CONFERENCE DAY ONE - SEPTEMBER 25
7:00 AM Check-In, Coffee & Light Breakfast
7:50 am Chair’s Opening Remarks
INNOVATING A NEW ERA OF PRECISION NEUROPSYCHIATRY
8:00 am Panel Discussion | Transforming ‘Precision Neuropsychiatry’ from Idea to Realization: Are we There Yet?
Synopsis
- Are we prone to have a biological marker for a psychiatric indication, and how far are we from reality of identifying best responders to a given treatment?
- From subtyping disorders, to combining treatments for personalization, to identifying best responders: What do we mean by ‘precision’?
- From evident success stories so far, what kind of data was collected and how did it affect recruitment, dropout rate and trial cost
8:30 am Leveraging Artificial Intelligence & Large Language Models (LLMs) to Help Bring Precision Medicine to the Field of Mental Healthcare
Synopsis
- Showcasing the potential of an AI model to predict outcomes in TRD using recordings during psilocybin treatment
- Highlighting how AI can increase predictive power and overcome biological variability
- Implications for how this can support delivery of more personalized treatments
9:00 am Implementation of CNS Biomarkers in Clinical Trials
Synopsis
- Current use of EEG biomarkers in clinical development projects
- Adapted strategies for successful EEG biomarker implementation e.g. site interactions, choice of hardware
- EEG data reporting and data visualization approaches
9:30 am Clinical Translation of Precision Medicine in a First Clinically & Biologically Defined Subgroup of Patients with Autism Spectrum Disorder
Synopsis
- A first clinically and biologically defined subgroup of ASD patients, named ASD-Phen1, was clinically validated in 2 prospectives biosampling studies with an observed incidence of 20-25% of the enrolled ASD population
- This subgroup was then biologically validated through multi-omics characterization revealing specific molecular signatures for ASD-Phen1 patients that were found to be reversed by STALICLA's precision medicine STP1
- Ensuing STP1 Phase 1b in ASD-Phen1 established good safety-tolerability, strong target engagement signals (EEG), and superiority on recognized-clinical efficacy endpoints (ABC, SRS, NIH toolbox) as well as convincing PK/PD profile
10:00 am Speed Networking
Synopsis
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.
10:30 AM Morning Break & Refreshments
Track 1: Discovery & Preclinical
Chair: Murali Gopalakrishnan, Global Head, Neuroscience Search & Evaluation, AbbVie
Track 2: Translational & Clinical
Chair: Patricio O'Donnell, Vice President of Translational Medicine, Alto Neuroscience
IDENTIFYING NEXT-GENERATION TARGETS: ENHANCING SPECIFICITY & REDUCING OFF-TARGET EFFECTS
EXPLORING INNOVATIVE METHODS FOR CLINICAL STRATIFICATION IN NEUROPSYCHIATRIC POPULATIONS
11:00 am Applying Circuit-Based Approaches in Neuropsychiatric Drug Discovery
Synopsis
- Understanding neurocircuit dysfunction in psychiatric and neurological disorders
- Translating knowledge of disease and treatment mechanisms into new drug discovery projects
- Identifying translational measures for agents with single versus multi-target pharmacology
- Exploring the cross-therapeutic potential of novel drug mechanisms
11:30 am Therapeutic or Drug of Abuse?
Synopsis
- Over the past decade, there has been an increase in clinical research with psychedelics for treating a number of neuropsychiatric conditions.
- Psilocybin (depression), MDMA (post-traumatic stress disorder) and LSD tartrate (anxiety disorder) along with DMT, 5-MeO-DMT, Ketamine and THC all have (re)newed therapeutic potential & interest.
- Whether your psychedelic drug is designed for a clinically monitored treatment or at-home microdosing, before you can develop a suitable drug treatment – the target compound needs to be characterized.
- Our work focuses on developing analytical tools to evaluate psychedelic compounds and their derivatives.
11:40 am Profiling of a Novel Orally Bioavailable NMDA Receptor Antagonist in Rodents & Humans Demonstrates Value of Translational Biomarkers
Synopsis
- In rodents GM-1020 achieves antidepressant-like activity at doses well below those causing motor impairment or disrupting sensory motor processing and has a better therapeutic window than ketamine
- GM-1020 doses that were antidepressant in rats produced marked effects on EEG power spectrum.
- In healthy volunteers doses of GM-1020 that produced similar robust effects on EEG were not associated with sedation, ataxia or dissociation paving the way for evaluating GM- 1020 in patients with MDD
11:00 am Unlocking the Potential of Digital Biomarkers to Overcome Biological Variability of Mood & Behaviour & Drive More Reliable Patient Selection
Synopsis
- Emphasizing the clinical value of objective and continuous measurements with wearable sensors
- Challenges and pitfalls in developing minimal burden portable biomarker assessment tools
- Selecting the right digital measures to identify and enrich patient population and generate Phase 1 through Phase 3 data
- Capturing trait and/or state digital markers: the value of longitudinal assessments from Phase 1 to Phase 3 in drug development
11:30 am Demonstrating Easily Accessible Parameters for Patient Selection in Major Depression Trials Utilizing Autonomic Markers for Treatment With the 11beta-HSD2 Inhibitors Glycyrrhizin & Enoxolone
Synopsis
- Demonstrate utility of patient selection based on biomarkers of autonomic regulation: blood pressure, heart rate, metabolism and endocrine markers
- Demonstrating predictive value of autonomic markers for symptom improvement and treatment differentiation in major depression
- Discussing an example based on the effect of the 11beta hydoxysteroid-dehydrogenase type 2 (11betaHSD2) inhibitors glycyrrhizin and enoxolone.
12:00 pm Biomarker-Based Benchmarking, Dose Selection & Demonstration of Preliminary Evidence for Efficacy in Early Phase Clinical CNS Drug Development
Synopsis
- CNS-based biomarkers exploring PD in first-in-human studies
- Experimental challenge models in proof-of-mechanism studies
- Application of biomarkers and challenge models in go/no-go decisions
12:10 PM Lunch & Networking
1:30 pm Innovating Symptom-Based Discovery Approaches to Identify More Personalized Mood Disorder Drug Targets
Synopsis
- Outlining promising new targets in mood disorders
- Using precision psychiatry pioneering approaches to identify patients most likely to benefit
Virtual
2:00 pm Roundtable Discussion | Identifying New Windows of Opportunity for Next-Generation Targets in Depression, Bipolar, PTSD & More
Synopsis
More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas.
Schizophrenia (presented by Nina Dedic) | Other Indications (presented by Gerard Marek)
Are there any specific targets showing success in early studies?
What are the most promising tools available to aid discovery of new targets?
What are understudied aspects of the brain and that are limiting us?
Moderator Feedback & Audience Debate
Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open wider audience debate.
12:30 PM Lunch & Networking
1:30 pm Emerging Dosing Concepts for Plasticity-Enhancing Drugs: Insights Supporting a Phase 2 Study of Once-Weekly Oral Zelquistinel in MDD
Synopsis
- Event-driven pharmacology is a new and important concept in emerging psychiatry treatments
- Understanding metaplasticity and optimizing repeat dose strategies
- Leveraging symptom clusters and objective biomarkers to stratify patients
2:00 pm Roundtable Discussion | Generating Additional Data Beyond Questionnaire & Mood Scale Ratings to Objectively Identify Patient Subtypes
Synopsis
More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas.
Selection based on:
Genetic Profiling | EEGs | Digital Biomarkers
What are the hesitancies to additional data collection and
what will it take to implement in large scale clinical practice?
Moderator Feedback & Audience Debate
Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open wider audience debate
2:50 PM Afternoon Break & Refreshments
REVIEWING PIPELINE PROGRESS & RECOGNIZING FUTURE INNNOVATION IN THE NEUROPSYCHIATRY TREATMENT LANDSCAPE
3:20 pm The Potential of the Muscarinic System: Highlighting the Journey of KarXT Through Phase 1-3
Synopsis
- Evaluating the landscape of muscarinics in development for schizophrenia
- Explaining how the combination KarXT minimizes off-target muscarinic side effects in the clinic
- Outlining the factors that contributed to the strong results of the late phase trials
3:50 pm Introducing CLE-905, a Potent Dual M1/M4 Receptor Agonist in Development for Schizophrenia and BPSD
Synopsis
- Mechanism of Action – discussing the potential contribution of M1 and M4 receptor agonism
- CLE-905 demonstrated dose dependent robust antipsychotic effect in pharmacological models, IND enabling studies ongoing
4:00 pm PROLIV: MOOD Study Results Leading to Home Based Neuromodulation Therapy for Patients Who Do Not Respond to Antidepressants
Synopsis
- FDA Breakthrough Designation
- First home based Neuromodulation Wearable Therapy to successfully treat severe and treatment resistant MDD
4:30 pm How Patient-Centric Prescription Digital Therapeutics Can Improve Clinical Outcomes
Synopsis
- Showcasing the impact of digital treatments on neuropsychiatric disorders
- Highlighting the potential for prescription digital therapeutics to work alongside pharmaceuticals to broaden accessibility and transform treatment options for patients
- Future implications for drug-software combination products in the neuropsychiatry space
5:00 pm Investigating & Developing an Evidence-Based Prescription Digital Therapeutic (PDT) to Target Negative Symptoms of Schizophrenia
Synopsis
- Approach employed to develop digital health products
- Outlining efficacy signals seen in early studies
- How evidence may support adoption of PDT
5:30 pm Chair’s Closing Remarks
5:40 pm Scientific Poster Session & Drinks Reception
Synopsis
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.