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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

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

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Industry Events

10th Annual Summit for Clinical Ops Executives

18-21 February 2019, Hyatt Regency Orlando, Florida

Celebrating its 10th successful year, SCOPE Summit 2019 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 19 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations, including...
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