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European Biopharmaceutical Review

ebr
Spring 2005
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 Tayton-Martin reviews the articles in this issue  
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BioBusiness, Finance & Communication
Dirk Kersten, Investment Manager at Gilde Investment Management, summarises the trends in financing that emerged in 2004 and offers a forecast on the Funding Outlook for 2005: Public or Private?  
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A guide to negotiating the complex domain of Intellectual Property Issues in Bio-Industry Corporate Transactions, is presented by George Godar, Partner and Selina Taylor, Solicitor at DLA Piper Rudnick Gray Cary LLP  
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Helen Tayton-Martin, Technology Consultant at London Technology Network and Advisory Editor of EBR, interviews CEO Christopher Pearce and uncovers the life story of a biotech company, in Entrepreneurship in Action - In Conversation with Proteome Sciences  
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Gugs Lushai, Manager of BioApproaches SW, and Julian Beer, Senior Lecturer and Director (Research), Social Research and Regeneration Unit, Faculty of Social Science and Business at the University of Plymouth, consider the training and employment issues to be resolved for optimisation of industry performance, in Biotechnology Workforce Development for Sector Promotion  
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Science and Innovation
In Vioxx: Lifting the Veil on the Dark Side of the Pharmaceutical Industry, Catherine Pichereau, Senior Consultant at Bionest Partners, considers the new concerns, objectives and possibilities arising from the withdrawal of Merck's COX-2 inhibitor  
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Superbugs: Apocalypse Now or The Day After Tomorrow? Malcolm Page, Head of Biology and Jutta Heim, Chief Science Officer at Basilea, discuss the self-negating quality of antibiotics, cautioning us on the need to keep pace with emerging resistant strains 46 Dr A Knowles, Raman Division Manager and Dr S FitzGerald, Raman and XRF Micro-Analysis Specialist at Horiba JobinYvon, investigate Biopharma Imaging and Analysis - Advancing Towards a More Detailed Picture of Chemistry  
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Thirty years after the publication of a method to develop monoclonal antibodies, their evolving potential is evaluated, in The New Wave in mAbs Therapeutics - Putting High Expectations in Perspective, by Dr John Wijdenes, General Director of Diaclone SAS  
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BioDiscovery
Robert Verhagen, Senior Director, Biomarker Development at MDS Pharma Services, discusses new methods of streamlining drug development, in Making Biomarkers Pay  
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In Multiplexed Microarray - New Approaches for Biomarker Discovery, Dr Jeremy Clarke, Global Product Manager at Genomic Solutions Ltd, welcomes the emergence of techniques to optimise drug discovery and personalise disease management  
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Pavel Hradecky, Pierre Stanislawski, Simon de Bernard and Laurent Buffat at IT.Omics, inform us of the latest developments in Biological Pathways in Pharma Discovery Strategies: From Information Source to Innovative Insight, stressing the necessity of an integrative approach to data interpretation  
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Indispensable in the field of molecular biology, the full potential of siRNA is yet to unfold, asserts Dr Klaus Giese, Chief Scientific Officer, Vice President of Research and Member of the Management Board at Atugen, in Poised to Change the Health Care Landscape - siRNA Therapeutics  
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BioDevelopment
Translational Medicine: Friend or Foe to Drug Discovery? Professor Anthony C Woodman, Professor of Translational Medicine at Cranfield University, expounds the benefits of improved enhanced communication and symbiosis within the health care industry  
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Intergration and collaboration are key to the success of drug discovery efforts, argues Dr Jon M Wigginton, Head of the Investigational Biologics Section, Pediatric Oncology Branch at the Center for Cancer Research, Maryland, US, in Translational Research and Oncology Drug Development: Opportunities and Obstacles  
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Victoria Doel, Clinical Integration Manager, Marie MacDonald Director of Strategic Product Development and Robyn Wood Operations Medication Management Specialist at ClinPhone, discuss the potential of voice and web response technologies to enhance drug reconciliation, in Bringing Information Technology to Drug Returns  
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BioManufacturing
In Advances in Immune Monitoring - New and Improved Tools for the Successful Development of Biologic Therapies and Vaccines, Dr Peter Trinder, Co-Founder and CEO of Thymed GmbH, puts forward new methodologies improving drug development  
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In The National Biomanufacturing Centre - Building on Bioprocessing Expertise, Dr Derek Ellison, Business Development Director of Eden Biodesign, underlines the importance of biotech to national economies and anticipates the addition of a valuable asset to the UK industry  
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Gerrit Hagens, President and COO of ExcellGene, describes the conceptual basis of the Production of Therapeutic Proteins from Mammalian Cells and recent developments in their manufacture  
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Traditional and single-use systems are compared in terms of cost, project timelines, flexibility and validation requirements in Biotech Process Optimisation Through Implementation Of Disposable Technologies - An Overview, by Miriam Monge, Marketing Director at Stedim SA  
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Dr Jose Arnau, Business Development Manager at Unizyme Laboratories A/S, outlines the value of His-Tag - A Powerful Tool for the Production of Recombinant Proteins in the Pharmaceutical Industry, providing an overview of production processes, choices and strategies  
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Regional Focus: Göteborg
In Göteborg - The Biotechnology Port of Call, Olivia Lindau-Jonsson, Project Co-ordinator at Business Region Göteborg, evaluates the challenges, successes and future ambitions of biotech in the Swedish city  
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Dr Patricia Lobo, Editor of PMPS and Associate Director of Technomark, reports on the official recognition of merit in an innovative company, in Bluepharma Awarded by European Commission  
   
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
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News and Press Releases

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White Papers

Extractables and Leachables Testing: A Risk Based Approach

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Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

14th World Advanced Therapies & Regenerative Medicine Congress 2018

16-18 May 2018, Business Design Centre, London, United Kingdom

In May 2018 the World Advanced Therapies & Regenerative Medicine Congress, will bring together 800+ attendees and explore the rapidly developing world of ATMPs (Advanced Therapy Medicinal Products).
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