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European Biopharmaceutical Review

ebr
Spring 2004
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 this quarter's EBR  
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Science and Innovation
Following the tragic events of 9/11, G Steven Burrill, CEO of Burrill & Company, looks at the steps taken to guard against bioterrorism, when he asks Are We Biosecure?  
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Professor Gordon McVie, Oncology Adviser and Phil Collis, VP of Scientific Affairs at Inveresk, consider three of the greatest challenges facing the pharmaceutical industry in the 21st Century, in CNS, Oncology and HIV Clinical Trials: Current Trends and Future Prospects  
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Richard Buick, Senior Scientist at Fusion Antibodies Ltd and Christopher Scott, Lecturer in Biomolecular Science at the School of Pharmacy, Queen's University Belfast, consider Protein Antigens for Therapeutic and Diagnostic Antibodies Biodevelopment and Manufacturing  
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BioBusiness Development
John Wilkinson and Nicola Maguire, Partners in the Life Sciences Group at Bird and Bird, advise on Preparing for the Due Diligence Process - Plan your Way to Success  
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In Understanding Due Diligence - Taking a Practical Approach, Patrick Martin, Partner at McGrigors, examines the necessity of due diligence when running a biotech company  
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Rupert Winckler, Consultant at PharmaVentures, explores the values of licensing deals when he asks, What is a Cancer Drug Worth?  
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Dimitri F Dimitriou, CEO of DyoDelta Biosciences Ltd, breaks down partnering issues in To Partner or Not to Partner? An Overview of the Partnering Field in the Industry in Four Simple Questions  
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Can the New Generation of Biomarkers Escape the Commodity Trap? Richard Barker, President at New Medicine Partners investigates the facts  
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Dr Helen Abbott, Technology Consultant at the London Technology Network and Editor of EBR, presents Science, Innovation and Technology Transfer - A New Model for Knowledge Acquisition by Technology-Based Businesses in London  
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Legal, Regulatory and Public Policy
Following the announcement that bovine spongiform encephalopathy (BSE) was found in one cow located in the US, Gail Sofer, Director of Regulatory Services at BioReliance, reviews Recent BSE Concerns and the Relevance of Clearance Studies  
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Adrian Tombling, Partner, and Rachel Wallis, an Associate at Withers & Rogers, keep us up-to-date with Developments in Patents and Trademarks - Putting IP Protection on the Global Map  
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Gareth Williams, Patent Attorney and European Trade Mark Attorney at Marks and Clerk, considers the patent as an essential business tool for firms in the biopharmaceutical field, in Patently Better - The Rights and Wrongs of Patent Protection Drug Discovery Technology  
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Biodevelopment and Manufacturing
The ICH E5 is designed to expedite the global development and availability of new medicinal products without impacting established safeguards relating to quality or safety between ethnic populations. Dr Jörg Täubel, Managing Director of Richmond Pharmacology, reviews the issues in Bridging Studies - What Questions Should be Asked in Phase I Clinical Research?  
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Kirk Daly, European Sales Director for CentraLabS Clinical Research, looks at the growing need to test prescription drugs on children, in Paediatric Clinical Trials - The Challenges Facing Central Laboratories  
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Dr Betsy Hughs-Formella, Managing Director at Bioskin GmbH, challenges us to optimise clinical development programmes and be informed by New Trends in Dermatology Clinical Research  
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Doris Heger-Mahn, Medical Director and Executive, Astrid Breitschaft, Sub-Investigator and Marjo Ramakers, Research Physician at dinox Clinical Research, review the Challenges in the Development of Hormonal Preparations for Women of a Reproductive Age  
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Dr Rocky Cranenburgh, Molecular Genetics Team Leader, Alexandra Bloor, Molecular Biologist, Matthew Leckenby, Molecular Biologist and Julian Hanak, Director of Production at Cobra Bio-Manufacturing Plc, consider Engineering Bacteria for DNA Medicine Production  
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Drug Discovery
In the second of a two-part series, Nick Haan and Graham Snudden, Co-Founders of BlueGnome Ltd, discuss the techniques used to extract results from microarray images, in Part Two Microarrays in the Real World: Image Analysis  
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In Allergen Microarrays: A Novel Tool for Improved Target Discovery and Individualised Therapy, Chistian Harwanegg, Senior Scientist, Proteomics and Reinhard Hiller, Head of Proteomics at VBC-GENOMICS Biosciences Research, discuss the application of microarray-based allergen profiling in the field of allergy vaccine development  
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SD Conzone, Manager of Research and Development and RJ Redkar, R&D Scientist at Schott Nexterion, consider Reproducible, Low Cost Arraying Achieved with a Multiplexed Approach  
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Tea Gunde, Scientist at ESBATech AG, discusses the application of functional cell-based screenings for the identification of specific RTK inhibitors, in In Vivo Veritas? Cell-Based Assays for Identifying RTK Inhibitors  
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Dr Mark Whittaker, Scientific Director of the Services Division at Evotec OAI Ltd explains how Drug Hunters become Drug Engineers  
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Klaus JW May, Director of Sales and Marketing at Genomatix Software GmbH, helps us to understand regulatory networks, in From System Statistics to Systems Biology  
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Regional Focus: Germany
Dr Tatiana Kassessinoff, Senior Project Manager at Biopolis Consultants, looks at the region of biosaxony and its growing biotech industry, in biosaxony - In Biotech, Saxony Matters  
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In SMOs in Germany - Conducting Quality Clinical Trials, Fransois Geelen, General Manager at Geelen and Geelen GmbH, offers an insight into the fast-emerging German SMOs market, which will form a critical catalyst in generating enormous data potential in the future  
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Preview
Freelance Biotech Writer Crispin Littlehales presents A Review of Burrill & Company's 18th Annual Report on the Biotech Industry  
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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

BioIVT to Focus on the Application of In Vitro Hepatocyte Models in Toxicology Research at the North American ISSX Meeting

BioIVT, a leading provider of research models and services for drug development, today announced that it will be participating in several sessions at the 22nd North American International Society for the Study of Xenobiotics (ISSX) Meeting. This conference will be held from July 15-19 at the Palais des congrès de Montréal in Montréal, Canada.
More info >>

White Papers

The Impact of Components on Drug Quality and Risk Mitigation

West Pharmaceutical Services, Inc.

Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
More info >>

Industry Events

Outsourcing Clinical Trials Nordics 2018

30-31 October 2018, Copenhagen, Denmark

Following on from the success of the 2017 Outsourcing in Clinical Trials Nordics conference, Arena International is pleased to announce that the event will return for its 6th year in 2018. The 2018 event welcomes biopharmaceutical and medical device companies from across the Nordic region to share knowledge and challenges of outsourcing and clinical operations.
More info >>

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