At the 7th Annual Innovations in Regulatory Science Summit, held January 11, 2026, an Oxford-style debate drew strong engagement around one of the most consequential questions in biomedical research: Is it time to get rid of animal testing?
Assigned to represent the affirmative position, Paul Watkins, Howard Q. Ferguson Distinguished Professor at the University of North Carolina at Chapel Hill and a CERSI Principal Investigator, argued that the continued reliance on animal models reflects systemic inertia rather than scientific superiority. The session was moderated by Steven Kozlowski, Chief Scientist at the U.S. Food and Drug Administration, and Joseph Wu, Professor and Director of the Stanford Cardiovascular Institute, setting the stage for a rigorous and balanced exchange.
Dr. Watkins argued that despite decades of commitment to the 3Rs—replacement, reduction, and refinement—animal testing remains the default in drug development largely because of entrenched incentives, infrastructure, and regulatory expectations. He cited persistent translational failures across cancer, sepsis, cardiovascular disease, and neurodegeneration, noting that most drug candidates that succeed in animals ultimately fail in humans, with significant cost to patients, time, and resources.
Opposing the motion, Jorg Blumel, Senior Vice President of Development Sciences at Genentech, emphasized that while human-relevant technologies are advancing rapidly, animal models continue to play a central role in safety assessment. He argued that industry will adopt alternatives as they become sufficiently robust and validated, cautioning against moving faster than the science and regulatory frameworks allow.
In his rebuttal, Watkins pointed to the practical realities of drug development, noting that established animal studies remain the fastest and most predictable path to first-in-human trials. Without finalized FDA guidance documents and clear mandates for how New Approach Methodologies must replace animal studies in regulatory submissions, he argued, meaningful reductions in animal use are unlikely to occur at scale.
Together, the debate highlighted both the urgency of transitioning toward human-relevant science and the complexity of doing so responsibly. The thoughtful presentation of evidence on both sides made the session a standout of the Summit, underscoring the need for continued cross-sector dialogue to modernize regulatory science.
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