This year the forum will be focusing on "The current status of the application of
Bayesian Methods in Drug Development"
In the last years the biostatistics community has increased its interest in the application of Bayesian methodology in drug development as it provides a framework for determining probabilities relevant to inferences from current trials and previous knowledge.
Bayesian statistics has the potential to play an important role throughout the drug/device development process life cycle and in particular in the decision-making process. Its range of applications contains early phase studies, dose- finding, safety analyses, meta-analyses, decision theory as well as the quantification of the benefits and risks essential to health economic evaluation. While the use of Bayesian methodologies has significantly increased in the recent years in exploratory clinical trials, its use in confirmatory clinical trials is still not common.
In total there will be 13 representatives at the Forum all of whom bring considerable expertise and a wide knowledge of the industry. Chairing the discussions will be Frank Fleischer who is the Global BCA at Boehringer Ingelheim Pharma GmbH & Co. Giacomo Mordenti the Senior Director Compound Development & Branding-Head of Biostatistics for Grünenthal, Jens-Otto Andreas who is the Head of EU Biostatistics at UCB Biosciences GmbH and Lisa Comarella who is the Director of Biostatistics and the Senior Project Manager at CROS NT Group.
The speakers at the forum will be;
Bruno Boulanger- CSO and Company co-founder of Arlenda.
Emmanuel Lesaffre - Professor in Biostatistics and Chair Department of Biostatistics.
Giuseppe Palermo - Statistician at F. Hoffman-La Roche.
Foteini Strimenopoulou - Senior Exploratory Statistician at UCB.
Pantelis Vlachos - Principal Biostatistician at Cytel Inc.
Heinz Schmidli - Statistical Methodology at Novartis Pharma AG.
Eugène Cox - Vice President & Managing Director for Quantitative Solutions BV.
Nicky Best - Senior Director at Statistical Innovation Group, GSK.
Dominic Magirr - Postdoc, Medical University of Vienna, Center for Medical Statistics and Informatics and Intelligent Systems.
The day promises to be interesting and informative for all industry professionals within biostatistics. Kubo are honoured to be a part of this and look forward to meeting with you. Feel free to call by our stand and introduce yourself during the coffee breaks.
During Phase III development, efficacy of the drug should be confirmed. Many new products have to find a very specific mechanism of effectiveness, so therefore subpopulations are necessary. Flexible study designs that allow for early termination and the use of fewer patients can be a successful solution for determining clinical efficacy. In oncology trials, we need to take into consideration differentiating factors such as slow patient recruitment, the importance of patient genotype, the use of various treatment combinations and the fact that the primary endpoint is overall survival time or time to progression. 
