spacer
home > ict > winter 2008 > cultural dimensions
PUBLICATIONS
International Clinical Trials

Cultural Dimensions

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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
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.
spacer
Gary Muddyman
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

The key to tackling drug development complexity: Collaboration.

Laupheim and Ravensburg, Germany, Milford, MA, and Skokie, IL, USA, July 6, 2020 – Vetter and Rentschler Biopharma, two globally operating Contract Development and Manufacturing Organizations (CDMOs), today announced their strategic collaboration, to enhance their services and offer complementary skills and experience along the biopharmaceutical value chain. With drug development growing increasingly complex and cost-intensive, biopharmaceutical companies are under significant pressure to streamline their products’ path to market. The desired goal of the collaboration is to create long-term value through the alignment of manufacturing approaches that enable clients to bring their products to patients more easily and faster.
More info >>

White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
More info >>

 
Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement