Pharmaceutical Technologist - September/October 2008 - (Page 14)

Market Watch low-cost manufacturing of established drugs, but outsourcing is now moving up the value chain. Industries, such as IT, automotive and aviation, are already sourcing significant elements of high-end work in Asia. Intellectual property concerns have inhibited this trend in pharma, but such concerns are being overcome and pharmaceutical companies are now stepping up their drug discovery investment in the region. The pharmaceutical business model is moving away from a fully integrated company structure to a future where companies use a wide range of outsourcing, partnership initiatives, as well as other contractual and relationship arrangements, to create networks of collaboration and discovery. Such investment is taking various forms. Direct investment in the establishment of research and innovation centres has been the route followed by AstraZeneca with its tuberculosis research centre in Bangalore (India) and, more recently, GlaxoSmithKline (GSK) with its investment, worth $100 million (€70.5 million) in the first year, in a new neuroscience research centre in China. Rapid expansion of clinical trials in Asia The volume of clinical trials being conducted in territories outside of Europe, North America and Japan has grown rapidly during recent years. Asian territories have led much of the growth with the number of trials conducted in China and India, in particular, growing fast because of recent moves to strengthen intellectual property protection (IPP) laws. Alongside IPP improvements cost has been a critical factor; for example, clinical trials in India are estimated to be up to 50% cheaper compared with the US. According to Clinicaltrials.gov, a website operated by the US National Institute of Health, the number of ongoing clinical trials in India increased from 40 to 50 in 2003 to approximately 270 by 2007. Large companies that are active in India now include Amgen, Biogen, Johnson & Johnson, Roche and GSK. Data from the same website also shows that China has overtaken India as one of the fastest growing locations for drug trials. By June 2008, China had 428 clinical trials registered on the website as under way, and a cumulative total of 870 completed or ongoing trials compared with 737 in India. Another key advantage of conducting trials in Asian territories is that many hospitals or doctors serve large numbers of patients, allowing companies to quickly recruit from a smaller number of sites. However, speedier recruitment can be offset by delays in securing local regulatory approval in certain territories. Delays of up to 12 months are not uncommon in China and, despite recent moves to streamline processes, 9-month waits are typical in India. In contrast, approval times in Singapore are approximately 3 months. The expectation is that approval times will shorten as governments seek to remove barriers to investment in trials. At the same time, there is a focus on stepping up measures to prevent the risk of fraud or poor quality data, which would make trials unreliable. FDA recently established an office in China and other regulators are also stepping up inspections. Additionally, local regulators are attempting to match the standards of Europe and the US. However, there is still wide variation among standards in the region with territories, such as Singapore, already level with international standards while others are much further behind. As with trials in any location, ethical issues require careful management. With low-income populations, additional issues arise such as ensuring that participants give truly informed consent and have post-trial access to treatment. Scaling up of pharma manufacturing in Asia Asian territories provide a significant cost advantage for pharmaceutical manufacturing. However, quality and safety are also important and must be considered. Recent reports of deaths linked to contaminated heparin in the US sourced from China highlight the critical issue of quality. However, the general trend in the region is of ever-increasing quality of work. As well as cost savings, the region boasts a large educated and appropriately qualified workforce that can run manufacturing plants equalling Western complexity and quality. Several CMOs operating out of Asia have also obtained approval from FDA, gaining credibility for their quality standards. In India, there are now more than 100 FDA approved pharmaceutical facilities — the largest number in any territory outside the US. Meanwhile, China completed Chinese GMP certification in July 2004 for all drug manufacturers in the territory. The author says ● ● ● ● The preferred outsourcing locations are India and China, but Taiwan and Korea are also becoming increasingly tempting locations. Previously, outsourcing was used for routine work, but many companies are now stepping up their drug discovery programmes in Asia. Many Asian countries are attempting to match the standards of Europe and the US. In the future, companies adept at managing and mixing a range of contractual relationships will be the most successful. 14 SEPTEMBER/OCTOBER 2008 PHARMACEUTICAL TECHNOLOGIST http://www.Clinicaltrials.gov

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - September/October 2008

Pharmaceutical Technologist - September/October 2008 Contents Industry Highlights Morpheus Market Watch Smoke and Mirrors Reducing Data Burdens Keeping it Simple Bringing Pharma Up to Date

Pharmaceutical Technologist - September/October 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.