New Approach Methodologies, or NAMs, are reshaping how researchers evaluate drug safety, toxicity, and translational risk before clinical studies. In this webinar, Mike Clements, PhD, explores how stem cell-derived models can move from promising research tools to trusted, standardized NAMs for preclinical safety testing.
The discussion focuses on how human iPSC-derived cardiomyocytes and neural models, combined with microelectrode array (MEA) technology can generate functional electrophysiology data that supports more predictive safety assessment. Topics include the role of assay reproducibility, functional acceptance criteria, standardization, and fit-for-purpose validation in building confidence in NAM-based workflows.
Viewers will learn how MEA-based assays are being applied in cardiac safety testing, including lessons from CiPA and FDA ISTAND, and how similar approaches may support neural safety applications such as seizure liability assessment. The webinar also highlights why shared datasets, regulatory alignment, and collaborative validation are essential for broader NAM adoption.
Watch the webinar to learn what makes a successful NAM platform and how stem cell-based MEA assays can help advance more human-relevant, predictive approaches to drug discovery and safety pharmacology.
