8.00 Coffee & Registration

8:30 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

8:40 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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9:20 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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9:50 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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10.20 Speed Networking & Morning Refreshments

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

11:20 am Impact of GABA Modulation & Role in Developing Episodic Treatments for Mood Disorders

Synopsis

• Diving into KarXT, a novel medicine for treating psychosis
• Preferentially targeting and stimulating muscarinic receptors in the central nervous system and leaving those in the peripheral tissues unaffected
• Sharing clinical data and outlining the steps involved in initiating the Phase III trial

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11:50 am Bipolar Depression: Unmet Needs Continue to Exist

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

12:20 pm Developing Rapid-Acting & Sustained Antidepressant Drugs

12.50 Networking Lunch

1:50 pm Exploring Mechanistic Approaches to Treating Neuropsychiatric Disorders such as Depression, Autism & Cognitive Impairment

Deep Dive into Clinical Case Studies for Schizophrenia Candidates

2:20 pm Emergence of the Next Generation of Anti-Psychotics

  • Steve Paul CEO and Chairman, Karuna Therapeutics, Inc

2:50 pm Schizophrenia, A New Treatment Option for Patients

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

15.20 Poster Session & Afternoon Refreshments

Deep Dive Approaches for Treating Post Traumatic Stress Disorder, a Truly Unmet Medical Need

4:00 pm Pioneering Novel Therapeutic Approaches to Address PTSD

4:30 pm BNC210: A Negative Allosteric Modulator of Alpha7 Nicotinic Acetylcholine Receptor in Development for the Treatment of Anxiety, Depression & Post Traumatic Stress Disorder

5:00 pm Developing a PTSD Therapeutic – Phase 3 Clinical Development

5:30 pm Chair’s Closing Remarks

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

17.40 End of Day 1: Neuropsychiatric Drug Development Summit