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PUBLICATIONS

European Pharmaceutical Contractor

epc
Spring 2009
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 the current issue of EPC.
   
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Marketplace & Business
With the expiry of pharmaceutical patents and supply pipelines running dry, the use of plant-based medicines is increasing worldwide. Jay Udani at Medicus Research LLC reports on the efforts to transform herbal medicines into botanical drugs.  
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The dynamics of pharma outsourcing in Asia are changing dramatically. Beatrijs Van Liedekerke and Sujay J Shetty at PricewaterhouseCoopers discuss the region's potential transformation from manufacturing centre to key player in drug discovery.  
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Safety concerns have forced a wide range of drugs and medical devices off the market in recent years. Sammer Thapar at Omnicare Clinical Research argues that companies need to have an effective contingency plan in place, in order to avoid panic in the event of a product recall.

 
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Legal & Regulatory
In the light of the latest legistlation involving risk assessment, Brian Szukala at SeerPharma Ltd discusses the difficulties faced by pharma management in reducing costs, while maintaining patient safety as a priority.  
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Gerry Kamstra at Bird & Bird LLP comments on the Preliminary Report of the European Commission's Pharmaceutical Sector Inquiry, investigating a perceived decline in innovation after a reduction in the number of new medicines reaching the market.  
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Tim Farrell of FutureSoft Inc reviews the legal issues surrounding economic espionage, and suggests steps that companies can take to protect themselves.  
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Clinical Development

The average cost of developing a new drug now stands at an estimated $1 billion, while new chemical entity approvals worldwide are declining. Kerry Gordon, Gary Shorter and Terry Weber Sosa at Quintiles explain how biostatistics can boost efficiency in development.

 
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Tom Parke at Tessella demonstrates how the extra effort made in adaptive clinical trials is rewarded by a more efficient development programme that reviews key response data as it is collected, and uses it to adapt the process.  
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A suitable study site is crucial to the success of a clinical trial: Michael Sigmund at SSS International examines the pivotal points to consider when selecting a testing ground.  
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The 'participant information sheet' plays a fundamental role in the recruitment of participants in clinical trials, and better readability can improve levels of adherence to trial procedures, argue Peter Knapp and DK Theo Raynor at the University of Leeds.  
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Given the lack of information available on the use of medicines in children, John Bolodeoku at Astellas Pharma considers the need for new EU paediatric regulation, and looks at the problems involved in its implementation.  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
Advances in biomarker technologies have the potential to increase understanding of a drug's mechanism of action at an early stage. Lydia Meyer-Turkson at Epistem examines how these technologies can reduce the cost of drug discovery and development.  
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Betsy Hughes-Formella and Joachim Fluhr at bioskin GmbH present an overview of the basic study designs for standard dermal safety tests, discussing methods to optimise Phase I cutaneous testing in humans.  
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The most reliable information about the pharmacological potential of a molecule is obtained using human subjects. Ruediger Haecker and Steve Dean at Harlan Laboratories discuss how the time to first-in-man studies can be shortened by streamlining non-clinical programmes.  
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New drugs are not conceived by chance; Mark Crane at Ricerca analyses the challenges for small, mid-sized and virtual biotech firms competing with the big pharmaceutical companies to develop new candidates.  
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Data Management & IT Solutions
Rachael King of CRF Inc unpicks the recent draft guidance from the FDA which emphasises the importance of patient reported outcomes (PRO) in clinical trials.  
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The accuracy of patient data recording has long given cause for concernin clinical testing. Aleck Harrison at AJH Partners highlights the advantages of using e-spirometric diaries in respiratory trials.

 
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As EDC becomes more and more widespread, the pressure for CROs to offer this system has never been greater. Claudia Horneck at clinIT AG explores the partnership between EDC vendors and CROs.  
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Peter Ketelaar at PRA International and Trish Meek at Thermo Fisher Scientific explain why market-specific, high-performance LIMS are indispensable in helping CROs to achieve operational excellence by improving productivity and minimising costs.  
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LABS & Logistics
 
Andrew McDonald at World Courier offers a guide to various systems which maintain temperatures during pharmaceutical air shipment, in order to meet the demanding timelines between procurement of active ingredients and distribution of investigational drugs.  
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Adele Davis and Amandip Sidhu at Pharmarama take us through the notoriously difficult logistics of effective cold chain clinical trial supplies management in seven steps, avoiding the obstacles from procurement to delivery.  
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ECG CORE LABS & CARDIAC SAFETY

Three years have passed since the introduction of E14 guidance, which requires that all new drugs pass ECG-passed cardiac safety testing. Alexandra Latypova at iCardiac Technologies, Inc looks at the new cardiac safety assessment challenges that the guidance has presented.

 
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Jeffrey S Litwin at eResearch Technology, Inc takes a look at ECG centralisation and the value of implementing metrics in order to maximise partnerships with ECG core laboratories.

 
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Recent drug recalls amid cardiac safety concerns have prompted a debate about the need for earlier cardiac evaluation in drug development. Tosja Zywietz at Cardinal Health provides recommendations for ECG-based cardiac safety drug studies.  
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