Monday, 16 November 2015 - Vienna, Vienna Marriott Hotel
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.
Recently there have been many new developments and applications in this field, for example extensions to the continual reassessment method (CRM) like time-to-event continual reassessment method (TITE-CRM) or inclusion of biomarkers, Bayesian group sequential designs and methods for efficient dose finding like Multiple Comparisons & Modeling (MCP-Mod). The use of such techniques has recently been embraced by EMA in the face of dose response testing and estimation models uncertainties. Statistics has thereby helped to improve the process of efficient drug development and is continuing to do so.
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 GmbH
Lisa Comarella - Director Biostatistics, CROS NT Group
Frank Fleischer - Global BCA, Boehringer Ingelheim Pharma GmbH & Co. KG
Giacomo Mordenti - Head of Biostatistics, Grünenthal
will share best practices, results and experiences in this field.
The conference is addressed to statisticians, pharmacometricians, physicians, regulators, academia and other experts interested in the field of early drug development, belonging to:
• Pharmaceutical, and Biotechnology companies
• Academic Research
Sunday, 15th November, 7:30 pm
Restaurant Der Kuckuck
Himmelpfortgasse 15, 1010 Vienna
The meeting is set for 7.15 pm at the restaurant.
If you would like to attend the conference + the pre-conference dinner, please check the option on the registration form or online.
The dinner will provide an opportunity for you to network informally with your industry peers. Please confirm your interest on the registration form.