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Synergy in Action

2009 Autumn Conference

05 – 06 October, 2009   //   San Diego, California, USA

Poster Awardees

Test-Retest Characteristics of the MATRICS Consensus Cognitive Battery in a 29-Site Schizophrenia Clinical Trial of Lurasidone Versus Risperidone
K Fox
Differential Response to Treatment Across Countries in a Randomized Clinical Trial of Ziprasidone and Haloperidol in Patients With Bipolar Mania
E Vieta

Related Publications

Y Ando, A Hirakawa, Y Uyama
Adaptive clinical trials for new drug applications in Japan
slides European Neuropsychopharmacology: February 2011 (Volume 21, Issue 2)

V Dragalin
An Introduction to adaptive designs and adaptation in CNS trials
slides European Neuropsychopharmacology: February 2011 (Volume 21, Issue 2)

T Park
ISCTM: Implementing phase 2 dose finding adaptive clinical trials
slides European Neuropsychopharmacology: February 2011 (Volume 21, Issue 2)

S Wang, J Wang, R O’Neill
Adaptive design clinical trials and trial logistics models in CNS drug development
slides European Neuropsychopharmacology: February 2011 (Volume 21, Issue 2)

J Severe
How Can Registries Contribute to the Development and Evaluation of CNS Therapeutics
Innovations in Clinical Neuroscience: May-June 2013 (ISCTM Supplement #1)

Day 1 (5 October 2009)

SESSION 1: Adaptive Design for CNS Trials Chairs:
A Leon
D Berry
President’s Welcome
Overview, Rationale and Objectives of Session 1
L Alphs
A Leon
slides
slides
video
An Introduction to Adaptive Design and Adaptation V Dragalin
slides
slides
video
Adaptive Design Approaches in CNS Clinical Trials – A US Regulatory/Scientific Perspective HM Hung
SJ Wang
video
Bayesian Adaptive Trials and How Such Designs Can Best Be Used in CNS Trials D Berry
slides
slides
video
Challenges and Solutions for Implementing Adaptive Design T Parke
slides
slides
video
Practical Considerations in Designing and Executing Early Phase Adaptive Trials: An Industry Perspective R Lenz
slides
slides
video
Session Discussion – Q&A  
Update on FDA Guidance for Adaptive Design* SJ Wang
Update on EU Guidance for Adaptive Design A Koch
slides
slides
video
Regulatory Issues Related to Use of Adaptive Design in Japan Y Ando
slides
slides
video
Discussion Panel A Leon
Y Ando
HM Hung
A Koch
SJ Wang
video
Case Study 1
Facilitators: V Dragalin, T Parke, C Mallinckrodt slides slides
D Berry
R Lenz
Case Study 2
Facilitators: P Lim, V Sutton, Y Ando, G Sachs
W Olson
slides
slides
Poster Session View All Poster Abstracts

Day 2 (6 October 2009)

SESSION 2: Workshops

 
Introduction
Sources And Management of Placebo Effects in CNS Clinical Trials
Plenary Session
SUMMARY
Chairs:
A Kalali
C Bowden
slides slides
slides slides
Assessing and Methodologies for Treating Suicidality in Trials with CNS Drugs
Plenary Session
Chairs:
W Goodman
L Greenhill
slides slides
video
Methodological Issues for Studying Negative Symptoms of Schizophrenia
Plenary Session
Chairs:
S Marder
D Daniel
video
Challenges in Conducting Multi-Center Academic Trials
Plenary Session
Chairs:
N Schooler
J Severe
slides
slides
video
SESSION 3: Preparing for Medicine of the Future: Personalized Medicine:
Its Opportunities/Challenges and How to Meet Them

Chairs:
L Alphs
G Garibaldi
Introduction G. Garibaldi
slides
slides
video
Personalized Medicine in the Age of Genomics S Potkin
slides
slides
video
Optimizing the Approach to Personalized Medication: Selection of Indications, Study Populations and Endpoints D Feltner
slides
slides
video
Design and Statistical Challenges for Personalized Medicine and How to Meet Them N Schork
slides slides
slides video
Identifying and Meeting Regulatory Challenges for Indications in Personalized Medicine
(Materials submitted, but not presented)
K Broich
slides
slides
Session Summary L Alphs
slides
slides
slides video
Adjourn  
* Presentation materials have not as yet been released for publication in this forum.