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European Pharmaceutical Contractor

epc
Autumn 2013

   
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Keynote
Editor’s Letter

Graham Hughes picks up on the theme of risk that runs through many articles in this edition, from informing patients about drug safety, to protecting business operations.
 
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Marketplace & Business
Academic Research Organisations

Lighting the Way

Academic bodies are making a big comeback, challenging contract research organisations in the global trials marketplace. Cyrus Park at Julius Clinical charts their history and addresses some misperceptions over their role.
 
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Business Performance

Battle Ready

Emerging markets are a critical battleground for pharma companies seeking to rejuvenate their R&D business. But is it better to partner with global or local contract research organisations? Igor Stefanov at Synergy Research Group investigates.

 
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Anti-Counterfeiting

False Move

In the ongoing war against fake drugs, legal moves worldwide tend to focus on digital traceability. Mark Davison at Blue Sphere Health emphasises that manufacturers should also consider physical security and processes as part of an integrated strategy.
 
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Legal & Regulatory
Regulatory Affairs

Legal Studies


Regulatory affairs professionals have a critical role in speeding up approvals, reducing risk and improving the efficiency of multiple processes along the product lifecycle. Preeya Beczek at Pharm-Olam International looks at the skills they need.


 
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Drug Safety

Worth the Risk?

The industry hasn’t got the best record when it comes to giving patients sufficient risk information about the safety of medicines. Lisa Bolitho and Mark NelsonTyrrell at ICON Clinical Research explain how regulatory developments aim for a more proactive approach.
 
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Falsified Medicines

Keeping it Real

This summer sees tougher rules on active substances imported into Europe come into force as part of the Falsified Medicines Directive. Michael Finn and Paul Clifford at Matheson look at the implications for those in the supply chain and how they can comply.
 
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India Focus

In Conclusion

Trying Times

There is divided opinion over India as a suitable destination for clinical trials: advocates point to new and improved regulations, but many remain disillusioned, says Graham Hughes.

 
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Science & Innovation
Dosage Forms

Putting the Fizz into Formulation

From ease of swallowing through to simplifed treatment regimens, effervescent tablets and granules provide numerous patient benefi ts. Not suprisingly, a large market exists for their innovative manufacture and development, as Detlev Haack and Martin Köberle at Hermes Pharma explain.
 
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Oncology R&D

Shared Vision

Using imaging-based surrogate endpoints as biomarkers can speed up trials, underline safety and efficacy, and support clinical data for decision-making and regulatory submission, says Oliver Bohnsack at Perceptive Informatics
 
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Therapeutic Innovation

Personalised Medicine

Next Generation

Circulating tumour cell diagnostic tests have only recently become mainstream but now look set to push a new era of targeted therapeutics in oncology – with China positioning itself to take commercial advantage. Ken Pennline at LabCorp Clinical Trials reports.

 
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Risk Management

Risk Management

Healthcare Ecosystem

Expanded boundaries, new technology and end-to-end solutions offer tremendous benefits, but also bring growing complexity and risk that life sciences companies must manage.Heather Fraser at IBM discusses the issues.

 
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Research and Development
Pharma Marketing

Picture This

Pharmaceutical and healthcare brands are tapping into the growing consumer trend which interconnects health and happiness by using imagery to communicate with customers and inspire trust. Michaela Schwing at Getty Images reports.

 
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Interview
Q&A: Patient Engagement

Personal Development

Warning that the current healthcare model is unsustainable, Judith Teall at Exco InTouch examines the industry’s evolution towards personal technologies for patient recruitment and engagement in clinical research.
 
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Interview: Aurélien Dupuy

Industry Forecast

GlobalData’s Director for Oncology, Haematology and Gender Health outlines his career path and argues that the industry – and particularly small pharma – is reaching a critical point.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

PCI Clinical Services Announces New Facility Dedicated to Clinical Trial Returns

Philadelphia, USA – October 15, 2018. Leading international pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced the completion of a dedicated Returns Management facility at its Clinical Services Center of Excellence at Bridgend, UK. PCI provides a full service Returns Management service for clients, providing visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study. Returning and reconciling Investigational Medicinal Product (IMP) on completion of a study is a critical part of a Clinical trial and can require complex reverse logistics. Trial outcomes can be impacted if Returns are not processed efficiently and precisely.
More info >>

White Papers

The Promise and Challenge of Adaptive Design in Oncology Trials

Medpace

Clinical oncology trials are more complex and time consuming than those in any other therapeutic area and failure rates are frustratingly high. Given the urgent need for new oncologic therapies, sponsors are eager to find more effective ways to conduct clinical research. Incorporating adaptive design methodologies into clinical trials can reduce costs and enhance efficiency while maintaining trial integrity. They can also reduce the number of patients on placebo and sub-therapeutic doses. In light of this promise, regulatory bodies have created guidelines supportive of adaptive design.
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Industry Events

Synthetic Biology Congress

8-9 November 2018, London, UK

Oxford Global is proud to present its Synthetic Biology Congress taking place on 8-9 November 2018 in London. As part of our Genomics and Synthetic Biology UK series, our congress will bring together Over 600 delegates representing internationally renowned research & academic institutions, clinical research institutions and pharmaceutical companies.
More info >>

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