Although new approach methodologies (NAMs) are not that new, they remain a crucial and evolving aspect of the development and production of biopharmaceuticals. “NAMs have been around for 20 years plus ...

Drug discovery requires experimental systems that more accurately capture the complexity of human tissues. However, animal models and conventional cell culture approaches often lack the physiological ...

Motivated by the latest drug development regulatory guidance, such as the US Food and Drug Administration Modernization Act 2.0, academic and biopharmaceutical industry professionals are increasingly ...

New approach methodologies (NAMs) aim to streamline early-stage drug discovery and revolutionize preclinical testing by replacing traditional animal-based models with human-relevant insights, directly ...