Michael Halassa

As neuropsychiatric drug development evolves, the field is moving beyond traditional symptom scales toward richer, multimodal endpoints capable of capturing true therapeutic impact. This workshop explores emerging approaches: from speech and digital behavioural biomarkers, to imaging-derived circuit measures, physiological readouts, ecological momentary assessments and fluid biomarkers — that offer more objective, sensitive and patient-centered ways to evaluate treatment response. Participants will examine how these endpoints can enhance early signal detection, refine patient stratification, reduce placebo interference, and support regulatory and clinical-practice relevance. Through cross-disciplinary discussion, the session will outline what high-quality endpoint innovation looks like and what is needed to bring these tools into mainstream neuropsychiatric trials.

Workshop Objectives

• Identify the strengths, limitations and use-cases of emerging digital, physiological, imaging and fluid-based endpoints in neuropsychiatric clinical development
• Evaluate how novel endpoints can improve signal detection, reduce variability, and support precision-based trial design across early and late clinical stages
• Define the evidence, validation steps and operational considerations required to make new endpoint technologies regulatory-ready and scalable for widespread clinical adoption