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European Biopharmaceutical Review

ebr
Autumn 2009

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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BioFinance and Management
In the current economic climate, high-tech small and medium enterprises (SMEs) need considerable funding in order to develop a product through to commercialisation. Dirk Carrez at EuropaBio lists five measures that aim to help biotech SMEs gain access to the money they need.  
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Risk sharing schemes in the UK offer patients access to innovative treatments, with payment based on the treatment's cost-effectiveness. Ruth McAllister, Linda Harrison and Christie Niziol at Abacus International look at existing schemes, and consider where the evolving processes for risk sharing may lead in the future.  
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BioBusiness Development
Recent estimates suggest that products worth around $25 billion are expected to come out of patent protection by 2017. Sumanth Kambhammettu at Frost & Sullivan discusses the challenges and opportunities facing companies in the biosimilar market, and reviews the competitive market.  
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The new discipline of Bio-IT has resulted from the need of patents to combine aspects from both the biotech and IT fields, often falling into the category of 'business method patents'. Demian Barbas and Alexandra Daoud at Ogilvy Renault explain why obtaining protection in this field has become increasingly challenging and why in-depth knowledge is crucial.  
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BioResearch and Innovation
Kirsty A Holden and Kevin Jones at Epistem Ltd review the latest oncology research suggesting that the key to stopping tumours from recurring lies in targeting the cancer stem cell.  
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Thomas Lundbäck of GE Healthcare explains how new, complementary, label-free technologies can provide information on biomolecular interactions and biophysical properties from native molecules, in order to meet the need for further experimental verification.  
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Developments in the monoclonal antibody market should not be limited by production constraints. Frank Detmers and Pim Hermans at BAC examine the latest research and developments in affinity purification of therapeutic antibodies.  
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Botulinum neurotoxin's effects of relaxing and paralysing muscles come from its ability to inhibit neurotransmitter release from nerve cells. Keith Foster from Syntaxin asks what the implications could be if this ability was widened to other cell types, and explains how a new class of biological drugs may turn this into a reality.  
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In developing countries, the context in which diagnostic tools will be used may be very different from the sophisticated labs that are common in industrialised settings. Steve A Harvey at the Center for Human Services details the factors that must be taken into account when developing new diagnostics, and suggests steps that can be taken to help end-users.  
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Discovery Technology
Banu S Zolnik and Nakissa Sadrieh at the US Food and Drug Administration report that new technologies are using nanotechnology to improve the success rate of drug development, and point out that this fast-growing field will have many applications in the future, tackling challenges such as personal medicine.  
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Biomarkers have the potential to increase productivity and decrease the costs of pharmaceutical development, but the validation process is proving to be an obstacle. Ruth A VanBogelen and M Walid Qoronfleh at NextGen Sciences, Inc propose a workflow model to improve the success rate of biomarker qualification.  
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It has been suggested that up to 30 per cent of cell cultures in use are infected by mycoplasmas. Björn Breth at Greiner Bio-One GmbH describes the new detection techniques that can be used as an alternative to traditional, time-consuming culture methods.  
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BioDevelopment and Regulatory
Biospecimen management is crucial to drug development research and clinical trials, and Trish Meek and Mark Murawski at Thermo Fisher Scientific explain how laboratory management systems (LIMS) can manage operational processes and workflow - thereby speeding up the development process and demonstrating compliance to the FDA.  
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Gian Schiava at The Patient Safety Company outlines possible steps towards introducing a successful clinical risk management system, pointing out that this is an area where you cannot afford to make mistakes.  
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Electronic document management systems (eDMS) can store and organise both digital and printed documents with full regulatory compliance. Keith Williams and Patrick Hughes at Good Products Ltd review the need for effective eDMS and the regulatory issues that surround it.  
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BioFormulation and Manufacturing
Compared to small molecule drugs, peptides offer benefits such as lower toxicity and high specificity. Gary Hu at the American Peptide Company looks at the production factors in the synthesis process that can increase yield, purity and quality.  
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Rigorous methodologies are crucial for risk management assessment, and the best strategy is to involve the entire development team, as opposed to each part of the chain working in isolation, as Hedley Rees at Biotech PharmaFlow and Tim Williams at I Balloon Ltd demonstrate.  
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BioRegional
Peter Heinrich at BIO Deutschland considers the state of the biotechnology sector in Germany, reviewing key statistics, the main fields of research and reaction to the present economic situation.  
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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

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Industry Events

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14-15 May 2019, Milan, Italy

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