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Tracking Progress: Key Milestones Toward Animal-Free Research with NAMs
As the pace of scientific innovation increases, there is a growing demand for research models that are not only more ethical, but also more predictive of human biology. In the United States, two major agencies—the FDA and NIH—are actively driving the transition away from animal testing through the advancement of New Approach Methodologies (NAMs). Through regulatory updates and strategic funding shifts, they are reshaping the landscape of biomedical research and drug development with a strong emphasis on human-relevant science.
April 10, 2025
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.
July 7, 2025
The FDA hosted a hybrid workshop on July 7, 2025, to focus on reducing animal testing in research and regulatory science. The agenda centered on the implementation of novel methodologies and strategies aimed at minimizing reliance on animal models.
Speakers from the FDA, the National Institutes of Health (NIH), and international regulatory agencies shared insights on the progress, challenges, and opportunities involved in adopting New Approach Methodologies (NAMs)—including human tissue-based models, organoids, and 3D culture systems.
During the workshop, the NIH announced a significant policy shift: it will no longer issue new funding opportunities that are limited to animal models of human disease. Moving forward, all NIH funding announcements must include explicit consideration of NAMs—a decisive step toward promoting more ethical, scientifically advanced, and human-specific research practices.
This reinforces support for a range of validated, non-animal models such as:
- Organ-on-a-chip systems
- Organoids, spheroids, and co-culture models
- Advanced 3D cell culture technologies
TheWell Bioscience Commitment
At TheWell Bioscience, our VitroGel® platform aligns with the New Approach Methodologies (NAMs) accepted by the FDA as valid alternatives to animal testing. Designed to support advanced 3D cell culture systems, VitroGel® offers many advantages to bridge the gap between i𝘯 𝘷𝘪𝘵𝘳𝘰 and 𝘪𝘯 𝘷𝘪𝘷𝘰 studies.
Whether you’re working with 2D or 3D cultures, organoids, stem cells, neurons, MSCs, spheroids, functional assays, co-culture systems, or PDX/CDX 𝘪𝘯 𝘷𝘪𝘷𝘰 models—VitroGel® provides a xeno-free, injectable, and room-temperature-stable platform that makes your workflow faster, easier, and more reproducible.
See the full comparison VitroGel® vs animal-based ECM
Xeno-free and Synthetic
100% animal/human origin-free synthetic hydrogel system.
Room Temperature Operation
20-min protocol. Gelation by mixing not temperature dependent.
Biofunctional and Biocompatible
Optimized with multi-functional ligands for many cell types. Biocompatible material suitable for xenograft and in vivo applications.
Reproducible Assays
Batch-to-batch consistency ensures reproducible results. Available for GMP process.
Injectable
Long-term injectability after gelation with no needle clogging. Unique shear-thinning and rapid recovery properties for excellent cell retention.
Ethical
Unlike animal-based ECM, no mice are sacrificed in product manufacturing..
Discover why VitroGel® is the leading animal-free hydrogel.
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