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 Progress and Prospects in EEG for Psychedelic Drug Discovery
Synopsis
- How can EEG inform us about the mechanism of action of psychedelic drugs?
- How can we differentiate between hallucinogenic and non-hallucinogenic compounds in this class?
- How can the translational power of EEG support drug discovery in the psychedelic space?
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 Operator-Led Innovation: A Venture Studio Approach to Accelerating Neuropsychiatric Drug Development
Synopsis
- Negev Labs Managing Partner Shlomi Raz will introduce the firm’s operator-led venture studio model, designed to identify and advance neuropsychiatric drug candidates through a capital-efficient, milestone-driven approach.
- Shlomi will highlight Ariadne Bio, Negev Labs’ first portfolio company, which is developing a non-hallucinogenic 5-HT2A/2C agonist for apathy in Parkinson’s disease—an area of high unmet need—leveraging supportive human data.
- Dr. Dan Jeffries, Principal at Negev Labs, will then preview Athena Neuro, the studio’s next company launching later this year, focused on treating agitation in genetically defined neuropsychiatric populations through receptor subtype selectivity and translational biomarker strategies.
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 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
2:00 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
2:30 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