CONFERENCE DAY ONE - SEPTEMBER 10
7:20 am Check-In, Coffee & Light Breakfast
8:20 am Chair’s Opening Remarks
SPEARHEADING DEVELOPMENT OF MORE TRANSFORMATIVE MENTAL HEALTH THERAPEUTICS IN 2025 & BEYOND
8:30 am Rethinking Neuropsychiatry: Moving from Symptomatic Frameworks to a Biology-Led Discipline
Synopsis
- Outlining attempts so far, from biomarkers to circuitry network analysis, to convert psychiatry into a biology oriented discipline
- Deciphering the biological underpinnings of neuropsychiatric disorders drawing the link to neurology
- Rethinking how psychiatric disorders are approached as diagnostic entities
9:00 am Panel Discussion: Overcoming the Phase II/III Roadblock: Reflecting on Lessons Learned to Drive Novel Mechanisms of Action Through Clinical Trials & Beyond
Synopsis
- What can we learn from successful pathways like Cobenfy to improve the success rate of phase II and III trials investigating new mechanisms?
- How can we mitigate the impact of high placebo response rates on clinical readouts?
- How did blinded data analytics feed into the results?
- What are the issues being encountered with patient selection in phase II and III? Are these new drugs being directed towards a responsive patient population?
- Are patients being stratified correctly and is a precision approach the key to seeing efficacy?
9:45 am Translating Pioneering Success of Precision Medicine in Oncology: How Applicable Are These Principles to Neuropsychiatry?
Synopsis
- Reviewing the building blocks, time frames, and roadblocks to success in precision oncology: How does this inform the journey ahead for precision psychiatry?
- Highlighting key factors in the DSM diagnostic system that make a precision approach particularly difficult
- Overcoming challenges of biological understanding, comorbidities and heterogeneity to truly advance the precision psychiatry movement
10:15 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.
10:45 am Morning Break & Refreshments
Track 1: Discovery & Preclinical
Chair: Matt Harlin, Senior Director, Discovery Research, Early Phase & Translational Medicine, Otsuka
Track 2: Translational & Clinical
Chair: Aaron Koenig, Chief Medical Officer, Delix Therapeutics
INVESTIGATING THE TRANSLATIONAL RELEVANCE OF IN VIVO MODELS IN PSYCHIATRY
EXPLORING THE PROMISE OF EMERGING BIOMARKERS FOR ENHANCED DETECTION & MONITORING OF PSYCHIATRIC INDICATIONS
11:15 am Panel Discussion: Debating the Value of Animal Models in Screening New Drugs for Antidepressant, Anxiolytic, or Antipsychotic Efficacy
Synopsis
- What role, if any, do animal models of psychiatric disorders play in drug discovery?
- What insights can we gain from the history of successfully developed treatments to inform their predictive value?
- What else can be done from a nonclinical standpoint to generate supportive data for moving new target compounds into the clinic? Should we still be investing in animal studies?
11:55 am Comparative Neurobehavioral Profiling of Candidate Neuropsychiatric Treatments
Synopsis
- The Inscopix Discovery Lab has developed a new preclinical assay for in vivo circuit-based profiling of candidate neuropsychiatric treatments
- The assay leverages a library of neurobehavioral drug profiles constructed according to their impact on disease-relevant circuits in the brain
- We will describe our latest work profiling candidate treatments and discuss how this assay can help inform preclinical drug discovery
12:05 pm Analytical Solutions for Monitoring Psychedelics
Synopsis
- GMP analytical certification services for testing controlled substances including narcotics and psychedelics.
- Characterization of innovative neuropsychiatric therapeutics including Psilocybin (depression), MDMA (post-traumatic stress disorder), Ibogaine (addiction) and LSD tartrate (anxiety disorder) along with DMT, 5-MeO-DMT, Ketamine, THC and many other psychedelic medicines.
- Our work focuses on developing analytical tools to evaluate potential therapeutic psychedelic treatments and their derivatives.
12:15 pm Combining Animal Models with Advanced Neuroscience, Machine Learning, and Drug Delivery Technologies to Advance KNX100 for the Treatment of Agitation in Dementia & Substance Use Disorders
Synopsis
- KNX100 is a novel, clinical-stage treatment being developed for the treatment of agitation in dementia and substance use disorders
- Using time-locked, high temporal resolution neural and video recordings to enhance confidence in the disease relevance of preclinical behavioural and biological readouts
- Chronic steady-state dosing in animal models to improve the precision and predictive utility of preclinical PKPD profiles guiding clinical studies
- Harmonization of preclinical and clinical methods to facilitate translation of neural biomarkers
11:15 am Advancing Metabolic Markers in Psychiatry: Investigating the Effects of TAAR1 Agonists on Metabolic Control in Schizophrenia Patients with Co-Morbid Metabolic Syndrome & Pre-Diabetes
Synopsis
- Employing metabolic biomarkers to study gastric emptying, insulin-glucose homeostasis, and liver fat
- TAAR1 agonism and potential utility of metabolic biomarkers
- Peripheral metabolic markers in combination with CNS markers: implications for schizophrenia drug development
11:45 am Session Reserved: Centre for Human Drug Research
12:15 pm Designing Digital Health Studies for Precision Psychiatry
Synopsis
- Value of digital in advancing precision psychiatry
- Digital measure/marker development and validation
- Lessons learned in designing studies with digital health technologies with a precision lens
12.45 Lunch & Networking
REVITALIZING THE PSYCHIATRY FLUID BIOMARKER LANDSCAPE: SHAPING NEW DISCOVERIES
STRENGHTENING TRANSLATIONAL & CLINICAL BIOMARKERS & INNOVATING PRECISION APPROACHES
1:45 pm Novel Fluid Biomarker Discovery for Psychosis Spectrum Disorders
Synopsis
- Collecting paired CSF and blood together with key phenotypes to enable biological stratification of the psychosis spectrum
- Analyzing existing biomarkers to identify phenotype correlations
- Generating proteomics and genomics to discover novel biomarker candidates
2:15 pm Revolutionizing Depression Treatment: Discovering Fluid Biomarkers for Precision Medicine
Synopsis
- Lessons learned from designing and applying a targeted biomarker panel to clinical trial samples
- Association of inflammatory biomarkers with treatment response and clinical symptoms
- Proposal to use proteomics platforms to generate subtypes and actionable signatures of depression
2:45 pm Roundtable Discussion: Searching for an Abundantly Expressed Fluid Biomarker of Neuroplasticity: Could There be an NfL or Aβ Equivalent?
Synopsis
More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas:
- Where do we see opportunities for neuroplasticity markers to be detected in blood or CSF?
- What are the opportunities for neuroinflammatory biomarkers to be implemented and in which populations this would be suitable?
- What will be required to implement these in 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.
1:45 pm Navigating Heterogeneity in Generalized Anxiety Disorder to Successfully Develop a Subtype-Selective Monotherapy Treatment
Synopsis
- Dealing with comorbidities and overlapping indications when recruiting an appropriate clinical population
- Determining which patients will be most responsive to a given anxiolytic therapy
- Accounting for fluctuations in anxiety levels in individual patients throughout the trial
2:15 pm Beyond DSM: Innovating a Symptom Domain-Based Biomarker Approach to Translate More Precise Targets into Early Clinical Development
Synopsis
- Deciphering the neurobiology underlying symptom domains such as impulsivity and cognition
- Applying this knowledge to identify subtype-specific targets for symptom domains across indications
- Translating these new targets into the early clinical space
2:45 pm AI Avatars in Neuropsychiatry: Enhancing Clinical Precision with Multimodal Assessments
Synopsis
- Multilingual AI avatars streamline clinical interviews, reduce provider burden, and present scalable access to standardized assessments for global trials
- Multimodal scoring minimizes human-rater variability in assessments, reduces subjective bias, and improves reliability and statistical power for detecting drug effects
- Integration of audiovisual emotion cues with LLM-interaction enhances diagnostic precision and fosters empathetic patient interactions
2:55 pm Roundtable Discussion: Navigating the Non-Static Nature & Complexity of Disease States to Develop More Precise Treatment Options for Bipolar & Substance Use Disorders
Synopsis
More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas:
- How can we tailor therapies to address the different disease states of patients in high addiction phases vs detoxing vs maintaining sobriety? Is there a way to screen for different addiction states?
- How can we overcome differences in depressive vs manic mood swings across patient populations?
- How can we achieve a precision medicine approach in bipolar disorder?
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.
3.30 pm Afternoon Break & Refreshments
DECIPHERING MUSCARINIC MECHANISMS & ADVANCING BEYOND APPLICATIONS IN PSYCHOSIS
4:30 pm Panel Discussion: Assessing the Pros & Cons of Muscarinic PAMs vs. Agonists, Evaluating their Potential Regarding Side Effects & Efficacy Across Symptom Domains
Synopsis
- What are the main advantages and disadvantages of preclinically developing and clinically investigating a muscarinic receptor agonist compared to a PAM, and how are the disadvantages currently being addressed?
- Evaluating differences in efficacy signals: are there specific indications where one approach might be more beneficial than the other?
- What are the differences in side effect profiles experienced with PAMs vs agonists?
5:00 pm Cobenfy Beyond Psychosis: What is the Potential of Muscarinics to Address the High Unmet Need for Cognitive & Negative Symptom Management?
Synopsis
- Exploring promising avenues for Cobenfy to target symptoms beyond psychosis
- Outlining future directions for Cobenfy to be investigated for negative schizophrenia symptoms and cognitive-related symptoms across psychiatry: how could it be used to achieve functional recovery?
- Addressing key obstacles to anticipate and address when targeting negative symptoms and cognitive deficits in clinical populations
5:30 pm Chair’s Closing Remarks
5:40 pm Scientific Poster Session
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.