6 days Ago By Republished By Plato
The U.S. Food and Drug Administration announced a major policy change on April 10, 2025, signaling its intent to reduce and potentially eliminate animal testing requirements for monoclonal antibodies and other drugs.
The new approach incorporates a set of technologies and data sources categorized under New Approach Methods (NAMs), including AI-based toxicity models, lab-grown human organoids, and organ-on-chip systems. These models are designed to simulate human physiological responses more accurately than traditional animal testing. The FDA also plans to incorporate real-world safety data from international regulatory environments deemed comparable to the U.
S., reducing the need for duplicative studies in animals.Initial implementation begins with investigational new drug (IND) applications, where the agency will now encourage inclusion of NAMs data.
Companies submitting strong non-animal safety evidence may be eligible for streamlined review. The FDA has released a regulatory roadmap outlining the transition and plans to host a public workshop later this year to solicit stakeholder input.The FDA stated that AI-driven software may be used to simulate pharmacokinetics and toxicity profiles of monoclonal antibodies, allowing early predictions of side effects based on molecular structure and distribution.
Similarly, lab-based testing using human-derived tissue models could reveal toxicity risks not observable in animal subjects.FDA Commissioner Martin A. Makary characterized the move as a “paradigm shift” in drug evaluation.
He noted that patients could benefit from faster access to treatments, while safety may improve due to the increased relevance of human-based testing systems. The agency also emphasized the ethical impact, with the potential to reduce the use of laboratory animals—including dogs and primates—in safety testing.The FDA is coordinating with other federal entities, including the NIH and the Department of Veterans Affairs, through the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), to accelerate the adoption of these tools.
A pilot program will be launched in the coming year to evaluate the effectiveness of primarily non-animal-based testing strategies for select monoclonal antibody developers, with further policy updates expected to follow based on its outcomes. Topics: Bioeconomy & Society SEO Powered Content & PR Distribution. Get Amplified Today.
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