Explore the Agenda
8:00 am Check-In, Coffee & Light Breakfast
Pre-Conference Workshop Day
Designed for medical directors, CMOs, clinical program leads, regulatory affairs professionals and more; navigate and proactively address regulatory and access bottlenecks to bolster development of late-stage neuropsychiatric candidates
Workshop A
9:00 am Novel Endpoints in Neuropsychiatry: Redefining How We Measure Meaningful Clinical Change
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
EEG Focus Day
With sleep EEG touted as the ‘golden route’ to understanding CNS disorders and pathologies; high relevance for modulating sleep architecture, healthy aging and neuropathologies, staying ahead of the innovation, potential and regulatory position on EEG as a predictive tool in R&D is critical for success in mood therapeutic development. Join this focus day to gain practical skills and insights to advance how EEG can be implemented as a translational tool across neuropsychiatric R&D progams.
Honing Standardization, AI Utility, Dose & Patient Selection to Sharpen EEG Strategy for More Effective Mood Therapeutics
8:55 am Chair’s Opening Remarks
9:00 am Precision Psychiatry 2.0: Reimagining Frameworks, Tools & Clinical Pathways to Deliver Individualized Mental Health Care
- Positioning EEG as a scalable, translational biomarker, integrating neural signals with clinical and biological data to improve patient stratification and development decision making
- Moving beyond symptom based diagnoses by leveraging EEG derived neurophysiological signatures to reduce heterogeneity and define biologically coh erent subgroups
- Translating EEG, digital phenotyping, and AI enabled analytics from research tools into deployable assets across clinical trials, endpoints, and real world settings
- Aligning pharmacological and non pharmacological interventions with EEG informed neural biomarkers to guide target engagement, dose selection, and personalized treatment strategies
10:00 am Morning Networking Break
11:00 am EEG & AI to Identify Glutamatergic Responders: A Path to Overcoming Schizophrenia’s Etiologic Heterogeneity
- Highlight the limitations of DSM 5 diagnostic categories in schizophrenia and illustrate how etiologic heterogeneity has contributed to repeated failures of mechanistically novel drug candidates
- Demonstrate how EEG derived cortical activity patterns, paired with AI driven analysis, can provide a mechanistic basis for prospectively identifying patients whose glutamatergic pathology aligns with specific therapeutic mechanisms
- Present evidence from pomaglumetad Phase 3 re analysis showing that baseline EEG markers can identify a ~20% subgroup with substantial cognitive and negative symptom improvement, revealing responders concealed within a non significant overall trial
- Outline how ongoing work in schizophrenia and autism aims to validate EEG based responder identification across disorders with shared cortical circuit disruption, supporting a broader precision therapy framework
12:00 pm Lunch
Workshop B
1:00 pm How do we Commercialize in the Interventional Psychiatry Space? Translating Interventional Psychiatry into Practice: Strategies for Real World Commercialization
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
Unlocking the Power of EEG & Sleep Biomarkers to Transform Diagnosis, Treatment Response & Precision Stratification
1:00 pm Roundtable Discussion: Advancing EEG Biomarkers to Enhance Translational Precision in Neuropsychiatric Drug Development
- Leveraging EEG and complementary neurophysiology approaches to map circuit level modulation and therapeutic mechanisms
- Combining immediate early gene readouts, single unit recordings, and local field potentials to construct multi modal circuit signatures
- Building translational frameworks that bridge preclinical circuit modulation to human biomarker endpoints
- Advancing biomarker driven decision making to de risk development and guide dose selection, target engagement, and clinical translatability
1:30 pm Interpreting Insomnia Signals as a Sleep Biomarker Across Mood Disorders
- Differentiating insomnia subtypes (difficulty initiating vs. maintaining sleep vs. early awakening) and their relevance as biomarkers across depression and anxiety
- How insomnia signatures may stratify patients, predict symptom trajectories, or serve as endpoints across mood disorder trials
- Opportunities and pitfalls when using sleep related EEG and behavioral signals to map emotional blunting, anhedonia, and anxiety phenotypes
- Integrating clinical, sponsor, academic, and technology vendor perspectives to advance insomnia as a validated, scalable biomarker
2:00 pm Afternoon Networking Break
2:30 pm Roundtable Discussion: Interpreting Insomnia Signals as a Sleep Biomarker Across Mood Disorders
- Differentiating insomnia subtypes (difficulty initiating vs. maintaining sleep vs. early awakening) and their relevance as biomarkers across depression and anxiety
- How insomnia signatures may stratify patients, predict symptom trajectories, or serve as endpoints across mood disorder trials
- Opportunities and pitfalls when using sleep related EEG and behavioral signals to map emotional blunting, anhedonia, and anxiety phenotypes
- Integrating clinical, sponsor, academic, and technology vendor perspectives to advance insomnia as a validated, scalable biomarker
3:15 pm Panel Discussion: Evaluating Unmet Needs in Sleep: Navigating EEG Utility & Limitations Across Complex Sleep Architecture
- Defining which facets of sleep (onset, maintenance, early awakening, quality, or EEG specific signals) truly matter as clinical biomarkers
- Understanding the practical and scientific limits of EEG in psychiatric sleep research: specificity, invasiveness, and placebo susceptibility
- How sponsors (orexin programs, sleep promoting or circadian targeting drugs) and EEG tech vendors interpret sleep architecture in different disease contexts
- Identifying core unmet needs in insomnia and sleep dysregulation across mood and psychiatric disorders, and what measurement innovation is required