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home > epc > Spring 2008
PUBLICATIONS

European Pharmaceutical Contractor

epc
Spring 2008
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
When it comes to locating clinical trials, South Africa is often overlooked despite being a cost-effective location with a diverse, willing population. Catherine Lund at OnQ Consulting explains why more trials should come Out of Africa  
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Igor Stefanov at Synergy Research Group analyses how the clinical research market in Russia is showing significant year-on-year growth and is becoming a dominant global player – a sure-fire sign of a Russian Revolution  
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Rob Sexstone of 3di Information Solutions recommends that you Don’t Get Lost in Translation by ensuring that a product’s internationalisation and localisation needs are addressed as early on in the development cycle as possible  
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In A Master Class, Dr Nicholas Breakwell assesses the significant benefits to both employers and employees in studying for a Master of Science in Pharmaceutical Medicine; a course he believes not as widely-available to graduates as it should be  
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The increasingly competitive nature of the pharmaceutical sector is forcing employers to work even harder to recruit and retain the best candidates in order to remain at the top, claims Martin Blake of Volt Life Sciences in The Pharmaceutical Candidate  
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Clinical Development
Properly-implemented adaptive designs are capable of improving all aspects of drug development. Olga Marchenko at i3 Statprobe assesses their importance for the entire clinical testing arena, in Trial and Error  
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Surrogate endpoints in drug development can be crucial when it comes to formulating more efficient clinical trial designs. In Surrogate Force, Tomasz Burzykowski at MSOURCE Medical Development considers the steps required to achieve this goal  
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Focus has recently been shifting to first-in-man and other early phase clinical studies; Keren Winmill at Penn Pharmaceutical Services Ltd analyses the quickest routes to Phase I, in On the Fast Track  
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Dr Graham Wylie of the Medical Research Network Ltd puts forward his strategies for more effective patient recruitment and retention in Western pharmaceutical markets, in On the Home Front  
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Legal & Regulatory
Once on the brink of a significant milestone, the Greek clinical trial industry has suffered in recent years due to the limitations imposed by red tape. Ana C Hernandez Daly and Vasiliki Poufti believe that The Clinical Trial Odyssey is finally reaching a favourable destination despite numerous setbacks  
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The continuous growth of the pharmaceutical industry is creating demand for statistical programmers, of which there is a severe shortage who specialise in clinical knowledge. In Practice Makes Perfect, Sunil Gupta and Mandyam Srirama at Quintiles offer advice on the importance of restructuring training programmes in order to take advantage of the abundance of available programmers from other industries  
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In Vigilant Competition, Annabelle Jerram at Wolters Kluwer discusses how the ever-increasing need for good pharmacovigilance practice is placing greater emphasis on the humble case report  
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Logistics
Geraint Thomas of Laminar Medica, in keeping with a key industry aim, searches for a cost-effective and safe transportation method for temperature-sensitive drugs, investigating the entire Protection Package and its implications for the pharma industry as a whole  
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In The Third Man, Angus G Cameron of Pharmarama assesses the strategic challenge of and the solutions available to procure specific comparator drugs for clinical trials, and the complications of managing such a procedure  
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DATA MANAGEMENT
Effective management of clinical trials is best undertaken At the Hub; investigator hub-sites employing electronic data capture are an optimal solution, purport Dr Hans-Detlev Stahl at Clinpharm International GmbH, and Maria Sumner and Rob Nichols at Phase Forward Europe Ltd  
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In Voicing Concerns, Claudia Horneck at Clinit AG assesses the use of interactive voice response systems in study settings, and the advantages they can present in terms of patient involvement and treatment allocation  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
The growth of the European oncology market is bringing with it added financial and regulatory concerns, though one can anticipate a bright future thanks to biotechnology-based targeted therapies, according to Paljit Sohal at Frost & Sullivan, in Optimal Oncology  
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In Cognitive Science, Andrew Blackwell of Cambridge Cognition talks to EPC about the significance of forward-looking specialised services and cognitive assessment products for achieving optimum treatment potential  
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The correct adoption of cognitive testing systems can significantly aid the clinical trial process. In Cerebral Intelligence, Mark Cusack at Cognitive Drug Research discusses the importance of clinically-relevant cognitive testing  
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ECG CORE LABS & CARDIAC SAFETY
Susan Boyle of Spacelabs Healthcare and Sasha Latypova of iCardiac Technologies, Inc, explore the potential of novel technologies in cardiac safety as a method to synchronise sensitive variables In a Heartbeat  
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Decreasing variability and optimising data quality is fundamental to the execution of thorough QT/QTc studies, argue Benoit Tyl, Bill Wheeler and Joy Olbertz at MDS Pharma Services in The Thorough QT Study  
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Improving cardiovascular safety in drug development is a continuous aim for the pharmaceutical industry in its entirety. Boaz Mendzelevski, a Cardiac Safety Consultant, examines the technologies available and methods involved in Safety First  
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Edited by
Dr Graham Hughes,
Consultant in
Pharmaceutical
Development
Published quarterly in
February, May,
August and November

Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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News and Press Releases

Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials

HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
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