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Synergy in Action

7th Annual Scientific Meeting

plus 2011 ISCTM National Mental Health Research-to-Policy Forum
21 – 23 February, 2011   //   Washington DC, USA

Poster Awardees

The Virtual Reality Functional Capacity Assessment Tool (VRFCAT): A New Co-Primary Cognitive Measure for Schizophrenia Drug Trials
K Fox, S Ruse, V Davis, R Pietrobon, P Harvey, R Krishnan, R Keefe
Neurocognitive Performance and Self-Reported Sedation Following Administration of Lorazepam
J Yen-Revollo, ABoyd, D Morgan, D Loring, K Meador
All poster abstracts are available for public viewing. Link found at end of Day 2

Day 1 (21 February 2011)

President’s Welcome L Alphs
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SESSION 1: Do Clinical Results to Date Suggest that Drug Development Based on the Amyloid Hypothesis of Alzheimer’s Disease Is Dead?
SESSION SUMMARY
Chairs:
R Anand
L Ereshefsky
D Feltner
  Introduction L Ereshefsky
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R Anand
L Ereshefsky

video
  The Amyloid Hypothesis of AD: A Critical Reappraisal of its Origin and Genetic Basis R Anand
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  Pre-clinical Models of Alzheimer’s Disease: Does the Evidence Predict Success of Aß Modifying Therapies F LaFerla
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 video not released
  Progress in biomarker research in AD: Summary of findings from ADNI initiative H Soares
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  Overview of Recent Clinical Trials: Ways Forward L Schneider
slides materials not released
  Unexpected Results from A Γ-Secretase Inhibitor for Alzheimer’s Disease: Implications for The Amyloid Hypothesis D Henley
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  Panel video
  Designing the Next Generation of Disease – Modifying Trials In AD ‐ Moving Forward G Grossberg
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  Under What Circumstances Would a Biomarker/Surrogate Measure be Accepted as a Primary Efficacy Variable? R Katz
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  What is Required to Accept a Biomarker as Primary Outcome Measure – an EU Regulatory Perspective K Broich
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  Panel video
R Anand
K Broich
L Ereshefsky
G Grossberg
R Katz
F LaFerla
L Schneider
Working Group Dinner Sessions  
  WG1: Adaptive Design  
  WG2: Suicidal Thinking and Behavior Assessment Summary
  WG3: Placebo  
  WG4: Mitochondrial Systems Summary
  WG5: Negative Symtoms Summary
  WG6: Biomarkers  

Day 2 (22 February 2011)

2011 ISCTM National Mental Health
Research-to-Policy Forum

Impact of National Health Reform and Shifting National Priorities on Mental Health Research-to-Policy-to-Implementation
R Ferziger
R Manderscheid
  Welcome, Introductions, Goals
Setting the Context for the Forum and for Policy
R Ferziger
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R Manderscheid
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Ferziger/Manderscheid
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  From Research to Policy (and Back Again): The View from NIMH T Insel
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  Research: A Matter of Mission (One Federal Agency’s Story) C Curie
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  Panel
(Panel discussion is located at the end of the Curie video)
A Basu
R Mahmoud
E Sorel
L Ostrow
  Audience Discussion  
  Aligning Information with Decision Making A Basu
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  The Future of Privately Funded CNS Clinical Research R Mahmoud
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  The Future of Privately Funded CNS Clinical Research E Sorel
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  Peer-Run and Delivered Mental Health Services L Ostrow
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  Panel/Audience Discussion video
SESSION 2: Class Labeling: Implications for Treatment and Challenges to Differentiation in Development S Romano
S Potkin
  Introductory Comments and Problem Statement S Romano
  Industry Perspective on Class Labeling: Opportunities and Challenges
(video contains Romano Introductory Comments / Problem Statement and Industry Perspective)
S Romano
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  Class Labeling for Psychiatric Drugs: Academic Perspective S Potkin
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  The Adequacy of Class Label Communication B Fischhoff
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  Effect of Class Labeling on CT Safety Parameter Assessments, Inclusion/Exclusion Criteria, General Trial Conduct Facilitated Panel
  Class Labeling for Psychiatric Drugs: FDA Perspective T Laughren
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  Class Labeling Implications for Treatment and Challenges to Differentiation in Development: Regulatory Viewpoints K Broich
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  Implications for Developing New Treatments and Post-Approval Data Requirements Facilitated Panel
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Poster Session View All Poster Abstracts

Day 3 (23 February 2011)

SESSION 3: Developing Products for Personalized Medicine: Facing the Challenges of Biomarkers L Alphs
K Broich
  Welcome and Introduction K Broich
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  The Opportunities and Challenges of Biomarkers: A View from the FDA J Woodcock
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  Short and Long-term Vision for Biomarkers L Alphs
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  Challenges for Biomarker Discovery: Psychiatric Disorders – An NIMH Perspective L Brady
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video not released
  Clinical Development of Biomarkers: Lessons Learned in CVD – An Industry Perspective J Creeden
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  Biomarkers as Tools for Clinical Development Expectations, Opportunities and Challenges: A Payer Perspective R Epstein
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  A Regulatory Perspective on Biomarkers in Psychiatric Drug Development: An FDA Perspective T Laughren
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  Biomarkers as Tools for Clinical Development: Emphasis on Safety: An EU Perspective K Broich
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  Biomarker Qualification: What it means, What it is for, What it is Not M Walton
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  ADNI Case Study: EU Experience and Views H Hampel
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  Workshop Report Back & Critique Panel video
R Epstein
T Laughren
K Broich
R Anand
E Petkova
  Breakout 1
Leaders: Bowden/Walton/Brady
Presentation
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  Breakout 2
Leaders: Garibaldi/Haynes/Lebowitz
Presentation
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  Breakout 3
Leaders: Leon/Meltzer/Messina
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  Breakout 4
Leaders: Cantillon/Marshall/Ereshefsky
Presentation
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  Final Discussion and Summary  
Meeting Adjourns  
* Materials have not been released.