Advances in immunopharmacology are rapidly transforming the way novel therapeutics are discovered, translated, and brought into early clinical development. This session will explore the critical path from mechanistic understanding of immune pathways to First-in-Human (FIH) studies, highlighting both scientific innovation and translational challenges.

Chaired by Matthijs Moerland (Centre for Human Drug Research, CHDR) and Amalia Dolga (Netherlands Pharmacological Society, NVF; with expertise in cellular and molecular pharmacology), the session will bridge preclinical and clinical perspectives. It will address how insights from cellular models, human-relevant systems, and biomarker strategies can improve the predictability of early-phase trials. Particular attention will be given to the integration of immunological readouts, safety considerations specific to immune-targeting agents, and the design of FIH studies in an era of increasingly complex modalities.

By bringing together expertise from translational pharmacology and fundamental pharmacological research, this session aims to provide a contemporary overview of how mechanistic insights are effectively translated into safe and informative early clinical studies, ultimately accelerating the development of innovative immunotherapies.