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| home > ebr > Spring 2004 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| Freelance Biotech Writer Crispin Littlehales presents A Review of Burrill & Company's 18th Annual Report on the Biotech Industry |
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News and Press Releases |
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Positive results from first preclinical in-vivo studies of Affimer therapeutics
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White Papers |
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Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials
Perceptive Informatics
Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events |
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BioPharm America™ 2017—10th Annual International Partnering Conference
26-27 September 2017, 39 Dalton Street, Boston, MA 02116
BioPharm America™ is a unique partnering event that forms the nexus of discovery and realization. Startup companies, established biotech and entrepreneurs from academia attend in search of finance, pharma and development partners.
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