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European Pharmaceutical Contractor

epc
Summer 2003
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 first Editor's Letter, Julia Lloyd-Parks reviews the articles in this Summer 2003 issue

 
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Marketplace & Business
Dr Grant Coren, Pharmaceutical Practice Leader at Astralis Group Plc, examines Uneasy Alliances - Managing the Relationships in Alliances and Joint Ventures  
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The majority of drug patents will expire before 2010 and the race is on to fill the emptying pipeline for new products. Guy Malchi, Director of the Life Science Division at Tefen UK Operations Management Consulting, takes us From Pipe Dreams to Reality  
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A worldwide survey in 2002 found that only 53 per cent of companies have a business continuity plan. Chris Tait, Life Science Account Manager at Chubb Insurance Company of Europe, asks why Life Science Companies Don't Plan to Fail, But Often Fail to Plan  
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Ben Rapinoja and Kristiina Laiho, Attorneys at law Borenius & Kemppinen Ltd, outline Legal Due Diligence and Biotech Transactions - Practical Aspects  
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Clinical Trials
Julia Lloyd-Parks, Editor of EPC and Senior Consultant at Technomark Consulting Services, conducts An Interview with John Kolthammer, Chief Executive Officer of the Institute of Clinical Research  
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Competitive pressures are forcing pharmaceutical companies to carefully examine the process of drug development. Dr Paul Bleicher, MD, PhD, Founder and Chairman at Phase Forward, Inc looks at ways of achieving shareholder value while controlling costs in, Managing the Information Supply Chain in Clinical Trials  
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Audrey Bottomley, David Myers and Chris Willoughby of the Reproductive Studies Group at Huntingdon Life Sciences, discuss the potential benefits of using young animals in preclinical studies, in Preclinical Juvenile Toxicity Studies: Will it be Safe for Children?  
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The chemical pathology or clinical chemistry laboratory provides biochemical information for the management of patients and/or trial subjects. Johann Terblanchй, Senior Director and Head, Clinical Division at Farmovs-Parexel, gives us a detailed examination of Abnormal Laboratory Findings in Healthy Subjects: Biochemical Tests in Clinical Research  
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Legal & Regulatory
New FDA draft guidance recommends the use of risk assessment techniques for 21 CFR Part 11; however it does not offer any help on how to conduct risk assessment. Sam Brooks, Principal Compliance Consultant at ABB Switzerland, is at hand with 21 CFR Part 11 - GAMP Risk Assessment Methodology for Delivering Compliance Measures  
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Wolfgang Winter, Senior Product Manager Networked Data Systems at Agilent Technologies GmbH, revisits Electronic Records and Electronic Signatures in The Impact of the New 21 CFR Part 11 Guidance on Data Systems and Networks in GxP Environments  
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In the second instalment of her article, Dr Manja Epping, Lawyer at Ashurst Morris Crisp, looks at Data Exclusivity Under Review - Striking the Balance Between Originator and Generic Medicines  
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Drug Discovery, Development & Delivery
Christopher Searcy, Vice President of Corporate Development at Nektar Therapeutics, explores Drug Delivery: An Evolving Concept  
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The importance of medical delivery devices with features that enable the non-invasive delivery of drugs is obvious. In The Application of Regimen Assurance and Assistance Devices for Future Inhaleable Pain Management Therapies, Chris Halling, Marketing Manager at Bespak considers the potential  
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Peter Fyhr, R&D Director, and Ken Downie, Director of Business Development, at Amarin Development AB, explore advances in Oral Drug Delivery Technology  
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e-Data
Only a few companies have implemented electronic data capture and electronic study management services as their standard clinical trial technology. Dr Max Horneck, Chief Technical Officer at clinIT AG, outlines Introducing e-Clinical Trial Systems Toda  
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The Future of Electronic Data Capture in Clinical Trials is predicted by Tony Dean, Director of Sales and Marketing at Datatrial Ltd  
Agostino Renna, Director of Life Sciences, Americas, and Matthias Maaz, Director of Life Sciences, Europe, at Johnson Controls, Inc., examine Validation Requirements for Building Management Systems in Pharmaceutical and Biomedical Manufacturing Facilities  
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Science & Innovation
In The Technology Conundrum: New and Old Technologies in Drug Discovery, Dr Roy Massingham BSc PhD, Director of Research Europe at UCB-Pharma, looks more closely at drug discovery and the lessons learned over the last 25 years  
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Henri Snijder, European Business Development Manager LC/MS Small Molecules at Applied Biosystems, describes Advances in LC/MS/MS for Drug Metabolite Characterisation e-DATA  
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LABS & Logistics
Evolving standards and technologies make e-logistics in temperature-controlled, on-time shipment delivery increasingly challenging. In E-Logistics in Cold Chain Management, Alastair Black, Project Director at Quintiles Clinical Supplies Europe, assesses the facts  
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Katrina Bray, Marketing Manager at Laminar Medica Limited, tells us why It's in the Bag: Shipping Infectious Substances and Diagnostic Specimens by Air Made Easy  
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Bioterrorism Focus
Bioterrorism: Preparing For the Worst. An overview from Terri Rebmann, Infectious Disease Specialist for the Center for the Study of Bioterrorism and Emerging Infections (CSB&EI) at Saint Louis University, School of Public Health  
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Nicolas Higgins, Chief Business Officer at Acambis, takes the threat of smallpox as an example, in Testing for Biosecurity Vaccines  
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Previews & Reviews
Julia Lloyd-Parks, Editor of EPC, and Dr Graham Hughes at Technomark Consulting Services Limited, report direct from DIA Euromeeting Rome, 3rd-10th March 2003  
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