As neuroimmunology drug development pushes toward greater translational efficiency, in vitro systems, especially patient-derived and cell-based models are gaining traction as alternatives to traditional animal studies. This workshop will examine how in vitro data can be used more strategically to justify clinical entry, where current models fall short, and how evolving regulatory perspectives are reshaping preclinical expectations.

Key Topics to Be Explored:

• Can cell-based efficacy data replace animal models as a viable route to early proof of concept in neuroimmune drug development?
• How can in vitro systems be optimized to model specific features or symptoms of complex CNS disorders, rather than entire disease pathologies?
• What role do patient-derived cells, co-culture systems, and human-relevant endpoints play in bridging preclinical and clinical evidence?
• How are regulatory agencies interpreting mechanistic in vitro data in the absence of strong in vivo correlation or validated biomarkers?
• When does strong human genetic evidence outweigh the need for extensive model validation and how can earlystage companies tailor their strategy accordingly?
• What lessons can be drawn from recent FDA or EMA submissions where in vitro results played a central role in moving programs forward?