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European Pharmaceutical Contractor

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Summer 2012
   
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Marketplace & Business

Business Management

Big Pharma in Crisis?

Despite the challenges the industry currently faces, Big Pharma is looking for new ways to render the drug development process more efficient and sustainable, as Chris Swain of Cambridge MedChem Consulting discusses.

 
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UK Survey

Life Science Expectancy

Nick Stephens at RSA explores the results of the UK Life Science Industry Leaders Survey, highlighting disappointment at the Government’s lack of support for the industry and the areas with potential for growth.

 
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Pain Management Therapeutics

In Search of Relief

With an ageing population and promising new treatments in the pipeline, the pain management market is set to continue its growth. Swapna Soni at GBI Research highlights the key trends in this sector.

 
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Clinical Trials

Strategic Outsourcing: Clinical Trial Management

Changing Landscapes

Outsourcing the management of a clinical trial can prove to be a beneficial strategy. Tom Avery at ERT considers the pros and cons of such an approach, with reference to respiratory therapeutics and ePRO.

 
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Regional Trials: Asia

Find your Partner

As Asia continues to grow as a centre for international drug development, it can be useful to consider the benefits of working with a local CRO, as Young Jack Lee at LSK Global PS discusses.
 
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Feasibility Studies

Weighing up the Options

Alexandra Terzakis at SIRO Clinpharm suggests that a feasibility study is essential to the success of a clinical trial, incorporating regulatory considerations, patient recruitment expectation and any anticipated costs.

 
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Early Phase Trials: Oncology

Starting Blocks

As the field of oncology drug development continues to grow, Jane Bentley at Novella Clinical explores the best way to optimise Phase 1 clinical trials, from improving protocol preparation to monitoring data.

 
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Legal & Regulatory

Obesity Drug Development: FDA Guidance

The Heart of the Matter

Regina M Ballinger at Thomson Reuters provides an overview of the obesity drug market, and considers the regulatory guidance in relation to a number of potential new drugs in the pipeline.

 
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Observational Studies: Regulatory Considerations

Seeing Clearly

Providing real-world data for decision making, non-interventional studies (NIS) must still adhere to the relevant regulations. Rohini Chari at United BioSource Corporation explores the key considerations for setting up an NIS.
 
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US Pedigree Laws

Patchwork Approach?

US drug pedigree laws were established in order to combat the rise in counterfeit drugs. Dirk Rodgers of RxTrace.com examines these regulations and suggests that they need to go much further in order to ensure supply chain integrity.
 
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Drug Development & Delivery
Drug Development: Virtual R&D

A New Dimension

Karyn Korieth at CenterWatch investigates the development of new virtual research companies, which seek to overcome declines in productivity by adopting radical new methods for R&D.
 
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Reviews & Previews

Book Review

A Problem Shared

Graham Hughes reviews Portfolio Programme and Project Management in the Pharmaceutical and Biotechnology Industries, edited by Pete Harpum.

 
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Data Management & IT Solutions

Strategic Outsourcing: Data Management

An Evolution of Engagement

Greater involvement in the CRO-sponsor relationship, coupled with a consideration of the technology involved in research, can help both parties to remain competitive, as Graham Bunn at Medidata Solutions Worldwide explains.

 
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Cool Chain, Labs & Logistics
Supply Chain: Outsourcing

Turning Tide

Outsourcing logistics activities need not be as daunting a task as many pharmaceutical companies perceive it to be. Fabio Mioli at DHL Supply Chain discusses the benefits of working with a specialist supply logistics service provider.
 
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In Conclusion

Paying the Price

Graham Hughes considers the industry’s approach to drug pricing.

 
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Medical Writing

Regulatory Submissions

Re-Writing the Rule Book

Outsourcing the process of writing regulatory documents provides reliable expertise, flexibility and cost-efficiency, as James Sawyer at Prism Ideas explores.

 
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Published quarterly in
February, May,
August and November

News and Press Releases

Source BioScience invest in digital pathology platform to enhance the outsourced histopathology service solution provided to the NHS and private healthcare

As a leading provider of outsourced histopathology services to the NHS and private healthcare centres in the UK Source BioScience has, after a detailed review of all other available alternatives in the digital marketplace, unveiled investment in a digital pathology platform from their preferred partner, Philips.
More info >>

White Papers

Clinical Trial Site Contracting: The Conservative, Progressive and Hybrid Models

DrugDev

For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality. One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.
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Industry Events

On Helix 2018

10-11 July 2018, The Cambridge Building, Babraham Research Campus

ON Helix is a two-day event aimed at informing delegates of how to turn early stage inventions and ideas into innovative health treatments (new medicines, novel biomarkers, useful medical devices or improved medical practices).
More info >>

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