PRE-CONFERENCE EEG FOCUS DAY - SEPTEMBER 9

08:00 am Check-In, Coffee & Light Breakfast

9:00 am Chair’s Opening Remarks

9:10 am Opening Discussion: What Value Do EEG Biomarkers Offer as Translational Tools for Neuropsychiatric Drug Development?

Synopsis

What are the potential, or anticipated challenges, of leveraging EEG data to:

  • Optimize dose selection: is EEG a relevant biomarker to leverage as a way of predicting and scaling therapeutic doses from animals into humans?
  • Aid patient selection: how can EEG monitoring be optimized as an objective tool for patient stratification?
  • Utilize as an outcome marker: is it beneficial to collect clinical EEG data as an additional endpoint?

10:00 am Advancing Translatable EEG Phenotypes Like Visual Processing to Inform Whether a Candidate is Working in Rodent Models

  • Sam Benezra Senior Scientist, Neural Circuits Group, Biogen

Synopsis

  • Identifying translatable sensory processing phenotypes in mouse models using EEG
  • Testing reproducibility and robustness of phenotypes across multiple cohorts
  • Using EEG phenotypes in rodent models to evaluate the minimal efficacious dose of targeted interventions

10:30 am Real-Time EEG in Psilocybin Rodent & IV Infused Psilocin Clinical Studies: Does This Provide a Tool to Optimize Precision of Psychedelic Dosing?

  • James Gilligan President & Chief Executive Officer, Tryp Therapeutics

Synopsis

  • Demonstrating changes in EEG patterns when entering the psychedelic state
  • Correlating EEG pattern changes with changes in brain entropy
  • Leveraging EEG to study the plasticity-enhancing effects of psilocybin and its active metabolite psilocin
  • Exploring strategies to correlate rat EEG data with initial clinical EEG results in order to optimize longer-term psychedelic clinical efficacy

11:00 am Morning Break & Networking

11:30 am Roundtable Discussion: Optimizing the Use of EEG as a Comprehensive Tool to Guide Your Program Through Endto- End Development

Synopsis

  • How can EEG be used to de-risk programs in phase 1, beyond just safety & dose findings?
  • How can we enhance the translation of task-related animal EEG studies to predict changes in human brain activity during cognitive processes?
  • How can the clinical development plan inform the design of preclinical research in EEG?
  • How can we evolve EEG recording methodology for larger phase 2/3 studies?

12:30 am Lunch & Networking

1:30 pm Current Status of Gamma Oscillations as a Translational Biomarker in Neuropsychiatric Disorders

  • Kevin Spencer Associate Professor of Psychiatry, Harvard University

Synopsis

  • Reviewing the strengths and weaknesses of gamma oscillations as translational tools
  • Leveraging the Auditory Steady-State Response (ASSR) and spontaneous gamma to assess the integrity of cortical circuits
  • Evaluating neurophysiological models of psychosis in light of evidence from gamma oscillations

2:00 pm Afternoon Break & Networking

2:30 pm Demonstrating the Utility of qEEG Methods Including MisMatch Negativity in Schizophrenia Drug Development

  • Heramb Chadchankar Senior Director & Head of Translational Science, Kynexis Therapeutics

Synopsis

  • Utilizing qEEG methods in the development of a new therapeutic mechanism for schizophrenia
  • Correlating mechanism of action with positive effects on EEG spectral analysis
  • Future directions for incorporating qEEG and EEG measurements of mismatch negativity as clinical endpoints

3:00 pm Roundtable Discussion: Debating the Potential of EEGs to be Utilized as Surrogates: What is the Regulatory Perspective on the Use of EEG Biomarker Data?

Synopsis

  • Are there particular neuropsychiatric indications where it could be valuable to incorporate EEGs as a regulatory endpoint?
  • How could we enhance the relevance of EEGs in the eyes of regulators?
  • Are there any lessons learned from previous experiences of including EEG data into an IND submission?

4:00 pm Chair’s Closing Remarks & End of Seminar Day