Day Two
Tuesday 11th February 2025
8:30 am Check In, Coffee & Light Breakfast
9:25 am Chair’s Opening Remarks
CLINICAL UPDATES ON NOVEL MECHANISMS FOR SCHIZOPHRENIA, MUSCARININCS & BEYOND
9:30 am CLE-905, a potent M1/M4 entering First-in-Human: Similarities to Xanomeline & targeted differentiation from Cobenfy
Synopsis
- Target engagement pattern is similar to Xanomeline, confirmed by qEEG
- Dual M1/M4 agonist
10:00 am KCC2 Direct Activators to Modulate Neuronal Hyperexcitation in Psychosis
Synopsis
- Transforming the treatment landscape for neurological disorders
- Reviewing a novel target which offers a promising new therapeutic avenue for neuropsychiatric, neurodevelopmental and neurodegenerative disorders
10:30 am The Ketamine Challenge Study Implemented Within a Clinical Pharmacology Unit: Objectives, Challenges, & Opportunities
Synopsis
- Principle and objectives of the ketamine challenge, typical endpoints
- Challenges of the setup and execution of these trials, opportunities offered by CPU implementation
- Opportunities offered by these trials: endpoints, value to development plan
10:40 am Morning Break & Refreshments
ADVANCING MORE TRANSLATABLE MODELS TO BETTER PREDICT ANTIPSYCHOTIC EFFICACY
12:00 pm Animal Models of Psychosis – How to Show Antipsychotic Efficacy of Novel Drugs Based on Non-Dopaminergic Mechanisms
Synopsis
- In vivo efficacy of xanomeline: how well the studies in animals capture its antipsychotic profile in humans?
- In vivo efficacy of muscarinic M4 agonists and positive allosteric modulators: what did we learn so far?
- Potential gaps in understanding the antipsychotic potential of muscarinic potentiators
12:30 pm Unmet Needs & Translational Aspects: Development of Next Generation Treatments for Psychiatric Indications
Synopsis
- Exploring target receptors and mechanisms of action across indications
- Assessing safety, tolerability, and compliance in psychiatric disorders
- Reviewing pharmacoeconomics in the psychosis landscape
1:00 pm Lunch & Networking Break
2:00 pm Novel Approaches for Clinical High Risk (CHR) Patient Populations to Prevent Disease Progression
Synopsis
- A definition of CHR and a brief history of clinical trials for CHR – exploring antipsychotic and non-antipsychotic therapies, such as omega fatty acids, to address early symptoms – lessons learned
- Private-public partnerships in large-scale observational studies of CHR individuals to characterize multimodal and digital biomarkers for use in characterization and prediction of outcomes
- Mechanistic research and target identification for intervention in a CHR patient population, highlighting auditory processing and cognitive deficits
2:30 pm Enhancing Safety, Minimizing Side Effects, & Improving Patient Outcomes
Synopsis
- Understanding how non-specific mechanisms contribute to widespread off-target effects and exploring new approaches to minimize these risks
BUILDING ON COBENFY TRIUMPH: WHAT DOES THIS MEAN FOR THE EVOLVING COMMERCIAL LANDSCAPE?
3:00 pm Investor Panel: Navigating Partnerships, & Investment Challenges in Psychosis Drug Development
Synopsis
- Explore the scientific, regulatory, and commercial uncertainties that make psychosis R&D a uniquely high-risk category, and how these risks shape both pharma and investor interest
- Discuss how innovative startups and emerging biotech companies can forge mutually beneficial relationships with pharma and venture investors
- What makes a small biotech compelling? Insights into what large pharma and venture funds evaluate when considering assets or partnerships in psychosis, including key milestones, data quality, and leadership
- Practical advice for startups on how to initiate, navigate, and sustain productive conversations with investors and BD teams. What are red flags vs. green lights in early outreach?
- How government funding bodies, NIH consortia, and public research initiatives can complement private capital and de-risk early-stage psychosis innovation