Last Updated on April 14, 2025 by The Health Master
Animal testing
The U.S. Food and Drug Administration (USFDA) has recently announced to stop animal testing in the development of monoclonal antibody therapies and other crucial drugs.
This important change will see the agency prioritize “human-relevant methods,” specially including the integration of artificial intelligence (AI)-based models.
This move aims to enhance drug safety and reduce the heavy costs associated with research and development of the drugs, and it will provide more affordable drugs to patients.
Driving Innovation and Reducing Costs:
The Promise of New Approach Methodologies (NAMs).
The USFDA’s forward-thinking strategy centers around the adoption of what are termed “New Approach Methodologies,” or NAMs.
These advanced techniques include a range of non-animal testing methods, with AI-driven systems playing an important role in predicting the behavior of the drug within the human body, including side effects.
This transition signifies a departure from traditional animal testing models, which often present limitations in accurately reflecting human responses to medications.
A Paradigm Shift for American Healthcare:
USFDA Commissioner Martin Makary hailed this initiative as a “paradigm shift in drug evaluation,” emphasizing its potential to “accelerate cures and meaningful treatments for Americans while reducing animal use.”
Dual benefits of this new approach:
Fastening the drug development process to bring life-saving therapies to patients quickly and addressing other concerns associated with animal experimentation in scientific research.
Industry Perspectives:
Meanwhile, the National Association for Biomedical Research (NABR) has offered a more cautious perspective.
NABR President Matthew Bailey highlighted the current lack of a complete replacement for animal testing models in all areas of biomedical research and drug development.
He emphasized that AI’s effectiveness heavily relies on the quality and comprehensiveness of existing data.
“The unknown variables could present the biggest risk to patients.
So, it will be interesting to see where AI is validated as a replacement to a whole biological organism and where it isn’t,” Bailey stated, pointing to the critical need for rigorous validation of AI-based methodologies.
A Pilot Program
Looking forward, the USFDA plans to launch a pilot program within the next year.
This program is specially for the selected developers of antibody-based drugs to use a completely non-animal-based testing process.
The valuable insights and findings gleaned from this pilot study will be instrumental in shaping broader policy changes and informing updates to regulatory guidance, which are expected to be implemented in a phased manner.
Q. What are New Approach Methodologies (NAMs)?
A. NAMs are advanced techniques that include a range of non-animal testing methods, with AI-driven systems playing an important role in predicting the behavior of the drug within the human body, including side effects.
Q. Why is the USFDA stopping the animal testing?
A. This move of stopping the animal testing aims to enhance drug safety, reduce the heavy costs associated with research and development of the drugs, and it will provide more affordable drugs to patients.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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