2020 Autumn Conference – Virtual Edition
21 – 25 September, 2020 // Virtual Conference
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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