Tracking Progress: Key Milestones Toward Animal-Free Research with NAMs

November 11, 2025 | UK Unveils Roadmap for Alternative Methods

The UK has introduced a new strategy aimed at speeding up the shift away from animal testing by promoting modern, human-focused research technologies. The plan sets clear goals for reducing animal use in specific types of testing and increases investment in alternatives such as organ-on-a-chip models, AI-based analysis tools, and advanced lab-grown tissues. With coordinated support from government, industry, and scientific organizations, this roadmap represents a major step toward more ethical, efficient, and accurate testing methods.

• The government has pledged to scale back and eventually end animal testing as modern alternative methods are introduced.
• Animal welfare and life sciences groups have described the new strategy as “ambitious” and “timely.”
• A £75 million funding package will support the development of advanced testing technologies for life-saving products and help clarify regulatory processes for researchers. New technologies include:

  1. Organ-on-a-chip: small devices that use human cells to act like real human organs.

  2. AI tools: use large datasets to predict whether new medicines are safe and effective.

  3. 3D-bioprinted tissues: lab-made human tissues (like skin or liver) that can be used to study biology and test for toxicity.

• The strategy was created jointly with industry, scientific partners, and animal welfare organisations, fulfilling a key commitment in the government’s manifesto.

September 25, 2025 | NIH Establishes SOM Center

The NIH is establishing the Standardized Organoid Modeling (SOM) Center, the nation’s first dedicated facility for organoid development, to reduce reliance on animal models and enhance reproducibility in organoid research.

Key points:

• The center has been awarded $87 million in contracts over the next three years and will be housed at the Frederick National Laboratory for Cancer Research.
• Its mission is to develop standardized, reproducible organoid-based protocols (new approach methodologies, or NAMs) using advanced tools like AI, robotics, and diverse human cell sources.
• The center will support researchers across academia, industry, and government, offering open access to protocols, data, and organoid resources.
• The initial focus will be on organoid models for the liver, lung, heart, and intestine, with future expansion to additional organs and disease models.
• SOM will collaborate with regulatory bodies (e.g., FDA) to ensure the models meet preclinical testing standards, thereby accelerating therapeutic development and safety evaluation.

April 10, 2025 | FDA Introduces NAMs Initiative

The U.S. Food and Drug Administration (FDA) recently announced a groundbreaking initiative to phase out the animal testing requirement for monoclonal antibodies and other drugs.  This marks a significant milestone in advancing preclinical research toward the gradual elimination of animal use in safety testing. As outlined in the agency’s roadmap, the FDA is embracing New Approach Methodologies (NAMs)—innovative, non-animal technologies such as organoids, microphysiological systems, and AI-driven models. These tools offer more ethical, scalable, and human-relevant alternatives to traditional animal testing.