-evidence package. Researchers should define the intended regulatory use early and seek agency feedback when appropriate.

• Does a synthetic matrix automatically make a workflow more NAMs-compliant?

  No. No universal NAMs-compliant designation exists, and a synthetic matrix alone does not establish readiness. Defined composition and lot consistency can reduce variability, but the matrix must support the intended biology and perform reproducibly within a controlled, documented workflow.

• Can Corning® Matrigel® matrix be used in NAMs-focused research?

  Yes. Corning Matrigel matrix can support organoid and other 3D models in NAMs-focused research. Because it is an animal-derived, biologically complex matrix, researchers should control lot, handling, and documentation. A synthetic matrix may be preferable when defined or animal-free components are required.

• What makes a model NAMs-ready?

  A NAMs-ready model is fit for a stated purpose and produces biologically relevant, technically characterized, reproducible, and interpretable evidence. Its cells, materials, process variables, quality criteria, endpoints, analysis methods, and limitations are defined to support the intended scientific or regulatory decision.

• Why are reproducibility and standardization important for NAMs adoption?

  Reproducibility shows that a result does not depend on one operator, reagent lot, plate, instrument, or laboratory. Standardization identifies which variables must be controlled and how methods are documented. Together, they build confidence that evidence can be repeated, compared, transferred, and evaluated.

• How can researchers evaluate the NAMs readiness of a 3D workflow?

  Start with the context of use, then examine model identity, culture method, process controls, output criteria, and reporting. Test performance across runs, operators, reagent lots, and relevant sites. Confirm that throughput and analysis remain reliable at the scale required for the intended decision.

• What are the biggest barriers to broader NAMs adoption?

  Major barriers include variable cells and matrices, labor-intensive protocols, immature quality standards, difficult imaging and analysis, limited cross-laboratory validation, and uncertain regulatory pathways. Cost, training, automation, data infrastructure, and accessibility also matter. Progress depends on coordinated biological, operational, and analytical improvements.