2026 Autumn Conference
Monday, January 19th, 2026Poster Deadline: 18 June Submission and Guidelines
Registration opens 28 April
Session Topics:
Biomarkers: Gatekeepers or roadblocks in neurology and psychiatry clinical trials
Methodological pathways to next-generation endpoints in mood and psychosis trials
Neuromodulation in CNS clinical development: Signal generation, circuit targeting, and clinical validation
Using wearable sensors and digital health technologies (DHTs) in the development of patient-relevant functional outcomes in CNS clinical trials
Watch for more details!
22nd Annual Scientific Meeting
Friday, August 22nd, 2025
Distinguished Poster Award Recipient:
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Siegel – Precision Imaging Drug Trials: Quantifying the Impact of Study Design on fMRI Biomarker Sensitivity and Statistical Power (Abstract) |
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All Poster PDFs and Abstracts are available here. |
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18 February 2026 |
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| Welcome from the President | Luca Pani slides video |
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| Keynote Address: CDER Office of Neuroscience | Valentina Mantua Michelle Campbell slides video |
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| New Investigator Award Presentations (Day 1) |
Judith Jaeger slides Jamie Courtland slidesClaire Erickson slidesMorgan Hardy slidesKeiko Kunitoki slidesYoojin Lee slides video – All Presenters |
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| Methodological opportunities and challenges with long-term post-marketing data | Chairs: Ole Andreassen Jenicka Engler Shaheen Lakhan |
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| Introduction
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Jenicka Engler slides video |
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| Long-term medical outcomes of antipsychotic treatment | Mark Weiser slides video |
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| Use of large real-world databases: Opportunities and challenges | Ole Andreassen slides video |
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| Safety trial methodology considerations for novel mechanisms of action in psychiatry trials | Tejendra Patel slides video |
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| Integrated evidence generation planning: Leveraging AI and real-world evidence to advance science | Mandeep Kaur slides video |
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| Regulatory perspective | Wei Hua slides video |
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| Panel Discussion | All speakers Facilitator: Shaheen Lakhan 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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| Behavioral and psychiatric symptoms in dementia (BPSD): Apathy/Agitation | Chairs: Krista Lanctôt David Miller summary slides |
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| Defining and standardizing vocal biomarker outcomes | Chairs: Alex Cohen Jan Sedway slides |
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| Workshop: Identifying and addressing hurdles to the introduction of new treatments and methodology into clinical practice | Chairs: Larry Alphs Ara Khachaturian summary |
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| Orphan diseases | Chairs: Joan Busner Gahan Pandina summary slides |
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| Sleep methodology in CNS trials | Chairs: Georg Dorffner Margaret Moline summary slides |
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19 February 2026 |
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| New Investigator Award Presentations (Day 2) |
Judith Jaeger slides Julia Longenecker slidesZev Nakamura slidesAikaterina Stravoravdi slidesAmy Wegener slides video – All Presenters |
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| Lewis Alan Opler Prize Presentations | Gary Sachs Mark Opler slidesCecilia Bergeria slidesSunny Tang slides video – All Presenters |
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| Emerging value and pitfalls of large language models in drug development | Chairs: Anzar Abbas Amir Kalali |
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| LLMs: Good or bad? | Amir Kalali slides video |
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| Introduction to session | Anzar Abbas slides video |
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| Use of LLMs for oversight in a phase 3 clinical development program
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Todd Solomon slides video |
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| Automated monitoring of dosing and other sessions in psychedelic trials using LLMs | Atul Mahableshwarkar slides video |
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| Novel methods to quantify changes in schizophrenia symptoms using PANSS interview transcripts | Jeffrey Cochran slides video |
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| The application of artificial intelligence/machine learning in drug development and regulation | Ruihao Huang slides video |
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| Panel Discussion | All speakers Panelist: Valentina Mantua slides video |
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| Use of regulatory flexibility to accelerate drug development | Chairs: Kemi Olugemo Siân Ratcliffe Smethurst |
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| Introduction | Kemi Olugemo slides video |
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| Path to prevention (P2P) therapeutics platform trial in early neuronal synuclein disease (NSD) | Christopher Coffey slides video |
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| Use of external controls for the primary analysis of a randomized phase 3 study to evaluate a higher dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA) | Richard Foster* slides |
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| Prognostic adjustment and other digital twin methods for improving trial efficiency | Roland Brown slides video |
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| Surrogate endpoint in Alzheimer’s disease | Tianle Chen slides video |
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| Precision medicine at scale: Operationalizing individualized trials | Sarah Glass slides video |
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| Panel Discussion
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All speakers Facilitators: Kemi Olugemo Luca Pani Panelist: Emily Freilich slides video |
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| The power of inclusion in clinical trials: It’s time to study all people, even if they have thought about suicide | Chairs: Jill Harkavy-Friedman Manish Jha |
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| Introduction: Goals of session and key issues to be addressed | Jill Harkavy-Friedman slides video |
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| The goal of clinical trials that include suicidal people is not just prediction of risk | Manish Jha slides video |
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| Current approach to including individuals with suicidal ideation and behavior (SIB) in clinical trials | Steven Szabo slides video |
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| Including people with suicidal ideations and behaviors in CNS clinical trials: Regulatory perspectives | Zimri Yaseen slides video |
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| Panel Discussion with Jha, Szabo, and Yaseen | Panel video |
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| Psychometric and statistical considerations for including patients with SI/B in clinical trials | Kari Nations slides video |
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| Implementation of suicide research into clinical settings | Elizabeth Ballard slides video |
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| Ecological momentary assessment of suicidal ideation and behavior in trials | Evan Kleiman slides video |
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| Clinically based suicide prevention: Veterans Affairs Health System suicide analytics and the REACH VET clinical program | John McCarthy slides video |
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| Panel Discussion | All speakers Facilitators: Jill Harkavy-Friedman Manish Jha video |
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| Poster Session/Reception | Poster PDFs and Abstracts | ||
20 February 2026
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Friday Working Group Sessions |
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| Development of novel endpoints for clinical trials in substance use disorders | Chairs: Martin Mumenthaler Tanya Ramey summary slides |
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| Emerging value and challenges of large language models (LLMs) in drug development | Chairs: Anzar Abbas Amir Kalali |
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| Estimands and missing data | Chairs: Elena Polverejan Lorenzo Guizzaro summary slides |
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| Accelerating development of psychopathology measures- ISCTM/ECNP joint working group: Subgroup meetings |
Chairs: Jenicka Engler Nina Schooler Celso Arango |
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| Bipolar disorder subgroup (Manpreet Singh, Eduard Vieta) | Bipolar subgroup summary | ||
| MDD subgroup (Jenicka Engler, Stephanie Sommer) | MDD subgroup summary | ||
| Schizophrenia subgroup (Anzalee Khan, Armida Mucci, Simon Desjardins) | |||
| Development, validation, and qualification of novel clinical endpoints | Chairs: Adam Butler Sonya Eremenco |
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| Introduction | Adam Butler slides video |
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| Development and qualification of the Virtual Reality Functional Capacity Assessment Tool-Short List for early Alzheimer’s disease | Sonya Eremenco slides video |
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| Qualification plan for the PSYCHS as a ClinRO for attenuated positive symptoms in patients at clinical high risk for psychosis | Scott Woods slides video |
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| Qualification of depression and anxiety AI-COA through ISTAND | Marc Aafjes slides video |
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| Patient perspective on clinical trials and rating scales | Emma C. slides video |
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| Regulatory perspectives: Development and qualification of novel drug development tools | Michelle Campbell slides video |
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| Panel Discussion | All speakers Facilitator: Adam Butler video |
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| Meeting Adjourned | Atul Mahableshwarkar slides video |
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| *Video not released | |||
2025 Advanced CNS Clinical Trials Course
Wednesday, January 15th, 2025A brief, intensive, interactive program for mid-career CNS clinical researchers who wish to expand and refine their trial design expertise
Location:
Syneos Health Headquarters, room TBA
1030 Sync Drive
Morrisville, NC 27560
(approximately 3 miles from Raleigh-Durham International Airport)
Housing: On own
Agenda at a Glance
| Wednesday 11 June 2025 | ||
| 1:00-1:15pm EDT | Registration Check-in / Meet & Greet | |
| 1:15pm | Introduction | Co-chairs: Kari Nations Larry Alphs Judith Jaeger |
| 1:30pm | Early Phase Trial Design: Session 1 – Regulatory Considerations and Research Goals | Luca Pani |
| 2:15pm | Early Phase Trial Design: Session 2 – Proof of Mechanism/Clinical Concept (PoM/PoC) Clinical Trials | Seth Hopkins |
| 3:15pm | Early Phase Trial Design: Session 3 – Proof of Mechanism/Clinical Concept (PoM/PoC) Clinical Trials | Gerard Sanacora |
| 4:15pm | Early Phase Trial Design: Session 4 – Statistical Considerations | Ginger Haynes |
| 5:00pm | Session Adjourns | |
| 5:30-7:00pm | Group Welcome Dinner | |
| Thursday 12 June 2025 | ||
| 8:00am EDT | Welcome Day 1 Recap Early Phase Q&A |
Judith Jaeger Early phase faculty |
| 9:00am | Breakout Session: Early Phase Trial Design Work Group | |
| 11:15am | Later Phase Trial Design: Session 1 – Regulatory Considerations and Research Goals | Luca Pani Ni Khin |
| 12:00pm | Break / Lunch served | |
| 12:15pm | Later Phase Trials Session 2 – Demonstration/Confirmation of Therapeutic Potential (Working lunch) | Stephen Brannan |
| 1:15pm | Later Phase Trials Session 3 – Demonstration/Confirmation of Therapeutic Potential | Lori Davis |
| 2:15pm | Later Phase Trial Design: Session 4 – Statistical Considerations | Elena Polverejan |
| 3:15pm | Break | |
| 3:30pm | Small Group Discussions – Session I: Special Later Phase Content | |
| 4:30pm | Small Group Discussions – Session II: Special Later Phase Content | |
| 5:30pm | Session adjourns | |
| 6:30-8:30pm | Dine-Around with faculty and preceptors (at local restaurants) | |
| Friday 13 June 2025 | ||
| 7:00am EDT | Lite Breakfast and Dine-Around Discussions with Faculty and Preceptors (lite breakfast provided) | |
| 8:00am EST | Welcome Day 2 Recap Early Phase Q&A |
Larry Alphs Later phase faculty |
| 9:00am | Breakout Session: Later Phase Trial Design Work Group | |
| 11:00am | Break | |
| 11:15am | Group Presentations/Discussion of Study Designs/Review Committee Simulation (lunch provided) | |
| 2:45pm | Closing Remarks | Kari Nations |
| 3:00pm | Meeting Adjourns | |
Faculty and preceptors (Bios and Disclosures Linked to Names)
Larry Alphs, MD, PhD, Larry Alphs Consulting
Stephen Brannan, MD, CNS Clinical Consulting
Carla Canuso, MD, Janssen Research and Development
Anita Clayton, MD, DLFAPA, IF, University of Virginia
Lori Davis, MD, Birmingham VA Medical Center
Ginger Haynes, PhD, Eli Lilly
Nanco Hefting, PharmD, H. Lundbeck A/S
Rebecca Hendrickson, MD, PhD, VA Puget Sound Health Care System
Seth Hopkins, PhD, Otsuka Pharmaceutical Development & Commercialization
Judith Jaeger, PhD, CognitionMetrics
Anzalee Khan, PhD, The Nathan S. Kline Institute for Psychiatric Research
Ni Khin, MD, Neurocrine Biosciences
Stephen Marder, MD, UCLA
Kari Nations, PhD, University of Texas at Austin
Luca Pani, MD, University of Miami / University of Modena
Elena Polverejan, PhD, Johnson & Johnson
Gerard Sanacora, MD, PhD, Yale University
Nina Schooler, PhD, SUNY Downstate Health Sciences Center
Faculty and Preceptor Disclosures
Questions? Email info@isctm.org
21st Annual Scientific Meeting
Monday, September 23rd, 2024
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 | |||
2025 Autumn Conference – Includes Joint Day with ECNP
Tuesday, July 30th, 2024
Distinguished Poster Award Recipient:
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| Kolár – Using large language models for endpoint oversight (Abstract) | |||
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View all Poster PDFs and Abstracts |
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10 October 2025 |
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| Welcome from the ISCTM and ECNP Presidents | Luca Pani Martien Kas slides video |
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| Session 1: From population to precision psychiatry: Promises, pitfalls, and paths forward | Chairs: Uma Vaidyanathan Andreas Reif |
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| Introduction | Andreas Reif slides video |
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| Biomarker discovery and development in neurological disorders – federated analyses as one potential solution | Bjoern Tackenberg* slides |
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| Can EEG become the “ECG of neuropsychiatry”? | Ken Wang* slides |
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| The role of digital health technologies (DHTs) in precision psychiatry approaches | Bill Simpson slides video |
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| Promise, provisos & pitfalls of precision psychiatry approaches in drug development | Carla Canuso slides video |
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| What does precision psychiatry mean, precisely? Sleep as an example | Thomas Pollmächer slides video |
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| Precision psychiatry in the UK NHS – focus on depression | Anthony Cleare slides video |
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| Precision psychiatry: A perspective on challenges and opportunities | Lorenzo Guizzaro slides video |
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| From population to precision: Regulatory pathways for biomarker‑driven psychiatry trials | Luca Pani slides video |
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| Panel discussion | Facilitator: Uma Vaidyanathan slides video |
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Session 2: Current gaps regarding the approval of psychedelic compounds: Design of clinical trials and engagement with regulators |
Chairs: Walter Dunn Gitte Knudsen |
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| Introduction – Current landscape of psychedelic drug development | Gitte Knudsen slides video |
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| Psychedelic drugs in psychiatry – From clinical trials to post-approval considerations: A European regulatory perspective | Marion Haberkamp slides video |
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| Restricted medical use of prohibited narcotics | Anna Rickli* slides |
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| Regulatory panel discussion including US perspective | Facilitator: Walter Dunn Discussant: Valentina Mantua video |
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| Knowledge gaps in psychedelic treatments and solutions through novel clinical designs | Amir Inamdar slides video |
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| Beyond acute dosing: Safety concerns and adverse effects surrounding psychedelic treatments | Corine de Boer slides video |
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| Managing expectation and bias in psychedelic clinical trials: Challenges and strategies | Guy Goodwin* video |
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| The ISCTM working group on methodological issues in psychedelic clinical trials | Joyce Tsai slides video |
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| Australian MDMA/psilocybin experience | Michael Winlo slides video |
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| Panel discussion | Facilitator: Walter Dunn video |
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Poster Session |
Poster PDFs and Abstracts | ||
11 October 2025 |
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| Session 3: Uncovering hidden lessons in CNS global clinical trials | Chairs: Dragana Bugarski-Kirola Dennis Hernaus |
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| Introduction | Dragana Bugarski-Kirola slides video |
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| Sharing the knowledge: Unpacking critical lessons from completed trials | Christoph von der Goltz* Corey Fowler* video |
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| Assessing regional and temporal differences in multinational clinical trials | Alan Kott slides video |
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| Considerations for risk-based data monitoring and eligibility review in depression global trials | Jenicka Engler slides video |
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| Lessons which have not been learned in clinical trials in schizophrenia | Stefan Leucht* |
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| Uncovering hidden lessons in CNS global clinical trials | Ricardo Marcelo Corral slides video |
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| Success in today’s complex clinical trials: Perspectives from various site staff | Elan Cohen slides video |
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| Conducting clinical trials in Serbia | Cedomir Miljevic slides video |
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| Panel discussion including regulatory perspectives on recent challenges in global trials and how to address them | Discussants: Ni Khin slides videoLorenzo Guizzaro slidesAll Speakers video |
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| Session adjourns | Luca Pani slides |
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Concurrent Working Group Sessions |
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| Accelerating development of psychopathology measures – ISCTM/ECNP joint working group | Chairs: Nina Schooler Celso Arango Jenicka Engler slides |
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| Defining and standardizing vocal biomarker outcomes working group | Chairs: Alex Cohen Jan Sedway slides |
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| Orphan diseases working group | Chairs: Joan Busner Gahan Pandina slides summary |
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| Sleep methodology in CNS trials working group | Chairs: Georg Dorffner Margaret Moline slides summary |
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| *Slides and/or video not released | |||
2024 Autumn Conference
Monday, January 22nd, 2024
Distinguished Poster Award Recipients:
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Hopkins – A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression (Abstract) Horan – Longitudinal convergence of dispersed clinical ratings and ecological momentary assessment burst assessments of negative symptoms in schizophrenia (Abstract) |
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All Poster PDFs and Abstracts are available here. |
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12 September 2024 |
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| Welcome from the President | Luca Pani slides video |
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| Use of Neurophysiological Markers to Design and Enrich Clinical Trials in Rare Neurological Diseases | Chairs: Kemi Olugemo Uma Vaidyanathan |
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| Introduction
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Kemi Olugemo slides video |
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| The parents’ journey through drug development: Making the impossible possible for Angelman Syndrome | Allyson Berent slides video |
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| EEG as a marker of direct mouse-to-human translation in clinical trials in neurodevelopmental disorders | Elizabeth Berry-Kravis slides video |
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| Beyond PSG: Sleep assessment endpoints, considerations and recommendations | Justin Brooks slides video |
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| Computational approaches to unlocking EEG and PSG as biomarkers in NDDs | David Matthews slides video |
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| Summary | Uma Vaidyanathan slides video |
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| Panel Discussion | Facilitators: Kemi Olugemo Uma Vaidyanathan video |
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Use of Neurophysiological Markers to Design and Enrich Clinical Trials in Psychiatric Disorders |
Chairs: Atul Mahableshwarkar Jenicka Engler |
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| Introduction | Atul Mahableshwarkar slides video |
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| Biomarker Driven RCTs for Mood and Anxiety Disorders: Has the Time Arrived? | Manish Jha slides video |
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| Can biomarker enrichment improve clinical outcome in PoC clinical trials for autism spectrum disorder? | Gahan Pandina slides video |
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| Discovery, validation and implementation of neurocognitive patient selection markers in drug development for depression | Adam Savitz slides video |
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| Regulatory considerations on the opportunities and challenges of neurophysiological markers | Luca Pani slides video |
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| Panel Discussion | Facilitator: Jenicka Engler video |
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Thursday Working Group Sessions |
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| Development of Novel Endpoints for Clinical Trials in Substance Use Disorders Working Group | Chairs: Tanya Ramey Martin Mumenthaler slidessummary |
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| Orphan Diseases Working Group | Chairs: Joan Busner Gahan Pandina slides |
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| Methodological Issues in Study Designs for Clinical Trials with Psychedelics Working Group | Chairs: Amir Inamdar Joyce Tsai summary |
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| Poster Session/Reception | Poster PDFs and Abstracts | ||
13 September 2024 |
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| Friday Working Group Sessions | |||
| Accelerating Development of Psychopathology Measures – ISCTM/ECNP Joint Working Group | Chairs: Nina Schooler Jenicka Engler Celso Arango slidessummary |
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| Diversity in CNS Clinical Trials Working Group | Chairs: Siân Ratcliffe Abhishek Pratap slides |
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| Sleep Methodology in CNS Trials Working Group | Chairs: Margaret Moline Georg Dorffner slidessummary |
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| How to Conduct Trials that Enroll Suicidal Patients | Chairs: Samuel Wilkinson Jill Harkavy-Friedman |
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| Introduction | Samuel Wilkinson slides video |
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| Choosing the right design and analytic approach for trials recruiting patients at risk for suicide | Larry Alphs slides video |
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| Designing and implementing studies in adult and adolescent patients with MDD at imminent risk for suicide | Dong-Jing (DJ) Fu slides video |
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| Practical experiences related to an NIMH-funded clinical trial of ketamine in adolescents with major depression and suicidality | Michael Bloch slides video |
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| Considerations on choosing the appropriate setting from which to enroll patients | Gerard Sanacora slides video |
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| Suicidal ideations and behaviors: Regulatory perspectives | Zimri Yaseen slides video |
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| Panel Discussion
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Facilitator: Jill Harkavy-Friedman video |
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| Decisions, decisions, decisions: How planning and conduct of RCTs influence outcomes | Chairs: Nina Schooler Stephen Brannan |
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| Introduction | Nina Schooler slides video |
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| Trying to find balance between speed, cost, and quality | Stephen Brannan slides Seth Hopkins slides video |
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| The journey balancing science and operations during protocol development: Case studies and examples | Emilio Neto Jane Twitchen slides video |
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| Impact of protocol decisions and modifications in RCT conduct | Steve Szabo slides Gerard Sanacora slides video |
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| Perspectives on protocol decisions and modifications from independent and academic site leaders | Dawn Velligan slides David Walling slides video |
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| Panel Discussion | Facilitators: Nina Schooler Stephen Brannan video |
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| Meeting Adjourned | Luca Pani slides video |
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20th Annual Scientific Meeting
Thursday, October 26th, 2023
Distinguished Poster Award Recipients:
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Measuring remission and response using CDRS-R and MADRS: An analysis in adolescents with MDD and imminent risk for suicide (abstract) – Cai Shi Relationship between sample size and responsiveness of speech-based digital biomarkers in ALS (Abstract) – Kothare Estimating heterogeneity of treatment effects in clinical trials (Abstract) – Siegel |
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All Poster PDFs and Abstracts are available here. |
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21 February 2024 |
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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 Luca Pani slidesRichard Keefe video |
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| ISCTM 20th Anniversary Session – Advancements & what can we do better in the future | Chairs: Amir Kalali Michael Ropacki |
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| Introduction and overview
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Amir Kalali slides video |
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| Overview of methodological advancements & room for improvement | Michael Ropacki slides video |
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| Real world evidence data from drug registration to reimbursement | Luca Pani slides video |
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| Diversity, equity, and inclusion in clinical trials | Carla Canuso slides video |
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| Adoption of novel clinical endpoints | Kemi Olugemo slides video |
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| Digital biomarkers and health measurement in clinical trials | Anzar Abbas slides video |
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| Impact of external factors on the future of CNS therapy development | George Garibaldi slides video |
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| Panel Discussion | Facilitators: Amir Kalali Michael Ropacki video |
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Wednesday 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 slidessummary |
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| Diversity in CNS Clinical Trials Working Group | Chairs: Abhishek Pratap Siân Ratcliffe slides |
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| Methodological Issues in Study Designs for Clinical Trials with Psychedelics Working Group | Chairs: Amir Inamdar Joyce Tsai 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 summary slides |
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| 20th Annual Celebration and Founders Reception | Gary Sachs George Awad slideshow video |
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22 February 2024 |
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| Lewis Alan Opler Prize Presentation | Gary Sachs Mark Opler slidesSeth Hopkins slides video |
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| Use of existing data to inform and speed development of personalized medicine for CNS disorders | Chairs: Larry Alphs Ole Andreassen |
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| Introduction: The vision for precision medicine and goals of the session | Larry Alphs slides video |
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| CNS precision medicine: From research to real-world impact | Ole Andreassen slides video |
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| Discovery and validation of a genetic biomarker for a triple reuptake inhibitor (liafensine) in TRD | Wen Luo slides video |
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| Biomarker identification for patient enrichment strategies in CNS clinical trials: Alternative approaches and challenges | Joseph Geraci slides video |
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| Using digital technologies to develop holistic patient-centered solutions for improving mental health outcomes | Abhishek Pratap* video |
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| Nordic networks for precision medicine research | Hakon Heimer slides video |
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| User perspectives on precision psychiatry | Tineke Mollema slides video |
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| Statistical principles and considerations for precision medicine in psychiatry and neurology: A regulatory perspective | Sue-Jane Wang slides video |
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| Panel Discussion | Facilitator: Larry Alphs video |
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| How to Implement the Estimand Framework in Clinical Trials – Examples, Examples, Examples | Chairs: Elena Polverejan Marc Walton |
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| Introduction | Marc Walton slides video |
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| The interdisciplinary process for implementing the estimand framework, with examples from Major Depressive Disorder | Nanco Hefting Elena Polverejan slides video |
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| What is the question? The importance of estimand thinking in clinical trials: Alzheimer’s disease example | Jennifer Murphy Stephen Ruberg slides video |
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| Estimands in CNS trials: A review of strategies accepted by EMA to handle intercurrent events | Lorenzo Guizzaro slides video |
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| Panel Discussion
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Discussants: Michael O’Kelly slidesH.M. James Hung (comment provided on his behalf) Marc Walton Facilitators: Elena Polverejan Marc Walton slides video |
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| Under What Circumstances Could Pediatric Extrapolation Occur? | Chairs: Manpreet Singh Robert Nelson |
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| Introduction | Manpreet Singh Robert Nelson slides video |
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| Pediatric extrapolation guidance framework | Lynne Yao slides video |
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| Optimizing pediatric drug development in psychiatry: Quantitative methods to support extrapolation of efficacy | Shamir Kalaria slides video |
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| Innovative pediatric trials: A statistical examination of design and analysis strategies | Forrest Williamson slides video |
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| Pathways for extrapolation in psychiatry | Tiffany Farchione slides video |
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| A recent example of pediatric extrapolation in psychiatry | Dana Cahill slides video |
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| Panel Discussion | Facilitator: Robert Nelson video |
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| Poster Session/Reception | Poster PDFs and Abstracts | ||
23 February 2023
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Friday Working Group Sessions |
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| Accelerating Development of Psychopathology Measures – ISCTM/ECNP Join Working Group | Chairs: Nina Schooler Jenicka Engler Celso Arango summary slides |
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| Advancing the Methods to Evaluate Abuse and Dependence Potential in Clinical Studies for CNS-Active Drugs and Novel Psychedelics Working Group | Chairs: Beatrice Setnik Jadwiga Martynowicz summary slides |
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| Assessment of Methods and Endpoints for Rapid-Acting Antidepressants-RAADs Working Group | Chairs: Christian Yavorsky Jan Sedway summary slides |
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| Behavioral and Psychiatric Symptoms in Dementia (BPSD) Apathy Working Group | Chairs: Krista Lanctôt David Miller summary slides |
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| Digital Biomarkers Decision Process Working Group | Chairs: Vikas Mohan Sharma Anzar Abbas summary slides |
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| Sleep Methodology in CNS Trials Working Group | Chairs: Margaret Moline Georg Dorffner summary slides |
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| Digital Health Measurement in CNS: Recruitment, Screening, and Endpoints | Chairs: Anzar Abbas Uma Vaidyanathan |
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| Introduction | Anzar Abbas slides video |
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| Objective measurement from subjective clinical interviews: Application to drug development | Seth Hopkins slides video |
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| The need for broad-spectrum multimodal markers in CNS drug development | Brian Murphy slides video |
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| The application of large language models to psychiatric measurement | Isaac Galatzer-Levy slides video |
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| Precision drug development using resting state EEG | Adam Savitz slides video |
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| Regulatory considerations pertaining to use of digital health measures | Anita Bajaj slides video |
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| Panel Discussion | Facilitators: Anzar Abbas Uma Vaidyanathan video |
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| Digital phenotyping in clinical trials: The path ahead | Uma Vaidyanathan slides video |
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| Meeting Adjourned | Luca Pani video |
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| *Slides not released | |||
19th Annual Scientific Meeting
Tuesday, September 27th, 2022
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 | |||
2023 Autumn Conference – Includes Joint Day with ECNP
Tuesday, September 13th, 2022
Distinguished Poster Award Recipient:
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| Psilocybin therapy for treatment resistant depression: Prediction of clinical outcome by natural language processing (Dougherty; Abstract) | |||
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View all Poster PDFs and Abstracts |
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6 October 2023 |
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| Welcome from the ISCTM and ECNP Presidents | Martien Kas Gary Sachs slides video |
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| Session 1: Novel quantitative analysis method to address placebo effects in CNS trials | Chairs: Danièle Laverdure-Dupont Eduard Vieta |
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| Introduction: Perspectives on the placebo effect – from academia to pharma | Danièle Laverdure-Dupont slides video |
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| Psychological and neurobiological mechanisms underlying placebo responses and their clinical consequences | Fabrizio Benedetti video*
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| Placebo prognostic covariates: Use of unique patient characteristics to leverage the full potential of prognostic covariates and their implementation in RCTs | Dominique Demolle slides video |
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| Biostatistical considerations around the use of traditional or AI-based covariates in registrational trials | Anzalee Khan slides video |
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| Predicting placebo responsiveness using machine learning and explainable AI | Manuel Montoya slides video |
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| Regulatory acceptability of placebo responsiveness prediction tools in registrational trials | Khadija Rantell slides video Dawn Velligan slides video |
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| Panel discussion | Facilitator: Eduard Vieta slides video |
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Session 2: Prescription digital therapeutics (PDTs) for CNS disorders |
Chairs: Shaheen Lakhan Gerard Dawson |
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| A primer on digital therapeutics | Shaheen Lakhan slides video |
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| Bringing digital therapeutics to the psychiatric patient population | Gerard Dawson slides video |
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| What are appropriate control conditions for prescription digital therapeutics (PDTs)? | Jacqueline Lutz slides video |
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| Developing neuromodulation interventions for mental health digital therapeutics | Brian Iacoviello slides video |
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| Regulating PDTs: The German experience | Jonas Albert slides video |
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| Digital therapeutic regulation pathways in the USA | Megan Coder slides video |
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| Prescription digital therapeutics: Optimizing third party coverage, operationalizing access | Paul Jeffrey slides video |
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| European taskforce for harmonized evaluation of digital medicine devices (DMDs) | Fruzsina Mezei slides video |
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| Panel discussion | video |
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Poster Session |
Poster PDFs and Abstracts | ||
7 October 2023 |
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| Session 3: Are our clinician rated psychopathology measures fit for purpose decades later? | Chairs: Nina Schooler Celso Arango Stephen Marder |
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| Introduction: Setting the problem into perspective | Nina Schooler slides video |
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| Schizophrenia and psychosis: What are identified deficiencies of our current psychopathology rating scales? | Celso Arango slides video |
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| Major depression: Are we asking the right questions? | Koen Demyttenaere video* |
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| Bipolar disorder: What are identified deficiencies of our current psychopathology rating scales for exemplar diagnoses? | Eduard Vieta slides video (includes discussion with Arango and Demyttenaere) |
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| Strategies for developing new and improved consensus instruments | Stephen Marder slides video |
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| Linking established clinical items to objective/passive measurements: In search of an elusive “gold standard” | Vikas Mohan Sharma slides video |
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| Using large banks of items and computer adaptive testing to improve clinical outcome assessment | Nina Schooler slides video |
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| Measurement resolution is the key to advancing digital phenotyping beyond “proof of concept” | Alex Cohen slides video |
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| Speaker and Stakeholder panel discussion | Panelist: Silvia Zaragoza Domingo All Speakers video |
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| Session adjourns | Gary Sachs slides video |
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Concurrent Working Group Sessions |
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| Accelerating development of psychopathology measures – ISCTM/ECNP joint working group | Chairs: Nina Schooler Celso Arango Jenicka Engler slides |
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| Methodological issues in study designs for clinical trials with psychedelics working group | Chairs: Amir Inamdar Joyce Tsai slides |
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| Orphan diseases working group | Chairs: Joan Busner Gahan Pandina slides |
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| *Slides not released | |||
2022 Autumn Conference
Wednesday, January 26th, 2022
Distinguished Poster Award Recipient:
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| A general theory of construct enrichment: Inclusion criteria for symptom structure not severity (Hopkins; Abstract) | |||
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View all Poster PDFs and Abstracts |
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8 September 2022 |
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| Welcome from the President | Gary Sachs slides video |
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| Session 1: New challenges in Alzheimer’s and Dementia – Adapting to the new environment | Chairs: Rhoda Au Judith Jaeger |
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| New approaches to cognitive endpoints in confirmatory trials of early Alzheimer’s Disease | Judith Jaeger slides video |
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| How can we use digital technology to augment conventional cognitive assessments? | Kristin Hannesdottir* Gul Erdemli slides video |
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| Scaling functional neurophysiology to clinical trials in Alzheimer’s and other neurodegenerative conditions | Brian Murphy slides video |
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| Developing barrier-breaking approaches in Alzheimer’s trials – global cohort characterization, clinical trials, and healthcare delivery | Rhoda Au slides video |
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| Commentary: Concepts of interest and outcome measurement tools at different stages of development | Lorenzo Guizzaro slides video |
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| Panel discussion | Facilitator: Judith Jaeger video |
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Session 2: Suicidality: What have we learned after a decade of research? What challenges remain? |
Chairs: Larry Alphs David Sheehan |
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| Introduction and agenda for session | Larry Alphs slides video |
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| Real world assessments of suicide ideation and behavior. Challenges and next steps. | Eric Chan slides video |
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| Veteran suicide surveillance and development and evaluation of the REACH VET clinical program | John McCarthy slides video |
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| Research in suicide ideation and behavior: Problems faced. What we have learned. Directions for the future. | Jill Harkavy-Friedman slides video |
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| Insights into study design and methodology for assessing suicide ideation and behavior in clinical trials for safety and efficacy: Hurdles and advances | David Sheehan* |
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| Statistical challenges and potential solutions for assessing suicide ideation and behavior endpoints | Kari Nations slides video |
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| Panel discussion | Facilitator: Larry Alphs video |
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Concurrent Working Group Sessions |
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| Algorithms/flags to identify clinical inconsistency in the use of rating scales in CNS RCTs | Chairs: Jonathan Rabinowitz Nina Schooler |
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| Behavioral and psychiatric symptoms in dementia (BPSD) Apathy | Chairs: Krista Lanctôt David Miller slides |
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| Digital biomarkers decision process | Chairs: Vikas Mohan Sharma Diane Hoffman slides |
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| Joint ISCTM/ECNP COVID-19 methodologies blueprint | Chairs: Dragana Bugarski-Kirola Gerard Dawson Kemi Olugemo |
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| Orphan diseases | Chairs: Joan Busner Gahan Pandina slides |
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Poster Session |
Poster PDFs and Abstracts | ||
9 September 2022 |
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| Session 3: Hot Topic Breakfast Session: Methodological implications of world events that impede subject recruitment | Chairs: Atul Mahableshwarkar Michael Ropacki |
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| Are critical world events confounding factors for clinical trials? | Steven Targum slides video |
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| Recent impacts on CNS clinical trial recruitment: Qualitative assessment of the impacts and resultant methodological assessment | Michael Ropacki slides video |
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| Impact of patient recruitment before and during COVID shelter-in-place: What do unblinded data reveal | Kerensa Saljooqi slides video video (discussion) |
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| Impact of war in Ukraine on clinical trials: Lessons learned from a phase 3 program in schizophrenia | Debra Phillips* slides video (discussion only) |
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| Commentary: Estimands, power and general considerations
Panel discussion |
Discussant: Lorenzo Guizzaro slides videoFacilitator: Michael Ropacki video |
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| Session 4: Post-traumatic stress disorder as a prototype disorder for heterogeneity in neuropsychiatry | Chairs: Lori Davis Tom Neylan |
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| Introduction | Lori Davis slides video |
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| Translational biomarkers and novel compounds to address the unmet need in the civilian PTSD population | Kerry Ressler slides video |
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| Drug development in heterogeneous disorders: When to target subgroups? Case example in PTSD | Thomas Neylan slides video |
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| Rationale and aims of a Phase 2, multi-center, multi-arm, randomized, placebo-controlled, double-blind, adaptive platform study to evaluate the safety, tolerability, and efficacy of potential therapeutic interventions in active duty service members and veterans with posttraumatic stress disorder | Elyse Katz slides video |
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| Operational complexities when managing PTSD trials | Kerrin Young slides video |
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| Panel discussion | Facilitator: Lori Davis video |
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| Session 5: Algorithms, clinical outcomes, and digital biomarkers – Next generation endpoints | Chairs: Adam Butler Jane Tiller |
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| Introduction | Jane Tiller slides video |
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| Verification, analytical validation, and clinical validation for biometric technologies | Ariel Dowling slides video |
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| Voice My Health: A multi-modal approach to digital phenotyping | John Reynders slides video |
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| Gaps in the evidentiary requirements framework: Traversing the last mile for regulatory qualification of sensor-derived digital endpoints | Ritu Kapur slides video |
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| US regulatory considerations | Ian Marcus slides Anita Bajaj slides video |
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| Panel discussion | Facilitator: Adam Butler video |
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| Meeting adjourns | Gary Sachs slides video |
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| *Slides and/or video not released | |||