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European Biopharmaceutical Review

ebr
Winter 2010

European Biopharmaceutical Review (EBR) is a journal designed to fill a unique position in scientific publishing. Published quarterly, it provides a dedicated platform of communication and information for the European biopharmaceutical market across Europe, North America & the rest of the world.

   
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Business Development and Financing

Using case studies from major players in the pharmaceutical industry, Peter Thornton at Business Insights reviews strategies to revitalise R&D and boost flagging pipelines.

 
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Implementing a ‘roadbook-controlled project’ that takes into account the development process and financial and risk parameters can limit the waste of invested money through strategically placed ‘go/no go’ decision points, explains Roel Bellens at Strategus.

 
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John Nash, Alan Beresford and Dawn Yates at BioFocus argue that outsourcing ADME to CROs can eliminate potential development liabilities, cut costs by reducing time spent on unsuitable candidates, and provide access to a wide range of testing resources.

 
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There is currently global political and economic pressure to reduce the costs of healthcare. Michael F Swanick at PricewaterhouseCoopers examines the impact that rising tax rates will have on the biopharmaceutical industry over the next year.

 
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The European Commission released its final report on the Pharmaceutical Sector Inquiry in July this year, and it clearly aims to promote practices that increase the level of generic entries. Michael McFalls and Frances Murphy at Jones Day compare the report to US legislation and fear that it may lead to limitations that are a step too far.

 
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As companies expand globally, it is crucial that they maintain their efficiency and reputation through effective communication structures. Simone Lamont and Alison Lamb of CLS Communication AG point out the benefits of using the services of life science language specialists that fully understanding your business, ensuring seamless integration.

 
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BioResearch and Innovation

Matthew Sleeman and Fabio Magrini at MedImmune review developments in using antibodies to treat autoimmune diseases and in other areas of unmet medical need, and hope that this will continue to stimulate research into the pathogenic mechanisms of autoimmunity.

 
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Cervical cancer is the second most common cancer in women, and around 80 per cent of deaths resulting from it occur in developing countries. Julie Zhu at QIAGEN discusses how tools and technologies can be adapted for low-resource settings to ensure that women at risk can be identified worldwide.

 
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Discovery Technology

Technological advances have led to quantitative polymerase chain reaction (qPCR) becoming a quality validation method for a range of scientific and medical approaches. Tobias Hampshire at Thermo Fisher Scientific provides an overview of recent developments in probe-based technology.

 
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miRNAs are ideally suited for use as biomarkers due to their role in controlling cellular activity. By indicating the biological state of cells and tissues, Peer Staehler at febit argues that they are important to diagnostics and may have the potential to become therapeutic targets and tools.

 
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BioDevelopment and Regulatory

Andy Bailey at ViruSure GmbH reviews the latest regulations leading towards a new approach to virus safety for investigational biotechnology products.

 
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Quality assurance should be integral to clinical development and trials to ensure the accuracy of test results. Martin Crockard at Randox describes different types of analyses and explains that the choice of scheme should be dependent on the size, duration and complexity of the trial.

 
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BioFormulation and Manufacturing

William Downey at HighTech Business Decisions provides an overview of the results of an investigation into the criteria that directors of biomanufacturing companies believed to be most important when choosing a contract manufacturing organisation.

 
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The move towards personalised medicine has meant that a great number of samples are collected during clinical trials. In order to manage this data, a flexible information system that works in real-time should be employed, explains Jennifer Benner at BioStorage Technologies.

 
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BioRegional

Bob Smailes at LeidenUniversity outlines the research taking place at LeidenBioSciencePark, the leading life science park in the Netherlands.

 
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A new cGMP production centre is being built in Wallonia, allowing three companies who work in the field of regenerative medicines to come together to create one platform, where each will have their own production space and the support they need.

 
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
Published quarterly in
January, April,
July and October

News and Press Releases

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
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White Papers

Utilising Big Data to Produce Faster and Cheaper Clinical Research

Medical Research Network (MRN) Limited

Recruitment and retention of patients remains the major challenge to ensuring trials run as fast as possible and give them the statistical power they are designed to produce. This is not just about getting better any more - but about stopping the deterioration of these metrics in modern clinical trials.
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Industry Events

14th World Advanced Therapies & Regenerative Medicine Congress 2018

16-18 May 2018, Business Design Centre, London, United Kingdom

In May 2018 the World Advanced Therapies & Regenerative Medicine Congress, will bring together 800+ attendees and explore the rapidly developing world of ATMPs (Advanced Therapy Medicinal Products).
More info >>

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