7:50 am REGISTRATION & BREAKFAST

8:50 am Chair’s Opening Remarks

9:00 am Examining the Potential of FAAH Inhibition for PTSD and Evaluating a Promising FAAH Inhibitor in Initial Clinical Testing

  • Kimberly Babson Senior Director, Clinical Development, Neuroscience, Jazz Pharmaceuticals

Synopsis

  • Introduction to Jazz and pipeline
  • Overview of scientific background on FAAH inhibition
  • Overview of the study design for an ongoing Phase 2 study of JZP150 (FAAH inhibitor) for PTSD

RECAPITULATING PSYCHIATRIC CONDITIONS IN PRECLINICAL MODEL SYSTEMS

9:30 am Panel Discussion: Evaluating the Current Ability for Preclinical Models & Biomarkers to Translate Psychiatric Programs into the Clinic

Synopsis

  • Critically analyzing animal models for accelerating translational development of psychedelic and non-psychedelic compounds
  • Deciphering the most promising preclinical systems for assessing therapeutic durability
  • Exploring the advantages and limitations of in vitro models for investigating potential drugs to target mental health disorders

10:20 am Use of Phenotypic Screening in Mice for CNS Drug Discovery

  • Dani Brunner Chief Innovation Officer, Chief Technology Officer, PsychoGenics

Synopsis

  • SmartCube is a non-biased, automated screening platform that uses AI to predict the therapeutic effects of unknown compounds based on mouse behavior
  • SmartCube has been central to the discovery of several drugs being evaluated in the clinic for CNS disorders, including Ulotaront (in Phase 3) for Schizophrenia
  • SmartCube reduces the cost and timelines from identification of a hit to a development candidate

10:30 am MORNING BREAK & REFRESHMENTS

11:00 am Exploring Beyond Head Twitch Response Assays to Effectively Monitor Psychedelic Therapeutics In Vivo

  • Dino Dvorak Senior Director, Data Science & Platform Technologies, Gilgamesh

Synopsis

  • Investigating the ability of animal models to measure the durability of psychedelic compounds
  • Establishing more objective monitoring of psychiatric conditions in animals to revolutionize preclinical understanding of psychedelic mechanisms of action and therapeutic effects
  • Optimizing imaging and EEG studies in in vivo models to distinguish between hallucinogenic and non-hallucinogenic molecules

11:30 am Ulysses Psychedelics 2.0: An Update on Our Research Platforms on Psychedelics

Synopsis

  • Using mouse cortical primary neuronal cell cultures to test efficacy of psychedelics on neuronal plasticity
  • Behavioral and molecular efficacy of psychedelics in the rat IFN-alpha model of depression
  • Rat EEG as a translational biomarker in psychedelics research
  • Potential fluid biomarkers in depression and anorexia nervosa

12:00 pm Using Machine-Learning to Enable High Throughput Development of New Therapies for Neuropathic & Nociplastic Pain

Synopsis

Utilizing proprietary AI algorithms to interpret experimental animal behavioral data to understand how psychedelics affect the psychological aspects of pain and how they work to promote neuroplasticity in pain circuitry

12:30 pm LUNCH & NETWORKING BREAK

MANAGING EVOLVING REGULATORY GUIDELINES & ACCEPTANCE WHEN ENTERING A COMPETITIVE NEUROPSYCHIATRIC MARKET

1:30 pm Roundtable Discussion: Navigating the Evolving Regulatory Landscape for Antipsychotic Treatments of Psychiatric Disorders

  • Gina Pastino Senior Director, Clinical Pharmacology & Pharmacometrics, Cerevel Therapeutics
  • Jadwiga Martynowicz Regulatory Consultant, Atai
  • James Rawls Senior Vice President, Head of Regulatory Affairs, Sumitomo Pharma America

Synopsis

More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas:

  • Due to the intense effects of psychedelics, how can sponsors address this challenge to optimize signal detection? Are there special considerations for shorter acting vs longer acting psychedelics?
  • How can psychiatric assessments be improved to enhance confidence of efficacy and mitigate safety concerns among regulators?
  • How can we overcome the bias nature of psychedelics and standardize preparation and observation guidelines?

Moderator Feedback & Audience Debate

Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open up wider audience debate

EXPLORING DISCOVERY TECHNQIUES & KNOWLEDGE ADVANCES TO IDENTIFY MORE EFFICACOUS TARGETS

2:15 pm Emerging Genetics of Psychiatric disorders Enables Next-Generation Therapeutics to Target Dysfunctional circuits in the Brain

  • Jen Pan Director, Translational Neurobiology, Broad Institute of MIT & Harvard

Synopsis

  • Studying sleep and wake neurophysiology in human patients and animal models
  • Deepening understanding of correlations between sleep physiology and neurocircuit to identify targets for novel psychiatric therapies

2:45 pm AFTERNOON BREAK & NETWORKING COFFEE

3:15 pm Employing Human Genetics for Discovery in the Psychiatric Disease Area

Synopsis

  • Building genetic databases, with a focus on exomes, for gene discovery in psychiatric disease
  • Exploring genetic risk factors shared across disorders that may reflect shared symptoms

3:45 pm Novel Discoveries of Psychedelic Medicines for Neuropsychiatry: Where Are We Now & Where Are We Headed

Synopsis

  • Overview of the current psychedelic drug development landscape for psychiatric disorders
  • Understanding the neurobiological, pharmacologic, and circuit mechanisms mediating the therapeutic effects of psychedelics.
  • Psychedelic-mediated modulation of glial plasticity: implications for drug discovery

4:15 pm Translating Genetics & Basic Research into Drug Discovery Projects to Innovate Mechanistic-Based Treatments in Neuropsychiatry

Synopsis

  • From risk genes to understanding mechanisms driving neural circuit activity, behaviour, and
  • potential therapeutic
  • The development of assays and tools to study disease pathophysiology, assess target engagement and therapeutic efficacy
  • Diversity across cell types, species and patients

4:45 pm Chair’s Closing Remarks & End of Conference