11th Annual Scientific Meeting
Includes Joint Scientific Session with ASENT
17 – 19 February, 2015 // The Fairmont, Washington DC, USA
Distinguished Poster Award Recipient: |
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| All Poster PDFs and Abstracts are available at the end of the second day. |
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Day 1 (17 February 2015) |
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| Presidential Welcome | S Romano slides video |
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| Forming and Utilizing Integrated Clinical Trials Databases to Advance Insights in Treatments for Cognition in Schizophrenia and Alzheimer’s Disease | Chairs: L Alphs G Haynes J Severe |
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| Session Overview | J Severe slides video |
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| Database of Cognitive Training and Remediation Studies (DoCTRS): Goals, Value, Potential | ||
| Trials and Tribulations: Personalizing Cognitive Treatment in Schizophrenia | T Wykes slides video |
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| Hurdles and Solutions Encountered with DoCTRS | S Morris slides video |
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| Large Integrated Databases in Alzheimer’s Disease | ||
| Data Sharing and Models in Pre(Non)-Competitive Space in Addressing Unmet Medical Needs – Critical Path Institute’s Alzheimer’s Drug Development Tool | V Sinha slides video |
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| Lessons from the Development and Regulatory Evaluation of a Clinical Trial Simulation Tool for Alzheimer’s Disease | K Romero slides video |
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| Impact of Varying Data Quality on Statistical Analysis of Integrated Datasets | E Andraca-Carrera slides video |
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| Panel Discussion | All Speakers video |
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Working Group Dinners |
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| Assessment of Abuse Liability in Drug Dependent Subjects | Chairs: M Sokolowska B Setnik M Klein Working Group Slides: SchoedelReport Back slides |
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| Addressing Methodological Challenges in International CNS Clinical Trials | Chairs: R Keefe A Kalali Working Group Slides: slidesReport Back slides |
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| Algorithms/Flags to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs | Chairs: J Rabinowitz N Schooler Report Back slides |
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| Behavioral and Psychiatric Symptoms in Dementia | Chairs: L Ereshefsky D Miller L Pani Report Back slides |
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| Biomarkers in Schizophrenia | Chairs: S Potkin D Goff Report Back slides |
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| Cognitive Assessment in AD and Its Precursors | Chairs: H Posner P Harvey Working Group Slides: Cosentino SchneiderReport Back slides |
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| Identifying/Reducing the Effects of Non-Adherence in Clinical Trials | Chairs: T Shiovitz E Bain Report Back slides |
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| Implementing Innovations in CNS Trials | Chairs: G Sachs M Detke Working Group Slides: slides |
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| Suicidal Ideation and Behavior Assessment | Chairs: M Stewart P Chappell L Alphs Working Group Slides: slidesReport Back slides |
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Day 2 (18 February 2015) |
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Parallel Sessions |
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| Session A: Adaptive Design in the Real World: Implications for Neuroscience Clinical Studies | Chairs: J Kando R Marcus |
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| Introduction | J Kando R Marcus slides |
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| Overview of Adaptive Design Methodology | V Dragalin slides video includes session introduction |
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| Review of Obstacles, Barriers, Problems and Logistical Issues with Adaptive Design Studies | J Quinlan slides video |
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| Bayesian Adaptive Trial Design: A New Approach for Phase 2 Clinical Trials in Alzheimer’s Disease | A Satlin slides video |
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| BMS-927711 for the Acute Treatment of Migraine: A Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Trial | R Marcus slides video |
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| Adaptive Design in Phase 2: Potential Treatment for Insomnia Disorder | M Moline slides video |
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| When is Adaptive Design Useful in Neuroscience | T Parke slides video |
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| Q & A and Panel Mediated Discussion | S J Wang* All Speakers video |
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| Session B: Regulatory Guidelines and Methodological Approaches to Assess Prescription Drug Abuse and Misuse During CNS Drug Development | Chairs: B Setnik M Sokolowska M Klein |
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| An Overview of the Regulatory Requirements for Assessing the Abuse Potential of CNS Active Drugs in Different Populations | M Klein slides video |
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| Human Abuse Potential Study Design and Interpretation for CNS Active Drugs | M Sokolowska slides video |
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| Statistical Considerations for Human Abuse Potential Studies | L Chen slides video*** |
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| Q & A and Panel Mediated Discussion | S Calderon* P Geoffroy* video |
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| Methodological Approaches to Assess Dependence Potential in Clinical Trials | S Ratcliffe slides video |
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| Evaluation of Dependence and Withdrawal in Clinical Trials and Human Dependence Study – Design and Considerations | A Lerner slides video |
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| Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse and Dependence of CNS-Active Drugs in Patient and Post-Marketing Trials | B Setnik slides video |
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| Q & A and Panel Mediated Discussion | S Butler* video |
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| Presentation of the Andrew C. Leon Distinguished Career Award | R Keefe slides S Romano slides video |
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| Challenges in Developing Therapeutics in Partially Responsive and Treatment Resistant Depression – Where Do We Go From Here? | Chair: H Martynowicz |
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| Introduction to the CHMP MDD Guidance and How the EFPIA Position Was Formulated | H Martynowicz slides video |
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| Clinical Perspective on Conducting Trials in Major Depressive Disorder | J Kent slides video |
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| Clinical Perspective on Conducting TRD Studies | H Eriksson slides video |
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| Regulatory Perspective—CHMP | K Broich slides video |
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| Advancing our Thinking About Partially Responsive MDD and TRD | T Laughren slides video |
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| Panel Discussion | J Kent H Eriksson K Broich T Laughren C Nelson M Mathis video |
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| Poster Session / Reception | Poster PDFs and Abstracts | |
Day 3 (19 February 2015) |
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| TBI Treatment Development | Chairs: G Ling A Faden R Ferziger |
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| Welcome from ISCTM and ASENT Presidents | S Romano H Federoff video |
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| Introduction | A Faden R Ferziger slides video |
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| State of Affairs | ||
| Traumatic Brain Injury State of the State | G Ling slides video*** |
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| State of the Science | ||
| Scientific Opportunities and Key Unknowns in TBI Research | S Hinds slides video*** |
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| TBI: Translational Issues and Opportunities 1 | A Faden slides video |
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| TBI: Translational Issues and Opportunities 2 | J Povlishock slides video |
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| Research at FDA on TBI Pathophysiology and Biomarker Development | C Welle slides video |
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| Discussant | D Hovda* video |
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| State of the Pipeline | ||
| TBI Clinical Trials: Past, Present and Future | D Hack slides video |
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| Reconceptualizing TBI Assessment and Clinical Trial Design | G Manley slides video |
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| Regulatory Perspectives | C Pena* video |
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| Discussant and Moderator | G Ling* video*** |
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| State of Investment What Would it Take to Increase Public-Private Partnership in TBI Treatment Development? |
M Anderson slides M Stebbins S Romano G Ling R Ferziger video |
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| State of Selected Treatment Targets Reports from TBI Treatment Development Working Group Chairs: |
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| Neuroinflammation | D Loane slides video |
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| Biomarkers Development for TBI | G Small slides video D Smith slides video |
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| TBI & Sleep Disorders | M Yochelson** video E Wickwire** video |
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| TBI – Neuropsychiatric Sequelae | L Davis slides video |
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| Post-Traumatic Headache: Opportunities and Challenges for Clinical Trials | J Erickson** video*** |
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| Responses from Experts Panel and Open Discussion | Panel video*** |
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| Meeting Adjourned | ||
| * No slides presented ** Slides not released *** Video not released |
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