21st Annual Scientific Meeting
19 – 21 February, 2024 // Washington DC
Distinguished Poster Award Recipient:
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Mourgues Codern – Qualification plan for the PSYCHS as a COA for attenuated positive symptoms in patients at clinical high risk for psychosis (Abstract) |
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All Poster PDFs and Abstracts are available here. |
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19 February 2025 |
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| Welcome from the President | Luca Pani slides video |
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| Andrew C. Leon Distinguished Career Award Presentation | Gary Sachs slides Stephen Brannan video |
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| New Investigator Award Presentations (Group 1) |
Gary Sachs slides Mitchell Arnovitz slidesIgor Bandeira slidesGeorgios Efstathiadis slidesPetros Petridis slidesMyuri Ruthirakuhan slides video |
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| Probing novel regulatory science precedents in Alzheimer’s, ALS, and schizophrenia for implications for all of neuroscience | Chair: Frank Sasinowski |
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| Introduction
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Frank Sasinowski slides video |
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| Recent drug approvals in the Office of Neuroscience at CDER: Lessons learned | Teresa Buracchio slides video |
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| Designing drug development programs to meet the standards needed to constitute confirmatory evidence in support of a single positive adequate and well-controlled study in neuroscience | Charles Raver slides video |
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| Givinostat effect on muscle fat fraction: Confirmatory evidence in Duvyzat NDA approval | Paolo Bettica slides video |
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| Success in rare disease drug development – Friedreich’s Ataxia | Barbara Tate slides video |
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| Use of single study plus confirmatory evidence pathway | Emily Freilich slides video |
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| The development of tofersen for SOD1-ALS | Teresa Fecteau* video |
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| Leverage quantitative tools to select novel endpoint for tofersen development in treating SOD1-ALS | Hao Zhu slides video |
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| Zolgensma (onasemnogene abeparvovec-xioi) gene therapy: Probing regulatory precedents | Wilson Bryan slides video |
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| Drug development program for an acute clinical state: Esketamine for major depression with suicidal intent example | Marc Walton slides video |
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| Panel Discussion | Facilitator: Ellis Unger slides video |
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Wednesday Working Group Sessions |
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| Advancing the Methods to Evaluate Abuse and Dependence-Potential in Clinical Studies for CNS-active drugs and Novel Psychedelics | Chairs: Jadwiga Martynowicz Beatrice Setnik slides |
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| Digital Biomarkers Decision Process Working Group | Chairs: Anzar Abbas Vikas Mohan Sharma slides |
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| Diversity in CNS Clinical Trials Working Group | Chairs: Abhishek Pratap Siân Ratcliffe Smethurst summary slides |
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20 February 2025 |
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| New Investigator Award Presentations (Group 2) |
Judith Jaeger slides Ritvij Satodiya slidesHui Yang slidesJoshua Siegel slidesAmanda Tamman slidesDionne Williams slides video |
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| Consortia biomarkers and evolving data analytics: Delivery of new tools for drug trials | Chairs: William Potter Anzalee Khan |
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| Introduction | Anzalee Khan slides video |
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| Leveraging data and analytic approaches in ADNI for enhanced clinical trial participant selection and characterization | Jeffrey Dage slides video |
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| Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) overview
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Cheryl Corcoran slides video |
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| PPMI – A biomarker engine for therapeutic development for PD and related synucleinopathies | Ken Marek slides video |
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| Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care: The EMBARC data repository and machine learning based EEG biomarkers | Michael Detke slides video |
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| Panel Discussion | Facilitator: Bill Potter Discussants: Valentina Mantua Kevin Krudys slides video |
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| Using Novel Biomarkers and Advanced Analytics to Optimize Measurement, Endpoint Selections, and Signal Detection: Lessons for the Broader Neuroscience Community from Orphan Diseases Trials | Chairs: Joan Busner Gahan Pandina |
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| Introduction | Joan Busner slides |
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| Digital outcomes and biomarkers in neuropsychiatry and neurology – the path forward | Gahan Pandina slides video |
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| The long and winding road of digital outcome: From academic study to regulatory qualification | Laurent Servais slides video |
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| Establishing clinical meaningfulness in rare/orphan disorder clinical trials – the role of the CGI | Joseph Horrigan slides video |
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| MDRI as an endpoint strategy for rare neurodevelopmental disorders | Alison Skrinar slides video |
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| Use of advanced analytical approaches to optimize measurement of treatment effects | Siân Ratcliffe Smethurst slides video |
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| Panel Discussion
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Discussant: Michelle Campbell slides video |
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| Development of Novel Endpoints for Clinical Trials in Substance Use Disorder | Chairs: Tanya Ramey Martin Mumenthaler |
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| Introduction | Martin Mumenthaler slides video |
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| Measuring patient improvement in symptom criteria for substance use disorder | Brian Kiluk slides video |
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| Craving: Endpoint, measurement, indication (Craving as a treatment endpoint: Rationale and evidence) | Marc Auriacombe slides video |
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| Statistical considerations for endpoints in stimulant use disorder clinical trials | Vlad Dragalin slides video |
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| Current and future considerations for non-abstinence outcomes | Kelly Dunn slides video |
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| Panel Discussion | Discussant: Marta Sokolowska slides video |
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| Poster Session/Reception | Poster PDFs and Abstracts | ||
21 February 2025
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Friday Working Group Sessions |
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| Developing Strategies to Improve Recruitment for Clinical Trials Targeting Neuropsychiatric Symptoms (NPS) in Memory Disorders Working Group | Chairs: Moyra Mortby Paul Rosenberg slides |
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| Development of Novel Endpoints for Clinical Trials in Substance Use Disorders Working Group | Chairs: Martin Mumenthaler Tanya Ramey slides |
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| Estimands and Missing Data Working Group | Chairs: Elena Polverejan Lorenzo Guizzaro summary slides |
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| Orphan Diseases Working Group | Chairs: Joan Busner Gahan Pandina slides |
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| Sleep Methodology in CNS Trials Working Group | Chairs: Margaret Moline Georg Dorffner summary slides |
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| Blinded Data Trial Analytics: Benefits and Risks in Psychiatry and Neurology Studies | Chairs: Stephen Brannan Jenicka Engler |
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| Introduction | Jenicka Engler slides video |
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| Application of BDA methodologies in clinical trials: Focus on neurology | Alan Kott slides video |
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| BDA payoffs and pitfalls: Examples from a phase 3 program | Colin Sauder slides video |
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| Improved data quality and site collaboration through blinded data analytics | Abigail Nash slides video |
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| Using blinded analytics to monitor data quality in psychiatry programs with centrally rated endpoints: Lessons learned in phase 2 and implementation into phase 3 | Todd Solomon slides video |
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| Panel Discussion | Facilitator: Stephen Brannan video |
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| Meeting Adjourned | Luca Pani video |
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| *Slides not released | |||