Outsourcing Clinical-Trial Materials Heats Up - Pharmaceutical Technology

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Outsourcing Clinical-Trial Materials Heats Up
The outsourcing of clinical-trial materials grows as pharmaceutical companies adapt to a changing market.

Pharmaceutical Technology
Volume 32, Issue 1

In addition, Bhatt notes that companies based in China, India, and Singapore are buying small contract research organizations (CROs) and clinical-trials companies in the US and Europe. He cites Jubilant Organosys's (Uttar Pradesh, India) purchase of Target Research (Berkeley Heights, NJ) and Manipal AcuNova's (Bangalore, India) purchase of Ecron (Frankfurt, Germany). These Asian companies are seeking to increase their size and influence, he says.

The growth of the offshore outsourcing of CTM projects brings new responsibilities to pharmaceutical companies. Clients must familiarize themselves with the working environment in the CMO's country. They must examine the supply chain, infrastructure, and patient population, among other things. According to Bhatt, companies will have to cooperate with their partners to analyze all the factors that will ensure success. "A great deal of planning, a great deal of strategizing, both at a high level and at a tactical level, is going to be required," he comments.

The infrastructure in Asia (especially in India, China, and Singapore) for conducting clinical trials and producing CTM deserves particular attention, in Bhatt's opinion. Companies must work to ensure that the product gets to the patients in a safe and timely manner. They must be certain that CTM can be delivered without jeopardizing its temperature or quality. "These are major issues in these countries," Bhatt cautions.

On the other hand, the obstacles may not be as daunting as they seem. Bhatt says Indian and Chinese clinical trials usually are conducted at certain capable hospitals. Companies don't conduct trials in remote places reached by poor roads or unreliable transportation. Still, Bhatt repeats that drugmakers must plan to ensure that they "choose the right locations and the right partners."

Spataro remarks that, in addition to new responsibilities, globalized CTM outsourcing will bring benefits to pharmaceutical companies. Working with companies in China and India will give sponsor companies "more cost-effective options, which will result in lower research and development costs," she says. As demand for outsourced CTM increases, more contract companies will likely emerge in Asia, Spataro predicts.

The corollary is that the growing number of international CTM providers will compete with US-based CTM manufacturers. Although this might not be good news for American CMOs, it could be a boon for pharmaceutical companies. Global competition might result in lower costs, improved customer service, and faster turnaround times among service providers, according to Spataro.

Although Bhatt claims that outsourcing CTM offshore, particularly to Asia, is "increasing dramatically," Meeks is skeptical. Offshore outsourcing has had no effect on Azopharma's business, he says. Furthermore, the pharmaceutical market has not embraced this strategy, in Meeks's opinion. "I'm not sure the expertise is out there," he says.

Spataro agrees that some drugmakers are justifiably cautious about hiring international contractors. She says that even if an Asian CMO, for example, has highly educated employees, it still might not have expertise in CTM preparation or compliance with GMPs. "With the recent news of safety concerns about products made overseas, sponsors must be vigilant," she warns.

Houlton sounds a more optimistic note. "The workforce in India and China is improving steadily," he says. "In addition, the large concentration of patient populations in Asia means that many clinical supplies needed will be dosed in that region."

What does the future hold?

The rise in CTM outsourcing doesn't show signs of abating anytime soon. "This is a natural progression that's taking place," according to Bhatt. Meeks notes that more pharmaceutical companies hired contract CTM providers in 2007 than in 2006, and he expects the increase to continue for the next three years.

Spataro concurs and adds, "Offshore outsourcing of CTM will continue to grow." What could change, however, is what drugmakers expect from CTM providers. Although many companies now look to contractors to offer more cost-effective services, "there will be an increased demand for speed," she predicts.


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