Explore the Agenda
8:00 am Check In, Coffee & Light Breakfast
9:00 am Workshop A: Neuroimmune Interactions as a Common Thread Across Psychosis and Mood Disorders
Psychosis and mood disorders have traditionally been treated as distinct psychiatric conditions, often approached through a behavioral lens. However, modern large-scale genetics studies suggest substantial overlap in both common and rare variant drivers of risk for schizophrenia, bipolar disorder and, to a lesser extent, major depressive disorder. Emerging evidence suggests that neuroimmune mechanisms may contribute to pathogenesis in one or more transdiagnostic subsets of patients. Beyond longstanding hypotheses involving systemic inflammation or peripheral cytokines, genetic and neurobiological studies implicate dysfunctional immune pathways and glial cells within the central nervous system as drivers of psychiatric symptoms. This workshop will explore recent and ongoing efforts to identify molecular biomarkers to stratify psychiatric patient populations, and insights from our evolving understanding of autoimmune contributions to psychiatric conditions. As boundaries blur between psychiatric diagnoses, between the clinical specialties of neurology and psychiatry, and mechanistic understanding accumulates, this session will use an interactive workshop format to explore what this convergence means for therapeutic development, biomarker discovery, and clinical trial design, and whether the field is ready to shift toward biologically targeted interventions.
Key Topics to Be Explored:
- What are some of the unique challenges to neuroimmune drug development for psychotic and mood disorders vs neurodegenerative disorders?
- What sort of data, tools or resources, if produced, would help “de-risk” investment in this area?
- For clinical progress, how important is it to have blood biomarkers (as opposed to CSF/imaging/ephys biomarkers)?
- If a person with a longstanding diagnosis of schizophrenia or bipolar disorder were to have complete symptom resolution after immunotherapy, does this mean they had been misdiagnosed? How relevant is the answer to this question to neuroimmune drug development efforts?
- What changes would need to happen in the way clinical psychiatry is practiced in the USA for neuroimmune drug development or deplopyment to be most successful in this space? How might these changes occur?
11:00 am Morning Break & Networking
11:30 am Workshop B: Advancing Biomarker Discovery in Neuroinflammatory Disease
Advances in molecular and cellular technologies have expanded the toolkit for biomarker discovery, yet distinguishing meaningful signals from background noise remains a central challenge. Fluid based, cellular and tissue level analyses offer new insight into disease biology, but their translational value hinges on careful validation and clear links to underlying mechanisms. This workshop will examine current strategies for identifying and validating biomarkers in neuroimmunology, the limitations of relying solely on RNA or protein based readouts, the role of patient samples, biobanks and computational approaches, and how the field is moving toward greater clinical relevance and impact.
Key Topics to Be Explored:
- Review strategies for identifying novel biomarkers in neuroinflammatory and neurodegenerative diseases using molecular, cellular, and fluid-based approaches
- Evaluate how potential biomarkers are validated experimentally, and the importance of functional studies in linking biomarker candidates to disease mechanisms
- Examine the limitations of RNA or protein-based biomarkers and the challenges of correlating molecular signals with disease outcomes
- Discuss the role of patient samples, biobanks and machine learning in advancing biomarker discovery
- Highlight current gaps in biomarker development and strategies to increase translational relevance and clinical applicability
1:30 pm Lunch Break & Networking
2:30 pm Workshop C: Preclinical Strategy: In Vitro Models for Neuroimmunology: Accelerating Proof of Concept Without In Vivo Dependencies
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?