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Synergy in Action

2007 Mid-Year Conference

17 – 18 September, 2007   //   Brussels, Belgium

Related Publications

NR Schooler, AH Kalali, L Alphs, R Anand, G Awad, M Davidson, S Dubé, L Ereshefsky, G Gharabawi, AC Leon, JP Lepine, SG Potkin, A Vermeulen What is Causing the Reduced Drug-Placebo Difference in Recent Schizophrenia Clinical Trials and What Can be Done About It?
Schizophrenia Bulletin 2008, Vol. 36, No. 3;

Day 1 (17 September 2007)

Welcome G Gharabawi
Global Clinical Trials: Opportunities and Challenges Co-chairs:
J Rasmussen
L Ereshefsky
Summary of Issues Session on Global Clinical Trials Part I L Ereshefsky
slides
Overview of Opportunities and Challenges to Global Clinical Trials J Rasmussen
slides
EUROPEAN VIEWPOINT  
Introduction C Sampaio
slides
Regulatory Issues and Concerns on Safety and Efficacy Data Obtained From CNS Global Trials: Focus on Neurology C Sampaio
slides
Issues and Concerns on Safety and Efficacy Data Obtained From Global Trials for Anxiety JP Lepine
slides
Case Study: Differences in Trial Design/Conduct and Results from Regional Clinical Trials R Kahn
slides
Issues and Concerns on Safety and Efficacy Data Obtained From Global Trials for Alzheimer’s Disease R Anand
ASIAN VIEWPOINT  
Introduction: Role of ICH E-5 Guidelines and New Strategies for Global Drug Development L Ereshefsky
slides
Regulatory Issues and Concerns on Safety and Efficacy Data Obtained From CNS Global Trials: View from Japan Y Uyama
slides
Update on Clinical Development and Regulatory Approval Issues in China BP Chan
BIOLOGICAL AND POLICY FACTORS THAT MAY INFLUENCE STUDY RESULTS  
Setting the Stage: Identified and Theoretical Issues to Consider – Factors that Influence Data Quality B Edwards
slides
Metrics Used for Site Selection in Global Clinical Trials A Kalali
Biological Differences Between Regions (Response Polymorphisms) K-M Lin
slides
Regional Policy and Procedural Issues that Influence Clinical Trial Results S Richter
slides
SUMMARY OF SESSION R Mahmoud
Final Comments G Gharabawi
Dinner Talk: “The ‘TeGenero incident’ and its effect onCRO approaches to Phase I work” J Lambert

Day 2 (18 September 2007)

WHAT IS CAUSING THE REDUCED DRUG-PLACEBO DIFFERENCE IN OUR RECENT SCHIZOPHRENIA TRIALS AND WHAT CAN WE DO ABOUT IT?” What Is Causing the Reduced Drug-Placebo Difference in Recent Schizophrenia; Aaron S. Kemp; Schizophrenia Bulletin  (free access) Co-chairs:
N Schooler
A Kalali
INTRODUCTION N Schooler
A Kalali
NATURE OF THE PROBLEM  
Historical Perspective on Drug-Placebo Differences: Implications for Future Trial Design L Alphs
slides
Reduced Drug Placebo Differences: Evidence from Recent Phase III Trials S Potkin
slides
What Have We Learned from Conducting Clinical Trials in Depression? S Dube
SEARCH FOR THE CAUSES  
Identifying the Nature of the Problem: The Use Of PK/PD Modeling to Understand Changes in Drug-Placebo Differences A VerMeulen
slides
Possible Causes of Diminishing Drug-Placebo Responsiveness A Kalali
N Schooler
ROUNDTABLE: POTENTIAL SOLUTIONS TO THE DIMINISHING DRUG RESPONSE DILEMMA  
Roundtable Discussants Anand, Ereshefsky, Gharabawi, Leon, Lepine
Round 1: Site Profiles L Ereshefsky
Round 2: Patient Profile R Anand
Round 3: Enhanced Assessment Procedures: Implications for Sample Size Requirements A Leon
Round 4: Study Design G Gharabawi
SUMMARY OF SESSION N Schooler
A Kalali
Adjourn G Gharabawi