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European Pharmaceutical Contractor

epc
Summer 2006
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 his latest Editor's Letter, Dr Graham Hughes surveys the current crop of articles  
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Keynote
The ECVAM's approval of five alternative methods that aim to reduce the need for certain drugs to be tested on animals, looks towards a point of consensus between political will and public concerns. Professor Dr Thomas Hartung of the Joint Research Centre reports on these Testing Times  
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In Fakes Heighten the Fear Factor, Julian Mount of Pfizer argues that a greater degree of security against counterfeit medicines is imperative, as the risks associated with the re-packaging of medicines continue to swell  
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A profit-making goldmine or the next unfulfilled technological promise? Del Stark of the European Nanotechnology Trade Alliance considers the big rewards available to a drug development industry willing to get to grips with the Science of the Small  
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Business and Finance
As the pharmaceutical sector goes from strength to strength, service providers operating in this changing environment need to understand how they can add real value to the development process. Paul Thomas of Penn Pharmaceuticals weighs up the options, in Sourcing Out Success  
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From Challenge to Opportunity - Giancarlo Carmosino and Oriana Zerbini of CROM srl encourage CROs to get a better feel for their market in order to fully maximise company growth  
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Choosing between different consultancies - and indeed understanding the advantages to using a regulatory consultancy for outsourcing work - may sound like hard work, but the effort will pay off assures Steve Trotter of Unicus Regulatory Services, in Advantages of Outsourcing  
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Legal & Regulatory
Julian Hitchcock and Jonathan Greenwood of Mills & Reeve consider the ramifications of the introduction of the latest IP Directive, in Revolting Patents: The 2005 Uprising  
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The Employment Law Headache may have you reaching for the aspirin, but fear not; Nicola Walker of Hogan & Hartson is on hand with soothing advice  
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Clinical Development
In Get with the Programme, Dr Florian Eichmann, Dr Dieter Komossa and Petra Ludwig of Kendle Global, Late Phase, weigh up the pros and cons of typical study management approaches for different types of Late Phase studies  
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It has been estimated that only one in every 25 candidate molecules complete the process to become an approved drug. High time then to shake up the early phase clinical trials process, conclude Rosalyn Forsey and Robin Longdin of LCG Bioscience, in Biomarkers: A Fresh Approach  
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With the testing of monoclonal antibodies in healthy subjects enduring close scrutiny, Alain Mignot of SGS Aster SAS tries to unravel the mysteries of Puzzling Biodrugs  
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The dark clouds looming over the continuance of the blockbuster pipeline model may have dispersed somewhat, but solutions are still called for, rallies Steve Heath of Medidata, in Technology to the Rescue?  
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QT Studies
The QT Intensive Study: Nuts and Bolts for Phase I Units - William Wheeler, Tania Issa, Mary Reed and Pauline Griffith of Spacelabs Medical Data describe simple methods that allow Phase I units to side-step common pitfalls  
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Dr Derek Terrar of Oxford Cardiac Pharmacology Ltd (OCP) and Oxford University discusses the advantages and disadvantages of available preclinical methods for identifying cardiac risk, in Cardiac Side Effects  
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Patient Recruitment
Research suggests that only 10 per cent of adults in the US have participated in a clinical research study. The conclusion to take from this contends Christine Pierre of RxTrials, Inc.- What Study Volunteers Don't Know Keeps Them Away  
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Timothy S LaCroix and Nermeen Varawalla of PRA International consider cause and effect, in Recruiting for Clinical Trials: International Dilemma, Universal Solutions  
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Therapeutics
The cardiovascular market, like all other key therapeutic groups, cannot rely on its top drugs to continue generating revenue. Paljit Mudhar of Frost & Sullivan suggests that it's time to consider Pumping Up the Cardiovascular Pipeline  
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The pool of patients in need of treatment for metabolic syndrome may be huge, but to date there has been a glaring lack of an approved indication for metabolic syndrome. In One Definition to Rule Them All, Datamonitor's Dr Nikolaos Karachalias looks for answers  
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Allergy Vaccination Receives a Positive Reaction - Consultant Kevin Wilkinson glimpses a new vaccine that hopes to redefine 'conventional' treatment of allergic rhinitis  
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A traditionally slow moving sector, the vaccine industry continues to surprise observers with a spate of rapid advancements. Howard Smith of Cambridge Biostability Ltd reviews a new class of trendsetting vaccines, in Path to a Panacea  
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Clinical Laboratories & Logistics
Building and maintaining excellent working relationships makes good business sense - never more so than in the varied and widespread interaction between customer and laboratory. Adrian Kirk of Reading Scientific Services Limited encourages us to Speak Easy  
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Independent contract laboratories, once seen as a lightweight sector, are now proving successful by maintaining customer loyalty and offering high quality competitive services. Paul Walsh of Bodycote Health Sciences hails an Independence Day for Labs  
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Following the widespread acceptance of IATA's new initiative, Cargo 2000, Juan Vertelman of KLM Cargo is ready and willing to investigate integration and multimodal information transparency as a means to start Navigating the Quality Process  
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2006 sees a degree of stability take a hold in the regulation of dangerous goods. In the Line of Infection, Sue Lee of World Courier (UK) Ltd steps into the breach to volunteer an invaluable update on diagnostic and infectious specimens  
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Reviews & Previews
The one meeting where professionals bringing new medicines to populations around the world can gather to learn about best practices and the latest regulations; don't miss the DIA 2006 Annual Meeting Update  
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Data Management & IT Solutions
The welfare of patients is of paramount importance. In Streamlining Safety, Barry Burnstead of Phase Forward presents data management strategies that bring a new era of co-operation to clinical trials  
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The advantages of EDC may be well publicised, but Radivoj Arezina and Adam Walker of Richmond Pharmacology Ltd see a technology that has far from maximised its potential, in Trials in Transition 86 Too Many LIMS? Nick Townsend of LabWare Europe provides an insight into how new generation, centralised systems can reduce the inefficiencies and overheads associated with running multiple LIMS and related software applications  
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