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European Pharmaceutical Contractor

epc
Spring 2004
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EPC 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 pharmaceuticals, take a look below at the range of articles featured in this issue of EPC
   
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introduction
In her Editor's Letter, Julia Lloyd-Parks reviews the articles featured in the Spring issue  
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Marketplace & Business
The pharmaceutical sector has seen frustrating sales, sinking profits and deflated expectations in recent years. Lorenzo Nanetti, Business Development Manager of Pharmaceuticals at BearingPoint, Switzerland and Michael J Desabris, Senior Manager, Enterprise Asset Management at BearingPoint, USA, look to a brighter future, in The Keys to R&D: The Rise of Enterprise Asset Management in the Pharma Industry  
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In From Fashion to Focus: Automation as a Practical Art, Philip J Holt, Vice President, Life Sciences and Jane Light, Principal Consultant, e-Solutions at Integic Corporation, highlight the value of approaching business problems practically  
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Stephen Foster, VP of European Marketing at Dendrite UK, tackles the causes and consequences of the US overtaking Europe in pharmaceutical sales, despite the similar sizes in population, in Europe at the Pharmaceutical Marketing Crossroads - Wising-Up to the US System  
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The FDA's latest guidance looks to pharmacogenomics to improve the drug development process and to identify more effective medicine. In Pharmacogenomics in Drug Development and Regulatory Decision-Making: The Genomic Data Submission Proposal, Dr Steven Little, Chief Executive and Co-Founder of DXS Ltd, outlines the benefits  
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Marketplace & Business: Translation Feature
Bob Clark, Linguistic Consultant at Translution Limited, makes an appeal for more consistent use of terminology, quality management and translation, in Taking Control of your Terminology  
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Clinical Trials
The ethical issues to be considered when designing and conducting clinical trials on female sex hormones have traditionally detered research in this field. 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 Reproductive Age  
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Dr Betsy Hughes-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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In SMOs in Germany - Conducting Quality Clinical Trials, Franзois Geelen, General Manager at Geelen & 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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Legal & Regulatory
Dr Manja Epping, Lawyer at Ashurst and Ina Gerstberger, Lawyer at Taylor Wessing, consider the ambitious new stance adopted by European institutions, in The Proposed European Approach to BOLAR: An Appropriate Adaptation of the Experimental Use Exemption for the European Community?  
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In The Cognitive Assessment of Herbal Products - Are the Effects Real or Imagined? Tamsin Manktelow, Scientific Development Manager and Andrea Zangara, Research Associate at Cognitive Drug Research, guide us through new EU legislation dealing with traditional herbal remedies Clinical Trials  
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Electronic Solutions
Colin Spink, Industry Specialist at IBM Business Consulting Services and Brent Cliveden, Vice President of Operations, North Africa, at Infermed Ltd, explain why abandoning low volume or pilot usage of EDC is worth the leap of faith, in EDC - The Key to Success  
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Despite substantial process improvements, many of today's EDC solutions have failed to address the whole e-Clinical process. Peter Barrie, Technical Director and Mark Wheeldon, Chief Executive Officer at Formedix, discuss in Accelerating Phase I Clinical Trials: Using CDISC Operational Data Model Study Specifications and High-Speed Translators to Auto-Generate Fully Featured Electronic Data Capture Systems  
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Drug Development & Delivery
In New Regulatory Aspects on Safety Pharmacology and Immunotoxicology, Professor Dr Ruediger Haecker, International Drug Regulatory Affairs Expert at RCC Ltd, reflects on two touchstone issues in the development of new active ingredients  
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Mel Snyder, Vice President of Market Development and Dr Thomas CK Chan PhD, Vice President of Research and Development and Chief Technology Officer at MacroChem Corporation, make the case for Absorption-Enhanced Topical Medications: Opportunity for New Speciality Pharmaceuticals  
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In Quality Control Aspects of Pharmaceutical Gamma Scintigraphy Studies, Simon Warren PhD, Scintigraphy Research Manager and Glyn Taylor PhD, Director of Scintigraphy Services at Simbec Scintigraphics Ltd, identify key processes in the conduct of pharmaceutical gamma scintigraphy studies, and consider a standardised approach to quality control measures  
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Medical imaging has grown substantially in the last 30 years - in 2002 it was estimated that over one billion medical images were acquired throughout the world. Dr Colin G Miller, Senior Vice President and Dr Klaus Noever, Director of Business Development & Clinical Affairs in Europe at Bio-Imaging Technologies Inc, examine the dramatic developments in Reading Medical Images in Oncology Clinical Trials  
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Electronic Solutions: IVRS Focus
In Dear Diary... A Comparison of Clinical Collection Tools, Kris Gustafson, Vice President of Interactive Technologies and Ashley B Threinen, IVRS Project Manager at ICON Clinical Research, establish IVR systems as a solid entry point to electronic data collection  
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The strengths of IVRS align themselves well with today's multi-site, multi-country clinical trial environment - combining ubiquity and ease-of-use with speed of deployment. In Revolutionising Clinical Trials with IVRS, Jennifer Aquino, Senior Director of Voice and Data Systems and Jean-Remy Behaeghel, Senior Manager at Perceptive Informatics, explore the characteristics of IVR systems  
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Therapeutic Innovation
Professor Gordon McVie, Oncology Advisor and Phil Collis, VP 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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In 2002 there were five million new infections and three million people died as a result of HIV infection or its end result, AIDS. Dr DC Herath, Senior Medical Advisor in HIV at Roche UK, asks the difficult question, Is Resistance Futile?  
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LABS & Logistics
Revolutionary materials, new style shippers and self-help opportunities via the web - Katrina Bray, Marketing Manager at Laminar Medica, explains How New Materials and Technologies are Putting Validated Shipping within Reach for Everyone  
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Central Labs
Dr Thomas Hengelage, Clinical Outsourcing Manager at Pfizer Global Pharmaceuticals and Martin Clark, Sourcing Manager/Clinical Laboratory Specialist at Pfizer Global Research and Development, predict a future where central lab management will focus on the working collaboration between sponsor and laboratory, rather than simply selection, in Central Clinical Laboratories and Sponsors - A Special Relationship?  
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