Dear Colleague,
after the great success of 2014 edition, EasyB – LS Academy is pleased to announce the sixth edition of European Statistical Forum:
Applications of statistical methodology in early drug development
Monday, 16th of November 2015
Vienna
The field of early drug development provides various challenges with respect to the application of statistical methodology. Main focus is to know the compound characteristics in terms of doses and regimen, efficacy and safety, subpopulations and predictive biomarkers, pharmacokinetics and pharmacodynamics. Drug development teams may need to identify Maximum Tolerated Doses, design trials for Dose Finding, Proof of Principle and Proof Of Concept, ensure efficient definition of Go/No Go criteria up to PK/PD modeling.
The sixth edition of the European Statistical Forum is therefore dedicated to the application of statistical methodology in early drug development, in particular by presenting:
• current state-of-the art dose finding trial designs like MCPMod
• Statistical techniques on the integration of biomarker as well as pharmacogenetic data into the early drug development process
• Implementation of efficient Proof of Principle and Proof of Concept trials
• Transfer of the preclinical knowledge into first in human trials
• New developments in and designs for PK and PK/PD trials
• Recent enhancements in statistical methodology by leaders in academia
Both case studies and methodological background will be covered. The conference aims at promoting the exchange of expertise, bringing together statisticians, pharmacometricians, physicians, regulators, academia and other experts interested in the field of early drug development.
The Scientific Board:
– Jens-Otto Andreas, Head EU Biostatistics, UCB Biosciences
– Lisa Comarella, Director Biostatistics and Senior Project Manager, CROS NT Group
– Frank Fleischer, Global BCA, Boehringer Ingelheim Pharma
– Giacomo Mordenti, Senior Director Compound Development & Branding-Head Biostatistics, Grünenthal
would like to invite you to be part of the panel of speakers. If you want to contribute to the agenda, please submit your abstract according to the attached guidelines by Thursday, 12th March.
For further information or if you would like to reserve a place, please visit the website www.esforum.eu and do not hesitate to contact me.
Best Regards,
Enrico Pedroni
Event Manager European Statistical Forum