Explore the Agenda
7:00 am Check-In, Coffee & Light Breakfast
7:55 am Chair’s Opening Remarks
Where Precision Psychiatry Meets Smarter Development & Modern Regulation to Unlock Meaningful Patient Impact
8:00 am Panel Discussion: Overcoming the Phase 2/3 Roadblock in Neuropsychiatric Drug Development: What Have We Learnt in 2026?
- How late stage failures continue to stem from heterogeneous patient populations and poor endpoint sensitivity, underscoring the critical need for biomarker driven stratification to boost Phase 2/3 success rates
- What 2025–2026 taught us about placebo inflation, highlighted by recent schizophrenia and depression trial outcomes, and how study site variability, digital tools, and speech/physiological biomarkers may mitigate expectation bias
- Why translational gaps persist across muscarinic, psychedelic, and neuroplasticity based mechanisms, and how emerging mechanistic and genomic biomarkers can better link target engagement with clinical effects in Phase 2/3
- How sponsors are redesigning global Phase 2/3 execution—leveraging faster moving regions, adaptive designs, and early signal-detection: to overcome long timelines, recruitment bottlenecks, and historically low CNS trial success rates
8:45 am Advancing Mood Disorder Innovation: Pipeline Expansion, Regulatory Momentum & Emerging Opportunities in Neurotherapeutics
- Increased emphasis on Bretisilocin as a leading next generation psychoplastogen investigational drug for mood disorders aligned with broader neurosciences research focused on advancing next generation therapeutic modalities
- Recent FDA and EMA engagement has been notably encouraging, reflecting a regulatory climate that is increasingly supportive of novel neuropsychiatric mechanisms
- Expansion of development plans into additional indications beyond depression mirrors the continued scientific push toward addressing high unmet need and psychiatric conditions
- High level regulatory experience suggests growing acceptance of innovative neuro-focused drug development approaches as the landscape continues to evolve
9:15 am Beyond Symptoms: Building a Biology First Framework for the Next Era of Precision Psychiatry
- Exploring how EEG, molecular biomarkers, and AI enabled physiological readouts can shift psychiatry from symptom clusters toward biologically grounded disease mechanisms
- Evaluating emerging immunopsychiatry insights showing how neuroinflammatory pathways and immune driven circuit changes may redefine diagnostic boundaries and treatment selection
- Assessing where psychedelic therapeutics stand today and how mechanistic understanding of neuroplasticity and receptor level signaling may open new biological targets beyond traditional symptom based categories
- Reimagining psychiatric classification by inverting the genetics to genomics pyramid—integrating genetic, epigenetic, and molecular signatures to build biology informed diagnostic frameworks
9:45 am Panel Discussion: Neuropsychiatry at a Crossroads: Where Science, Strategy & Deal Making Converge
- What indications are you excited about and actively exploring?
- Which drug modalities are you excited about and actively exploring?
- In 2026 are we ready for precision psychiatry, and what might we need to improve in terms of diagnostics to get there (genetics, etc.)?
10:15 am Speed Networking
A prime chance to make the most of in-person networking and forge new connections as new companies enter, and existing ones broaden their presence within the psychiatric drug development space. Designed to maximize your introduction to numerous new individuals and serve as a catalyst for ongoing discussions during the summit.
10:45 am Morning Break & Refreshments
Track 1: Preclinical & Translational
Track Chair: Matt Harlin, Senior Director, Discovery Research, Otsuka Pharmaceutical Companies (U.S.)
Driving Precision From The Start: Modernizing Preclinical Models & Early Patient Selection Strategies
11:15 am Roundtable Discussion: Genetics Anchored Animal Models as a New Foundation for Psychosis Drug Discovery
- Leveraging large scale human genetics to define biologically grounded entry points for schizophrenia and bipolar disorder
- Designing next generation animal models that capture disease relevant circuits and synaptic phenotypes rather than surface behaviors alone
- Using genetically informed models to distinguish causal mechanisms from downstream correlates in psychotic disorders
- How genetics anchored models can enable more rational discovery of novel drug targets and translational biomarkers
11:45 am Harnessing Orexin Biology to Advance Sleep Regulation & Novel Neuropsychiatric Therapeutics
- Illuminating the mechanistic role of orexin pathways in stabilizing sleep-wake architecture and behavioural states
- Applying emerging orexin targeted strategies to address unmet needs across sleep related and broader neuropsychiatric disorders
- Integrating molecular, pharmacologic, and translational insights to shape next generation therapeutic candidates
- Exploring how expanding orexin centric biology opens doors to new indications beyond traditional mood and psychotic disorders
12:15 pm Unravelling the Therapeutic Potential of Metabotropic Glutamate Receptor 7 (Mglu7) Negative Allosteric Modulators in Neuropsychiatric Disorders
- mGlu7 is a promising target for neuropsychiatric disorders based on brain distribution, modulation of glutamatergic and GABAergic neurotransmission in the stress neural circuit and reduced anxiety-, aggressivity and depression-like reactivity of KO mice
- NTX-819, a potent and selective mGlu7 negative allosteric modulator, discovered internally, is being developed for mood disorders
- NTX-819 and related compounds, have shown promising efficacy profiles in a range of models of neuropsychiatric disorders, including isolation rearing model of schizophrenia and repeated stress-induced model of depression
Track 2: Clinical & Regulatory
Track Chair: Magali Haas, Chief Medical Officer, Psilera
New Targets Or Known Targets, Where Do We Go Now?
11:15 am MT1988: Phase 2 Insights in Identifying & Treating Cognitive Impairment in Schizophrenia
- Exploring digital biomarker driven stratification, based on cognitive measures, to move toward biologically homogeneous patient groups and reduce trial heterogeneity
- Investigating a fixed dose combination approach to nicotinic agonism to improve working memory and attentional deficits relevant to a range of neuropsychiatric disorders
- Advancing the first Phase 2 study to target the clinical high risk for psychosis population
- Leveraging the high profile Accelerating Medicines Partnership for Schizophrenia to identify individuals most likely to benefit from early intervention
11:45 am Session Reserved: Clerkenwell Health
12:15 pm Modulating Oxidative Stress via KAT II Inhibition: Phase 1 Insights from KYN 5356 for Cognitive Impairment in Schizophrenia
- How KYN 5356, a first in class KAT II inhibitor, targets the kynurenine pathway to address CIAS, a major unmet driver of disability in schizophrenia
- Phase 1 results demonstrating excellent safety, tolerability, and robust CNS penetration with favorable plasma and CSF pharmacokinetics
- Evidence of target engagement through dose dependent reductions in CSF kynurenic acid and EEG improvements linked to cognitive pathways
- Early signals of cognitive improvement supporting progression to Phase 2 trials in CIAS and broader precision medicine applications
12:45 pm Lunch & Networking
Getting AI Right: Strategies to Streamline Psychiatric Drug Discovery
1:45 pm Use of RWD & AI for Stratifying Psychiatric Risk & Treatment Matching
- Evaluate the strengths and limitations of AI-based algorithms applied to real-world data for stratifying risk of psychiatric outcomes and guiding treatment selection
- Describe how these tools could be responsibly integrated with clinical judgment and evidence-based interventions to support clinical decision-making
2:15 pm Integrating AI to Advance 5 HT Receptor–Driven Neuroplasticity: Rewiring Neural Circuitry with Next Generation Computational Neurotherapeutics
- How AI driven molecular design accelerates the development of selective 5 HT–modulating neuroplastogens now progressing into first in human evaluation
- Leveraging early PoC data, behavioral readouts, and advanced receptor profiling to refine mechanism driven therapeutic hypotheses
- Integrating computational chemistry, circuit level neuroscience, and PD biomarkers to optimise next generation non hallucinogenic neuroplastogens
- Translating scalable AI workflows into a diversified clinical pipeline spanning depression, pain, and substance use disorders
Advancing Precision Assessment: From Brain Circuit Imaging To Digital Biomarkers In Modern Neuropsychiatry
1:45 pm Advancing Early Neuroscience Trials Through Integrated Biomarkers & Smarter P1b Design
- How combining multimodal biomarkers can strengthen proof of mechanism for early neuroscience programs
- Approaches for designing P1b trials that capture signal in psychiatry–neurology overlap indications
- Lessons from industry on executing efficient early phase studies with limited resources
- Opportunities to accelerate CIAS, BPD, and emerging neuropsychiatric assets through unified translational frameworks
2:15 pm Session Reserved: Sama Therapeutics
2:45 pm Afternoon Break & Refreshments
From Early Stage Signals to Strategic Capital: Defining the Technologies & Investments Shaping Tomorrow’s Neuropsychiatry
3:15 pm Panel Discussion: What Tools Can Be Used to Demonstrate Efficacy Through Early-Stage Clinical Trials? Evaluating Digital Biomarkers, EEG, PROs & Fluid Measures to Support with a Richer Analysis of Disease State
- How multimodal digital biomarkers can sensitively capture early treatment signals and behavioral change before traditional clinical endpoints emerge
- The role of EEG and other neurophysiological readouts in demonstrating target engagement and pharmacodynamic effects during first in human and Phase 1/2 trials
- How structured patient reported outcomes enrich early datasets by capturing subjective symptom shifts that complement objective biomarker trends
- How fluid biomarkers – from inflammatory to neurodegenerative signatures – can provide quantifiable, mechanistic insight into early biological response and disease modulation
3:45 pm From Domain Specific Biology to COAs: Advancing Endpoints for Cognition & Impulsivity
- 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
4:15 pm Session Reserved: Transpharmation
4:45 pm Panel Discussion: Future Directions & Strategic Investment to Fuel the Next Wave of Neuropsychiatric Therapeutics
- How emerging scientific modalities such as circuit level biomarkers, data integrated platforms, and next generation neuroplastogens are shaping the future landscape of neuropsychiatric innovation
- What investors and R&D leaders look for in early stage assets, including differentiated mechanisms, strong biomarker strategies, and clear pathways to clinical and commercial de risking
- How strategic capital allocation across discovery, translational technologies, and Phase 2/3 ready programs can build sustainable, multi mechanism therapeutic pipelines
- Where the field is heading next, and how cross disciplinary innovation and coordinated investment can accelerate the next transformative wave in neuropsychiatric therapeutics
5:15 pm Chair’s Closing Remarks
5:40 pm Scientific Poster Session
This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. With an audience of preclinical, translational, and clinical scientists eager to hear the latest advancements in neuropsychiatric therapeutic development, you will have the opportunity to display a poster presenting your own work and innovations. Don’t miss out on the chance to connect, learn, and present.