PRE-CONFERENCE WORKSHOP DAY - SEPTEMBER 24

8 AM Check-In, Coffee & Light Breakfast

Psychedelic R&D

9:00 am Workshop A: From Underlying Mechanisms to Clinical Efficacy: Deepening Understanding of the Psychedelic Mode of Action & Hallucinogenic Effects

  • Kurt Rasmussen Chief Scientific Officer, Delix Therapeutics
  • Dalibor Sames Co-Founder, Gilgamesh Pharmaceuticals & Faculty, Columbia University
  • Umed Boltaev Associate Research Scientist, Columbia University

Synopsis

Investment in psychedelic R&D is growing, with notable approvals on the horizon, however, the underlying mechanisms and receptor interactions driving clinical efficacy remain poorly understood.

Join this workshop to uncover new knowledge of underlying psychedelic mechanisms, decipher the role of 5HT2A, debate the necessity hallucinogenic effects, and examine recent clinical efficacy data.

Address critical questions, such as:

  • What are the compounds doing in the body to create long-lasting effects?
  • What is happening to various brain pathways during the trip, and how long does a trip need to be?
  • What is currently understood about how psychedelics induce neuroplasticity and the receptors involved?
  • What is the evidence for and against the need for a hallucinogenic experience to demonstrate efficacy

Traditional R&D

9:00 am Workshop B: Highlighting the Value of EEGs as Translational Tools in Neuropsychiatry & Beyond

Synopsis

From efficacy to target engagement to pharmacodynamics, this workshop will delve into the wide range of possibilities that EEG biomarkers offer in the field of neuropsychiatry. Furthermore, it will explore the additional data gained from implementing EEGs in neurodevelopmental disorders, such as Angelman Syndrome and ADHD.

Join this workshop to:

  • Discuss how EEG can be implemented as a relevant biomarker in neuropsychiatric drug development and to gain additional real-word data
  • Investigate the common symptoms and underlying mechanisms shared by neuropsychiatric and neurodevelopmental disorders, such as increased delta waves or thalamo-cortical deficits, which can be studied using EEG biomarker techniques
  • Highlight advancements in EEG hardware and the development of standardized headsets which can be deployed across multiple sites

12 PM Lunch

1:00 pm Workshop C: Navigating Evolving Regulatory Hurdles in an Era of Growing Potential for Psychedelic Drug Approvals

Synopsis

As psychedelic drug assets progress into late phase clinical studies, there are some critical questions at the forefront of everybody’s minds:

  • What is the optimal amount of psychological support that is necessary from a regulatory perspective in clinical trials for psychedelics?
  • What are regulatory agencies looking for in terms of higher quality evidence or more rigorous trial design?
  • What would the regulatory framework be if the compound is found to have any hallucinogenic properties?
  • Can expected effects of psychedelics be considered adverse events?

Address all this and more with leading clinical experts navigating the journey towards psychedelic approval. Review the latest regulatory frameworks and anticipate their implications on upcoming trial designs.

1:00 pm Workshop D: Bridging the Translational Gap for Clinical Success: Modelling Heterogenetic Psychiatric Phenotypes in Behavioural vs Circuit-Based In Vivo Models

  • Daniel Smith Executive Director & Head of Translational Medicine, Alkermes

Synopsis

The need for more human-relevant model systems to predict clinical efficacy of anxiolytics, antipsychotics and more remains fundamental to translating the plethora of preclinical psychiatric drug candidates into phase 1 studies. Moreover, the constraints of behavioural models in predicting clinical efficacy have redirected focus toward exploring the potential of modelling neurological deficits and specific brain circuits. Join this workshop to explore recent preclinical innovation and collaboratively discuss novel ideas to enhance translatability.

Highlights include:

  • Leveraging transgenic animal studies to elevate understanding of disease pathophysiology and investigate receptor interactions leading to behavioural traits
  • Evaluating the ability of animal behavioural models to model underlying brain circuitry; can they predict anxiolytic and antidepressant effects?
  • Exploring to what extent circuit-based approaches have succeeded so far
  • Evaluating types of models most suitable for human experimental studies