Key Takeaways
- The NIH is investing $87 million in the Standardized Organoid Modeling Center to reduce animal testing in drug development.
- This initiative aims to develop lab-grown organoid models that mimic human organs for preclinical testing.
- The SOM Center will leverage AI and machine learning to enhance drug discovery and provide resources for researchers globally.
NIH Launches Center to Advance Drug Testing Alternatives
The National Institutes of Health (NIH) is intensifying efforts to minimize animal usage in drug testing by awarding $87 million in contracts for the establishment of the Standardized Organoid Modeling (SOM) Center. This initiative, announced on September 25, is designed to advance the NIH’s mission and will unfold over the course of three years at the Frederick National Laboratory for Cancer Research in Maryland, part of the NIH’s National Cancer Institute (NCI).
NIH Director Jay Bhattacharya emphasized the goal of the SOM Center, stating, “By creating standardized, reproducible and accessible organoid models, we will accelerate drug discovery and translational science, offering more precise tools for disease modeling and public health protection, while reducing reliance on animal models.” The center represents a collaborative effort among several NIH institutes, including the NCI, the National Institute of Allergy and Infectious Diseases, the National Human Genome Research Institute, and others, with additional institutes expected to join.
The SOM Center primarily aims to assist regulatory agencies like the FDA, as well as academic and industry scientists, by establishing standardized organoid models for preclinical drug testing. These organoids, lab-grown tissue structures that replicate human organs such as the liver, lung, heart, and intestine, serve as an innovative approach to examining drug efficacy and safety before human trials.
Nicole Kleinstreuer, acting deputy director for program coordination, planning, and strategic initiatives at NIH, remarked that the center will be a national resource, employing a unique blend of artificial intelligence (AI) and machine learning to create effective organoid protocols. Additionally, advanced robotics will facilitate large-scale production, and open-access repositories will provide both physical samples and digital resources for researchers.
The move towards alternative methods of animal testing is not new. It gained momentum following significant developments during the latter part of the Trump administration. Included among these advancements is a partnership network established in August by the Foundation for the National Institutes of Health. This public-private network aims to support innovative alternatives for drug testing, particularly the use of organoids.
Moreover, earlier this year, the FDA announced plans to eliminate animal testing requirements for new monoclonal antibody drugs, reflecting a broader shift in regulatory perspectives towards more humane and scientifically relevant testing methodologies. In tandem, the NIH has launched a new office dedicated to promoting the development and adoption of novel alternative methods (NAMs).
The SOM Center exemplifies a significant step forward in the ongoing quest to replace animals in drug testing with more relevant and ethical alternatives. With its innovative focus on organoids and commitment to collaboration, the center is poised to impact the landscape of biomedical research and drug development persistently.
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