14th Annual Scientific Meeting
20 – 22 February, 2018 // The Fairmont, Washington DC
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 |
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| 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 |
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| 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 |
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| Meeting Adjourned
*Slides not released |
C Canuso | ||