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European Pharmaceutical Contractor

epc
Autumn 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
Dr Graham Hughes surveys this edition's contributions in the Editor's Letter  
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Marketplace & Business
In Synching Up in Pharma, Michael Cislo and Craig Wylie, Senior Managers, Life Sciences, at BearingPoint, impress upon us the need for a 'single source of truth' for product information  
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With clinical trials no longer the low risk prospect they used to be, Chris Tait, Life Science Account Manager at Chubb Europe, wonders if the end is nigh for calculated gambles, in Risky Business?  
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Active Relationship Management during Outsourced Clinical Trials - A Marriage Made in Heaven... or Hell? speculate Helen Springford, Business Development Director, UK & North America, at Imform International Clinical Research and Dr Dave Webber, European Outsourcing Manager at Procter and Gamble Pharmaceuticals  
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The pharma industry's ability to generate revenue to drive the search for new drugs is being eroded. In Investing in the Future, Nick Hughes, Head of Life Sciences at PA Consulting Group, concludes that it is time to re-evaluate priorities  
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Legal & Regulatory
Julian Hitchcock, Senior Solicitor at Mills & Reeve, finds himself traumatised by UK legislation governing Research under the Human Tissue Act. Over-simplified and poorly drafted, life is going to get a lot tougher, he cautions  
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Striking a balance between innovator rights and generic opportunities has proved to be one of the most contentious issues in the development of the recently enacted EU medicines legislation. Linda R Horton, Partner, Jacqueline Mailly, European Regulatory Advisor and Jaime T Gallimore, Associate at Hogan & Hartson, give their expert insight on Innovator Rights Under the New European Union Medicines Legislation  
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Clinical Development
In Early Phase Trials - Redefining The Boundaries of Phase I, Dr Jorg Taubel, Co-Founder and Managing Director of Richmond Pharmacology, hails a new integrated approach to counteract inflated costs and time, adding value to the industry by merging pharmacology and patient studies into one  
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The growing percentage of trials being conducted outside the Western hemisphere, combined with perpetual changes affecting regulatory and ethical standards, as well as logistical and operational issues, call for urgent change. Nicky Dodsworth, Director of Quality Assurance at Pharm-Olam International (UK) Ltd, moots Harmonising SOPs for Global Clinical Trials: Myth or Reality?  
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Himanshu C Parmar, Industry Analyst, Pharmaceuticals and Biotechnology, at Frost & Sullivan UK, presents Opportunities in the Chinese Pharmaceutical Market - a region poised to emerge as an attractive hub for pharmaceutical R&D and clinical trials  
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With nearly one billion people as potential patients and a large number of highly skilled investigators, India is a unique new player on the clinical development scene. Dr IS Gandhi, Medical Director at Vimta Labs and Jim Worrell, CEO of Pharma Services Network, Inc, US, look beyond the hyperbole to examine the Practical Issues for Conducting Clinical Trials in India  
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IT Solutions
It's Time to 'Get Real' - Mark Tomlinson, Director Clinical Services at Phase Forward, casts his mind ahead to a more efficient future using web-based, real-time data systems that are set to transform the way data is recorded and managed  
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Adopting EDC - The Time to Falter is Past, chides Lynne Mackenzie, EDC Executive, Electronic Data Capture Solutions, at Chiltern International, keen to exorcise any memory of voluminous paper trails bogging down the clinical trials process  
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How long can corporate users stick with outmoded, ineffective legacy systems, ponders (the somewhat baffled) Dr Philippe Verplancke, Managing Director of Xclinical, as he outlines The Advantages of CDISC in the Real World of EDC and CDM  
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A new growth area in specialised drug delivery systems is investigated in Orally Disintegrating Tablets, by Dr Dev K Mehra, Team Leader of the Health and Nutrition Group at Huber Engineered Materials, part of JM Huber Corporation  
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Drug Discovery & Delivery
Troels Keldmann, Co-founder and Managing Director of Direct-Haler A/S, claims a Call for Combined Asthma and Rhinitis Treatment Offers Opportunities for Drug Delivery Innovators  
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Therapeutic Innovation
In Partnerships to Roll Back Malaria, Gareth Thomas, UK Member of Parliament, Parliamentary Under-Secretary of State for International Development, believes governments and the pharmaceutical industry have shown that they can work together to bring life-saving health interventions to the world's poor  
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Professor Hans Reiber, Director of the Division of Image Processing at the Leiden University Medical Center, Dr Cornelis Van Kuijk, Vice Chair and Director of Clinical Operations for the University Medical Center at the University of Nijmegen, and Dr Larry Schwartz, Director of Magnetic Resonance Imaging at Memorial Sloan-Kettering Cancer Center, deliberate Medical Imaging and Its Use in Clinical Trials  
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The way we conduct, finance and recruit for clinical trials is changing. In The Globalisation of Clinical Oncology Therapeutic Investigations, Wayne Brenckman Jr, MD, Vice President and Global Head of i3 Oncology at i3 Research, asks "where do we go from here?"  
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Despite considerable progress in our understanding of the biological basis of many CNS disorders, the cause remains a mystery. Mohammad S Alavijeh, Co-founder and COO, and Alan M Palmer, CEO of Pharmidex, probe CNS Disorders: the Major Health Care Challenge of the 21st Century  
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Clinical Laboratories & Logistics
In Key Factors in Successful Selection of a Professional Global Central Laboratory Provider, Jerry Boxall, Managing Director at Pivotal Laboratories and Kathy Murray, Executive Director of Global Operations and Strategic Business Development at ACM, challenge some of the perceived wisdom that dogs sponsors  
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Stephen Westcott, Managing Director at Melbourn Scientific Limited and Lesley George, Consultant Pharmacist at Oak Pharmaceutical Services, return to The EU Clinical Trials Directive - One Year On for Analytical Laboratories  
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Connecting people, sites and processes securely requires Data Storage Protection Strategies - after all says Ron Penny, Senior Marketing Manager at BT Global Services, prevention is better than cure  
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Reviews & Previews
Drug Information Association takes stock of another successful year, in 41st DIA Annual Meeting 2005  
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Get a feel for PABORD '05 - The Pharmaceutical & Biotech Outsourcing, Research & Development Expo & Conference, 14th-15th September 2005  
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Low productivity and economic stagnation: the CORDIA Convention seeks to re-energise the European scene, in Six Months to Save Lisbon - What is the Role of Biotechnology?  
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