Organoids Unleashed: Engineering Mini-Organs in a Dish to Accelerate Veterinary and Comparative Pharmaceutical Research

The Precision One Health Initiative (POHI) at the University of Georgia is pioneering the development of adult stem cell-derived 3D organoids from veterinary species to streamline preclinical (human and veterinary) drug development. These models serve as in vitro screening tools for evaluating drug safety, efficacy, and exposure-response relationships, reducing reliance on live animal testing in alignment with the FDA’s commitment to the 3Rs (Replacement, Reduction, Refinement). Importantly, the use of 3D organoids provides a high-throughput method for assessing new compounds in tissues that reflect the targeted species (and, in some cases, tissues from the disease in question) thereby avoiding the pitfalls that can accompany interspecies extrapolations.

As a proof of concept, Dr. Jon P. Mochel, Director of the POHI at the University of Georgia, will present ongoing research efforts to develop and deploy companion animal-derived organoids. Along with its direct relevance to human medicine, the development of 3D organoids in dogs and cats can be used to support our understanding of homologous diseases and to facilitate the collaboration and data sharing in novel therapeutics targeting the canine and human patients.

FDA Collaboration and Translational Relevance:
The POH program operates under a 5-year Research Collaboration Agreement with the U.S. Food and Drug Administration’s Center for Veterinary Medicine. Dr. Mochel’s lab leads the development and application of animal organoid systems that recapitulate native tissue architecture and function. These models enable rigorous evaluation of pharmacokinetics, pharmacodynamics, and toxicity while mirroring naturally occurring diseases in veterinary patients—offering a promising new tool for regulatory science and drug development.

Presentation Highlights:
1. Spontaneous Disease Models: Canine and feline organoids reflect clinically relevant pathologies such as cancer, gastrointestinal inflammation, and kidney injury, conditions that are biologically and histologically aligned with human diseases.
2. Human-Relevant, Non-Animal Testing: These organoids enable middle- to high-throughput, reproducible testing in a physiologically relevant format, addressing key limitations of traditional in vitro systems.
3. Regulatory Impact: The models provide mechanistic insights into exposure-response relationships and drug safety, contributing to next-generation regulatory frameworks consistent with the FDA Modernization Act 2.0.