James Cronican
Head Vice President, Experimental Medicine Neuroscience & Mental Health Boehringer Ingelheim
Seminars
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
- Progress in developing novel clinical outcome assessments targeting specific domains such as cognition in schizophrenia and impulsivity in bipolar disorder
- Using scalable, crowdsourced behavioral tasks with large normative datasets to strengthen translational relevance and signal detection
- Lessons learned from early regulatory interactions on qualifying new endpoints and defining their context of use
- Why cross industry collaboration is critical to gaining acceptance and adoption of new psychiatric endpoints across trials and populations
