Current Region: Europe
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Oct 2 2013 9:00AM - Oct 4 2013 4:00PM | Hilton London Docklands Riverside Hotel
265 Rotherhithe Street
Lifecycle management is a widely accepted concept for development and marketing of medicines. At each step of this process, pre- and post-licensing, statisticians work to develop methods that can improve efficiency and can enhance decision making through optimal study design, analysis and inference.
The meeting aims to discuss the latest developments in statistical methodology and decision making in exploratory development, confirmatory development, licensing decisions and management of benefits and risks post-licensing. The discussions will consider not only the methods themselves, but how best to integrate methods for use in a regulatory context. Beyond this, the meeting seeks to ask whether there are advances in the collection and understanding of real world data that can inform and improve the design of confirmatory clinical trials.
PRE-WORKSHOP TUTORIAL ON KEY STATISTICAL TOPICS IN DRUG DEVELOPMENT (HALF-DAY) AVAILABLEWEDNESDAY I 2 OCTOBER 2013 | 09:00-12:30
Tutorial 2 - DOSE-FINDING IN DRUG DEVELOPMENT: CHALLENGES AND SOLUTIONSTutorial Instructors:
Bjoern Bornkamp, Expert Statistical Methodologist – Integrated Information Sciences, Novartis Pharma AG, SwitzerlandByron Jones, Senior Biometrical Fellow/Executive Director, Novartis Pharma AG, Switzerland
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Who Will AttendProfessionals with an interest in the application of, and research into, statistics in the drug development process from the pharmaceutical industry, academia, regulatory and governmental agencies, as well as contract research organisations.
Hilton London Docklands Riverside265 Rotherhithe StreetSE16 5HW LondonUnited Kingdom
Tel.: +44 (0)20 7231 1001Fax: +44 (0)20 7231 0599Email: email@example.com
At the rate of GBP 139.00 per room inclusive of breakfast, exclusive of VAT.
In order to book you room, please use this booking link:
The special room rate will be available until 16 August 2013 or until the group block is sold-out, whichever comes first.
If cancellation occurs within 7 days of arrival, a 100% cancellation charge will apply.
KÜCHENGASSE 16, POSTFACH
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
Statistics Unit ManagerMHRA , United Kingdom
DirectorCPRD, United Kingdom
Head of Epidemiology, VRMMMHRA, United Kingdom
Statistical MethodologistNovartis Pharma AG, Switzerland
Professor of Medical Statistics and Clinical TrialsImperial College London, United Kingdom
Head of early stage statisticsMerck Sharp & Dohme, Netherlands
Head, Early Clinical Development BiometricsAstraZeneca, United Kingdom
Head of Drug Discovery StatisticsBayer Pharma AG, Germany
Historically, the selection of doses for Phase III confirmatory studies has often been poor due to a lack of understanding of the relationship between efficacy and dose.
For an informed Phase III dose selection it is essential that the full shape of the dose-response curve is characterized in Phase II trials. Traditional Phase II designs that use a fixed choice of doses and rely on comparisons between dose means can be poor at doing this. Using analysis methods that estimate the complete dose-response relationship and allow the choice of doses to change in an adaptive manner during a Phase II trial lead to more informative studies and ultimately better planning for Phase III.
In this course we will describe methods for dose-response modeling with some focus on the MCPMod methodology, in addition we discuss adaptive dose-finding designs and will describe the main features of the DoseFinding R package. This package implements the methods described in this tutorial and will be illustrated on several examples
2) Dose-Response Modelling
4) Optimal designs / Adaptive design
Practical Decision Making Across The Lifecycle: Quantitative benefit risk analysis
There is a significant change coming to Europe regarding access to patient level data. EMA has decided to make individual patients' data from clinical trials available to third parties beginning January 1st, 2014. This session will present the ongoing rapid developments in this area from academic, regulatory and industry perspectives. It will touch upon key topics like ensuring patient confidentiality, data formats and transparency of requests and scientific purpose and will highlight the importance to the EU statistical community.
Many biologic medicines are being developed with the expectation that they may only be effective in a subgroup of patients. Planning a development programme investigating the utility of companion diagnostics and considering the subsequent population enrichment, is an active area of research. This session will provide an opportunity to hear about the current views and activities in the development of companion diagnostics and in population enrichment designs
Conducting a clinical trial is a risky business. Risk based monitoring is a phrase that can mean different things to different people. The session will focus on two different but important areas. Firstly, how clinical trials can be monitored in a proportional fashion, how risk-based approaches might be adopted, and how new legislation facilitates that. Secondly, how clinical trials can and should be monitored so that risks to the integrity of the trial are picked up, and crucially how statisticians should be involved in the process. The session will conclude with a round table discussion to discuss the issues raised with the wider audience.
Practical Decision Making across the lifecycle: Bayesian Approaches
The first part of the regulatory hot topics session will focus on 3 areas where there has been a lot of recent activity, both from regulators and from Industry: subgroup analyses, analysing recurrent event data, and handling missing data. These talks will set the scene for the key challenges in the area, highlighting the challenges for regulators, industry and academia alike.
Group Discounts Available – Send 3 participants and the 4th is free!
Conditions apply. Online registration not available for this offer. Call DIA in Europe on +41 61 225 51 51 or email for further information.