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![]() ![]() |
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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![]() ![]() |
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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![]() ![]() |
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Hurdles and Solutions Encountered with DoCTRS | S Morris![]() ![]() |
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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![]() ![]() |
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Lessons from the Development and Regulatory Evaluation of a Clinical Trial Simulation Tool for Alzheimer’s Disease | K Romero![]() ![]() |
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Impact of Varying Data Quality on Statistical Analysis of Integrated Datasets | E Andraca-Carrera![]() ![]() |
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Panel Discussion | All Speakers![]() |
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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: ![]() Report Back ![]() |
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Addressing Methodological Challenges in International CNS Clinical Trials | Chairs: R Keefe A Kalali Working Group Slides: ![]() Report Back ![]() |
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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 ![]() |
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Behavioral and Psychiatric Symptoms in Dementia | Chairs: L Ereshefsky D Miller L Pani Report Back ![]() |
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Biomarkers in Schizophrenia | Chairs: S Potkin D Goff Report Back ![]() |
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Cognitive Assessment in AD and Its Precursors | Chairs: H Posner P Harvey Working Group Slides: ![]() ![]() Report Back ![]() |
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Identifying/Reducing the Effects of Non-Adherence in Clinical Trials | Chairs: T Shiovitz E Bain Report Back ![]() |
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Implementing Innovations in CNS Trials | Chairs: G Sachs M Detke Working Group Slides: ![]() |
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Suicidal Ideation and Behavior Assessment | Chairs: M Stewart P Chappell L Alphs Working Group Slides: ![]() Report Back ![]() |
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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 ![]() |
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Overview of Adaptive Design Methodology | V Dragalin![]() ![]() |
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Review of Obstacles, Barriers, Problems and Logistical Issues with Adaptive Design Studies | J Quinlan![]() ![]() |
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Bayesian Adaptive Trial Design: A New Approach for Phase 2 Clinical Trials in Alzheimer’s Disease | A Satlin![]() ![]() |
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BMS-927711 for the Acute Treatment of Migraine: A Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Trial | R Marcus![]() ![]() |
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Adaptive Design in Phase 2: Potential Treatment for Insomnia Disorder | M Moline![]() ![]() |
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When is Adaptive Design Useful in Neuroscience | T Parke![]() ![]() |
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Q & A and Panel Mediated Discussion | S J Wang* All Speakers ![]() |
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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![]() ![]() |
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Human Abuse Potential Study Design and Interpretation for CNS Active Drugs | M Sokolowska![]() ![]() |
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Statistical Considerations for Human Abuse Potential Studies | L Chen![]() ![]() |
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Q & A and Panel Mediated Discussion | S Calderon* P Geoffroy* ![]() |
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Methodological Approaches to Assess Dependence Potential in Clinical Trials | S Ratcliffe![]() ![]() |
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Evaluation of Dependence and Withdrawal in Clinical Trials and Human Dependence Study – Design and Considerations | A Lerner![]() ![]() |
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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![]() ![]() |
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Q & A and Panel Mediated Discussion | S Butler*![]() |
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Presentation of the Andrew C. Leon Distinguished Career Award | R Keefe![]() S Romano ![]() ![]() |
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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![]() ![]() |
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Clinical Perspective on Conducting Trials in Major Depressive Disorder | J Kent ![]() ![]() |
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Clinical Perspective on Conducting TRD Studies | H Eriksson![]() ![]() |
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Regulatory Perspective—CHMP | K Broich![]() ![]() |
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Advancing our Thinking About Partially Responsive MDD and TRD | T Laughren![]() ![]() |
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Panel Discussion | J Kent H Eriksson K Broich T Laughren C Nelson M Mathis ![]() |
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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 ![]() |
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Introduction | A Faden R Ferziger ![]() ![]() |
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State of Affairs | ||
Traumatic Brain Injury State of the State | G Ling![]() ![]() |
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State of the Science | ||
Scientific Opportunities and Key Unknowns in TBI Research | S Hinds![]() ![]() |
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TBI: Translational Issues and Opportunities 1 | A Faden![]() ![]() |
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TBI: Translational Issues and Opportunities 2 | J Povlishock![]() ![]() |
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Research at FDA on TBI Pathophysiology and Biomarker Development | C Welle![]() ![]() |
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Discussant | D Hovda*![]() |
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State of the Pipeline | ||
TBI Clinical Trials: Past, Present and Future | D Hack![]() ![]() |
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Reconceptualizing TBI Assessment and Clinical Trial Design | G Manley![]() ![]() |
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Regulatory Perspectives | C Pena*![]() |
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Discussant and Moderator | G Ling*![]() |
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State of Investment What Would it Take to Increase Public-Private Partnership in TBI Treatment Development? |
M Anderson![]() M Stebbins S Romano G Ling R Ferziger ![]() |
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State of Selected Treatment Targets Reports from TBI Treatment Development Working Group Chairs: |
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Neuroinflammation | D Loane![]() ![]() |
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Biomarkers Development for TBI | G Small![]() ![]() D Smith ![]() ![]() |
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TBI & Sleep Disorders | M Yochelson**![]() E Wickwire** ![]() |
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TBI – Neuropsychiatric Sequelae | L Davis![]() ![]() |
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Post-Traumatic Headache: Opportunities and Challenges for Clinical Trials | J Erickson**![]() |
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Responses from Experts Panel and Open Discussion | Panel![]() |
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Meeting Adjourned | ||
* No slides presented ** Slides not released *** Video not released |