8.30 Online Registration & Virtual Coffee Networking

9:00 am Chair’s Opening Remarks

  • Gopi Shanker Director, Head of Psychiatry, Novartis Institutes for Biomedical Research

Synopsis

A critical overview of the current status of knowledge in neuropsychiatric drug development, setting the tone of openness, discussion and collaboration

9:10 am Kick-off Panel Discussion: What is Preventing Experts from Redefining the Field & Developing Transformative Drugs for Psychiatric Patients in Need?

  • Gopi Shanker Director, Head of Psychiatry, Novartis Institutes for Biomedical Research
  • Patricio O’Donnell Executive Medical Director and Head, Neurocircuitry Biomarkers , Takeda Pharmaceuticals

Synopsis

• Poor understanding of the disease biology for successful target selection
• Heterogenous patient selection and low patient adherence
• Animal models that lack translatability
• Low precision of clinical endpoints
• The need for more translatable biomarkers
• Have we defined psychiatric disorders correctly yet?

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9:50 am Advancing Neurophysiology & Cognition Translational Biomarkers to Drive Drug Development for Neuropsychiatric Disorders

  • Patricio O’Donnell Executive Medical Director and Head, Neurocircuitry Biomarkers , Takeda Pharmaceuticals

Synopsis

• Addressing challenges in drug development for psychiatry requires establishing and validating translational biomarkers
• Biomarkers that capture modulation of neural function are key for pharmacodynamic assessments in disease-relevant circuits
• Objective digital measures can overcome the lack of precision in current clinical tools
• The ultimate goal is to move towards precision medicine in psychiatry by adopting biomarker sets that can contribute to patient selection for clinical trials

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10:10 am The Role of the CRO in Patient-Centric CNS Clinical Trials

  • Gary K. Zammit President & CEO, Clinilabs Drug Development Corporation

Synopsis

• Gain insight into the role of the CRO in the engagement and retention of subjects with neuropsychiatric disorders
• Appreciate the value of the CRO in the deployment and use of technology in patient-centric CNS trials
• Learn how CROs manage the patient-centric CNS trial process from selection of endpoints to study execution and reporting
• Understand important aspects of data management and data integrity in patient-centric CNS trials

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10:30 am Live Q&A

  • Gary K. Zammit President & CEO, Clinilabs Drug Development Corporation
  • Patricio O’Donnell Executive Medical Director and Head, Neurocircuitry Biomarkers , Takeda Pharmaceuticals

10.50 Speed Networking & Morning Break

Driving More Effective Clinical Trial Design

11:20 am Core Clinical Trial Design Issues that Prevent us From Developing Effective & Transformative Drugs

  • Nassir Ghaemi Translational Medicine, Neuroscience, Novartis Institutes for Biomedical Research

Synopsis

  • Deep dive into clinical diagnosis and why our clinical phenotypes are not valid
  • Limitations of DSM definitions for psychiatric research
  • Drug development in psychiatry remains symptomatic, not transformative

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11:40 am Data Driven Analysis to Drive our Understanding of Placebo Responses in Neuropsychiatric Drug Development

12:00 pm Pushing the Envelope: Discovering Consequential Trial Design

  • Gerard Sanacora Director Yale Depression Research Program, Yale University School of Medicine

Synopsis

  • The issue of “placebo response” is increasingly recognized as a major hindrance to
    drug development, especially in the CNS space
  • How can we leverage our growing understanding of the factors that mediate and
    moderate non-specific treatment effects to optimize clinical trial results?
  • Is it possible to capitalize on the non-specific effects to amplify the benefits
    associated with the pharmacological treatments for neuropsychiatric disorders?

12:20 pm Live Q&A

  • Gerard Sanacora Director Yale Depression Research Program, Yale University School of Medicine
  • Nassir Ghaemi Translational Medicine, Neuroscience, Novartis Institutes for Biomedical Research
  • Srikanth Gottipati Associate Director, Think Team, Otsuka Pharmaceuticals

12.40 Lunch Break

Driving More Effective Clinical Trial Design

1:50 pm Spearheading Innovation in Clinical Development & Approval for New Neuropsychiatric Drugs

Synopsis

• Path to a TD indication with no regulatory precedent
• Approaches used to decrease placebo response
• Overview of Neurocrine’s Pipeline

2:10 pm Exploring Why it is Pivotal to Include Suicidal Patients in Neuropsychiatric Clinical Studies

Synopsis

• Design considerations when including suicidal patients
• Reengaging pharma into suicide prevention, target selection and patient stratification
• Evaluating progress in the field and identifying promising areas to yield impactful
insights and strategies for suicide prevention

2:30 pm Using Biotypes to Propose Rational Targets & Enrich Study Population

  • Carol Tamminga Lou & Ellen McGinley Distinguished Chair, McKenzie Chair in Psychiatry, Translational Neuroscience Division in Schizophrenia, UT Southwestern

Synopsis

• Biotyping across psychosis, multiple diagnosis of psychotic illnesses
• Identifying biomarkers that mark genetic subtypes and selection of patients by
these biomarkers and using this to show target engagement
• Leveraging tools for deep phenotyping including electrophysiology, brain imaging,
cognition, eye tracking
• Seeking biomarkers for diagnosis and how this led to sorting based on biological
biomarkers

2:50 pm Live Q&A

  • Carol Tamminga Lou & Ellen McGinley Distinguished Chair, McKenzie Chair in Psychiatry, Translational Neuroscience Division in Schizophrenia, UT Southwestern
  • Jill Harkavy Friedman Vice President of Research, American Foundation for Suicide Prevention
  • Angel Angelov VP Medical Affairs, Neurocrine

3.20 Networking Break & Poster Session

A New Wave of Innovation – Fresh Approaches in Discovery to Yield Novel Mechanisms of Action

3:50 pm Bipolar Depression: Unmet Needs Continue to Exist

  • Sharon Mates Chairman, President & CEO, Intra-Cellular Therapies, Inc.

Synopsis

• Identify areas of unmet need
• Share efficacy and safety results of novel agent
• Discuss next steps in development

4:10 pm Unique Mechanism of Action Associated with NMDA Antagonists for Treating Suicidal Bipolar Depression

Synopsis

NMDA antagonist drugs show particular promise for patients with suicidal and
bipolar depression.
• Bipolar depression is associated with high risk of suicidal ideation and rumination
• SSRI antidepressants pose unique risk of suicide in this condition, perhaps linked to
akathisia
• NMDA antagonist antidepressants are shown to decrease suicidal ideation
• Basic science data suggests that effect may be linked to increased glutamine/
glutamate in the cortex, similar benefit has been shown for ECT
• Recent nonclinical studies demonstrate that NMDA antagonists restore dedritic
connections in the cortex.
• The challenge is to inhibit NMDA with drugs that are non-hallucinogenic, nonaddictive, and non-neurotoxic

Deep Dive into the Opioid Crisis & Effective Drug Development for Substance Use Disorders

4:30 pm Addressing the Opioid Crisis & Driving a Change

  • Kurt Rasmussen Director, Division of Therapeutics & Medical Consequences, The National Institute on Drug Abuse (NIDA)

Synopsis

  • How can the pharmaceutical industry tackle the opioid crisis? What are the current limitations and hesitations?
  •  Exploring biotech activity for the treatment of addiction
  •  How NIDA can be a catalyst for finding treatments for addiction

4:50 pm Fighting Fire with Fire: Development of Intranasal Nalmefene to Treat Synthetic Opioid Overdose

Synopsis

  • Synthetic opioids like fentanyl now drive the opioid epidemic, responsible for more overdose deaths than both heroin and prescription opioids
  • Nalmefene is a potent, long acting opioid antagonist; these properties make it especially well-suited to treat overdose caused by synthetic opioids
  • OPNT 003 is a proprietary formulation of nalmefene nasal spray. The pharmacokinetic properties (Cmax and tmax) of OPNT 003 indicate its onset of action is faster than an intramuscular dose of nalmefene previously approved to treat overdose
  •  Defining the path towards filing a New Drug Application (NDA) for this product in 2020

5:10 pm Trailblazing Non-Hallucinogenic & Hallucinogenic Solutions to Psychiatric Disorders

  • Stephen Hurst Co-founder, Executive Chair & Co-CEO, Mind Medicine

Synopsis

  • Discovering, developing and deploying psychedelic inspired medicines through clinical trials
  • To what extent does the hallucinogenic experience add therapeutic value for those suffering mental disorders?
  • Designing a phase 2 pivotal study targeting opioid withdrawal and opioid use disorder

5:30 pm Live Q&A

6:00 pm Chair’s Closing Remarks

  • Gopi Shanker Director, Head of Psychiatry, Novartis Institutes for Biomedical Research

18.00 End of Day 1