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European Pharmaceutical Contractor

epc
Summer 2005
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
Graham Hughes reviews the latest crop of articles in the Editor's Letter  
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Marketplace & Business
In his quarterly roundup, Craig Wylie, Senior Manager at BearingPoint, suggests that waning consumer confidence is forcing big pharma to re-evaluate their methodologies, in Clearer Thinking: Increased Transparency in Clinical Outsourcing  
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In Diversify or Die - Innovation Helps Big Pharma Out of a Tight Spot, Dr Sam McCormick, Scientific Advisor at Enhance Biotech, points to a surprising source in the quest for blockbuster drugs of the future  
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As R&D costs rise, revenues on drugs continue to tumble. A gloomy picture agree Loic Kubitza, Assistant Director in the Valuation and Strategy practice, Divya Mistry, Senior Manager and Tom Gunson, Partner, Treasury and Working Capital Practice, at PricewaterhouseCoopers LLP - all the more reason to focus on The Increasing Importance of Freeing Up Cash, Improving Cash Flow and Reducing Costs  
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Francois Deneux, Partner in the Paris office, Robert L Kane, Health Care Practice Leader in the UK management consulting practice, Rolf Lundh, Senior Manager in the Stockholm office, Albert Schaper, Senior Manager in the Berlin office, and Frederic Thomas, Senior Manager in the Paris office at Arthur D. Little, face up to a Mid-Life Crisis: New Challenges in Pharmaceutical Life Cycle Management  
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Legal & Regulatory
In The EU Clinical Trial Directive: Effects for CROs Operating in Europe, Dr Steve Pinder, Director, Regulatory Affairs at MDS Pharma Services, mulls over the story of implementation one year on  
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The European Directive on Clinical Trials: Is Harmony Always a Happy State? Alison Dennis, Senior Associate at Reed Smith LLP, reflects on the pros and cons of greater consistency across the 25 member states of the EU  
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As one of the first countries to implement the EU Clinical Trials Directive into national law, Belgium's experience to date makes for intriguing reading, conclude Aude Gobert, Regulatory Affairs Manager and Hanne Geudens, Clinical Trial Regulatory Affairs Manager at SGS Life Science Services, in Clinical Trials in Belgium Clinical Development  
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With the pressure on to reinvigorate the drug development process and fast-track innovative products to market, tough but exciting times are ahead, contends Paul J Clewlow, Business Development Director at Pharmaceutical Profiles Group Ltd, in Human Microdosing - A Revolution in Early Clinical Development  
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In Biotechnology Today - Emerging Opportunities, Professor Gita Sharma, Director & CSO at Magene Life Sciences Pvt Ltd, hopes to convince us that now is the time for the pharma industry to shed any wariness of biologics  
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Kenneth Getz, Research Fellow at the Tufts Center for the Study of Drug Development and founder and Chairman of the Center for Information and Study on Clinical Research Participation, and James Kremidas, Director of Global Enrollment Optimization at Eli Lilly and Company, make A Call to Action - Educating and Engaging the Public and Volunteers in the Clinical Research Process  
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Breaking down barriers between clinical trial investigators and patients continues to preoccupy the industry - with due cause. In Patient Recruitment - Site Management as a Tool for Success, Klemens Schuette, Executive Vice President of Clinical Operations and Branka Duvnjak, Head of Site Management at Ergomed Group, put forward their case  
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Providing CRO Access to Sponsor Data Management Systems is an invaluable process putting trust and communication at the heart of the relationship between sponsors and CROs, affirm Adam Baumgart, Assistant Director for Biometrics Support (Europe), and Gill Lawrence, Assistant Director for Clinical Data Management (Europe) at Kendle  
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Drug Discovery & Delivery
Genomics and Proteomics Technologies - Is Europe Better Geared-up? Giridhar Rao, Senior Industry Analyst, Technical Insights at Frost & Sullivan, investigates a field with enormous potential 78 To date, the pharma industry has been slow to take on board the need for tQT studies and slower still to conduct them. Dr Leo James, Clinical Researcher at Charles River Laboratories, argues that it's a question of comply or face the consequences, in QT Prolongation: Implications for Drug Safety  
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The use of non-invasive bioengineering techniques to monitor therapeutic responses is not new; nor is it always optimised in topical drug development. Dr Betsy Hughes-Formella, Managing Director at Bioskin GmbH, makes a case for the balance to be redressed, in A Review of Bioengineering Methods Used in Dermatology Clinical Trials  
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In Market Factors and Drug Delivery, Faiz Kermani, Budgets, Proposals and Marketing Executive at Chiltern International Ltd, celebrates the array of delivery technology options available that bring new life to old drugs - but cautions that not all will offer the ideal technical or commercial solution  
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Therapeutic Innovation
Our understanding of how cancer is caused and the ways in which it can be treated continues to progress at a dazzling pace. Patrick Therasse, Director and Sylviane Carbonnelle, Fellowship student at the EORTC Data Center, inspect Information Highways and Technology Advances: Clinical Cancer Research Under the Spotlight  
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Shaun Falkingbridge, Senior Respiratory Analyst at Datamonitor, singles out once-daily products as the bright, new hope for Establishing Compliance in Asthma Therapy  
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Clinical Laboratories & Logistics
With the onus on clinical laboratories to define and implement their own systems, Dr Andrew Waddell, Managing Director at Tower Mains Ltd, believes that every lab must master Good Clinical Laboratory Practice: A Prerequisite in Clinical Trial Research  
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In Determining Nature's Advice - The FDA Wants to Hear What Genes Have to Say, Paul Debenham, Life Sciences Director at LGC, and Phillip Birch, General Manager at AKOS Ltd, embrace the pharmacogenomics movement  
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Transporting dangerous materials by air: a risk worth taking? Jean Abouchaar, Director, Cargo Regulatory & Industry Affairs, at the International Air Transport Association (IATA), puts our minds at rest, in Air Transport of Dangerous Goods, Infectious Substances and Clinical Specimens  
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Serge Alezier, International Sales Manager, Pharmaceutical Logistics, at KLM Cargo, tests The Response of the Airline Industry to Cold Chain Quality Standards  
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Data Management & IT Solutions
Implementing and Managing Adaptive Designs for Clinical Trials may be hard work, say Eva Miller, Manager of Biostatistical Services, Stephane Deleger, West Coast Business Development Manager, and Jim Murphy, Vice President of Business Development and Marketing at Interactive Clinical Technologies, Inc (ICTI), but it's well worth the effort  
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Chris Nichols, Director, IVR, and Jeff Flecken, Director of Peri-Approval Business Solutions at etrials Worldwide, Inc, chart the evolution of interactive voice response sytems, in Going Beyond the Dial Tone  
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