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PUBLICATIONS

European Pharmaceutical Contractor

epc
Winter 2014

   
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introduction

Editor's Letter

Graham Hughes draws on the focus of clinical research careers in this issue – underlining the fact that, in the CRO industry, it is all about the people.

 
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Business and Finance
Market Performance

Sales Force


Pharma sales departments which lack the innovative approach matched by the rest of the sector run the risk of falling behind, argues Mark Garritt at ByBox. The traditional representative model needs refreshing if companies are to enjoy ample market growth once more.
 
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Legal & Regulatory
EU Clinical Trials Regulation

New and Approved


Although the new EU Clinical Trials Regulation is set to improve transparency, streamline processes and reduce administrative burden, Shuna Mason, Roland Wiring and Andrew Payne at CMS are concerned that it will not be a smooth transition.


 
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Serialisation Regulation

Stay on Track


An effective serialisation solution will provide overall business benefits, in addition to greater visibility and collaboration across the entire supply chain. Bearing in mind the scale of counterfeit products and strict regulations, this has never been more essential, contends Diane Palmquist at GT Nexus.
 
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Clinical Trials Supplies
Supply Chain Management

Pooling Resources


Distributors and sponsors often experience difficulty when maintaining clinical supply availability and a flexibile supply chain. For enhanced manufacturing and management, Kurt Lumsden at PAREXEL Informatics advises adopting a pooling strategy and interactive response technology.

 
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Electronic Solutions
Electronic Trial Master Files

Wearing Thin


Concerns over electronic trial master file adoption should be discarded, maintains Rik van Mol at Veeva Systems. The costs and regulatory barriers involved are far outweighed by the vast advantages to be had from exploiting this technology.
 
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Clinical Development
Drug Resistant Bacteria

Immediate Action

Dawn Firmin
at MGB Biopharma highlights the threat of drug-resistant bacteria, which are constantly growing in number. Along with recent political support, she insists that a novel class of antibiotics should become an industry priority

 
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Science & Innovation: Cancer Focus
Gastric and Oesophageal Cancer

On Target

The survival rate for gastric and oesophageal cancers is stubbornly low, in spite of promising pipeline drugs and the relative success of monoclonal antibodies. Dominic Trewartha at GBI Research investigates this unmet need, stressing the lack of targeted therapies.
 
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DATA MANAGEMENT
Uniform Data

One for All


To create a complete picture of the drug development world, clinical trial management system data should be collated to enable a common data-sharing platform between businesses, say DrugDev’s Claire Sears and Graeme Benson.
 
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Risk Management
Risk-Based Monitoring

A Little More Action


BioClinica’s Courtney McBean urges pharma to stop stalling and embrace risk-based monitoring. This modern approach can allow for the most effi cient trial management – when implemented with the correct components – so hesitation in its adoption is unfounded, she asserts.
 
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STAFF RECRUITMENT & TRAINING
CRO Recruitment

Talent Trap


Retaining top talent is the name of the game, says INC Research's Jan Schreur. As outsourcing and worldwide strategic partnerships have increased, so too has career competition, as well as new opportunities - and for these reasons, boths CROs and clinical research professionals must up their efforts.

 
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Recruitment: Asia Focus

East Meets West


In today's Asian recruitment landscape, there is a desire to employ more local people in senior roles - but the talent pool is somewhat shallow. With a clear skills gap in the region, developing and holding best-in-class staff is no mean feat. RSA's Susan MacDonald discusses the issue with Thomas Meininghaus at Siemens Audiology Solutions.
 
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Professional Development

Through the Ranks


Nikki Harrison at Clinical Professionals reflects on her career path and entry into the industry. She examines how difficult it can be to get a foot in the door of clinical research, and recommends the reintroduction of more substantial support and training for new recruits.

 
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Recruitment Providers

Quality Check


A poor employee provider can damage both wider brand image and internal quality. Matthew Beedle at NonStop Recruitment suggests that companies seek greater awareness of how their staffing is carried out, and ensure their supplier is regulatory-compliant and ethically sound.
 
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Cool Chain, Labs & Logistics
Temperature-Sensitive Shipments

Sun Screen


In order to sufficiently protect products, a more robust defence is required for air freight cargo, explains Malik Zeniti at DuPont. At a time when global warming shows no sign of slowing, failing to have a reliable solution in place for temperature-sensitive shipments can result in huge losses.
 
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Research and Development
Neurodegeneration and Ageing

Links of Life


Paul Gard and Sara Fidalgo at the University of Brighton look at the links between old age, dementia and depression. They assess their aetiologies and the negative effects that cognitive-enhancing drugs can have on the gastrointestinal tract.
 
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Engineered Nanotechnology

Nano Debate: Part 2


Although we are exposed to nanoparticles through natural sources and in everyday products, they have been shown to damage human health and the environment. Shelley Bowers at Asons Solicitors suggests halting use of engineered nanotechnology until further research is carried out.
 
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Interview
Industry Insight: Data Monitoring

Quality and Quantity


Marc Buyse at CluePoints tells EPC that monitoring improvements and significant expenses do not need to go hand-in-hand.
 
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In Conclusion

Going Viral


When it comes to this year's Ebola outbreak, Graham Hughes questions whether we can still rely on pharma's investment to curb the crisis.
 
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Published quarterly in
February, May,
August and November

News and Press Releases

Tired of pushing hand hygiene standards?

Teknomek’s sanitising door handles offer a new level of support for hygiene routines in the pharmaceutical sector. The new products automatically release virucidal hand gel when pulled, helping prevent pathogens from being brought into laboratories and sterile environments.
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White Papers

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Perceptive Informatics

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events

Cell Therapy Manufacturing & Gene Therapy Congress

6-7 December 2017, RAI, Amsterdam

Bringing together 300+ leaders and key influencers from pharma and biotech companies on 6 - 7 December 2017 in Amsterdam, Cell Therapy Manufacturing & Gene Therapy Congress will provide you with the latest advice for driving manufacturing and commercialisation through direct access to transforming innovative research to prosperous cell & gene manufacturing.
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