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International Clinical Trials
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| Clinical trials present a number of challenges for global pharmaceutical companies, says Gary Muddyman of Conversis, but additional issues are raised when the trials are extended to developing countries
The global clinical trials industry is currently estimated to be worth nearly $10 billion, and is expected to grow even further as concerns over safety and a highly competitive pharmaceutical market continue to drive demand for large clinical trials. In fact, according to a report from pharmaceutical R&D experts LeadDiscovery, global revenues from clinical trials have increased by almost 15 per cent in the last year alone (1).
Increasingly, developing countries are becoming a desirable location for much of this clinical research. To understand the reasons behind this change in policy, one simply needs to look at the complete drug development cycle. The entire process, which starts in the research labs and ends with a new drug being launched in the market, is not only time consuming but also extremely expensive.
As a result, global pharma companies based in developed countries are increasingly turning to developing countries and emerging economies around the world for their clinical trials, as reduced costs – as well as easy availability of patients with varied diseases – make developing regions a preferred destination for clinical research outsourcing. WHAT DEVELOPING COUNTRIES DELIVER
According to the Offshoring Times, the cost of drug development is now estimated at $1 billion, and clinical trials on humans – a critical phase in new drug development – can sometimes account for 40 per cent of the total cost (2). Outsourcing clinical research to developing countries can allow global pharma companies to trim costs considerably. Clinical trials in India, for instance, can often cost 50 to 60 per cent less than the average cost in the US. Even more than cost, time is a crucial factor for pharma companies. When you consider that a patent only lasts 20 years, more than half of that time is often already gone by the time the drug is discovered, approved for clinical trials, tested and finally marketed. |
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Gary Muddyman is Managing Director and CEO of Conversis, a UK-based provider of globalisation, internationalisation, localisation and translation (GILT) services. Gary, together with a team that brings more than 60 years to the GILT market, founded Conversis with the idea of advancing the understanding and use of localisation and translation as a strategic business tool. Prior to joining Conversis, Gary served as Director of Operations for K International Plc, where he was responsible for all the development and implementation of business strategies. Prior to this, he spent 16 years working for HSBC Asset Finance UK Ltd, where he helped create the Metropolitan Collection Services, the debt management arm of HSBC. Gary received his MBA from Warwick University. |
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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