As FDA Moves Away From Animal Testing, AI and Organoids Can Shine

Johns Hopkins’ Thomas Hartung discusses how drug discovery and development will change under evolving regulatory policies that embrace AI technology as well as organoid and other non-animal models of human biology.

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Last year, the FDA announced it would be phasing out animal testing requirements for some therapies. The NIH followed suit. According to Thomas Hartung, professor and chair at Johns Hopkins Bloomberg School of Public Health, these policy shifts are an “overdue adaptation to scientific progress.”

In this special edition of The Weekly, Hartung discusses how artificial intelligence (AI) and various non-animal models such as human organoids will transform drug development and delivery, especially now that the regulatory side is catching up. The FDA Modernization Act, now making its way through Congress, codifies the FDA’s stated goal of starting to move away from animal testing. And in making that announcement last year, the FDA put out a roadmap for how to do this.

In May, Hartung will attend the National Biotechnology Conference in San Diego as a keynote speaker. BioSpace is a media partner of the meeting, and Managing Editor Jef Akst will also attend to moderate the executive track.

The 2026 National Biotechnology Conference runs May 11–14. You can find the agenda here.

Jef Akst is managing editor of BioSpace. You can reach her at jef.akst@biospace.com. Follow her on LinkedIn and Twitter @JefAkst.
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