CONFERENCE DAY TWO - SEPTEMBER 11
8:50 am Chair’s Opening Remarks
NAVIGATING THE NEUROPSYCHIATRIC INVESTMENT LANDSCAPE
9:00 am Panel Discussion: A New Era of Investment in Neuropsychiatry: What Are the Biggest Catalysts Driving Deal- Making Momentum in 2025 & Beyond?
Synopsis
- How do you currently view the commercial opportunity within the neuropsychiatry space?
- Where do you see the focus for future investments and deal-making within psychiatry?
- What’s at the forefront of your mind when evaluating new investments? What does your pipeline for investment look like?
- What are you looking for when assessing the next wave of readouts in 2025 and beyond?
BRIDGING THE TRANSLATIONAL GAP TO PROGRESS PLASTICITY-ENHANCING COMPOUNDS THROUGH THE CLINIC
9:45 am Bolstering the Development of Novel Neuroplastogens & Deciphering Their True Classification
Synopsis
- Outlining the research paradigms that can be leveraged during discovery to prioritize compounds that will most likely have non-hallucinogenic effects in man
- Utilizing translationally relevant assays to decipher the complex activity profile of novel neuroplastogens before moving into humans
- Clarifying the classification of neuroplastogens: what key testing criteria should be used to benchmark novel plastogens?
10:15 am Session Reserved: Ulysses Neuroscience
10:45 am Morning Networking 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
DEEPENING UNDERSTANDING OF DISEASE MECHANISMS TO BOLSTER TARGET DISCOVERY
TRANSLATIONAL & CLINICAL UPDATES ON NOVEL NEUROPLASTOGENS
11:15 am Deciphering the Complexity of the Addiction Phenotype & Underlying Mechanisms of Substance Use Disorders
Synopsis
- Evaluating how different drugs of abuse impinge upon different reward circuits
- Studying the biological and genetic features associated with addiction
11:55 am Leveraging In vitro & In vivo Assays to Decipher Neuronal Circuit Complexity & Better Understand New Drug Profiles
Synopsis
- Utilizing in vitro and in vivo studies to build a picture of network complexity and understand a compound’s polypharmacology profile
- Considerations for translational preclinical models, in vitro and in vivo
11:15 am Highlighting Clinical Advancements in Serotonergic Neuroplastogens in Postpartum Depression & Adjustment Disorder
Synopsis
- Preclinical and early phase examination of 4-OH DIPT
- Evidence of potential efficacy in Post Partum Depression
- Prospects for application in Adjustment Disorder in Cancer and Other Medical Illness
11:45 am Spotlighting Breakthrough Progress in MM120, a Potentially Transformative Therapy for GAD & MDD
Synopsis
- Delving into the underlying mechanisms of MM120-induced plasticity
- Reviewing the developmental journey of MM120 so far in clinical research
- Developing innovative methodology to mitigate functional unblinding
12:15 pm Lunch & Networking
OPTMIZING TARGET DISCOVERY & SELECTION TO ENHANCE TRANSLATIONAL SUCCESS
DISCOVERING INNOVATIVE STRATEGIES FOR MITIGATING PLACEBO EFFECTS
1:30 pm Discovery & Selection of Novel Lymphatic-Targeted Prodrug Candidates to Treat Neuropsychiatric Disorders Using Clinical Evidence
Synopsis
- Selecting neuropsychiatric targets based on clinically validated mechanisms with existing limitations
- Using Seaport’s Glyph platform, a lymphatic-targeted prodrug technology to overcome these limitations, such as poor oral bioavailability or side effects of neuropsychiatric treatments and beyond.
- Sharing examples of the approach of identifying drugs with proven clinical efficacy and applying the Glyph platform to address previous challenges
2:00 pm From Genetics to Biomarkers and Therapeutic Hypotheses in Psychiatric Disorders
Synopsis
- Reviewing how genetics and multi-omics are being pursued for neuropsychiatric drug development
- Drawing conclusions from large-scale genetics to inform new therapeutic targets
- Showcasing emerging evidence for CSF biomarkers in schizophrenia and bipolar that may correlate with cognitive decline
1:30 pm Implementing Initiatives into Clinical Trial Execution to Minimize Placebo Effects in Psychiatric Drug Development
Synopsis
- Highlighting the importance of careful trial design to mitigate placebo
- Developing strategies to minimize placebo influence in patient assessments during a trial
- Showcasing numerous initiatives to reduce noise in psychiatric clinical trials
2:00 pm Roundtable Discussion: Benchmarking Trial Execution & Data Manipulation Strategies to Reduce Placebo-Induced Fluctuations
Synopsis
- How do we better educate patients and sites to help mitigate the placebo response during trial execution?
- How can statistical modelling and data science be leveraged to predict and pre-specify covariates for placebo response?
2:30 pm Afternoon Break & Refreshments
EVOLVING THE REGULATORY LANDSCAPE TO ALIGN WITH PRECISION PSYCHIATRY INITATIVES
3:00 pm Panel Discussion: Securing Regulatory Buy-In for Precision Psychiatry: What is the Regulatory View on Targeting More Precise Patient Subtypes & How Will This Effect Drug Labels?
Synopsis
- What is the regulatory guidance on how to use biomarkers and outcome measures to identify and target specific patient populations?
- Do regulators believe it is feasible to develop a selective population initially to confirm the treatment’s utility?
- How are trial enrichment criteria going to translate in the real world and affect indication statements?
- What are the risks and pitfalls of going after a biologically informed population? E.g. depression vs MDD vs anhedonia
- Trial design associated with selecting a subtype: What are the statistical considerations here?
3:30 pm Navigating the Evolving FDA & EMA Guidance to Accelerate Approval of MDMA, Psilocybin & DMT-Derived Therapies
Synopsis
- Reviewing the latest regulatory research in the psychedelic field
- Tackling the unique regulatory hurdles of MDMA vs psilocybin vs DMT
- Regulatory considerations for psychedelic trials, phase 1-3
4:00 pm Considerations For How Biomarker-Driven Stratification of Depressive Subtypes Will Be Viewed in the Eyes of the Regulators
Synopsis
- Evaluating the availability of validated or un-validated biomarkers in depression
- Deciphering the road to regulatory acceptance of a biomarker-identified population
- Navigating challenges of implementing robust biomarker criteria in the real world
- Discussing the pathway to commercialization for a precision therapy for mental health