8:00 am Chair’s Opening Remarks

8:15 am Progressing from Treatment Resistant Depression with Novel Impactful Therapeutics

Synopsis

  • Expanding on the role of alternative receptors and allosteric modulation in therapeutic options
  • Uncovering updates from research to predict drug response patterns
  • How can patients with depression be stratified to streamline treatment decisions?

Updates on Clinical Development for Psychiatry

8:45 am Acute Treatment of Social Anxiety Disorder: Emerging Regulatory Landscape Facilitates Pipeline Development

Synopsis

  • Reviewing current chronic and acute FDA-approved and off-label drug treatment for SAD
  • Emerging regulatory landscape has paved the path for rapid development of fast-acting medications for acute treatment of SAD without the liabilities of benzodiazepines
  • The pipeline of candidates in development for acute treatment of SAD will be reviewed

9:15 am Psychedelics 2.0 – Novel preclinical approaches to investigate mechanisms of action and efficacy of glutamatergic and serotonergic psychedelics

Synopsis

  • Acute and long-term behavioural and molecular efficacy of ketamine in the rat IFN-alpha model of depression
  • Exploring changes in synaptic markers (BDNF; pre-synaptic SV2A and synaptophysin; post-synaptic PSD-95 and spinophilin) induced by psychedelics
  • Using established and innovative behavioural endpoints to understand psychedelic effects on brain function
  • Preclinical electrophysiology as a translational biomarker of acute and long-term effects of psychedelics on brain activity

9:45 am Speed Networking

Synopsis

Grab a quick cup of tea or coffee and jump into the speed networking session. Don’t miss this fantastic opportunity to connect with new contacts from active companies involved in drug development for psychiatric disorders. Network and form lasting connections in this exclusive Speed Networking session.

10:15 am Morning Break & Networking

10:45 am Tackling the Opioid Overdose Crisis: Where Are We Now?

Synopsis

  • Examining the evolution of the opioid overdose crisis
  • Outlining innovative approaches to treat opioid overdose
  • Can the efficacy of rescue agents be evaluated in controlled clinical trials?

11:15 am Attending the Holistic Care of Schizophrenia: The Negative & The Positive

  • John Renger Chief Scientific Officer, Cerevel Therapeutics

Synopsis

  • Reviewing therapeutic development to cover negative symptoms of schizophrenia
  •  Examining novel mechanisms of action for antipsychotics to yield refined results
  •  Discussing the future potential within schizophrenia for symptom-centric treatment

11:45 am IGALMI: Sublingual Dexmedetomidine for the Acute Treatment of Agitation in Schizophrenia and Bipolar Disorder

  • Frank Yocca Senior Vice President & Chief Scientific Officer, BioXcel

Synopsis

  • Use of AI for identifying and developing a therapeutic for an underserved indication
  • Overview and key decisions/data in the discovery, formulation and development of IGALMI for treating acute agitation
  • Applying a “Land and Expand” strategy for new indications and broadening commercial opportunities for IGALMI

12:15 pm Lunch & Networking

Translating the Language of the Mind – From Models to Clinic

1:15 pm Avoiding Pitfalls in Clinical Trial Design & Execution in the Post-Big Pharma Era

Synopsis

  • Understanding up-to-date methodologies to identify
  • Capitalizing on insights from efficient and suboptimal designs
  • Exploring navigation of studies in the modern setting

1:45 pm A General Theory of Construct Enrichment: Inclusion Criteria for Symptom Structure not Just Severity

  • Seth Hopkins Executive Director Translational Science, Sunovion Pharmaceuticals

Synopsis

  • Exploring case studies from depression and schizophrenia indication registration trials
  • Optimizing the match between psychiatric scale, trial population, and endpoint to increase the validity and power of clinical trials

2:15 pm Accelerating Biomarker Identification & Endpoint Optimization through Quantitatively-Derived Clinical Phenotypes

Synopsis

  • Major challenges to our current psychiatric nosology
  • Reviewing a quantitatively-derived dimensional model of psychopathology to provide better framework
  • Exploring how quantitatively-derived phenotypes can be used improve biomarker identification and endpoint development

2:45 pm Afternoon Break & Networking

3:30 pm Highlighting the Integration of Machine Learning to Enhance Preclinical Drug Discovery

  • Zoe Hughes Vice President & Head of Biology, Gilgamesh Pharmaceuticals

Synopsis

  • Implementing machine learning based classification of animal behavior to guide drug development
  • Using quantitative biomarkers to refine translational data for the identification of lead molecules
  • Dissecting key examples to outline utility of novel AI discovery platform

4:00 pm Translational & Cross-Species Approaches to Anhedonia: Implications for Treatment Development & Stratification

Synopsis

  • Utilization of fMRI, EEG and PET in identification of neural substrates
  • Reviewing the importance of anhedonia as an endophenotype of depression
  •  Outlining the considerations to be made in therapeutics development for depression based on findings

4:30 pm The Hype & The Hope: Utilization of Model Behaviors to Accurately Predict Clinical Efficacy

  • Scott Thompson Professor & Chair Department of Physiology, University of Maryland

Synopsis

  • Examining the insufficiencies in current models for psychiatric drug development
  • Evaluating validation of models of anhedonic rodent behavior for application in pipelines
  • Exploring application of translational models in reviewing action of psychedelic therapeutics

5:00 pm End of Day Wrap-Up