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European Pharmaceutical Contractor

epc
Winter 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
Faced with internal struggles, companies must now look to resolve concerns about clinical procedures and marketing, whilst maintaining, and indeed enhancing, the production cycle. Claudia Heinen and Craig Wylie of BearingPoint, Inc assess Pharma's Challenge: The Balancing Act  
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Unlocking Germany's Potential tops the list of priorities for Henning Mennenoeh and Wolfgang Kircher of Hogan & Hartson, keen to introduce the advantages of outsourcing to a country at risk of falling behind its closest competitors  
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In the last few decades, large and medium pharma companies have increasingly extended their R&D efficiency by in-licensing products from biotechs. In In- and Out-licensing, Erich Mayer and Dr Lucio AA van Rooijen of van Rooijen & Partners Ltd, explain the growing shift  
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R&D Tax
The UK's expenditure on R&D, as a proportion of GDP, is lower than the majority of its international competitors. David O'Keeffe and Mark Hobbs of KPMG LLP (UK) make the case for an effective relief regime for R&D tax to stimulate development, in Taxed by Tax?  
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Getting the Real Deal on Tax Relief - David Cobb and John Henshall of Deloitte look at the UK and beyond to assess the strategies employed abroad and review the international implications of such relief for multinational companies  
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Legal & Regulatory
The role of animals in research has been the subject of heated debate in the UK and elsewhere. Baroness Perry of Southwark, Chair of a Report by the Nuffield Council on Bioethics, dismisses the notion a polarisation of views stands in the way of progress, in Research Involving Animals: Ethical Dimensions  
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In Patent Power, Dr Peter Harrison of Walker Morris takes us through the 'Bolar' exemption (2004/27/EC) - a very useful tool for manufacturers of generic pharmaceuticals, but one which should still be used with care  
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Clinical Development
Integrated protocols with flexible design can reduce development costs and minimise the risk of late-stage failures in Phase I, report Mathieu Peeters and Dries De Pauw at SGS Life Science Services, in Combining Protocols in Clinical Trials  
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The merger and acquisition route is viewed by many as a way of achieving the critical mass necessary to widen a company's portfolio. In Managing Japan's Merger Mission, Dr Faiz Kermani of Chiltern asks whether the new wave of consolidation in the Japanese pharmaceutical sector has added a new dimension to the globalisation strategy of Japanese firms  
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The combined population of CEE and Turkey currently stands at more than 230 million inhabitants. Dr Marcin Dudek of Remedium Oy/Ltd anticipates the continued growth of registered trials in the region, in Pulling Down the Iron Curtain  
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The CRO industry today has realised that one of the keys to success in a competitive marketplace is effective customer management. Elke Feliers of MSOURCE presents the do's and don'ts of Conducting a Customer Satisfaction Survey  
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Drug Discovery & Delivery
The ability to predict the impact of environmental conditions on clinical products is an essential part of the regulatory approval process. Dr Timothy Rhines and Richard Crowley of Covance consider the critical components of stability testing, in Drug Development on Solid Ground  
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In Getting with the Flow, Yin Liu at the University of Oxford reports on the growing willingness to find an effective alternative method to traditional needle and syringe administration - and how CFD flow simulation technology hopes to revolutionise the development of needle-free epidermal vaccinations  
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Human-animal hybrids may sound macabre, but they are showing rich potential in the development of valuable new therapies. In The Rise of the Chimera, Nicola Kenward and Julian Hitchcock of Mills & Reeve look beyond the media exaggeration, and charge researchers to participate fully in informed debate and the development of appropriate regulation - a critical step if they are to maintain public confidence in their important work  
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Therapeutic Innovation
The development of effective anti-cancer agents with a reasonable safety margin has a notoriously chequered past. Many have appeared since the 1980s; most have failed at various stages of development. Marinus W Lobbezoo and Eric van der Putten at NDDO Oncology provide fresh hope, in Targeted Anti-Cancer Agents Come of Age  
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In a golden era for experimental cancer therapy, John Whittaker of Kendle International considers some of the implications for those involved in developing and evaluating new treatments, in Targeted Therapeutics  
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Once a fast-developing market, concern is mounting that there will be limited advances in the HIV therapy market until 2009-2010, due to the lack of late-stage products in development. In Holding Back the Tide, Laura Harris of Datamonitor wonders if entry inhibitor class drugs can add much needed value  
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Clinical Laboratories & Logistics
Cold Chain Logistics: No Room for Failure, Martin Peter of Envirotainer reminds us - the value of temperature-sensitive pharmaceutical products inside a standard air cargo container can easily pass the $1 million mark  
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In the ever more complex environment in which pharmaceutical organisations operate, striking the right balance when dealing with information management for regulation is imperative in order to deliver greater levels of efficiency, maintains Steve Benton of BT, in Information v Regulation  
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Keeping Compliant is vital insists Adrian Carter of SMARTTECH Consulting Services Ltd, as companies look for integrated technology to provide better business returns and to assist in areas such as project management, LIMS and instrument interfacing  
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Reviews & Previews
Innovation in Europe goes under the microscope, at the 18th annual DIA EuroMeeting - be there at the Palais des Congrès, Paris, 6th-8th March 2006  
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Data Management & IT Solutions
Underestimate CDMS at Your Peril, cautions Barry Burnstead at Phase Forward - while some are quick to suggest that clinical data management is dead, the particular needs that it addressed some 25 years ago remain very real today  
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CDISC Set the Standard, argues Jozef Aerts of XML4Pharma in his review of a central framework widely used by many pharma companies and CROs to establish clinical studies and to collect, exchange and archive research data  
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