Organoids, AI, and the FDA’s Move Away from Animal Models

Is this the end of animal testing? | Biotech Blueprint Podcast

For nearly a century, animal testing has been a cornerstone of drug development. But that paradigm is starting to shift.

In this episode, I speak with Dr. Patrick Creisher, PharmD, PhD, a scientist who’s worked with both animal models and human organoids, about the FDA’s new roadmap for preclinical testing. We unpack the agency’s April 2025 announcement, what it means for the future of drug safety, and how emerging technologies like AI, organoids, and organs-on-chips are beginning to reshape the landscape.

We discuss:

• The science behind organoids and chips, and where they fall short

• Why the FDA believes New Approach Methodologies (NAMs) may be more human-relevant

• What role AI could play in making drug development faster, cheaper, and more ethical

• Whether companies like Charles River and Jackson Labs need to adapt or risk falling behind

The question is no longer if we move away from animal testing, but when, and how fast.

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