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International Clinical Trials

Sample Management Strategy

 

BioStorage Technologies are hosting Global Sample Management Benchmarking Symposium – the perfect opportunity to learn about the upcoming changes to the EU Clinical Trials Directive and discover innovative ways to make the most of research samples.

The conduct of clinical trials in Europe has been a complex and costly proposition since the implementation of the 2004 EU Clinical Trials Directive (EUCTD). The EUCTD established specific provisions regarding the conduct of clinical trials, including multi-centre trials, trials on human subjects and those involving medicinal products. In order to foster research in Europe, the European Commission is working on an overhaul to the existing directive that is expected to be released in 2012. The proper management of clinical trial research samples will be vital in order to support the expansion of new product research in Europe.

With this in mind, BioStorage Technologies has partnered with International Clinical Trials for its upcoming Global Sample Management Benchmarking Symposium. ‘The Future of Clinical Research in Europe: The Value of a Comprehensive Sample Management Strategy’ will be held in conjunction with Informa’s Partnering with Central Labs, ECG and Imaging Labs conference. Attendees will have the opportunity to hear first-hand about forthcoming changes to the EUCTD and how this may affect clinical trials taking place in Europe. This includes updates anticipated on patient informed consent, electronic communications and Good Clinical Practice.

The symposium will also focus on how to strategically plan for and leverage samples within clinical trials from an experimental, active clinical trial and post-trial perspective, and how technology can be used to support virtual sample management for improved research decision-making.

Today, biomaterials such as whole blood, human tissue, DNA and RNA serve as the foundation for translational research that promises to bring personalised therapeutics from bench to bedside. Furthermore, these materials are being used by organisations around the world as the basis for biomarker programmes, which can give researchers insight into predicting future patterns of disease. By incorporating biospecimen and biomarker components into discovery initiatives, it allows researchers to better understand cell biology and its impact on treatment options and patient prognosis. Through this new understanding, novel treatment options may be developed to target specific pathways for a wide range of diseases, such as cancer and Alzheimer’s. Biomarker assays may also help identify patients with specific mutations or abnormal protein expression in certain cell pathways, allowing for individualisation of therapies addressing specific abnormalities.

Given the intrinsic value of these materials, preserving research samples to the highest standards is critical, not only from an operational and scientific perspective, but also from regulatory, ethical and financial standpoints. As a result, it has become critical for biotechnology and pharmaceutical companies of all sizes to have a profound understanding of sample management strategies, and to employ biorepository operations that help ensure the long-term preservation of biospecimen samples.

The BioStorage Technologies Global Sample Management Benchmarking Symposium will take place on Tuesday, 22nd May 2012 from 4pm to 6pm at the Sheraton Hotel in Brussels, Belgium. Moderated by Dr Graham Hughes, Consultant in Pharmaceutical Development and Editor of International Clinical Trials, this educational symposium will provide an update on the future of clinical trials in Europe. Presenters will focus on the importance of establishing a comprehensive sample management strategy to support the development of novel biomarkers and new drug therapies and will showcase how innovative technology solutions are enabling virtual management of research samples. The symposium will also highlight emerging models, processes and metrics for the optimisation of sample assets to support future drug development, approvals and expanded use that will enable research companies the opportunity to maximise research efforts, minimise risk and generate value.

The distinguished speaking faculty includes:

  • Dr Xavier Luria, Senior Consultant, Drug Development & Drug Regulation
  • Hyung Park, Director Translational Development Operations at Celgene
  • Agnes Rivaille, Senior Scientific Affairs Director-Europe at PRA International, Inc
  • Steve Sweeney, Head of Clinical Technologies at Infinity Pharmaceuticals, Inc

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For additional information or to register for the event, visit www.biostorage.com/symposium or visit www.biostorage.com.
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