28bioLIVE

Neurological drug development faces some of the highest failure rates in the pharmaceutical industry, largely due to the poor translatability of animal models. Recent announcements from major U.S. agencies, including the FDA, NIH, and EPA, to shift away from animal models in favor of New Approach Methods (NAMs), such as organoid toxicity testing, offer new promise in addressing the growing neurological health crisis.

Alif Saleh will discuss these regulatory developments and introduce the Nexon^TM platform, which is being used by several of the world’s largest pharmaceutical companies to improve the prediction of therapeutic efficacy and toxicity in humans.

Organoid Intelligence combines human brain organoids with brain-machine interfaces to model memory, learning, and cognition in vitro, offering novel functional cognitive biomarkers with the potential to reshape drug development in neurodegenerative disorders including Alzheimer’s disease. The session will cover practical uses in research and considerations for oversight.

Dr. Corey Rountree of 28bio will discuss findings from a recent preprint detailing early data on the use of organoid intelligence for biomarker development in neurodegenerative disease.

Development of a cortical brain organoid model that exhibits robust spontaneous calcium waveform activity that is compatible with HTS methodology and provides a clinically relevant endpoint for phenotypic profiling. 

Dr. Rountree will review a preprint highlighting how PNS-3D organoids model human peripheral nerve function, enabling predictive, scalable neurotoxicity assessments that outperform traditional preclinical systems in translation.