Bio: James Munday is the Global Director for the Immunology & Immunotoxicology (I&I) Department at Labcorp. In this role he manages scientific and operations teams across North America, Europe and Asia-Pacific. James holds a PhD from the University of Oxford, where his research focused on the cloning and characterization of a novel family of cell adhesion molecules called Siglecs which are found on a variety of immune cells. James also completed a post-doctoral fellowship at the Mount Sinai School of Medicine in New York where his work focused on embryonic stem cells. His current focus includes the integration of NAMs into preclinical immunotoxicology, with an emphasis on improving translational relevance, reducing animal use, and aligning with evolving regulatory expectations.

Abstract: New Approach Methodologies (NAMs) represent a shift in toxicology assessment, moving away from traditional animal-based testing and moving towards greater human-relevant approaches. This is of particular importance in the field of immunotoxicology where the immune response in pre-clinical species is often not translatable to human outcomes. Regulatory acceptance of NAMs is growing, driven by international collaboration, scientific validation, and policy initiatives promoting the 3Rs (Replacement, Reduction, and Refinement of animal use). This presentation will review the current landscape, challenges, and future directions of NAMs, with specific case studies highlighting how NAMs have been used to develop novel therapeutics that modulate the immune response. This will show the value of this approach and highlight how this approach can deliver safer human outcomes for development of immunomodulatory based therapeutics.