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European Biopharmaceutical Review

ebr
Winter 2003
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EBR provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of of biopharmaceuticals, take a look below at the range of articles featured in this issue of EBR.
   
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In her Editor's Letter, Dr Helen Abbott reviews the articles featured in the Winter issue  
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STRATEGY AND FINANCE
In the current economic climate, raising capital is a challenge and building biopharmaceutical manufacturing reactors is not easy. Dr Raju Adhikari, Mbiochem, Dphil, Research Analyst at Frost and Sullivan, Europe, asks Will Demand Exceed Supply for Biopharmaceutical Manufacturing?  
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Dr David Griffiths, Head of Business Development at LCG Bioscience, advises a change of approach in Streamlining Phase I through a Successful Partnership Strategy  
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Simon Shohet, Head of Healthcare and Life Sciences Consulting Team at Cambridge Consultants Ltd, tells us why the need for due diligence has never been more important for the integrity of the industry, in Technical and Commercial Due Diligence in Biotech Transactions: Doing the Right Things and Doing them Right  
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Science and Innovation
Dr Joanna Grabarek, Research Scientist, Polgen Division, Dr Lisa Frenz, Clinical Research Scientist, Dr Graham Bell, General Manager, Polgen Division and Professor David M Glover, FRSE, Chief Scientist, Polgen Divison at Cyclacel Ltd, review RNAi technology, in RNAi in the Gene to Drug Approach  
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Dr Graham Cotton, PhD, Senior Research Scientist at Albachem Ltd, finds that the development of technologies for protein production is paving the way for the next generation of enhanced protein therapeutics, in The Chemical Synthesis of Proteins: Beyond the Genome  
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Inhibition of p38 MAP kinase and subsequent decreased production of multiple cytokines has the potential to provide therapeutic benefits in multiple diseases. Clinical Applications of Small Molecule p38 MAP Kinase Inhibitors, by Dr Leslie Williams, Program Executive for Vertex's p38 MAP Kinase Development Team, explores this potential  
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BioDevelopment
In the follow up to her article in Autumn, Sharon Grimster, Director of Westerly Projects Ltd, looks to The Future of Biomanufacturing  
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The emergence of biopharmaceuticals as effective therapeutics, coupled with a trend to outsource biologic manufacturing, has led to unprecedented growth in 'third party' contract manufacturing organisations. Dr David Cox, PhD, CEO of KS Avicenna Inc, looks at Contract Manufacturing for Small Biotechs  
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In Data Safety Monitoring Committees - Practical Considerations for Data Management and Biostatistics, Gьnter Schmieder, Director of Data Management, at PRA International, reviews practical issues surrounding the operation of a drug safety monitoring board  
In The Progress of Clinical Trials, Professor Trevor Jones, Director General at ABPI, discusses how high standards of research and medical care make Britain an attractive destination for future clinical research  
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Legal, Regulatory and Public Policy
Jim Cook, Senior Vice President, Product Marketing and Strategy at Liquent, takes on Present and Future Challenges in Management of Critical Documentation over the Entire Product Life Cycle  
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Dr Helen Abbott discusses Irish biotech in conversation with Mary Harney, Irish Deputy-Prime Minister and Minister for Enterprise Trade and Employment  
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THERAPEUTICS FOCUS - VACCINES AND INFECTIOUS DISEASES
Seventeen million people die from infectious disease each year. In Killer Apps for Killer Diseases, G Steven Burrill, CEO of Burrill & Company, asks whether biotechnology can buck the trend.  
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In Cowpox to Conjugates: Trends in Vaccines, Ian Sellick, Director of Marketing at Pall Life Sciences, offers an overview of the current and potential future uses of conjugate vaccines  
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The trend of HIV-infected patients showing resistance to tested treatments is addressed by Dr D C Herath, Senior Medical Advisor in HIV at Roche UK, as he asks Is Resistance Futile?  
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Drug Discovery
Complexity and diversity of kinase pathways place a high demand on the quality of information required for drug development strategies, concludes Robert Karlsson, Director of Biochemistry and Chemistry at Biacore AB, in Understanding Drug-Kinase Interactions with Surface Plasmon Resonance (SPR)  
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Proteomics is regarded as a pivotal technology in defining the transition from health to disease. Peptides in Metabolic Diseases - Peptidomics as a Comprehensive Profiling Tool by Imke Schulte, Metabolic Syndrome Project Research Manager, Hartmut Selle, Biomarker Discovery Project Research Manager, and Peter Schulz-Knappe, CSO and Co-founder of BioVisioN, expands on this theory  
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In Capturing Recombinant Proteins, Beate Rygg Johnsen, Product Manager at Dynal Biotech, looks at a novel method to rapidly isolate structurally and functionally intact histidine-tagged recombinant proteins using superparamagnetic beads  
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In the first of a two-part series, Julian White, CEO at genapta Ltd, looks at the various practical issues encountered in reading a real chip, in Microarrays in the Real World  
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Drug Discovery in the Post-Genomic Era by Steve Lombardi, Vice President of Corporate Development at Affymetrix Inc, finds that the benefits of high-throughput array analysis are only beginning to be realised, and looks forward to a rapid advance in microarray applications in multiple disciplines  
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IP AND TECHNOLOGY TRANSFER
Dr Manja Epping, Lawyer at Ashurst, and Ina Gerstberger, Lawyer at Taylor Wessing, talk about the pros and cons of a BOLAR exemption in the EU, in The Proposed European Approach to BOLAR: An Appropriate Adaptation of the Experimental Use Exemption for the European Community?  
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In Colours as Registered Trademarks, Sara Elwyn Jones, Associate at Taylor Wessing, explores how pharmaceutical companies are using the power of branding to capture the hearts and minds of the public  
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EDC FOCUS
The Future of Electronic Data Capture in Clinical Trials is predicted by Tony Dean, Director of Sales and Marketing at Datatrial Ltd  
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For over 15 years the industry has been engaged in discussions on how to improve the process of capturing data in clinical trials. Anders Hansson, Business and Data Management Consultant at VVTT, outlines The Most Important Current and Future Data Management Tasks Ahead  
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Jane Baguley, Director at Cornaxis Ltd, argues that a more modest approach involving readily available technology applied consistently across an organisation can have surprising benefits, in e-Meetings and e-Learning - How the Internet can be Harnessed to Achieve Efficiencies in Clinical Drug Development  
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In EDC - The Key to Success, Colin Spink, Industry Specialist at IBM Business Consulting Services and Brent Cliveden, Vice President of Operations North America at InferMed Ltd, explain why breaking out of low volume or pilot usage of EDC is well worth the leap of faith  
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CORDIA REVIEW
Dr Helen Abbott gives us her initial impressions from the CORDIA-Europabio Convention 2003  
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
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