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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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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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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: 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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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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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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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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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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