7:20 am Registration & Breakfast
8:20 am Chair’s Opening Remarks
A NEW ERA IN NEUROPSYCHIATRY: REVOLUTIONARY PIPELINE ADVANCES
8:30 am Panel Discussion: Reviewing the Current Therapeutic Landscape & Pipeline Advances in Neuropsychiatry
Synopsis
- Evaluating the latest advancements in psychedelic and non-psychedelic therapeutic development
- Are the ‘mind altering’ effects of psychedelics necessary for therapeutic action?
- Exploring new potential treatment options for neuropsychiatric disorders
INNOVATING CLINICAL MODELS TO MITIGATE PLACEBO & STRATIFY PATIENT POPULATIONS
9:00 am VIRTUAL – Implementing Practical Measures to Account for Placebo-Induced Effects in Psychedelic Trial Results
Synopsis
- Deciphering how to size a clinical trial properly to account for placebo effects without exhausting resources
- Exploring alternative trial approaches to minimize patient expectation and moderate risks of higher placebo responders
9:30 am Exploring Potential Impacts of COVID on Major Depressive Disorder Trial Data
Synopsis
- The talk will present the results from CLEO phase 2 trial to assess the safety and efficacy ofbCLE-100 as an adjunctive treatment for Major Depressive Disorder (MDD) with inadequate response to previous antidepressants
- It will explore Potential Impacts of COVID-19 on Major Depressive Disorder Trial Data
- CLE-100 is an oral esketamine tablet formulated with abuse-deterrent technology for daily use at home as an adjunctive treatment for Major Depressive Disorder (MDD) patients with an inadequate response to antidepressants (AD)
10:00 am SPEED NETWORKING & MORNING REFRESHMENTS
Synopsis
An optimal chance to network with an expanding community of experts adopting novel and innovative approaches to target neuropsychiatric indications using psychedelic and non-psychedelic compounds. Connect with peers across discovery, preclinical, translational, and clinical neuropsychiatry to collaboratively discuss and share ideas to advance psychiatric pipeline investments.
11:15 am From Margins to Mainstream: Key Milestones & Metrics in Psychedelic Clinical Research, Significance of the Recent FDA Guidance, & Outlooks for the Near Future
Synopsis
- A review of the key milestones and metrics in psychedelic clinical trials from past to present.
- Highlights from the recent FDA draft guidance
- Surveying the landscape for future trials and approvals
11:45 am Digitalized Psychiatry: Utilizing Software to Treat & Monitor Mental Health Conditions
Synopsis
Leveraging digital platforms for improving cognition and behavioral symptoms
12:15 pm Progress with Psychedelics Drug Testing
Synopsis
- GMP analytical services for testing controlled substances including narcotics and psychedelics
- Method development, method transfer and method validation from our GMP R&D laboratory
- Release and confirmatory testing in our GMP chemistry and microbiology labs
- Worldwide scientific leader with unmatched expertise and comprehensive solutions for psychedelic testing and certification
12:25 pm LUNCH & NETWORKING BREAK
1:30 pm Unlocking Event-Driven Pharmacology: New Translational Data Supporting Clinical Development of the ‘Stinels’, a Novel Class of NMDAR Modulators
Synopsis
- Enhancing synaptic function through direct NMDAR-mediated mechanism shows rapid and durable anti-depressant effect
- Using translational tools to predict and test dose model, confirmed through clinical qEEG biomarkers now with a second molecule in the class
2:00 pm Employing Genetic & Multiomics Studies to Better Characterize Psychiatric Symptoms & Stratify Patient Subtypes
Synopsis
- Strengthening understanding of the link between biology and psychiatry to facilitate symptomatic characterization of patients
- Discovering strong correlations of genetic components to specific symptoms to enhance categorization of patient subtypes
- Applying genetic and endophenotying to select for best responding patients based on upregulation or downregulation of certain genes associated with clinical symptoms
2:30 pm In Vitro Drug Discovery Strategies for Neuropsychiatric Disorders
Synopsis
- From neurite to network level – applying neuroplasticity in vitro models for Drug Discovery
- Combining high content imaging and functional methods
- Addressing challenges of low throughput and high variability
2:40 pm AFTERNOON BREAK
3:10 pm Designing a Novel Clinical Model to Study Therapeutic Candidates for Panic Disorder
Synopsis
- Innovating clinical study designs to more effectively model symptoms of anxiety in healthy patient populations
- Optimizing physiological measurements as suitable endpoints for panic disorder
3:40 pm Transprognostic Biomarkers from Bench to Bedside: An AI-Powered Multimodal Platform for Precision Neuropsychiatry Trials
Synopsis
- The fall and rise again of neuropsychiatric drug discovery, reviewing historical challenges and emerging opportunities
- Limitations of DSM-based phenotypes VS utilizing endophenotypes to close the translational gap via multimodal, evolutionarily preserved biomarkers for objective readouts
- Opportunities presented by the psychedelic renaissance to integrate subjective experience with real time, state-based biosensing for predictive biomarker development
NON-HALLUCINOGENIC PSYCHOACTIVE AGENTS: REDUCING THE SAFETY RISKS OF PSYCHEDELICS
3:50 pm Innovating Entactogens, a Novel Class of Psychoactive Agents, to Revolutionize Applications of MDMA & Related Molecules
Synopsis
- Mapping the chemical space around MDMA to identify optimized entactogens with the off-target effects minimized
- Removing patient-excluding side effects, such as hypertension and anxiety, to enhance the accessibility of MDMA treatment
- Mitigating the variable pharmacodynamics of MDMA to precisely refine patient dosing and selection
4:20 pm AI/ML-based Discovery of Novel, Orally Bioavailable 5-HT2A Receptor Agonists Mimicking Psilocin for Unmet Mental Health Needs
Synopsis
- The psychedelic psilocybin, a prodrug of Psilocin, has demonstrated rapid and lasting antidepressant efficacy after a single administration
- Psilocin may promote neuroplasticity and alters the connectivity between different regions of the brain, which may promote alleviation of depressive symptoms
- This presentation will highlight the use of an artificial intelligence (AI) – and machine learning (ML)-based drug design approach to discover novel 5-HT2A receptor agonists that show pharmacological effects consistent with psilocin, including antidepressant-like activity
4:50 pm Chair’s Closing Remarks
5:00 pm SCIENTIFIC POSTER SESSION
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere and continue forging new and beneficial relationships. With an audience of psychiatry enthusiasts eager to hear the latest cutting-edge advancements, you will have the opportunity to display a poster presenting your own work. Additionally, you will have the chance to review other’s posters displaying novel approaches to model neuropsychiatric disorders, validate antipsychotic targets, precisely stratify psychiatric populations and more.