Validating and Using Cardiac NAMs for Toxicity Screening and Drug Development

A new publication from the HESI Global Cardiac Safety Committee, titled “Validating and Using Cardiac NAMs for Toxicity Screening and Drug Development” (Pierson et al., International Journal of Toxicology, 2025), presents a comprehensive evaluation of novel, human-relevant models for assessing cardiac toxicity.

This work addresses longstanding challenges in drug development, where traditional animal models often fail to predict human cardiac outcomes. Through a multi-year FDA-funded grant, the committee assessed the performance of new approach methodologies (NAMs), including human-induced pluripotent stem cell–derived cardiomyocytes (hiPSC-CMs), engineered heart tissues, and microfluidic vascular systems.

The publication outlines how these tools can detect key cardiac failure modes such as contractility changes, arrhythmias, and vascular injury earlier in the development process. It also provides insight into their potential integration into regulatory frameworks, with a focus on increasing predictive accuracy and reducing animal use.

This work supports HESI Global’s mission to collaboratively advance science for a safer, more sustainable world by promoting ethical, efficient, and scientifically robust alternatives for cardiac safety evaluation.

Read the full article here:
Pierson et al., 2025. Validating and Using Cardiac NAMs for Toxicity Screening and Drug Development. International Journal of Toxicology. DOI: 10.1177/10915818251375348