PRE-CONFERENCE WORKSHOP DAY - SEPTEMBER 9

8:00 am CHECK-IN, COFFEE & LIGHT BREAKFAST

9:00 am WORKSHOP A

Revitalizing Psychedelic Clinical Trials: Harnessing Lessons Learned to Drive Operational Excellence & Regulatory Alignment

  • Jamileh Jemison Medical Director, Clinical Development, MindMed
  • Matt Harlin Senior Director, Discovery Research, Early Phase & Translational Medicine, Otsuka
  • Steve Levine Chief Patient Officer, Compass Pathways
  • Amir Inamdar Chief Medical Officer, Cybin

Synopsis

With last year’s FDA rejections and clinical setbacks highlighting inherent challenges of safety, site quality, efficacy, and regulatory alignment, join this workshop to benchmark valuable lessons learned and optimize your clinical trial strategy to successfully bring transformative psychedelic therapies to market.

Highlights Include:

  • What is the impact of standalone therapy vs when used in conjunction with psychotherapy? How do we assess these two threads in alignment with what FDA wants to see?
  • What is the key to sourcing high quality clinical sites capable of executing psychedelic trials in a timely manner?
  • How can we navigate limitations in a clinical site’s ability to handle and safely administer scheduled compounds in line with the protocol?
  • What can be done to enhance patient monitoring outside of the clinic and how can patients be effectively informed when it’s time for their next dose?
  • How can we apply lessons learned to ultimately aid the commercialization of these compounds? Are there initiatives to diversify trials to generate data more representative of the real world?

12:00 pm LUNCH & NETWORKING

1:00 pm WORKSHOP B

Enhancing the Selectivity, Sensitivity & Predictive Validity of Animal Models to Successfully Translate Novel Antidepressant, Antipsychotic & Anxiolytic Therapeutics

  • Jacob Jacobsen Chief Executive Officer, Evecxia Therapeutics
  • Michael Bowen Chief Scientific Officer, Kinoxis Therapeutics
  • Janet Nicholson Global Asset Lead, CNS Diseases, Translational Medicine, Boehringer Ingelheim
  • Zhanyan Fu Associate Director, Broad Institute of MIT & Harvard
  • Jackie von Salm Co-Founder & Chief Scientific Officer, Psilera

Synopsis

With a pressing need for in vivo assays that more accurately predict the effects of antidepressants, antipsychotics and anxiolytics in humans, join this collaborative workshop to benchmark new strategies, from recreating exact phenotypes to optimizing dose selection, to bridge the translational gap.

Highlights Include:

  • Leveraging advancements in systems neuroscience: which animal behaviours are meaningful indicators of antipsychotic, antidepressant, or anxiolytic effects?
  • Improving predictability: can we find a stimulant that better replicates the disease state and back translate to enhance predictive power?
  • Enhancing sensitivity and specificity: how can we refine the model to accurately detect signals from the specific drug being studied while minimizing false positives?
  • Informing human dose selection: how can we translate animal efficacy data into accurate clinical dose predictions?

4:00 pm END OF PRE-CONFERENCE WORKSHOP DAY