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European Pharmaceutical Contractor

epc
Spring 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
In her Editor's Letter, Julia Lloyd-Parks reviews the latest offerings in this our Winter issue  
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Marketplace & Business
In Drug Safety Makes Another Leap, Bearing Point’s Craig Wylie, Senior Manager Life Sciences, takes us through the FDA’s latest reporting requirements and considers how they will impact global pharma  
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Maxwell Noble,Managing Director of Britannia Pharmaceuticals Limited, gets out his microscope to examine US and European Pharmaceutical Markets: Lessons from Across the Pond  
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With increasing competition, and audiences that have become more discerning, demanding and better informed, Iain Johnston, Chairman of Core, encourages pharmaceutical companies to get focused on Diagnosing the Communications Gap  
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Clinical Trials
The implementation of the EU Clinical Trials Directive proved to be one of the defining moments in 2004 for the pharmaceutical community.We invited Dr John Hooper, CEO of The Institute of Clinical Research, to present his perspective on the Challenges and Trends in Clinical Research  
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Unravelling the Advantages of Conducting Clinical Trials in the Emerging World – Nermeen Varawalla, Vice President, International Business Development, at PRA International, takes us through the pros and cons when looking beyond the West  
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As R&D costs grow, sponsors are compelled to consider ways to improve the efficiency of the clinical development phase. Penny Westmacott, Account Manager, Clinical Trials Practice, and Dr Louise Sarup, Senior Account Manager/Marketing Manager at De Facto Communications plc, suggest Effective Patient Recruitment Strategies – Maximising your Return on Investment  
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Dr Anton van Weert, Senior Director of Scientific Services at Bio- Imaging Technologies and Professor Hans Reiber,Director of the Division of Image Processing,Department of Radiology at the Leiden University Medical Center (LUMC), explore the application of Core Lab Analysis Validation in Cardiovascular Clinical Trials  
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Legal & Regulatory
Dr Mark Richardson, Senior Director Regulatory Affairs at i3 Research, ponders the complexities of Legal Representation in EU Clinical Trials for Non-EU Sponsors – Where Do CROs Stand?  
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In the second part of his series,Dr Robert M Nelson, Associate Professor of Anesthesia and Pediatrics, Department of Anesthesiology and Critical Care Medicine at The Children’s Hospital of Philadelphia and the University of Pennsylvania, continues his study on Stimulating Paediatric Drug Research – Comparing International Ethical and Regulatory Standards  
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IT Solutions
Every extra day a drug is stuck in development can cost the sponsor US$600,000 in lost sales. In Meeting Patient Recruitment Timelines, David Stein, Director of Strategic Business Development and Dr Bill Byrom, Product Strategy Director at ClinPhone Inc, single out strategies to optimise recruitment and retention  
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Michael Hehenberger, Leader of the Development and Delivery of Clinical Genomics Solutions for IBM’s Information Based Medicine Unit, and Bill Rapp, IBM Distinguished Engineer at IBM Healthcare & Life Sciences, Information Based Medicine, and Christopher Yoo,Worldwide Director of Commercial Markets at Applied Biosystems, discuss Clinical Genomics IT Solutions for Pharmacogenomics  
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In Science and Compliance: The Hidden Benefits of Transparency, Correy Voo, Head of Business Technology at BT’s Global Services Division, makes plain the obligation on life science organisations to deal effectively with information management issues  
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Drug Discovery & Delivery
Kevin Maynard, Business Development Director at Imprint Pharmaceuticals Ltd, highlights the cause of sustained release forms that are Gaining the Competitive Edge in Injectables  
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Whilst over 80 per cent of pharmaceuticals are powders at some stage, conventional manufacturing processes usually allow relatively poor control of a powder’s physical form and crystallinity. Peter York, Senior Research Fellow at the University of Bradford and Co-Founder and Chief Scientist at Nektar Therapeutics, investigates Supercritical Fluids: The Crystal Clear Benefits  
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Therapeutic Innovation
Technological advances in the last 20 years have underlined the design of humanised and ‘fully’ human mAbs, instilling increased optimism in their therapeutic possibilities.With this in mind, Dr Raju Adhikari, Industry Manager at Frost & Sullivan Healthcare Practice, believes that Monoclonal Antibodies Offer Promising Therapeutic Alternatives in Oncology Indications  
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Despite decades of investigation, an effective HIV vaccine seems no nearer fruition. In Investigating Potential HIV Vaccines, Laura Harris, Infectious Disease Analyst at Datamonitor,weighs up the challenges ahead in combating this global pandemic  
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Dr Faiz Kermani, Budgets, Proposals and Marketing Executive at Chiltern International Ltd, makes the case for an under-diagnosed, under-reported and inadequately researched disease – Osteoporosis: Tackling Poor Awareness to Avert a Health Care Crisis  
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Labs & LIMS
In the Challenges of Sample Transportation Logistics, Dr Hermann Schulz, CEO and Co-Founder of Interlab Central Lab Services Worldwide GmbH, examines the dos and don’ts for sponsors and central laboratories  
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The average length of a global oncology trial is estimated to be an exhausting four and a half years: the collection of laboratory data is complex; and the cost and additional time needed to complete these trials is high. Jaap Dijkman,General Manager of Covance Virtual Central LaboratorySM and Dr Gordon F Kapke,Vice President of Global Technical Affairs for Covance Central Laboratory, present a much-needed New Model for Optimising Laboratory Data Collection during Clinical Studies in Oncology and Critical Care  
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LABS & Logistics
Working in Central and Eastern Europe – Utopia or Logistical Nightmare? Helen Springford, Business Development Director, UK and North America at IMFORM International Clinical Research, reviews the situation  
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Express, temperature-controlled transportation of biotech products represents a great challenge for air cargo carriers, argues Francis Ramuz, Cool Products Specialist at Swiss WorldCargo, in A Matter of Life or Death  
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With great pressure on pharmaceutical organisations to move products from conception to market as quickly as possible in order to maximise the market life of patented drugs, it is vital to choose the right Qualifying Vendors of HVAC Environmental Control Solutions. Walfried Laibacher,Validation Service Lead for Honeywell Building Solutions in Europe, explains why and how to do it.  
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Chiltern Acquires Japanese Clinical Research Organization Integrated Development Associates Co. Ltd.


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Industry Events

6th Annual Cancer Vaccines Conference

27-28 September 2017, Copthorne Tara Hotel, London UK

Cancer Vaccines 2017: Overcoming hurdles to cancer immune response: Cell therapies, vaccine development and combination therapies. SMi Group is thrilled to present the 6th annual Cancer Vaccines conference, taking place on 27th & 28th September 2017 in Central London, UK. Overcoming hurdles to cancer immune response: Cell therapies, vaccine development and combination therapies.
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