All articles tagged with #nams
NIH is investing over $150 million to advance human-based research methods (NAMs) and reduce animal testing, creating technology development centers, a NAMs data hub, and a validation network; four pilot NAMs projects on preterm birth, developmental neurotoxicity, inhalation toxicity, and acute oral toxicity will be funded, with a separate $7 million Reduction to Practice Challenge with FDA and EPA to push NAMs toward regulatory use.
The FDA issued a draft guidance to help drug developers validate new approach methodologies (NAMs) as replacements for animal testing in drug development, outlining four core validation principles—context of use, human biological relevance, technical characterization, and fit-for-purpose—and encouraging early consultation with FDA review divisions. NAMs encompass advanced in vitro systems, organoids and organ-on-chip models, in silico methods, and even phylogenetically lower organisms like zebrafish. The goal is to rely on human-relevant data to improve safety predictions and accelerate access to safer therapies, building on previous efforts to reduce animal testing and update related guidance on pyrogen/endotoxin testing.
Governments from the UK, US, and EU are accelerating plans to reduce or phase out animal testing, backed by rapid advances in new approach methodologies (NAMs) such as organs-on-chips, organoids, and AI-based models. Regulators are beginning to accept NAM data and fund or pilot related tools (e.g., FDA ISTAND), and industry is investing in human biology models. Yet experts warn that many biological systems remain too complex for non-animal methods, and full replacement will take time; the trend is a staged 3Rs-driven decline, not an immediate end to animal research.
The article discusses the nuanced debate between traditional animal models and new approach methodologies (NAMs) in biomedical research, emphasizing that both have their strengths and limitations. It advocates for a balanced, model-specific approach rather than outright replacing animal testing with NAMs, highlighting technological advances and ethical considerations.
Innovative approaches called NAMs are replacing animal testing in biomedical research, offering more human-relevant, ethical, and cost-effective methods for drug testing and understanding biology. Despite progress and regulatory support, adoption faces resistance, especially in publishing and funding, highlighting the need for systemic change in scientific practices.