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Workshop Agenda
Novel Molecular Targets for Mood Disorders and Psychosis: A Workshop
March 8–9, 2021 | Via Zoom
WORKSHOP OBJECTIVES
This public workshop will bring together experts and key stakeholders from academia, government, industry, and nonprofit organizations to explore novel molecular targets for mood disorders and psychosis, including ketamine, other NMDA receptor antagonists, neurosteroids, muscarinic antagonists, and serotonergic receptor modulators.
Invited presentations and discussions will be designed to:
- Review the current landscape of novel therapeutic targets and agents in development for mood disorders.
- Discuss commonalities among mechanisms of action and lessons learned in translation and clinical development that could be applied across programs to develop novel therapeutics for mood disorders.
- Examine key clinical and ethical questions—such as those related to dosing, safety, treatment aims, duration, diagnosis, place in the sequence of treatments, strategies to prolong efficacy and minimize risk, and the treatment setting—and regulatory challenges and opportunities.
- Explore the different types of bioethical frameworks that will be needed to guide the regulation and administration of novel therapeutics that mediate profound effects on consciousness.
- Consider emerging molecular targets for treating psychosis and cognitive impairment in schizophrenia and how therapeutic development could be informed by lessons learned in developing novel therapeutics for mood disorders.
- Discuss open research questions and opportunities to move the field forward.
DAY 1, MARCH 8, 2021
Session 1: Introduction to Drugs and Drug Targets for Mood Disorders and Psychosis
Objectives:
- Provide a high-level overview of the current landscape of novel molecular targets for mood disorders and psychosis.
- Discuss the scientific and clinical limitations of current pharmacological interventions to address mental illness.
- Highlight the unmet needs of people living with schizophrenia and treatment-resistant depression via testimonials from individuals who can speak to the subjective experience of these disorders.
2:00pm EST | Welcome and overview of workshop |
LINDA BRADY, National Institute of Mental Health (NIMH), Workshop Chair |
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2:10pm | The lived experience and unmet needs of individuals with schizophrenia and depression |
CARLOS LARRAURI, National Alliance on Mental Illness |
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ASHLEY CLAYTON, Yale University |
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2:30pm | Introductory talk: Scientific perspective on the history of drug treatments for mood disorder and psychosis |
STEVE PAUL, Karuna Therapeutics |
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2:50pm | Audience Q&A |
3:00pm | BREAK |
Session 2: Promising Developments with Glutamate Receptors
Objectives:
- Review clinical and preclinical data of ketamine as a case study of a novel, rapidly acting antidepressant that acts by blocking glutamate receptors.
- Examine possible explanations for the underlying mechanism of action.
- Explore the clinical and regulatory ramifications of rapidly acting antidepressants.
- Identify lessons learned and how they can help advance drug development targeting novel pathways.
3:10pm | Session overview |
HUSSEINI MANJI, Janssen Research & Development, LLC | |
3:15pm | GluRs as a novel molecular target: Clinical data on the use of ketamine and esketamine |
CARLA CANUSO, Janssen Research & Development, LLC
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3:35pm | GluRs: Investigating the mechanism of action for therapeutic ketamine |
JOHN KRYSTAL, Yale University
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3:55pm | Panel discussion: Identifying lessons learned and key open questions |
The Session 2 speakers above will be joined by panelists: | |
MORGAN SHENG, Broad Institute of the Massachusetts Institute of Technology and Harvard University | |
CARLOS ZARATE, NIMH | |
4:35pm | Audience Q&A |
4:50pm | Day 1 synthesis and closeout |
LINDA BRADY, NIMH, Workshop Chair | |
5:00pm | ADJOURN |
DAY 2, MARCH 9, 2021
Session 3: Promising Developments with GABA Receptors
Objectives:
- Review clinical and preclinical data demonstrating that novel drugs targeting gamma-aminobutyric acid receptors (GABARs) can alleviate depressive symptoms.
- Examine how drug development directed toward novel targets and pathways could be informed by a new understanding of GABA modulators in depression.
- Discuss how emerging drug targets for GluRs and GABARs advance our understanding of excitation/inhibition balance in mood circuits.
10:00am | Overview of session |
CHARLES ZORUMSKI, Washington University School of Medicine |
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10:05am | GABARs as a novel molecular target: Promising clinical data |
SAMANTHA MELTZER-BRODY, University of North Carolina at Chapel Hill
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10:20am | GABARs: Mechanisms of action for GABA-A modulators in depression |
JAMIE MAGUIRE, Tufts University
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10:35am | Panel discussion: Tuning the balance of excitation and inhibition |
The Session 3 speakers will be joined by: | |
GYÖRGY BUZSÁKI, New York University |
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LISA MONTEGGIA, Vanderbilt University |
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JOHN MURRAY, Yale University |
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11:15am | Lessons learned from a regulatory perspective |
TIFFANY FARCHIONE, Food and Drug Administration (FDA)
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11:45am | Audience Q&A |
12:00pm | LUNCH |
Session 4: The Road Ahead for Emerging Drug Targets
Objectives:
- Consider emerging drug development pathways for mood disorders and psychosis.
- Discuss lessons learned in translation and clinical development that could be applied across programs to develop novel therapeutics.
- Explore how these emerging targets inform new scientific strategies for drug development.
1:00pm | Overview of session |
DAVID GRAY, Cerevel Therapeutics |
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1:05pm | mTOR signaling in depression treatment |
EDDINE SAIAH, Navitor Pharmaceuticals |
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1:15pm | Serotonin 5-HT2 receptor agonists for mental disorders |
GABRIELLA GOBBI, McGill University |
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1:25pm | TAAR1/5-HT1AR agonists in schizophrenia treatment |
KENNETH KOBLAN, Sunovian Pharmaceuticals |
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1:35pm | M1/M4 acetylcholine muscarinic receptor targets |
ALAN BREIER, Indiana University–Purdue University, Indianapolis |
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1:45pm | Panel Q&A: Emerging developmental pathways in mood disorder and psychosis |
The Session 4 speakers will be joined by: | |
ROBERT DAVIS, Intracellular Therapies |
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BRYAN ROTH, University of North Carolina at Chapel Hill
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2:30pm | Audience Q&A |
2:45pm | BREAK |
Session 5: Bioethical Considerations
Objective:
- Explore the different types of bioethical and scientific frameworks that will be needed to guide drug development as additional emerging targets are identified.
2:50pm | Overview of session |
SHARON MATES, Intracellular Therapies |
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2:55pm | The bioethical considerations of using psychoactive drugs to treat mental illness |
PAUL APPELBAUM, Columbia University
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3:15pm | Panel discussion |
Dr. Appelbaum will be joined in the discussion by: | |
MASON MARKS, Gonzaga University |
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ILINA SINGH, Oxford University
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3:50pm | Audience Q&A |
4:00pm | BREAK |
Session 6: Synthesis and Next Steps
Objectives:
- Synthesize key themes.
- Discuss critical research gaps, next steps, and promising areas for future action.
4:05pm | Synthesis of workshop’s key themes |
LINDA BRADY, NIMH, Workshop Chair |
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4:10pm | Next steps and opportunities |
TIFFANY FARCHIONE, FDA |
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MAGALI HAAS, Cohen Veterans Bioscience |
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STUART HOFFMAN, Department of Veterans Affairs |
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RUPERT McSHANE, Oxford University |
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VENKATESHA MURTHY, Takeda |
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GREG SIMON, Kaiser Permanente |
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BRANDON STAGLIN, One Mind |
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JOSHUA GORDON, NIMH |
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4:55pm | Acknowledgments and concluding remarks |
LINDA BRADY, NIMH, Workshop Chair |
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5:00pm | END OF WORKSHOP |