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Appendix B: Workshop Agenda
Pages 67-74

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From page 67...
... • 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.
From page 68...
... 2:00pm EST Welcome and overview of workshop LINDA BRADY, National Institute of Mental Health (NIMH) , Workshop Chair 2:10pm The lived experience and unmet needs of individuals with schizophrenia and depression CARLOS LARRAURI, National Alliance on Mental Illness ASHLEY CLAYTON, Yale University 2:30pm Introductory talk: Scientific perspective on the history of drug treatments for mood disorder and psychosis STEVE PAUL, Karuna Therapeutics 2:50pm Audience Q&A 3:00pm BREAK
From page 69...
... • Explore the clinical and regulatory ramifications of rapidly acting antidepressants. • Identify lessons learned and how they can help advance drug develop ment targeting novel pathways.
From page 70...
... 10:00am Overview of session CHARLES ZORUMSKI, Washington University School of Medicine 10:05am GABARs as a novel molecular target: Promising clinical data SAMANTHA MELTZER-BRODY, University of North Carolina at Chapel Hill • How long does it take for a treatment effect to be observed? • What is the treatment effect size relative to the standard of care?
From page 71...
... • Why are some GABAergic modulators, but not o ­ thers, effective antidepressants and what does that tell us about the etiological specificity of depressive disorders? 10:35am Panel discussion: Tuning the balance of excitation and inhibition The Session 3 speakers will be joined by: GYÖRGY BUZSÁKI, New York University LISA MONTEGGIA, Vanderbilt University JOHN MURRAY, Yale University 11:15am Lessons learned from a regulatory perspective TIFFANY FARCHIONE, Food and Drug Administration (FDA)
From page 72...
... • Explore how these emerging targets inform new scientific strategies for drug development. 1:00pm Overview of session DAVID GRAY, Cerevel Therapeutics 1:05pm mTOR signaling in depression treatment EDDINE SAIAH, Navitor Pharmaceuticals 1:15pm Serotonin 5-HT2 receptor agonists for mental disorders GABRIELLA GOBBI, McGill University 1:25pm TAAR1/5-HT1AR agonists in schizophrenia treatment KENNETH KOBLAN, Sunovian Pharmaceuticals 1:35pm M1/M4 acetylcholine muscarinic receptor targets ALAN BREIER, Indiana University–Purdue University, Indianapolis 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 BRYAN ROTH, University of North Carolina at Chapel Hill • What are the challenges and opportunities of develop ing drug compounds that act on mechanisms down stream of the primary target?
From page 73...
... 3:15pm Panel discussion Dr. Appelbaum will be joined in the discussion by: MASON MARKS, Gonzaga University ILINA SINGH, Oxford University • Is a precautionary approach appropriate here?
From page 74...
... 4:05pm Synthesis of workshop's key themes LINDA BRADY, NIMH, Workshop Chair 4:10pm Next steps and opportunities TIFFANY FARCHIONE, FDA MAGALI HAAS, Cohen Veterans Bioscience STUART HOFFMAN, Department of Veterans Affairs RUPERT McSHANE, Oxford University VENKATESHA MURTHY, Takeda GREG SIMON, Kaiser Permanente BRANDON STAGLIN, One Mind JOSHUA GORDON, NIMH 4:55pm Acknowledgments and concluding remarks LINDA BRADY, NIMH, Workshop Chair 5:00pm END OF WORKSHOP


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