CONFERENCE DAY TWO - SEPTEMBER 26
8 AM Check-In, Coffee & Light Breakfast
9:05 am Chair’s Opening Remarks
REINVENTING THE REGULATORY LANDSCAPE & FUELING NEXT-GENERATION APPROVALS TO MEET THE GROWING UNMET NEED IN PSYCHIATRY
9:15 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
9:45 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?
10:30 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
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 TO ASSESS PRECLINICAL DRUG ACTIVITY
NON-HALLUCINOGENIC PSYCHOPLASTOGENS: EXAMINING EARLY CLINICAL PROGRESS
11:30 am Sensorium Discovery Engine: Leveraging Human iPSC Cell Models to Drive Discovery of Novel Therapeutics for Neuropsychiatric & Neurological Disorders
Synopsis
- Discovery Engine leverages human iPSC models, machine learning, and phenotypic screening to develop novel classifiers based on standard of care
- Novel therapeutic compounds identified through Knowledge Graph screened in iPSC models to understand mechanisms and differentiation
- Screening data used to nominate and develop novel therapeutics for the treatment of neuropsychiatric and neurological disease
12:00 pm Session Reserved: bit.bio
Synopsis
12:15 pm 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
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
12:30 pm Grounding the Excitement of Psychedelics: Developing Non-Hallucinogenic Compounds That Are Commercially Viable
Synopsis
- Developing therapeutics that will be embraced by mainstream payers and realistically adopted by pharmaceutical companies
- Considerations for patient adoption: eliminating the psychotropic acute phase of their dosing
12:45 PM Lunch & Networking
BIOMARKER DISCOVERY IN NEUROPSYCHIARTY: EVALUATING THE PROMISE OF FLUID & IMAGING MARKERS
EVALUATING CLINICAL PROGRESS & MODERNIZING CLINICAL TRIAL DESIGN PROTOCOLS
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
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 Exploring Novel Innovation to Meet Significant Unmet Needs in Post-Traumatic Stress Disorder
Synopsis
- Reviewing the current developmental landscape for treatment of neuropsychiatric symptoms in PTSD
- 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
3 PM Afternoon Break & Refreshments
EXPLORING REAL-WORLD OUTCOMES & 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 Value of Medical Affairs in Supporting a Successful Drug Launch in Neuropsychiatry
Synopsis
- Providing medical expertise to support new drug launch
- Gaining clinician insights to inform strategy and decision making
- Engaging with clinicians to support medical education
- Developing medical materials and providing training
- Supporting publications, phase IV and real-world evidence generation
4:30 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?