2012 Autumn Conference
01 – 03 October, 2012 // Marina del Rey, California USA
Poster Awardee: |
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Circadian Rhythms and Cognition: Using Time of Day Effects To Enhance Signal Detection in Clinical Trials of Pro-Cognitive Therapies for Schizophrenia M Hufford, V Davis, N Dgetluck, M Gawryl, D Hilt, A Rappaport, R Keefe |
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All Poster Abstracts are available at the end of the second day Sample Presentation: Lon Schneider – Link found on Day 3 |
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Day 1 (1 October 2012) |
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Session 1: Concurrent Workshops | ||
Adaptive Design | G Haynes T Parke ![]() ![]() J Kando ![]() ![]() ![]() |
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Integrated Imaging and Genetic Biomarkers in Schizophrenia | H Riordan![]() S Potkin ![]() Session Summary |
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Cognitive Assessment in AD | H Posner![]() P Harvey ![]() T Goldberg ![]() V Logovinsky ![]() N Raghavan ![]() D Mungas ![]() S Hendrix ![]() ![]() |
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Medication Development for Stimulant Dependence | J Palumbo![]() T Kosten ![]() T Whitfield ![]() ![]() |
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Negative Symptoms | S Marder D Daniel ![]() ![]() Session Summary |
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Precision Medicine in CNS Clinical Trials | D Feltner A Power ![]() ![]() |
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Psycho-social Treatment Platforms in Psychopharmacology | N Schooler D Velligan ![]() ![]() |
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Signal Detection | A Kalali![]() |
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Day 2 (2 October 2012) |
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Presidential Welcome | R Keefe![]() ![]() |
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Session 2: Statistical, Clinical, Payer and Regulatory Perspectives on Dimensions that Define the Spectrum of Efficacy/Explanatory and Effectiveness/Pragmatic Trials | Chairs: L Alphs N Schooler G Haynes |
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Introduction | N Schooler![]() ![]() |
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What are the Major Considerations for Explanatory (efficacy) and Pragmatic (effectiveness) Trials? | G Haynes![]() ![]() |
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Assessing Effectiveness in Naturalistic Data | D Faries![]() ![]() |
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Epidemiologic, Regulatory, and Methological Considerations in the Design of a Trial with Both Pragmatic and Explanatory Features: the InterSePT Experience | R Anand![]() ![]() |
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Combining Medications to Enhance Depression Outcomes (CO-MED): A Clinical Trial that Combined Explanatory and Pragmatic Elements | J Severe![]() ![]() |
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Addressing Explanatory and Pragmatic Endpoints in a Single Trial: PRIDE a Study in Schizophrenic Persons Who Have Been in the Criminal Justice System | L Alphs![]() ![]() |
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Where Did Pragmatic Trials Come From? The Slow Train Coming . . . | C Adams![]() ![]() |
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Pragmatic Studies: Why Do Payers Care? | R Epstein![]() ![]() |
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Where are Pragmatic Trials Going? Keeping the Slow Train on the Tracks | C Adams![]() ![]() |
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US Regulatory Perspective | NA Khin![]() |
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Australian Regulatory Perspective | G McColl![]() ![]() |
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Panel and Audience Discussion | ![]() |
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Summary | L Alphs![]() |
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Session 3: Neurocognition and Social Cognition as Endpoints for Clinical Trials | Chairs: M Green S Marder |
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Neurocognition and Social Cognition: Overview and Relationships to Outcome | M Green![]() ![]() |
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Evaluating Outcome Measures for Clinical Trials of Social Cognition in Schizophrenia | P Harvey![]() ![]() |
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Experience from Multi-Site Clinical Trials on Neurocognition versus Global Cognition Endpoints | K Nuechterlein![]() ![]() |
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Addressing Challenges in the International Assessment of Social Cognition | G Hellemann![]() ![]() |
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Regulatory Impressions and Discussion | NA Khin | |
Panel and Audience Discussion | ![]() |
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Poster Reception | Poster Abstracts | |
Day 3 (3 October 2012) |
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Parallel Sessions | ||
Session 4A: Clinical Trials in Autism Spectrum Disorders: Methods, Measurements, Designs, and Outcomes | Chairs: D Feltner J Horrigan |
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Introduction | D Feltner![]() ![]() |
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The Autism Spectrum: Clinical Features and Targets for Treatment | L Scahill![]() ![]() |
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Practical Issues in the Design and Conduct of Autism Spectrum Disorder Clinical Trials | J Horrigan![]() ![]() |
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Translational Methods for Demonstrating Clinical Efficacy | J Veenstra-VanderWeele![]() ![]() |
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Review of Trial Designs in Past Randomized Controlled Trials in Autism Spectrum Disorders | C Erickson![]() ![]() |
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Methodological Lessons Learned from an Autism Development Program and Approval | L Scahill![]() ![]() |
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Two Industry-Sponsored Clinical Development Programs in Autism Spectrum Disorders | D Umbricht![]() ![]() S Graham |
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Panel and Audience Discussion | ||
Session 4B: Stratified Medicine and Targeted Clinical Trials for Alzheimer’s Disease Drug Development in Light of Recent Phase III Trial Results: Example ApoE Genotype | Chairs: L Schneider T Goldberg L Ereshefsky SESSION SUMMARY |
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Introduction and Objectives of Session | Chairs![]() |
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Stratified Medicine for AD Drug Development | M Trusheim![]() ![]() |
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The Impact of ApoE4 Carriage on Clinical Trials | T Goldberg![]() |
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Strategies for the Accelerated Evaluation of Preclinical AD Treatments in ApoE4 and Autosomal Dominant Mutation Carriers | E Reiman![]() |
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Simulating Stratified Medicine Trials in AD | L Schneider![]() ![]() |
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Discussion: What Have We Learned About Stratified Trials and Development Programs? Next Steps and What Can Be Done Now | B Greenberg (Discussant) ![]() ![]() |
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Panel and Audience Discussion | ![]() |
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Meeting Adjourns |