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Synergy in Action

2012 Autumn Conference

01 – 03 October, 2012   //   Marina del Rey, California USA

Poster Awardee:

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
All Poster Abstracts are available at the end of the second day
Sample Presentation: Lon Schneider – Link found on Day 3

Day 1 (1 October 2012)

Session 1: Concurrent Workshops  
  Adaptive Design G Haynes
T Parke
slides slides
slides audio
J Kando
slides slides
slides audio
slides Report Back
  Integrated Imaging and Genetic Biomarkers in Schizophrenia H Riordan
slides slides
S Potkin
slides Report Back
Session Summary
  Cognitive Assessment in AD H Posner
slides slides
P Harvey
slides slides
T Goldberg
slides slides
V Logovinsky
slides slides
N Raghavan
slides slides
D Mungas
slides slides
S Hendrix
slides slides
slides Report Back
  Medication Development for Stimulant Dependence J Palumbo
slides slides
T Kosten
slides slides
T Whitfield
slides slides
slides Report Back
  Negative Symptoms S Marder
D Daniel

slides slides
slides Report Back
Session Summary
  Precision Medicine in CNS Clinical Trials D Feltner
A Power

slides slides
slides Report Back
  Psycho-social Treatment Platforms in Psychopharmacology N Schooler
D Velligan

slides slides
slides Report Back
  Signal Detection A Kalali
slides Report Back

Day 2 (2 October 2012)

Presidential Welcome R Keefe
slides slides
video
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
  Introduction N Schooler
slides slides
video
  What are the Major Considerations for Explanatory (efficacy) and Pragmatic (effectiveness) Trials? G Haynes
slides slides
video
  Assessing Effectiveness in Naturalistic Data D Faries
slides slides
video
  Epidemiologic, Regulatory, and Methological Considerations in the Design of a Trial with Both Pragmatic and Explanatory Features: the InterSePT Experience R Anand
slides slides
video
  Combining Medications to Enhance Depression Outcomes (CO-MED): A Clinical Trial that Combined Explanatory and Pragmatic Elements J Severe
slides slides
video
  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
slides slide
video
  Where Did Pragmatic Trials Come From? The Slow Train Coming . . .  C Adams
slides slides
video
  Pragmatic Studies: Why Do Payers Care? R Epstein
slides slides
video
  Where are Pragmatic Trials Going? Keeping the Slow Train on the Tracks C Adams
slides slides
video
  US Regulatory Perspective NA Khin
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  Australian Regulatory Perspective G McColl
slides slides
video
  Panel and Audience Discussion video
  Summary L Alphs
video
Session 3: Neurocognition and Social Cognition as Endpoints for Clinical Trials Chairs:
M Green
S Marder
  Neurocognition and Social Cognition: Overview and Relationships to Outcome M Green
slides slides
video
  Evaluating Outcome Measures for Clinical Trials of Social Cognition in Schizophrenia P Harvey
slides slides
video
  Experience from Multi-Site Clinical Trials on Neurocognition versus Global Cognition Endpoints K Nuechterlein
slides slides
video
  Addressing Challenges in the International Assessment of Social Cognition G Hellemann
slides slides
video
  Regulatory Impressions and Discussion NA Khin
  Panel and Audience Discussion video
Poster Reception Poster Abstracts

Day 3 (3 October 2012)

Parallel Sessions
Session 4A: Clinical Trials in Autism Spectrum Disorders: Methods, Measurements, Designs, and Outcomes Chairs:
D Feltner
J Horrigan
  Introduction D Feltner
slides slides
video
  The Autism Spectrum: Clinical Features and Targets for Treatment L Scahill
slides slides
video
  Practical Issues in the Design and Conduct of Autism Spectrum Disorder Clinical Trials J Horrigan
slides slides
video
  Translational Methods for Demonstrating Clinical Efficacy J Veenstra-VanderWeele
slides slides
video
  Review of Trial Designs in Past Randomized Controlled Trials in Autism Spectrum Disorders C Erickson
slides slides
video
  Methodological Lessons Learned from an Autism Development Program and Approval L Scahill
slides slides
video
  Two Industry-Sponsored Clinical Development Programs in Autism Spectrum Disorders D Umbricht
slides slides
video
S Graham
  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
  Introduction and Objectives of Session Chairs
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  Stratified Medicine for AD Drug Development M Trusheim
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video
  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
slides slides
  Simulating Stratified Medicine Trials in AD L Schneider
slides slides
video
  Discussion: What Have We Learned About Stratified Trials and Development Programs? Next Steps and What Can Be Done Now B Greenberg
(Discussant)
slides slides
video
  Panel and Audience Discussion video
Meeting Adjourns