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Synergy in Action

4th Annual Scientific Meeting

25 – 27 February, 2008   //   Washington DC, USA

Day 1 (25 February 2008)

Welcome G Gharabawi
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SESSION I: Addressing Controversies Surrounding Antidepressant Black Box Warnings Co-chairs:
AC Leon
RJ Baldessarini
Identifying the Issues and Case Study AC Leon
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Overview of Clinical Perspectives RJ Baldessarini
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Statistical Issues: Meta-Analytic Approaches to Safety Data S-L Normand
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Panel Discussion video AC Leon
R Baldessarini
SL Normand
Consumer Perspective on Black Boxes J McNulty
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Legal Implications of a Black Box Warning N Chayet
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Audience Q&A video  
The Regulatory Basis for a Black Box Warning T Laughren
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Panel Discussion video  
Summary of Session R Baldessarini
Dinner Debate: Views on the Evolving Relationship Between Journal Editors and Authors: Is a Two-Tiered Approach for Industry and Academic Authors Beneficial? Chair:
R Keefe
Summary of Dinner Debate A Breier
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J Kane
W Carpenter

Day 2 (26 February 2008)

SESSION II: Patient Reported Outcomes: New Approaches Using Item Banks and Computerized Adaptive Assessments Co-chairs:
G Awad
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N Schooler
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Objectives and Introduction N Schooler
G Awad
Overview of the NIH PROMIS Roadmap Initiative W Riley
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Patient Reported Outcomes: Use in Psychiatry and Neurology: Experience with PROMIS and Neuro-QOL D Victorson
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Patient Reported Outcomes in the Experiences of Participating in Clinical Trials Study (EPICS) J Weissman
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Application Of New Patient Reported Outcome Measures and Methods in Psychiatry and Neurology Clinical Trials D Revicki
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FDA Perspective: Regulatory Perspective on New Approaches to Endpoint Measurement L Burke
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Industry Perspective: Item Banks and Computerized Adaptive Assessment R Morlock
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General Discussion G Awad
Summary of Session N Schooler
SESSION III: Methodological Challenges in Clinical Trials to Develop Devices for CNS Indications Co-chairs:
R Keefe
S Lilienfeld
Objectives and Introduction S Lilienfeld
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FDA Perspective: The Role of Basic Science in the Design of Clinical Trials of CNS Devices V Krauthamer
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General Statistical Challenge for CNS Devices – A Regulatory Perspective G Campbell
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Clinical Trail Methodology Challenges Faced in Evaluating a Medical Device for Diagnosis and Medication Response Monitoring: Regulatory Issues Encountered M Teicher
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Clinical Trial Methodology Challenges
in a Device Used in Chronic
Neurological/Psychiatric Disorders
S Brannan
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Clinical Trial Methodology and
the Study of Medical Devices in
Major Depression
M Demitrack
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Panel and General Discussion video S Lilienfeld
M Teicher
M Demitrack
S Brannan
SUMMARY OF SESSION R Keefe
S Lilienfeld

Day 3 (27 February 2008)

SESSION IV: Strategies For Using Data From Large Clinical Trials To Develop Public Health Policy Co-chairs:
L Alphs
R Ferziger
Introduction and Objectives R Ferziger
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Designing Clinical Research to Inform Mental Health Policy P Wang
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Value of Research Analysis on the Comparative Cost Effectiveness of Antipsychotic Drugs D Meltzer
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National Comparative Effectiveness Policy: The Case for Antipsychotic Drugs D Polsky
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The Changing Landscape of Stakeholders and Collaborators in Psychiatry Clinical Trials H Goldman
Panel Discussion video R Ferziger
D Meltzer
M Schoenbaum
J McNulty
R Manderscheid

D Regier
S Gottlieb
SUMMARY OF SESSION R Ferziger
SESSION V: Methodological Challenges in Neuropathic Pain Trials Assessments Co-chairs:
R Anand
P Marchettini
Introduction and Objectives R Anand
New Approaches to Nosology, Diagnosis, and Treatment of NP R Anand
Challenges in the Nosology, Diagnosis and Treatment of NP P Marchettini
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Pharmaceutical Industry Perspective and Developing Treatments for NP J Messina
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Limitations of the New Definition of Neuropathic Pain D Bouhassira
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Roundtable Discussion video  
Alternative Approaches to Nosology and Diagnosis of Neuropathic Pain: Perspective of a Neurologist J Serra
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Regulatory Concepts of NP: An EU Perspective C Sampaio
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Roundtable Discussion video  
Closing Remarks L Alphs
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Adjourn