17th Annual Scientific Meeting – Virtual Edition
Tuesday, June 29th, 2021
Distinguished Poster Award Recipient:
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| Facial and vocal markers of schizophrenia measured using remote smartphone assessments (Koesmahargyo) | |||
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View all Poster PDFs and Abstracts |
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6 April 2021 |
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| Welcome from the President | Ramy Mahmoud slides video |
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| Novel clinical trial designs: Can we define CNS clinical trial inclusion criteria and outcomes based on RDoC circuits and mechanisms? | Chairs: Uma Vaidyanathan Andrew Krystal |
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| Research Domain Criteria (RDoC) initiative: An overview | Uma Vaidyanathan slides video |
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| Fast-Fail Trials in mood and anxiety spectrum disorders: Using brain biomarkers vs diagnoses for improving CNS trial design | Andrew Krystal slides video |
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| Psychiatric Ratings using Intermediate Stratified Markers (PRISM): Transdiagnostic markers for social dysfunction across schizophrenia and Alzheimer’s disease as outcome measures | Martien Kas slides video |
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| Moving towards a new psychiatry: Targeting patient subtypes and symptom domains | Giacomo Salvadore Wayne Drevets slides video |
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| Stratifying a dimensional psychosis population for CNS trials using results from B-SNIP Network | Carol Tamminga slides video |
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| From intentions to applications: An industry perspective on RDoC inspired drug development | Vikas Mohan Sharma slides video |
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| Challenges in moving to a circuit/mechanism-based approach such as RDoC from FDA and EMA perspectives | Michael Davis slides video Lorenzo Guizzaro slides video |
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| Panel/Regulatory Discussion | video |
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Poster Session |
Poster PDFs and Abstracts | ||
| New Investigator Awardees – Poster Presentations | Awardees noted * in above list | ||
7 April 2021 |
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| Wednesday Working Group Sessions | |||
| Assessment methods and endpoints for Rapid-Acting Antidepressants – RAADs | Chairs: Elizabeth Ballard Mark Opler Christian Yavorsky |
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| Estimands and missing data | Chairs: Elena Polverejan Pilar Lim summary |
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| ISCTM/ECNP joint COVID-19 CNS clinical methodologies blueprint | Chairs: Kemi Olugemo Dragana Bugarski-Kirola Gerard Dawson summary |
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| Approaches to multimodal therapies: From psychedelics to neuromodulation – Psychedelics | Chairs: Walter Dunn Stephen Marder |
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| Welcome | Stephen Marder slides video |
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| Integrating multiple therapeutic modalities framework and design challenges | Nina Schooler slides video |
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| Integrated therapeutics: Rationale and unresolved questions | Gerard Sanacora slides video |
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| Seven controversies in psychedelic medicine | Alexander Belser slides video |
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| FDA: Regulatory perspectives on psychedelic-based integrated therapeutics | Javier Muniz slides video |
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| EMA: Regulatory considerations on integrated therapeutics: Design features and other regulatory considerations | Lorenzo Guizzaro slides video |
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| Panel/Regulatory Discussion | video
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8 April 2021 |
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| Inaugural Lewis Alan Opler Prize Presentation | Carla Canuso Mark Opler slidesAlex Cohen slides video |
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| Approaches to multimodal therapies: From psychedelics to neuromodulation – Neuromodulation | Chairs: Walter Dunn Stephen Marder |
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| Introduction | Walter Dunn slides video |
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| Integrating cognitive interventions with neuromodulation | Sarah Lisanby slides video |
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| Current and future studies of neuromodulation combined with other health interventions | Jeff Daskalakis slides video |
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| Studies integrating neurocognitive, social cognitive, or functional skills training with medication | Michael Sand slides video |
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| Fostering innovative digital health technologies: An FDA digital health center of excellence perspective | Ian Marcus slides video |
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| FDA psychiatric device pipeline and regulations: A staff perspective | Anita Bajaj slides video |
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| Discussion | video
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| EMA Regulatory perspectives on multimodal therapies: Neuromodulation | Florence Butlen-Ducuing slides video |
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| Panel / Audience Discussion | video |
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Thursday 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 summary |
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| Innovative technologies for CNS clinical trials | Chairs: Richard Keefe Michael Davis |
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| Negative symptoms: Remote trial design methodologies | Chairs: Stephen Marder David Daniel summary |
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| Orphan diseases | Chairs: Joan Busner Gahan Pandina summary |
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9 April 2021
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| Andrew C. Leon Distinguished Career Award Presentation | Ramy Mahmoud Carla Canuso slidesStephen Marder slides video |
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Issues and strategies regarding polypharmacy in clinical trials |
Chairs: Mark Weiser Philip Harvey |
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| Introduction | Philip Harvey slides video |
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| Antipsychotic polypharmacy in schizophrenia | Mark Weiser slides video |
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| Statistical issues in clinical trials with polypharmacy | Jonathan Rabinowitz slides video |
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| Discussion | video
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| Polypharmacy in people with HIV: Effects on the brain | Scott Letendre slides video |
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| Issues and strategies regarding polypharmacy in clinical trials: Bipolar Disorder | Andrew Nierenberg slides video |
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| Hypertension treatment and trials as model polypharmacy | Franz Messerli slides video |
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| Panel / Regulatory Discussion | Facilitator: Stephen Brannan All Speakers and Panelist: Florence Butlen-Ducuing video |
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| Meeting Adjourned
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Ramy Mahmoud slides video |
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2021 Autumn Conference – Includes Joint Day with ECNP
Monday, August 31st, 2020
Distinguished Poster Award Recipient:
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| Placebo Response Propensity Scale (PRPS) scores and probability of placebo response by disease severity (Morlock) | |||
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View all Poster PDFs and Abstracts |
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30 September 2021 |
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| Welcome from the President | Ramy Mahmoud slides video |
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| Session 1: Applications of Lessons Learned from 2020: Diversity in CNS clinical trials | Chairs: Carla Canuso Jerry Sanacora H. Lynn Starr |
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| Introduction | Carla Canuso video slides |
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| Why is diversity in clinical trials important? | David Henderson slides video |
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| How are we doing? One company’s assessment of diversity in clinical trials | H. Lynn Starr slides video |
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| Putting new learnings and best practices into action | Lionel Phillips slides video |
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| The Yale model and our partnered approach: Increasing clinical trial representation through community collaboration and innovation | Tesheia Harris slides video |
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| Cultural adaptation frameworks and use of real world evidence in the study of diverse populations | Shanaya Rathod slides video |
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| Recruitment and enrollment panel discussion | Moderators: Carla Canuso Jerry Sanacora video |
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| FDA OMHHE: Working to advance racial and ethnic minority participation in clinical trials | Richardae Araojo slides video |
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| Statistical approaches under heterogeneous treatment effects | Mark Rothmann slides video |
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| EMA Regulatory comment | Florence Butlen-Ducuing slides video |
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| Discussion | Regulatory speakers video |
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| Session Summary | Jerry Sanacora Carla Canuso video |
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Poster Session |
Poster PDFs and Abstracts | ||
1 October 2021 |
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| Welcome from the Presidents | Gitte Knudsen Ramy Mahmoud slides video |
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| Session 2: Knowledge of COVID-19 biology / syndromes: How does it lead to new research considerations | Chairs: David Baldwin Kemi Olugemo |
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| Introduction | Kemi Olugemo slides video |
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| COVID-19 and mental health: A global perspective | Christoph Correll* slides video |
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| Nature and course of psychological symptoms in the general population during the pandemic: Insights from national cross-sectional and longitudinal studies | Samuel Chamberlain* |
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| 6-month neurological and psychiatric outcomes in 236,379 survivors of COVID-19: A retrospective cohort study using electronic health records | Maxime Taquet slides video |
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| Early effects of the pandemic on individuals with serious mental illness: Findings from multisite Ecological Momentary Assessment (EMA) studies | Raeanne Moore slides video |
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| Panel discussion: Includes patient advocacy perspective | Discussant: Erik Van der Eycken video |
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| Challenges for trial design and analysis during the pandemic era: Development of the CONSERVE statement | Richard Emsley slides video |
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| Discussion – DeMartinis and Emsley | video
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| Session Summary | Kemi Olugemo video |
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| Session 3: Lessons learned for the good – Overcoming obstacles | Chairs: Dragana Bugarski-Kirola Gerard Dawson |
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| Introduction | Gerard Dawson slides video |
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| COVID-19 lockdown conditions and depression assessment data from an exploratory MDD clinical trial | Nicholas DeMartinis slides video |
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| Panel: Impact of COVID-19 pandemic on participants, operational aspects of clinical conduct and implication for data analysis | |||
| Introduction | Dragana Bugarski-Kirola video |
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| Impact of COVID-19 pandemic on Seriously Mentally Ill (SMI) subjects in clinical trials | Robert Litman slides video |
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| Case study of an Alzheimer’s disease (AD) international trial successfully initiated during the first wave of the COVID pandemic | Joanne Bell slides video |
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| Clinical trial continuity in the wake of a pandemic | Ramzey Odetalla slides video |
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| Conducting a pediatric orphan (Tourette’s study pre & during COVID shutdown: Experience and lessons learned | Atul Mahableshwarkar slides video |
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| Panel Discussion | Facilitator: Gerard Dawson video |
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| Impact of COVID-19 lockdown on data integrity and analysis of a transdiagnostic study with two patient populations | Dennis Hernaus slides video |
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| Panel: Regulatory discussants | Discussants: intro video Valentina Mantua slides videoLorenzo Guizzaro slides video |
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| Panel Discussion | All speakers video |
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| Session Summary | Gerard Dawson video |
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2 October 2021 |
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Saturday Concurrent Working Group Sessions |
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| Innovative technologies for CNS clinical trials | Chairs: Richard Keefe Michael Davis |
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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 |
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| *Full presentation not released | |||
2020 Autumn Conference – Virtual Edition
Friday, January 17th, 2020
Distinguished Poster Award Recipients: |
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| The Impact of Contextual Factors on Performance of a Smartphone-Based Word List Test (Parrish) | ||
| All Poster PDFs and Abstracts are available here. | ||
Day 1 (21 September 2020) |
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| Presidential Welcome | Ramy Mahmoud slides video |
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| Implications of pediatric initiatives on CNS drug development for all ages – 2020 and beyond | Chairs: Gahan Pandina Joan Busner |
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| Welcome / Session objectives | Gahan Pandina video |
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| Introduction to pediatric aspects of drug development | Joseph Horrigan slides video |
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| Drug development – the chicken or the egg? How the approach to research in pediatric populations affects the drug development process or vice versa | Gahan Pandina slides video |
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| Unique issues in outcome measurement when including pediatric populations | Christine McSherry slides video |
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| IRB / Ethics committee requirements for pediatrics and how these may affect drug research | Alison Bateman-House slides video |
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| Regulatory considerations when including pediatric populations | Tiffany Farchione slides video Luca Pani slides video |
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| Expanded discussion on other needs to facilitate peds-first drug development approach | Facilitator/Discussant: Judith Kando slides video |
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Day 2 (22 September 2020) |
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| Day 1 Highlights | Philip Harvey video |
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| Hot Topic: Regulatory viewpoints from EMA and FDA on contemporary challenges and strategies for conducting and analyzing clinical trials in the COVID-19 era | Chairs: Richard Keefe Mike Davis Valentina Mantua |
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| Regulatory Panel / Audience Discussion | Facilitators – Richard Keefe Mike Davis Valentina Mantua Panelists – Florence Butlen-Ducuing Sylva Collins Bernard Fischer Lorenzo Guizzaro Elektra Pappadopoulos Isaac Rodriguez-Chavez Leonard Sacks slides video |
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| Special challenges in pediatric drug development |
Chairs: Philip Harvey Gahan Pandina Joan Busner |
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| Introduction | Philip Harvey video |
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| Measurement of cognition and behavior: How do we measure a moving target? | H. Gerry Taylor slides video |
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| Securing patients – value of pre-competitive consortia | Meg Grabb slides video |
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| Rater training for pediatric trials: pathology, parents, placebos, pandemics | Joohi Jimenez-Shahed slides video |
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| Speaker / Audience discussion including regulatory perspectives | Facilitator – Philip Harvey Panelists – Tiffany Farchione Lucas Kempf Speakers video |
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Day 3 (23 September 2020) |
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| Day 2 Highlights | Gary Sachs video |
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| Patient centricity: Design and conduct of clinical trials in orphan diseases | Chairs: Joan Busner Gahan Pandina |
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| Introduction | Joan Busner video |
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| Session background – Patient-centric designs: Involving patients and families | Simon Day slides video |
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| Case study: Lessons learned in an adolescent schizophrenia trial | Eva Kohegyi slides video |
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| Case study: Lessons from a Tourette’s study | Atul Mahableshwarkar slides video |
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| Regulatory perspective | Lucas Kempf slides video Maria Sheean slides video |
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| Incorporation of treatment preferences to endpoint selection | Judith Dunn slides video |
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| Including families in protocol design, protocol simulation, identification of meaningful clinical aspects, with patients | Traceann Rose slides video |
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| Panel Discussion | Facilitator – Simon Day Panelists – Renie Moss Speakers video |
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Day 4 (24 September 2020) |
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| Day 3 Highlights | Ramy Mahmoud video |
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| Borderline personality disorder: Clinical development challenges and opportunities in the current regulatory environment | Chairs: Michael Ropacki Gary Sachs |
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| Introduction | Gary Sachs slides video |
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| Methodological issues and barriers faced in Borderline Personality Disorder clinical development | Michael Ropacki slides video |
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| Beginning with the endpoint in mind | Gary Sachs slides video |
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| Adaptive clinical trials: A modern approach to drug development | Ben Saville slides video |
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| Regulatory feedback and commentary on Borderline Personality Disorder clinical development | Zimri Yaseen slides video Lorenzo Guizzaro slides video |
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| Panel Discussion | Facilitator – Michael Ropacki Panelists – Speakers video |
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| Poster Session | Poster PDFs and Abstracts | |
Day 5 (24 September 2020) |
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| Day 4 Highlights | Stephen Brannan video |
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| Toward personalized medicine: Methodological challenges in implementing clinical trials | Chairs: Nina Schooler Stephen Marder |
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| Introduction | Nina Schooler video |
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| Awaiting the biomarker fairy: Risk stratification in clinical trials | Roy Perlis slides video |
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| Adaptive enrichment designs: Modifying pre-specified enrollment criteria | Ronald Marcus slides video |
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| The application of machine learning to advance phenotyping, selection, and prediction of treatment response | Isaac Galatzer-Levy slides video |
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| Assessment of clinical profiles and outcomes in personalized medicine | Robert Gibbons slides video |
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| Regulatory perspective
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Valentina Mantua slides video Elena Martinez-Lapiscina slides video |
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| Panel Discussion | Facilitator – Stephen Marder Panelists – Speakers video |
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| Meeting Adjourns
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Ramy Mahmoud slides video |
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Working Groups |
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| Algorithms/Flags to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs Working Group
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Chairs: Jonathan Rabinowitz Nina Schooler summary |
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| Assessment Methods and Endpoints for Rapid-Acting Antidepressants-RAADs
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Chairs: Elizabeth Ballard Mark Opler Christian Yavorsky summary |
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| Behavioral and Psychiatric Symptoms in Dementia (BPSD) Working Group
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Chairs: Larry Ereshefsky Krista Lanctot David Miller Cedric O’Gorman Paul Rosenberg summary |
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| Orphan Diseases | Chairs: Joan Busner Gahan Pandina summary |
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| Utilizing Artificial Intelligence and Machine Learning for CNS Clinical Trials | Chairs: Larry Alphs Adam Butler summary |
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Advanced CNS Clinical Trials Course
Thursday, January 16th, 2020A new, brief, intensive, interactive program for mid-career CNS clinical researchers who wish to expand and refine their trial design expertise
APPLY BY 5 MARCH – See below
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
| Thursday 2 December 2021 | ||
| 7:00-7:45am EST | Registration / Safety Measures Check-in | |
| 8:00am EST | Introduction | Carla Canuso Kari Nations |
| Early Phase Trials Session 1 – Proof of Mechanism Studies | Andrew Krystal Daniel Umbricht |
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| Early Phase Trials Session 2 – Proof of Concept Studies | Daniel Umbricht Andrew Krystal |
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| Early Phase Statistical Considerations | Craig Mallinckrodt | |
| Regulatory Perspectives on the Use of Digital Health Technologies in CNS Drug Development | Mike Davis | |
| Learning Lab Breakout A: Study Design Group Assignment (lunch provided) | ||
| Late Phase Trials Session 1 – Moving from Early Phase to Late Phase Drug Development: Determining and Confirming Therapeutic Potential | Bruce Kinon | |
| Late Phase Trials Session 2 – Clinical Trials: When Design Dreams meet Clinical Reality | Lori Davis | |
| 5:15pm EST | Session Adjourns | |
| 5:30-7:30pm EST | Dine-around with Faculty and Preceptors (optional) | |
| Friday 3 December 2021 | ||
| 7:00am EST | Lite Breakfast with Faculty and Preceptors (optional – lite breakfast provided) | |
| 8:00am EST | Late Phase Statistical Considerations | Elena Polverejan |
| Learning Lab Breakout B: Study Design Group Assignment | ||
| Group Discussion of Study Designs (lunch provided) | ||
| 2:30pm EST | Meeting adjourns | |
Faculty and preceptors (Bios and Disclosures Linked to Names)
Carla Canuso, MD, Janssen Research and Development
Lori Davis, MD, Tuscaloosa VA Medical Center
Michael Davis, MD, PhD, FDA
Don Goff, MD, NYU School of Medicine
John Kane, MD, The Zucker Hillside Hospital
Bruce Kinon, MD, Cyclerion Therapeutics
Andrew Krystal, MD, University of California, San Francisco
Craig Mallinckrodt, PhD, Cortexyme
Kari Nations, PhD, Syneos Health
Elena Polverejan, PhD, Janssen Research and Development
Bill Potter, MD, PhD, Independent expert (retired from NIMH, Lilly, and Merck)
Nina Schooler, PhD, SUNY Downstate Medical Center
Madhukar Trivedi, MD, University of Texas Southwestern Medical School
Daniel Umbricht, MD, xperimed LLC
Faculty and Preceptor Disclosures
COVID Safety Measures:
We will adhere to the safety guidelines of our host facility. Vaccination required. Rapid antigen tests will be administered upon entry. Face mask and social distancing requirements will follow local guidelines.
Questions? Email info@isctm.org
16th Annual Scientific Meeting
Friday, July 12th, 2019
Distinguished Poster Award Recipient:
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| Up-Front Matching for Prospective Observational Studies to Mimic Randomization (Turkoz) | |||
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All Poster PDFs and Abstracts are available at the end of the second day. |
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19 February 2020 |
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| Welcome from the President | Carla Canuso slides video |
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| Unresolved Problems in Neuroscience Drug Development | |||
| Drugs with abuse liability: Issues facing their use as treatments for psychiatric disorders and how to address them
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Chair: Walter Dunn slides video Discussants: Jerry Sanacora slides videoCharles Nemeroff slides videoRaye Litten slides video |
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| Panel/Audience Discussion | video |
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| Are current digital measures ready for prime time? | Chair: Phil Harvey Discussants: Elektra Papadopoulos slides videoGreg Strauss slides videoValentina Mantua* |
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| Panel/Audience Discussion | video |
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Wednesday Working Group Sessions |
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| Artificial Intelligence (AI) and Machine Learning (ML) for CNS Clinical Trials | Chairs: Adam Butler Larry Alphs summary |
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| Autism Spectrum Disorder | Chairs: Valentina Mantua Tiffany Farchione Celso Arango summary |
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| Behavioral and Psychiatric Symptoms in Dementia—Agitation Subgroup | Chairs: Cedric O’Gorman Paul Rosenberg summary |
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| Developing Integrated Interventions: Clinical Trials for Drug/Neuromodulation-Psychotherapy Combinations | Chairs: Walter Dunn Zimri Yaseen summary |
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| Estimands and Missing Data | Chairs: Pilar Lim Elena Polverejan summary |
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| Prevention Trials in Alzheimer’s Disease | Chairs: Holly Posner Phil Harvey |
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20 February 2020 |
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| Andrew C. Leon Distinguished Career Award Presentation | Steve Marder Carla Canuso slidesRobert Heinssen video |
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| Enhancing drug development through artificial intelligence (AI) and machine learning (ML) | Chairs: Adam Butler Larry Alphs Saeed Ahmed |
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| Introduction: Improving clinical trials with modern techniques | Adam Butler slides video |
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| What is artificial intelligence? | Saeed Ahmed slides video |
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| Applications of machine learning for psychiatry | Joe Geraci slides video |
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| Using AI/ML to differentiate drug and placebo responders in mood disorders: Offering the opportunity for enhanced patient selection | Jane Tiller slides video |
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| AI-enabled digital phenotyping as a vehicle for clinical trial qualification and tracking of change during intervention | Dennis Wall* |
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| Regulatory considerations when utilizing AI and ML applications in the design and execution of a CNS clinical trial | David Millis slides video |
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| Panel Discussion | Discussant: Vikas Mohan Sharma slides video |
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| Summary | |||
| The Brain – Gut Axis in Psychiatry and Neurology: Focus on the Microbiome | Chairs: Jill Rasmussen Ron Marcus |
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| Introduction | Jill Rasmussen slides video |
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| Microbes, brain and behavior- Focus on depression | Ted Dinan slides video |
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| The brain immune gut axis- a big approach to developing new medications for psychiatric disorders in the new decade | Robert Yolken slides video |
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| Microbiome and Alzheimer’s disease | Miia Kivipelto slides video |
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| Microbiome and Parkinson disease: Therapeutic implications | Peter LeWitt slides video |
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| Regulatory considerations for microbiome based therapeutics | Paul Carlson slides video Luca Pani video |
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| Panel / Audience Discussion | Facilitator: Ron Marcus video |
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| Is There a Fundamental Rethinking in the Way We Plan Clinical Trials? The Estimand Change in Mindset | Chairs: Pilar Lim Michael Davis Steve Brannan |
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| Introduction | Pilar Lim slides video |
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| Introduction to the ICH E9(R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials”: A clinical perspective | Florence Butlen-Ducuing slides video |
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| Putting the ICH E9(R1) Guidance into practice – A multi-disciplinary collaboration | Elena Polverejan slides video |
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| Development of an estimand for acute treatment of Major Depressive Disorder trials: Keeping the new mindset in mind | Zimri Yaseen slides video |
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| Regulatory implications of the ICH E9(R1) Guidance | Robert Temple slides video |
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| Panel and Regulatory Discussion | Facilitator: Michael Davis Panelists: James Hung Michael O’Kelly Marc Walton video |
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| Summary | Michael Davis |
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| Poster Session/Reception | Poster PDFs and Abstracts | ||
21 February 2020
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Friday Working Group Sessions |
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| Assessment Methods and Endpoints for Rapid-Acting Antidepressants-RAADs | Chairs: Mark Opler Elizabeth Ballard Christian Yavorsky summary |
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| Behavioral and Psychiatric Symptoms in Dementia—Apathy Subgroup | Chairs: Krista Lanctôt David Miller summary |
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| Curriculum Development – Advanced CNS Clinical Trials Course | Chairs: Carla Canuso Kari Nations summary |
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| Innovative Technologies for Clinical Trials | Chairs: Richard Keefe Michael Davis summary |
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| Orphan Diseases | Chairs: Joan Busner Gahan Pandina Ravi Anand summary |
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| Role of Reward Processing Assessment as a Tool in Drug Development | Chairs: Larry Ereshefsky Raimund Buller |
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| Introduction | Raimund Buller Larry Ereshefsky video |
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| The neurobiology of anhedonia: Circuitry and relevance to drug development and patient stratification | Diego Pizzagalli slides video |
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| Reward processing mechanisms underlying negative symptoms in schizophrenia | Gregory Strauss slides video |
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| Reward processing in neurological disorders: Focus on Parkinson’s disease | Masud Husain slides video |
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| Pragmatic aspects of including reward processing tasks in drug development trials | Stephane Pollentier slides video |
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| Comment: Translational considerations – NIMH | Sarah Lisanby slides video |
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| Regulatory view on use of reward processing in patient segmentation and as a marker for treatment response | Tiffany Farchione slides video |
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| Panel / Audience Discussion | video |
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| Summary | |||
| Meeting Adjourned
*Slides not released |
Ramy Mahmoud video |
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Platform Trials – An Adaptive Design: Construct, Advantages and Challenges
Thursday, October 25th, 2018View Webinar Online
If you were a registrant of the live webinar:
Members: (You must be logged in to access the video – Select Member Access upper right of page)
Member Access Webinar Video – Fee Waived
Non Members: Non Member Access Login
If you did not register for the ‘live’ webinar and wish to view:
Members: Log in and Select link above
Non-members –Register to View (Fee $50) or Join/Renew and view fee-waived
Webinar details:
Presented by ISCTM Adaptive Design Working Group
Co-chairs: Ron Marcus, MD, Presenter; Judy Kando, PharmD, Moderator, with Kyle Wathen, PhD, Guest Presenter
What You’ll Learn:
The key issues and pragmatic challenges in designing and implementing a Platform Trial, how to proactively and reactively resolve issues, and regulatory expectations.
Additional questions? Email the Secretariat
15th Annual Scientific Meeting
Thursday, July 12th, 2018
Distinguished Poster Award Recipient:
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| Trials, errors, and placebo prediction: Tradeoffs between effect size and sample size in machine learning models to mitigate the placebo response (Anderson) | |||
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All Poster PDFs and Abstracts are available at the end of the second day. |
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19 February 2019 |
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| Welcome from the President | Carla Canuso slides video |
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| Unresolved Problems in Neuroscience Drug Development: Point/Counterpoint | Facilitator: Amir Kalali video |
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| Are patients with any degree of suicidal ideation or behavior acceptable for inclusion in clinical trials?
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Chair: Carla Canuso slides video Discussants: Jill Harkavy-Friedman slides videoTom Laughren slides video |
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| Panel/Audience Discussion | Panelists: Jean Kim slides videoGalia Siegel video |
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| Are acute rapid onset anti-depressant results valid or just a consequence of functional unblinding? | Chair: Steve Brannan slides Discussants: Mark Opler slides videoTorsten Madsen slides video |
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| Panel/Audience Discussion | Facilitator: Steve Brannan video |
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Tuesday Working Group Sessions |
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| Assessment Methods and Endpoints for Rapid-Acting Antidepressants-RAADs | Chairs: Mark Opler Dawn Ionescu summary |
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| Behavioral and Psychiatric Symptoms in Dementia—Apathy Subgroup | Chairs: Krista Lanctôt David Miller slidessummary |
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| Cognitive Trajectories in Schizophrenia | Chairs: Philip Harvey Kiri Granger summary |
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| Estimands and Missing Data | Chairs: Pilar Lim Elena Polverejan slides |
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| Orphan Diseases | Chairs: Joan Busner Ravi Anand Patient Centricity Subgroup summary Case Histories Subgroup summary |
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20 February 2019 |
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| Strategies for Generating Meaningful Data for Payers: Methodological Challenges | Chairs: Dawn Velligan Rob Epstein |
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| Introduction | Rob Epstein |
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| European perspective: Real world outcome needs of payers current and anticipated | Emma Medin slides video |
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| US perspective: Real world outcome needs of payers current and anticipated | Jennifer Graff slides video |
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| When novelty is not enough: Assuring adoption, access as well as approval within the clinical development process | Michael Murphy slides video |
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| Models for increasing real world evidence in registration and post-approval clinical trials | Larry Alphs slides video |
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| Health economics and outcomes research: What can be done differently in registration trials and in post-approval trials | Steven Kymes slides video |
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| Regulatory Perspective | Peter Stein slides video |
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| Panel Discussion | Facilitator: Dawn Velligan video |
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| Methodological Issues Associated with the New Alzheimer’s Draft Guidance | Chairs: Judith Jaeger Adam Butler |
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| Introduction | Adam Butler slides video |
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| ADCOMS, new composite score, demonstrates improved sensitivity to disease progression and treatment effects in early AD | Veronika Logovinsky slides video |
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| Bayesian adaptive design employing ADCOMS for dose selection | Chad Swanson* |
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| Cognitive composites for preclinical and early AD derived from longitudinal registries: PACC-R and EMACC | Clint Hagen slides video |
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| Is there a cognitive test that can detect cognitive impairment associated with AB+ in the absence of dementia? | Jason Hassenstab slides video |
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| Informant report to detect amyloid related cognitive decline in the absence of dementia | Anna-Karin Berger slides |
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| Panel / Audience Discussion | Discussant: Judith Jaeger slides video |
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| Andrew C. Leon Distinguished Career Award Presentation | Steve Marder Carla Canuso slidesJanet Williams slides video |
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| Finding the Signal: Strategies for Achieving Participant-Centric Trials in the Face of Participant-Introduced Validity Changes | Chairs: Sian Ratcliffe Tim Mariano Kari Nations |
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| Introduction and goals | slides Tim Mariano videoSian Ratcliffe video |
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| Case studies on how stakeholders (sponsors, sites, patients) influence risks | Steve Brannan slides video |
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| Evidence-based, data-driven design examples from various MDD programs | Eva Kohegyi* | ||
| Testing our assumptions: Moving from speculative to evidence-based trial design | Fabrizio Benedetti slides video |
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| Panel / Audience Discussion Site and patient perspectives: Balancing risk mitigation with site/patient burden and acceptability |
Panelists: Lori Davis, facilitator slides videoSarah Atkinson slides videoPenney Cowan slides videoDavid Walling slides videoPanel video |
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| Regulatory perspective on design and method solutions Panel / Audience Discussion |
Tom Laughren slides video Valentina Mantua* Panel video |
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| Concluding Remarks | Tim Mariano Sian Ratcliffe slides |
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| Poster Session/Reception | Poster PDFs and Abstracts | ||
21 February 2019 |
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Thursday Working Group Sessions (summaries to be posted) |
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| Algorithms/Flags | Chairs: Jonathan Rabinowitz Nina Schooler |
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| Autism Spectrum Disorder | Chairs: Valentina Mantua Tiffany Farchione Celso Arango summary |
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| Behavioral and Psychiatric Symptoms in Dementia—Agitation Subgroup | Chairs: Cedric O’Gorman Paul Rosenberg |
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| Innovative Technologies for Clinical Trials | Chairs: Richard Keefe Michael Davis |
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| Late Onset Depression: A Distinct Indication? | Chairs: Patricia Capaccione Peter de Boer summary |
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| Prevention Trials in Alzheimer’s Disease | Chairs: Holly Posner Philip Harvey slides |
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| Untangling the Regulatory and Statistical Challenges When Designing Trials for Disease Modification | Chairs: Larry Alphs Luca Pani |
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| Introduction and reprise of prior ISCTM work | Luca Pani slides video |
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| Prospects for a disease-modifying claim in neurodevelopmental disorders | Tiffany Farchione slides video |
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| Prospects for a disease-modifying claim in schizophrenia: Prevention, effects on cognitive function | David Millis slides video |
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| Clinical trials that demonstrate disease modification: The challenges and a possible solution for schizophrenia | Larry Alphs slides video |
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| Application of doubly-randomized delayed-start, matched control designs to demonstrate disease modification | Ibrahim Turkoz slides video |
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| Statistical challenges of proposed modification approaches | James Hung slides video |
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| Regulatory reflections on disease modification: EU perspective | Valentina Mantua* |
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| Panel / Audience Discussion | |||
| Meeting Adjourned
*Slides not released |
Carla Canuso | ||
2019 Autumn Conference – Includes Joint Day with ECNP
Thursday, July 12th, 2018
Distinguished Poster Award Recipient: |
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| The potential benefits of utilizing a standard of care treatment study to prepare participants for enrollment in a treatment resistant depression (TRD) clinical trial (Sauder) | ||
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All Poster PDFs and Abstracts are available at the end of the second day. |
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5 September 2019 |
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| Welcome Reception | ||
6 September 2019
|
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| Welcome from the Presidents | Carla Canuso Celso Arango slides video |
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| Clinical Trials for Treatment Resistant Neuropsychiatric Conditions | Chairs: Phil Harvey Christoph Correll |
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| Introduction | Christoph Correll Rich Keefe video |
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| Clinical trials for treatment resistant neuropsychiatric conditions: Lessons from treatment resistant schizophrenia | Oliver Howes slides video |
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| Methodological issues in treating treatment resistant affective disorders | Mark Weiser slides video |
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| Regulatory perspectives on treatment resistance | Tiffany Farchione slides video Valentina Mantua* |
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| Panel / Audience Discussion | Discussant: Tiffany Farchione Speakers video |
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| Cognitive Challenges in Treatment Trials for Epilepsy and Multiple Sclerosis | Chairs: Jill Rasmussen Christoph Helmstaedter |
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| Introduction | Jill Rasmussen slides video |
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| Neuropsychology in epilepsy: Assessment challenges and issues | Christoph Helmstaedter slides video |
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| Cognition in epilepsy: Issues, challenges, clinical trials to date, next steps | Kimford Meador slides video |
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| Cognition in multiple sclerosis: Measurement and application to clinical trials | Dawn Langdon slides video |
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| Regulatory perspective on cognitive challenges in treatment trials for epilepsy and multiple sclerosis | Marion Haberkamp slides video |
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| Panel / Audience Discussion | Speakers video |
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| Drug Development for Autism Spectrum Disorder: Challenges and Opportunities | Chairs: Valentina Mantua Tiffany Farchione Celso Arango |
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| Introduction | Tiffany Farchione video |
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| Biomarkers in autism spectrum disorder: The Autism Biomarkers Consortium for Clinical Trials | Jamie McPartland slides video |
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| Personalized medicine in autism spectrum disorders – AIMS2 trials | Declan Murphy slides video |
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| Role of digital medicine in Autism Spectrum Disorders clinical trials | Gahan Pandina slides video |
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| Methodological challenges in designing clinical trials for Autism Spectrum Disorders | Evdokia Anagnostou slides video |
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| The way forward in drug development for Autism Spectrum Disorders | Jeremy Veenstra-Vanderweele slides video |
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| Regulatory Comment | Tiffany Farchione slides video Valentina Mantua* |
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| Panel Discussion – including family members/patient associations | video |
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| Concluding remarks | Celso Arango video |
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| Joint meeting adjournment | Carla Canuso Celso Arango |
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| ISCTM Poster Session | Poster PDFs and Abstracts | |
7 September 2019 |
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| Developing Pharmacological Treatments for the Rapid Reduction of Suicidal Ideation in Depression | Chairs: Carla Canuso Philippe Courtet Suresh Durgam |
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| Introduction | Carla Canuso slides video |
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| Is suicidal depression a specific phenotype? | Philippe Courtet slides video |
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| Unique methodological considerations in this novel indication | Jerry Sanacora slides video |
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| Moderated Panel / Audience Discussion | Moderator: Suresh Durgam slides videoPanelists: Wieslaw Cubala Dong-Jing Fu Jonathan Javitt Emilie Olié |
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| Biomarkers to enrich and predict response to rapidly acting antidepressants | Elizabeth Ballard slides video |
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| Ecological momentary assessment (EMA) and machine learning: Digital phenotyping in suicide behavior | Enrique Baca-Garcia slides video |
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| How can we study the effects of new treatment on suicidal behavior? | Greg Simon slides video |
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| Regulatory and Payor perspective | Jean Kim slides video Maarten Postma slides video |
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| Discussion / Summary | ||
| Meeting Adjourns | Carla Canuso video |
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Working Group Sessions |
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| Artificial Intelligence and Machine Learning for CNS Clinical Trials | Chairs: Larry Alphs Adam Butler slides-summary |
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| Assessment of Methods and Endpoints for Rapid Acting Antidepressants – RAADs | Chairs: Elizabeth Ballard Christian Yavorsky summary |
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| Autism Spectrum Disorder | Chairs: Valentina Mantua Tiffany Farchione Celso Arango summary |
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| Innovative Technologies for Clinical Trials | Chairs: Richard Keefe Mike Davis summary |
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| Orphan Diseases | Chairs: Gahan Pandina Ravi Anand summary |
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| * Presentation not released | ||
2018 Autumn Conference
Saturday, September 30th, 2017
Distinguished Poster Award Recipients: |
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| Development and Validation of a patient-reported outcomes symptom measure (ePRO) for assessing Awareness of Insight in Schizophrenia: Preliminary Findings (Lucic) Deep Learning-Based Human Activity Recognition for Continuous Activity and Gesture Monitoring for Schizophrenia Patients with Negative Symptoms (Umbricht) |
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| All Poster PDFs and Abstracts are available at the end of the first day. | ||
Day 1 (15 October 2018) |
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| Presidential Welcome | C Canuso slides video |
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| Innovative Uses of Technology for Measuring Outcomes in Clinical Trials (Part 1) | Chairs: P Harvey T Farchione |
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| Introduction | T Farchione slides video |
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| Landscape of technology utilization of outcomes assessment in neuropsychiatric disorders | P Harvey slides video |
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| Technology enabled clinical endpoint innovation: Foundational concepts and pathway for development | M Walton slides video |
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| Devil, details, and data: Measurement models and analysis strategies for novel technology-based clinical outcome assessments | B Bilder slides video |
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| The path to FDA acceptance of technological strategies | M Davis slides video |
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| Panel Discussion | A Kalali – Facilitator Discussants – A Atkins slidesR Curiel slidesK Granger* H Mahncke slidesR Moore slides video |
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| Innovative Uses of Technology for Measuring Outcomes in Clinical Trials (Part 2) | Chairs: R Keefe M Davis |
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| Introduction | R Keefe video |
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| Technologies for measuring cognition in clinical trials | S Arnerić slides video |
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| Statistical methods for wearable technology in CNS trials | A Potter slides video |
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| Balancing the thrill of innovation and the fear of humiliation in choosing technology for CNS trials | K Daniels slides video |
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| Validating digital biomarkers measured by patients’ own smart devices: Case studies from Parkinson’s disease and Multiple Sclerosis | C Gossens slides video |
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| Advances in assessment technologies: Clinical informatics considerations | D Warfield slides video |
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| Panel discussion with regulatory comment | T Farchione – Facilitator Discussants – M Davis V Mantua * L Pani slidesA Potter M Walton D Warfield video |
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| Poster Session/Reception | Poster PDFs and Abstracts | |
Day 2 (16 October 2018) |
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Workshop Breakfasts |
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| Algorithms/Rules to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTS | Chair: N Schooler Summary |
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| Autism Spectrum Disorder | Chairs: T Farchione, V Mantua, C Arango Molecular Targets Endpoints Trial Design Biomarkers: Pandina Dawson-McPartland |
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| Cognitive Trajectories in Schizophrenia | Chairs: P Harvey, K Granger Summary slides |
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| Orphan Diseases | Chairs: J Busner, R Anand Summary |
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| Prevention Trials in Alzheimer’s Disease | Chair: H Posner Summary-Slides |
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Parallel Sessions |
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| Session A: The Promise and Challenges of Gene Therapy for CNS Disorders |
Chairs: B Ravina W Dunn |
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| Introduction | W Dunn slides video |
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| Gene therapy: The basics | M Kay slides video |
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| Gene therapy: Early clinical development challenges | S Hersch** slides |
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| Clinical development of gene therapies: Safety evaluation and monitoring | L Xu slides video |
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| Clinical trial paradigms in gene therapy | B Ravina slides video |
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| Panel Discussion | Speakers video |
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| Session B: Biomarkers in Psychiatric Drug Development: An Update | Chair: D Goff |
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| Introduction | D Goff video |
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| New computational approaches for characterizing clinical phenotypes and analyzing biomarkers | I Galatzer-Levy slides video |
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| Using machine learning approaches to identify imaging markers that predict antidepressant response | A Etkin slides |
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| Functional NMDA receptor-based target engagement biomarkers for schizophrenia research | D Javitt slides video |
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| Imaging biomarkers for the assessment of placebo response | A Anderson slides video |
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| Panel/Audience Discussion | D Umbricht – Discussant slides video |
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| Novel Technologies to Identify Underlying Molecular Pathology in Neurodegeneration | Chair: H Soares |
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| Introduction | H Soares video |
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| Mixed pathologies in dementia and movement disorders | E Lee slides video |
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| CSF assays to detect patients with seeding-competent aggregates of Abeta, tau and alpha-synuclein: Applications to identify mixed pathologies in AD, DLB, FTD and PD | C Soto** slides |
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| PET neuroimaging approaches to characterizing underlying molecular pathology in neurodegenerative disease | S Landau slides video |
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| Clinical trial design opportunities for mixed pathologies in neurodegenerative disorders | N Mendonca** | |
| Panel Discussion | Soares – Facilitator slidesV Mantua* Speakers video |
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| Meeting Adjourned |
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| *Presentation not released **Video not released |
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14th Annual Scientific Meeting
Wednesday, July 26th, 2017
Distinguished Poster Award Recipients:
|
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| Use of a Prediction Algorithm for Randomized Stratification in an Amyotrophic Lateral Schlerosis Study (VanMeter) | |||
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All Poster PDFs and Abstracts are available at the end of the second day. |
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20 February 2018 |
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| Welcome from the President | S Marder slides video |
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| Unresolved Problems in Neuroscience Drug Development: Point/Counterpoint | Chair: A Kalali video |
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Is it time to move past the amyloid hypothesis: An affirmative response? Is amyloid a good AD drug target? |
Lead: A Butler |
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Does increasing the sample size provide greater precision for detecting treatment effects? Why simply increasing sample size for obtaining greater trial power often does not work: caveats you should know |
Lead: G Sachs |
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Working Group Sessions |
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| Abuse Liability: The functional excipient conundrum | Chairs: M Klein B Setnik M Sokolowska summary |
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| Adaptive Design | Chairs: J Kando R Marcus slides-Marcus slides-Wathen |
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| Addressing Methodological Challenges in International CNS Clinical Trials | Chairs: A Kalali E Pappadopulos |
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| Algorithms/Flags | Chairs: J Rabinowitz N Schooler summary |
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| Behavioral and Psychiatric Symptoms of Dementia-Apathy Subgroup | Chairs: K Lanctôt D Miller slides/summary |
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| Behavioral and Psychiatric Symptoms of Dementia – Agitation Subgroup | Chairs: C O’Gorman P Rosenberg slides/summary |
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| Estimands and Missing Data | Chairs: P Lim E Polverejan summary |
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| Late-Onset Depression | Chair: H Martynowicz slides |
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| Negative Symptoms | Chairs: D Daniel S Marder summary |
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| Prevention Trials in Alzheimer’s Disease – Design Considerations | Chairs: P Harvey H Posner summary |
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21 February 2018 |
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| Andrew C. Leon Distinguished Career Award Presentation | S Marder S Romano slides videoW Potter |
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| Use of Regulatory Databases as Exemplars for Improving RCT Efficiency and Guidance Development: Can the Model Be Extended? | Chairs: T Farchione H Martynowicz |
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| Session Objectives | T Farchione slides video |
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| Clinical trial database analyses to inform regulatory guidances: Improving the efficiency of schizophrenia clinical trials | I Younis slides video |
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| Clinical trial database analyses to inform regulatory guidances: Suicidal ideation and behavior assessment | J Kim slides video |
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| Opportunities for the use of regulatory data | F Pétavy slides video |
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| Statistical challenges of meta-analyses of randomized clinical trials in a regulatory setting – US Perspective
Statistical challenges of meta-analyses of randomized clinical trials in a regulatory setting – EU Perspective |
E Andraca-Carrera slides F Pétavy slides video (Includes Andraca-Carrera) |
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| Improving the specificity and precision of PANSS factors: One approach to facilitate development of novel treatments in schizophrenia | S Hopkins slides video |
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| Panel Discussion | Facilitator: N Schooler slidesPanelists: T Farchione H Martynowicz F Pétavy W Potter video |
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| Methodological Challenges Related to Rare and Orphan Disease Drug Development | Chairs: J Busner J Dunn R Anand |
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| Introduction | J Busner slides video |
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| The unmet need – Partnership with patient advocate groups | R DeBellis slides video |
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| Clinical outcome assessment endpoints for rare diseases: Challenges and methods for clinical trials | D Revicki slides video |
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| Statistical challenges: Designs for clinical trials with limited patient populations | S Day slides video |
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| Clinical and Regulatory Challenges in Developing New Treatments for Rare Diseases | R Anand slides video |
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| Rare Disease Clinical Research: Collaboration is the key to success | J Ng-Cashin slides video |
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| Orphan Drug Topics: Discovery of FDA’s flexibility/Evolving voice of the patient in drug review | F Sasinowski slides video |
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| Panel Discussion | video |
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| Summary | |||
| Poster Session/Reception | Poster PDFs and Abstracts | ||
22 February 2018
|
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| Innovative Approaches for Slowing Disease Progression in Parkinson’s Disease | Chairs: K Budur I Turkoz I Shoulson M Frasier |
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| Welcome from the President | C Canuso video |
||
| Introduction | K Budur slides video |
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| Parkinson’s Disease: Current concepts of pathophysiology and disease modification | A Lang* | ||
| Moving treatment earlier: Disease modification in early PD | R Postuma slides video |
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| Novel targets of disease modifying therapy of Parkinson’s disease | D Standaert slides video |
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| Role of biomarkers and clinical markers in patient selection and monitoring in PD | K Marek slides |
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| Panel Discussion | Facilitator: M Frasier slides video |
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| Clinical trial measures to capture important motor and non-motor outcomes in PD | K Kiebertz slides video |
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| Innovative statistical design and analysis in PD | C Coffey slides video |
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| Panel Discussion | Facilitator: I Turkoz slides video |
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| A perspective on “preclinical” Alzheimer’s disease trials | P Tariot slides video |
||
| Regulatory perspectives on interventions to slow progression in PD | A Bhattaram C Leptak |
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| Panel Discussion | Facilitator: Ira Shoulson slides video Panelists: K Jin L Pani D Stephenson |
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| Summary | K Budur Karl Kiebertz video |
||
| Meeting Adjourned
*Slides not released |
C Canuso | ||