Explore the Agenda
8:30 am Check-In, Coffee & Light Breakfast
9:05 am Chair’s Opening Remarks
Deciphering Muscarinic Mechanisms & Advancing Beyond Applications in Psychosis
9:15 am Panel Discussion: To What Degree Does Neuroplasticity Underpin Psychedelic Efficacy?
- Examining the evidence linking psychedelic induced synaptic and dendritic remodeling with changes in mood, cognition and emotional processing
- Exploring whether neuroplasticity is a mechanistic driver of efficacy or a downstream accompaniment to broader network level changes
- Comparing plasticity linked biomarkers, such as EEG signatures, sleep architecture shifts and neurotrophic factor changes, to determine which most reliably map onto clinical response
- Debating how much neuroplasticity is necessary, sufficient or even predictive for therapeutic benefit across different psychedelic and non psychedelic compounds
- Considering maladaptive behaviors underpinned by neuroplasticity in the brain
- How might we treat “neuroplastogens” differently: as a separate class
10:00 am Session Reserved: Ulysses Neuroscience
10:30 am Panel Discussion: Ketamine & Rapid Acting Antidepressants: Plasticity, Metabolites & the Next Generation of Therapeutic Innovation
- What emerging preclinical and clinical data reveal about ketamine induced synaptic plasticity as a unifying mechanism for rapid antidepressant effects
- The role of ketamine metabolites, including HNKs, in disentangling efficacy from dissociation and informing more targeted drug design
- Progress toward non dissociative and next generation ketamine derived therapies, and how these may reshape safety, scalability, and patient access
- Lessons from S-ketamine on regulatory pathways, payer expectations, and commercial adoption; and what this means for the broader psychedelic and rapid acting psychiatry landscape
11:00 am Morning Break & Refreshments
Track 1: Preclinical & Translational
Track Chair: Matt Harlin, Senior Director, Discovery Research, Otsuka Pharmaceutical Companies (U.S.)
Expanding Indications in Neuropsychiatry to Drive Treatments to Unmet Patient Populations
11:30 am Advancing Therapeutics for Apathy: Integrating Dopaminergic & Non Dopaminergic Strategies to Restore Motivation
- Translating animal models of effort-based decision making into clinical insights to better characterize apathy and motivational deficits across neuropsychiatric and neurodegenerative disorders
- Targeting dopaminergic mechanisms, including modulation of dopamine transmission with atypical dopamine transport inhibitors to address apathy‑related motivational dysfunctions
- Exploring non dopaminergic pathways such as adenosinergic mechanisms and other emerging targets that offer complementary routes to restoring motivation
- Building an integrated therapeutic framework that combines dopaminergic and non-dopaminergic strategies to overcome unmet needs in treating apathy and motivational impairments
Track 2: Clinical & Regulatory
Track Chair: Magali Haas, Chief Medical Officer, Psilera
Translational & Clinical Updates on Novel Neuroplastogens
11:30 am Transforming Psychiatric Care: From Psilocybin Breakthroughs to Scalable, Multi-Indication Therapeutics
- Detailing Phase 3 successes of COMP360 psilocybin in treatment resistant depression, including rapid onset, durability to 26 weeks, and FDA submission readiness
- Examining early signal-generation studies exploring COMP360’s potential in PTSD and anorexia nervosa, and planned expansions into anxiety and mood disorder indications
- Exploring the use of biomarkers, digital support tools, and retreatment protocols to optimize patient stratification, dosing, and long-term efficacy
- Discussing operational strategies, including site selection, regulatory engagement, and therapy scalability, to drive commercial readiness and global deployment
12:00 pm Lunch & Networking
Repairing Dysfunctional Reward & Mood Circuits Through Neuroplastic Mechanisms that Drive Lasting Therapeutic Benefit
1:00 pm From Neuroplasticity to Symptom Relief: Converging Mechanisms Driving Durable Therapeutic Benefit
- Examining how neuroplastic changes translate into meaningful clinical improvement across depression and related disorders
- Understanding disease related circuit pathology and how targeted therapeutics can repair dysfunctional synapses and circuits
- Comparing neuroplasticity signatures across ketamine, psychedelics, and emerging agents to identify shared mechanistic pathways
- Bridging the gap between molecular plasticity findings and the encoding of lasting therapeutic effects
1:30 pm Circuit Level Mechanisms of Ketamine’s Antidepressant Action: From Stress Induced Nucleus Accumbens Atrophy to Plasticity Driven Rescue of Motivation
- Describe how chronic stress produces profound effort related deficits and structural atrophy in D1 medium spiny neurons of the nucleus accumbens, a hub of reward computation, and how these circuit changes map onto anhedonia in depression
- Explain how a single ketamine administration, assessed after the drug has fully cleared, induces lasting synaptic plasticity that restores activity in NAc D1 MSNs and rescues stress driven motivational impairments
- Highlight how ketamine re engages two stress sensitive excitatory pathways (medial prefrontal cortex NAc and hippocampus NAc), each contributing complementary but distinct roles in restoring reward seeking behavior
- Outline next steps to translating these circuit findings to humans using functional connectivity and morphometric data analyses as a biomarker of antidepressant treatment outcome
Reimagining Anxiety Treatment: Integrating Mechanistic Understanding with Emerging Therapies
1:00 pm Transforming Anxiety & Mood Disorder Therapeutics: Advancing GlyphAgo™ (SPT 320), SPT 300, & SPT 348 in Next Generation Neuropsychiatric Care
- Advancing clinically validated mechanisms such as allopregnanolone, agomelatine and non hallucinogenic neuroplastogens through the Glyph™ platform, which overcomes limitations like low oral bioavailability, hepatotoxicity and poor PK profiles
- Enabling safer, more predictable anxiolytic and antidepressant activity by rerouting drug absorption through intestinal lymphatics, reducing liver exposure and supporting therapeutic plasma levels at lower doses, as demonstrated in early studies of GlyphAgo™ (SPT 320)
- Positioning SPT 300, an oral allopregnanolone prodrug, as a potential new option for major depressive disorder by unlocking a previously IV only mechanism through improved systemic exposure and tolerability
- Expanding treatment reach with SPT 348, a next generation non hallucinogenic neuroplastogen aimed at mood and neuropsychiatric disorders, designed to improve pharmacokinetics and tolerability while maintaining circuit modulating effects
1:30 pm Panel Discussion: Understanding Anxiety: Key Biology & Clinical Features, Sleep Cross-section & Comorbidities
- Exploring the core brain and stress response mechanisms that drive anxiety across different disorders
- Understanding how specific sleep problems: trouble falling asleep, staying asleep, early waking, or poor quality sleep can worsen anxiety and shape symptom patterns
- Recognizing how common comorbidities like depression, anhedonia and PTSD interact with anxiety and influence clinical presentation
- Identifying practical tools and measures clinicians and researchers can use to build a clearer picture of anxiety across diverse patient groups
2:00 pm Afternoon Break & Refreshments
Evolving the Regulatory Landscape to Align With Precision Psychiatry Initatives
2:30 pm A Landscape Review of Neuropsychiatric Therapy Development
- The drug landscape, displaying critical data-driven therapeutic and clinical trial highlights, as well as current trends
- A look at the developer landscape, allowing for understanding of the commercial market involving these drugs’ development
- The outlook for the future of the mental health therapeutics field from a preclinical and clinical perspective
3:00 pm Advancing Therapeutics for Psychiatric Disease: Novel Targets & the Promise of Precision Neuroscience
3:30 pm Panel Discussion: Redefining Therapeutic Potential in Muscarinics: Interrogating the M1/M4 Debate to Advance Next Generation Neuropsychiatric Treatments
- How the recent FDA approval of an M1/M4 targeting muscarinic agonist–antagonist therapy has opened the door for next generation mechanisms, prompting the field to explore which muscarinic pathways hold the greatest future therapeutic potential
- How M1 and M4 receptor modulation may diverge in future clinical applications, with emerging evidence suggesting distinct roles in cognitive processing, behavioural regulation, and symptom domains underserved by dopamine based treatments
- How advancing Phase 1 muscarinic programs is helping define optimal translational strategies for the future, including biomarker guided dosing, refined safety monitoring, and strategic choices around patient versus healthy volunteer enrolment
- How next generation M4 selective PAMs and other muscarinic focused innovations may expand the therapeutic footprint across neuropsychiatric and neurodegenerative indications, positioning muscarinic pathways as a long term pillar of future CNS drug development
- Will PAMs recapitulate efficacy of orthosteric agonists, as seen with Cobenfy?