Pre-Conference Workshop Day

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

Interventional psychiatry is advancing rapidly, but commercializing new treatments in this space requires navigating scientific complexity, clinical-workflow integration, regulatory ambiguity and evolving payer expectations. This workshop brings together leaders across drug development, clinical services, digital therapeutics and health-system innovation to unpack what it takes to bring interventional psychiatric treatments to market effectively and responsibly. Through real-world case studies and cross-sector perspectives, attendees will explore how to position novel modalities, build scalable delivery models, integrate biomarkers and patient-selection tools, evaluate reimbursement pathways, and ensure safe, consistent implementation across diverse clinical environments.

• Define the commercial, clinical and operational considerations required to bring interventional psychiatric treatments to market, including positioning, differentiation and workflow integration
• Examine the infrastructure, training, safety and scalability requirements needed for real-world delivery across clinics, health systems and community-based care settings
• Identify viable reimbursement and market-access pathways by understanding payer priorities, value demonstration, and the evidence needed to support sustainable adoption