New Approach Methodologies (NAMs) are transforming the way we develop, study, and regulate medicines, chemicals, and medical devices. Originally referring to “non-animal methods”, the term “NAMs” has expanded to reflect a broader range of novel technologies. NAMs now encompass any innovative, non-animal approach that improves our ability to predict human responses to drugs or environmental exposures. NAMs reduce our reliance on animal testing while providing better methods that more closely reflect how human health will be impacted in the real world.
From artificial intelligence models that predict biological systems to tissue chips that mimic human organs, NAMs are redefining what high-quality, human-relevant data looks like.
The impact of NAMs is no longer hypothetical. NAMs are having real impacts on how we evaluate drugs and devices today.
Who Benefits from NAMs
NAMs touch almost every part of the healthcare and product development ecosystem. Every stakeholder benefits:
- Patients & Consumers – Safer, more effective medicines and products, available faster and at lower cost.
- Industry (Drug, Device, Chemical, Consumer Product Developers) – Higher success rates, reduced development cost, and better predictive data earlier in development.
- Regulators – More relevant, human-centered data to support confident safety and efficacy decisions.
- Animals – Fewer animals used in research with more ethical scientific approaches for those that can’t be replaced.
Regardless of the stakeholder, the outcome is the same: better, safer, more cost-effective, more ethical science.
What Technologies Are Considered NAMs
The most inclusive regulatory-aligned definition of NAMs is: “any new scientific methods that improve our ability to model and test human biology“.
This definition is very broad, but can be clarified by three major technology classes:
In Vitro NAMs (Human Cells and Tissues)
- Cell-Based Assays
- Organoids and Spheroids
- Microphysiological Systems (MPS) / Organs-on-a-Chip
- Stem Cell-Derived Tissue Systems
- Emerging Cell-Derived Technologies
Using living human cells, these technologies capture key features of human physiology that are not consistently mirrored in animals.
In Silico NAMs (Computational and Predictive Models)
- Artificial Intelligence and Machine Learning Toxicity Models
- Systems Biology and Pathway-Based Simulations
- Language Processing Models to Evaluate Health Outcomes
- Machine-Learning Systems to Evaluate Human Behavior
- Emerging Computational Systems
These tools analyze patterns in biological and chemical data to predict outcomes faster and at scale.
In Chemico NAMs (Chemical Interaction Assays)
- Peptide and Protein Reactivity Assays (e.g., DPRA, ADRA, GSH reactivity)
- Oxidative Stress and Radical Generation Assays
- Photochemical and Environmental Reactivity Tests
- Emerging Chemistry Systems
These methods use practical experiments to measure molecular interactions linked to toxicity without the need for cells or organisms.
What’s Next for NAMs
NAMs have been used in early drug development for decades. But for NAMs to be more widely adopted, regulators (FDA, EMA, etc.) must open pathways for NAMs to demonstrate their reliability (“Validation”) and to be formally approved for regulatory submissions (“Qualification”) over traditional methods. Key initiatives are setting the stage for widespread acceptance and standardization:
- FDA ISTAND Program is qualifying NAM-based Drug Development Tools for regulatory use, helping novel technologies gain official recognition.
- Validation & Qualification Network (VQN) is advancing collaborative validation frameworks to harmonize performance standards in NAMs assessment with pathways to pursue qualification.
- NIH’s Standardized Organoid Modeling Center is building shared protocols and reference standards for complex in vitro systems.
- Other Global NAMs Advocates the NC3Rs in the UK, ESTIV in the EU, PETA Science Consortium International, ICCVAM through the NIH and dozens of governmental and non-governmental programs like ECVAM and JaCVAM demonstrate a groundswell among scientists, animal welfare advocates, and regulators in recognizing the importance of NAMs.
- Update: one week after this blog was published, the UK announced their plan to replace animals in science by supporting the uptake of alternative methods.
Together, these initiatives reflect a coordinated global effort to move from proof-of-concept to regulatory acceptance, ensuring NAMs are not only scientifically valid but also trusted for decision-making. As NAMs become the norm for regulators, industry will rapidly follow suit, integrating NAMs and replacing animals in every stage of their development pipeline.
NAMs are being deployed at every stage of drug development, with different applications, to improve the chances of success.
During discovery and lead selection, thousands of potential drugs are assessed. NAMs are used to “thin the herd” by rejecting the most troublesome candidates. This information is not sent to regulators and doesn’t require validation. Later studies generally focus on just one or two compounds. NAMs are used here to answer critical safety and efficacy questions. These data are sent to regulators. Validation of the system is generally required and qualification is increasingly recommended.
Over the next year, the first NAMs will begin receiving true “qualified” status through the FDA ISTAND program. This represents a major milestone that is likely to act as a critical tipping point in the adoption of NAMs globally.
Partner with InnovApproach Consulting
At InnovApproach Consulting, we specialize in guiding innovators through every stage of NAM qualification and regulatory adoption. From ISO-aligned quality systems to FDA ISTAND submissions, our expertise bridges the gap between cutting-edge science and regulatory credibility.
Whether you are developing an organ-on-a-chip system, an AI toxicity model, or a novel predictive assay, InnovApproach Consulting helps ensure your technology achieves recognition, qualification, and real-world impact.
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