19th Annual Scientific Meeting
15 – 17 February, 2023 // Washington, DC
Distinguished Poster Award Recipient:
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Latency distributions in speech during structured psychiatric interviews of patients with bipolar depression: automated speech analysis may provide a simple cognitive biomarker (abstract) – Hopkins |
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All Poster PDFs and Abstracts are available here. |
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15 February 2023 |
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| Welcome from the President | Gary Sachs slides video |
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| Andrew C. Leon Distinguished Career Award Presentation | Gary Sachs Ramy Mahmoud slidesLarry Ereshefsky slides video |
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| From Real World Data to Real World Evidence – Implementation of regulatory guidance in drug development | Chairs: Michael Davis Ibrahim Turkoz |
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| Introduction
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Michael Davis slides video |
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| FDA’s Real World Evidence program | John Concato slides video |
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| Real World Evidence: PDUFA VII commitments and FDA use cases | Motiur Rahman slides video |
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| Gathering and use of RWE in a European setting | Karl Broich slides video |
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| Recruitment strategy for prospective observational studies to mimic randomization: Up-front matching | Ibrahim Turkoz slides video |
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| Enhancing CNS product labels with pragmatic trials: Challenges, solutions, and outcomes that support the road to RWE | Larry Alphs slides video |
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| Panel Discussion | Facilitators: Michael Davis Ibrahim Turkoz Discussants: Samuel Wilkinson slidesAndrew Potter slides video |
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Wednesday Working Group Sessions |
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| Behavioral and Psychiatric Symptoms in Dementia (BPSD) Apathy Working Group | Chairs: Krista Lanctôt David Miller summary |
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| Estimands and Missing Data Working Group | Chair: Elena Polverejan summary |
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| Negative Symptoms Working Group | Chairs: David Daniel Stephen Marder summary |
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| Orphan Diseases Working Group | Chairs: Joan Busner Gahan Pandina slides |
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16 February 2023 |
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| Lewis Alan Opler Prize Presentation | Gary Sachs slides Søren Østergaard slides video |
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| Use of existing data to inform and speed development of personalized medicine for CNS disorders | Chairs: William Potter Larry Alphs |
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| Use of existing data to inform personalized CNS pharmacotherapy: What we have and what we need | William Potter slides video |
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| The Critical Path Institute: Data drives therapeutic innovation in the neurosciences | Klaus Romero slides video |
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| The Critical Path Institute: Impact of data sharing, regulatory successes | Diane Stephenson slides video |
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| RWE in behavioral health: its history and its future | Kenneth Park slides video |
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| Past data mining efforts and challenges | Ni Khin slides video |
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| Future regulatory opportunities and challenges | Valentina Mantua slides video |
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| Panel Discussion | Facilitator: Larry Alphs video |
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| Remote cognitive testing: An exploration of methodological considerations in designing clinical trials | Chairs: Raeanne Moore Philip Harvey |
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| Introduction | Philip Harvey slides video |
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| Is a composite a composite? Reflections from research on general cognitive ability | Dwight Dickinson slides video |
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| Need for equivalent in-person and remote-based cognitive tests: A perspective from pharma | Maura Furey slides video |
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| Nuts and bolts of mobile cognitive testing | Raeanne Moore slides video |
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| Current regulatory perspectives on instrument development for remote testing | Luca Pani slides video |
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| Panel Discussion
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Facilitators: Raeanne Moore Philip Harvey video |
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| Neuroinflammation and CNS disorders: Construct to potential treatments | Chairs: Ronald Marcus Kemi Olugemo |
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| Introduction | Ronald Marcus Kemi Olugemo slides video |
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| Neuroimmune mechanisms as therapeutic targets for major depressive disorder | Wayne Drevets* slides
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| Anti-inflammatory trials in patients with schizophrenia: Focus on specificity of symptoms and circuits | David Goldsmith slides video |
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| Uncharted territories: Methodologies to develop new treatments to resolve inflammation | Mark Rapaport slides video |
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| Methodological considerations in clinical trials with persons with schizophrenia and bipolar disorder | Faith Dickerson slides video |
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| Are inflammatory biomarkers the new frontier in Alzheimer’s disease research? | Jacobo Mintzer slides video |
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| Panel/Regulatory Discussion | Discussants: Elena Hernandez Martinez de Lapiscina Florence Butlen-Ducuing slides video |
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| Poster Session/Reception | Poster PDFs and Abstracts | ||
17 February 2023
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Friday Working Group Sessions |
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| Assessment of Methods and Endpoints for Rapid-Acting Antidepressants-RAADs Working Group | Chairs: Christian Yavorsky Jan Sedway summary |
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| Digital Biomarkers Decision Process Working Group | Chairs: Vikas Sharma Diane Hoffman summary slides |
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| Working Group to Review Methodology/Collaboration Focused Grant Opportunities | Chairs: Atul Mahableshwarkar Gary Sachs summary |
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| Unresolved problems in neuroscience: Topic 1 – Improving trial design in the precision psychiatry era | Chairs: Amir Kalali Eric Lenze |
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| Introduction | Amir Kalali video Lauren Liss slides video |
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| Precision clinical trials: How to overcome the limits of DSM | Eric Lenze slides video |
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| Precision clinical trials: Lessons from oncology | Stephen Liu slides video |
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| The future of trial design in the precision psychiatry era | Olusola Ajilore slides video |
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| Using EEG to predict and monitor response to intervention in global CNS trials | Gregory Light slides video |
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| Panel Discussion | Facilitator: Amir Kalali video |
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| Unresolved problems in neuroscience: Topic 2 – Methodological issues in psychedelic trials | Chairs: Amir Inamdar Joyce Tsai |
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| Introduction to psychedelics and overview of key methodological issues | Amir Inamdar slides video Joyce Tsai slides video |
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| Comparator selection in psychedelic clinical trial design | David Hellerstein slides video |
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| Bias and blinding in psychedelic trials | Christine Moore slides video |
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| Panel Discussion | Facilitators: Amir Inamdar Joyce Tsai video |
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| Meeting Adjourned
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Gary Sachs slides video |
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| *Video not released | |||