Organoids in the Spotlight: What FDA and NIH’s New Guidance Means
FOR IMMEDIATE RELEASE
July 2025
Ann Arbor, MI — In the past year, both the FDA and NIH have announced major policy shifts that signal a clear direction for the future of drug development: a move away from animal testing and toward more predictive, human-relevant models like organoids.
In April, the FDA released a landmark plan to phase out the requirement for animal testing in the development of monoclonal antibodies and other drugs. The agency emphasized the importance of New Approach Methodologies (NAMs)—including organoids, microphysiological systems, and other advanced tools—to ensure safety and efficacy without relying exclusively on animal studies.
👉 Read the full FDA announcement.
Building on that momentum, the NIH announced that it will no longer fund grants that propose animal-only research. Effective immediately, applicants are expected to incorporate NAMs into their study designs and is creating an Office of Research Innovation, Validation, and Application (ORIVA) to champion these efforts. This initiative is part of NIH’s broader commitment to accelerating the development and use of human-based research technologies that improve the translation of scientific discoveries into effective treatments. The shift represents a powerful realignment of federal funding priorities toward tools that more accurately model human biology and better predict clinical outcomes.
👉 NIH increasing funding for NAMs research
👉 NIH announces stopping funding to animal-only grant proposals
Together, these policy changes represent a significant leap forward for the field—and validate what many researchers have known for years: we need models that better reflect the complexity of human biology.
At Intero Biosystems, we’ve built our technology around this future. Our GastroScreen platform uses human iPSC-derived intestinal organoids that mimic key cell types and functions of the gut. With the presence of all major intestinal cell types (epithelial, mesenchymal, neuronal, endothelial, and smooth muscle), GastroScreen is scalable, reproducible, and biologically relevant—exactly the kind of platform envisioned in the FDA and NIH’s call for next-generation tools.
We’re excited to see the nation’s leading health agencies aligning policy with scientific progress. This isn’t just good news for research—it’s a step toward faster, safer, and more effective therapies for patients.
If you’re applying for NIH funding or planning preclinical studies and looking for a validated, human-based model—reach out. We’d love to help.
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ABOUT INTERO BIOSYSTEMS
Intero Biosystems is a biotechnology company developing advanced adult human stem cell–derived intestinal organoid platforms for drug discovery and development. Founded in 2024 as a spin-out from Dr. Jason Spence’s lab at the University of Michigan, Intero’s mission is to improve the predictability and efficiency of preclinical testing—failing ineffective drug candidates faster and helping identify safer, more effective treatments for patients in need.
MEDIA CONTACT
Charlie Childs, Ph.D.
CEO, Intero Biosystems
charlie@interobiosystems.com
www.interobiosystems.com