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  slides audioJ Kando slides audio Report Back |
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| Integrated Imaging and Genetic Biomarkers in Schizophrenia | H Riordan slides S Potkin Report BackSession Summary |
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| Cognitive Assessment in AD | H Posner slides P Harvey slidesT Goldberg slidesV Logovinsky slidesN Raghavan slidesD Mungas slidesS Hendrix slides Report Back |
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| Medication Development for Stimulant Dependence | J Palumbo slides T Kosten slidesT Whitfield slides Report Back |
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| Negative Symptoms | S Marder D Daniel slides Report BackSession Summary |
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| Precision Medicine in CNS Clinical Trials | D Feltner A Power slides Report Back |
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| Psycho-social Treatment Platforms in Psychopharmacology | N Schooler D Velligan slides Report Back |
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| Signal Detection | A Kalali Report Back |
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Day 2 (2 October 2012) |
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| Presidential Welcome | R Keefe slides video |
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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 slides video |
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| What are the Major Considerations for Explanatory (efficacy) and Pragmatic (effectiveness) Trials? | G Haynes slides video |
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| Assessing Effectiveness in Naturalistic Data | D Faries slides video |
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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 slides video |
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| Combining Medications to Enhance Depression Outcomes (CO-MED): A Clinical Trial that Combined Explanatory and Pragmatic Elements | J Severe slides video |
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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 slide video |
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| Where Did Pragmatic Trials Come From? The Slow Train Coming . . . | C Adams slides video |
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| Pragmatic Studies: Why Do Payers Care? | R Epstein slides video |
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| Where are Pragmatic Trials Going? Keeping the Slow Train on the Tracks | C Adams slides video |
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| US Regulatory Perspective | NA Khin slides |
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| Australian Regulatory Perspective | G McColl slides video |
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| Panel and Audience Discussion | video |
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| Summary | L Alphs video |
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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 slides video |
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| Evaluating Outcome Measures for Clinical Trials of Social Cognition in Schizophrenia | P Harvey slides video |
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| Experience from Multi-Site Clinical Trials on Neurocognition versus Global Cognition Endpoints | K Nuechterlein slides video |
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| Addressing Challenges in the International Assessment of Social Cognition | G Hellemann slides video |
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| Regulatory Impressions and Discussion | NA Khin | |
| Panel and Audience Discussion | video |
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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 slides video |
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| The Autism Spectrum: Clinical Features and Targets for Treatment | L Scahill slides video |
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| Practical Issues in the Design and Conduct of Autism Spectrum Disorder Clinical Trials | J Horrigan slides video |
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| Translational Methods for Demonstrating Clinical Efficacy | J Veenstra-VanderWeele slides video |
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| Review of Trial Designs in Past Randomized Controlled Trials in Autism Spectrum Disorders | C Erickson slides video |
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| Methodological Lessons Learned from an Autism Development Program and Approval | L Scahill slides video |
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| Two Industry-Sponsored Clinical Development Programs in Autism Spectrum Disorders | D Umbricht slides video 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 slides |
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| Stratified Medicine for AD Drug Development | M Trusheim slides video |
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| The Impact of ApoE4 Carriage on Clinical Trials | T Goldberg slides |
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| Strategies for the Accelerated Evaluation of Preclinical AD Treatments in ApoE4 and Autosomal Dominant Mutation Carriers | E Reiman slides |
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| Simulating Stratified Medicine Trials in AD | L Schneider slides video |
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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) slides video |
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| Panel and Audience Discussion | video |
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| Meeting Adjourns | ||