CONFERENCE DAY TWO - SEPTEMBER 26
8:30 AM Check-In, Coffee & Light Breakfast
9:20 am Chair’s Opening Remarks
REINVENTING THE REGULATORY LANDSCAPE & FUELING NEXT-GENERATION APPROVALS TO MEET THE GROWING UNMET NEED IN PSYCHIATRY
9:30 am Securing Alignment with Regulators Around the Endpoints Used in Trial Design
Synopsis
- Translating learnings from approval success stories
- Outlining general framework to apply and follow through developmental plan and into pivotal studies
- Timing and considerations for which authorities to prioritize alignment with
10:00 am Capturing the Patient Voice in the Development of Novel Endpoints & Precision Psychiatry
Synopsis
- Considering patient voice in the development of new, more objective instruments
- Triangulating all the different instrument modalities in development to enable a more precision-based approach
10:15 am Panel Discussion | Moving the Gold Standard Beyond Subjective Mood Scales & Evaluating the Potential of Surrogate Endpoints
Synopsis
- What are the right endpoints to use in indications, such as substance use disorder, where a defined mood scale is not clear?
- Critically evaluating the value of Hamilton and MADRS scales: are there different, more objective ways of tracking the severity of various psychological illnesses?
- Are we close to having a surrogate in psychiatry with any kind of biological or digital marker?
10:50 am Microtubule Proteins as Central & Peripheral Biomarkers of Neuroplastinogen Efficacy: Preclinical & Clinical Evidence
Synopsis
- Overview on the involvement of microtubule dynamics in the pathogenesis and treatment of depression
- Microtubule proteins are altered in in vitro and in vivo models following challenge with neuroplastinogens such as psychedelics
- First clinical evidence of altered microtubule proteins in post-mortem brain and plasma of depressed patients
11 AM Morning Break & Refreshments
Track 1: Discovery & Preclinical
Chair: Patricio O'Donnell, Vice President of Translational Medicine, Alto Neuroscience
Track 2: Translational & Clinical
Chair: Matthew Harlin, Senior Director, Discovery Research, Early Phase & Translational Medicine, Otsuka
EMPLOYING IN VITRO & IN VIVO TOOLS FOR NEUROPSYCHIATRIC DRUG DISCOVERY
NON-HALLUCINOGENIC PSYCHOPLASTOGENS: EXAMINING EARLY CLINICAL PROGRESS
11:30 am Examining the Preclinical Pharmacology of Novel Neuroplastogens
Synopsis
- Presenting effects on in vivo structural and functional neuroplasticity
- Activity in animal models of antidepressant activity
- Opportunities across neuropsychiatric indications
12:00 pm Leveraging bit.bio’s CNS Toolkit of Best-in-Class Human iPSC-Derived Cells to Build Complex Cellular Models for Target Discovery Through to Translation
Synopsis
- Highlighting deep characterisation and functional data for bit.bio's ioCells including gene expression, morphology and MEA
- Leveraging scalability and consistency of deterministically programmed ioCells in creating reproducible results in mixed culture systems
- Demonstration of a tri-culture system to explore functional dysregulation of excitatory and inhibitory neurons
11:30 am De-Risking the Translation & Early Development of Novel Neuroplastogens to the Clinic
Synopsis
- Highlighting opportunity for compounds with novel neuroplasticity-promoting properties to rapidly treat MDD and other related disorders
- Where do these neuroplastogens live within the new and emerging landscape of novel neuropsychiatric treatments?
12:00 pm Streamlining Translation of a Next-Generation Psilocybin Derivative to Reduce Behavioural Symptoms Associated with FTD
Synopsis
- Expanding our understanding of non-SSRI serotonergics for symptom management of Frontotemporal Dementias (FTD)
- Presenting the effects of a non-hallucinogenic psilocybin derivative, PSIL-006, on translational biomarkers for neuroinflammation and neuroplasticity
- In vivo mouse models for neurodegeneration and psychiatric symptomology including compulsive behaviors, circadian rhythm, and apathy
12:15 PM Lunch & Networking
BIOMARKER DISCOVERY IN NEUROPSYCHIARTY: EVALUATING THE PROMISE OF FLUID & IMAGING MARKERS
2:00 pm Exploring the Potential of Synaptic Markers in Patients with Psychosis
Synopsis
- Outlining the proposed role of synapse dysfunction, microglia, and synaptic pruning in schizophrenia
- Exploring the possible links between neuroinflammation and synaptic pruning
- Highlighting the potential of synaptic pruning biomarkers in schizophrenia, bipolar and other psychiatric indications
2:30 pm Innovating Translatable Image-Based Tools & Measurements to Accelerate Clinical Progress of Psychiatric Drug Targets
Synopsis
- Performing in vivo studies to identify translatable biomarkers of target engagement and pharmacodynamics
- Understanding the role of specific targets and processes in preclinical systems
- Overcoming translational barriers associated with neuroimaging for psychiatric disorders
1:29 pm
ADVANCING CLINICAL SELECTION & TRIAL DESIGN IN PHASE 3 & BEYOND
1:30 pm Employing a Biomarker-Driven Approach to Depression with Selection Based on Neuroendocrine Changes
Synopsis
- Showcasing a precision medicine study of ANC-501 for MDD
- Outlining the rationale for harnessing biomarker-driven stress hormone system disruptions
- Next steps for advancing the precision medicine study into phase 3 and beyond
2:00 pm Succeeding in Phase 3: Enhancing Signal & Minimizing Noise
Synopsis
- Choosing the right population for your study
- Key elements in study design
- Minimizing placebo response
2:30 PM Afternoon Break & Refreshments
3:00 pm Exploring Novel Innovation to Meet Significant Unmet Needs in Psychiatry
Synopsis
- Reviewing the current developmental landscape for treatment of neuropsychiatric symptoms in psychiatric conditions that benefit from exposure/training therapies.
- Outlining where we have seen evidence of progress and where the field must improve
- Uncovering significant learnings from past failings and optimistic implications for the future
- Clinical trial designs that could unlock new therapies
ANTICIPATING COMMERCIAL BOTTLENECKS TO STREAMLINE PATH TO MARKET
3:30 pm Spotlighting Future Implications from the Recent & Growing Commercial Success of Spravato: Are Psychedelics Commercially Viable for Mental Health?
Synopsis
- Interpreting the predicted trajectory of sales for Spravato
- Evaluating the commercial viability of additional emerging psychedelic treatments
- Anticipating & mitigating concerns of reimbursement
4:00 pm Panel Discussion | Navigating the Commercial Challenges of Reimbursement & Market Access to Streamline Route to Market for Psychiatric Therapeutics
Synopsis
- What does the infrastructure look like for commercializing neuropsychiatric products and getting payers to pay?
- How can we lower human resource costs as much as possible to increase profitability?
- How do we determine which areas are worth the greatest commercial investment in psychiatry?