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Apr 1, 2009 (Vol. 29, No. 7)

Traditional Strengths Solidify Chilean Biotech Industry

South American Country Makes Name for Itself in Clinical Trials and Aquaculture

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    According to CORFO, the Chilean biotechnology industry consists of 70 firms, 56% of which are linked to natural resources (agriculture, fishing, and forestry).

    Chile has set its sights on biotech. Now the question is whether biotech will set its sights on Chile. The South American nation is taking a two-pronged approach—seeking to attract multinational clinical trials by virtue of an accessible population and internationally trained investigators, and bolstering its traditional strengths in aquaculture, agriculture, forestry, and mining with biotech-based enhancements. It is also developing funding mechanisms to help companies become established, and boasts minimal bureaucracy. It is estimated that a Chilean business can be set up and operational in less than one month.

    The Chilean Economic Development Agency—(CORFO)—made the case for Chile earlier this year during a University of California at San Francisco seminar. 

    Chile is a small country, with a population of 16.6 million. “But, population isn’t everything,” insists Graciela Rácero, senior director of Latin America operations for Parexel International. Because 85% of Chile’s population lives in cities, patients are readily available. Retention is increased through a combined public/private healthcare system that results in an average of 4,715 physician visits per 1,000 persons per year, Rácero says.

    “Many investigators, trained in the EU and U.S., actively participate in international congresses, and are experienced in multinational trials,” she says. Physicians in Chile are generally eager to participate in trials, she adds.

    Most of the trials currently under way in Chile are multinational in scope and focus on cardiology, oncology, infectious disease, pulmonology, obstetrics and gynecology, and neurology. There also is a strong interest in pediatric trials. Traditionally, children were not allowed to participate in clinical trials, with the results that “two of three drugs used for children had never been tested on children. They were treated as small adults. We now know that was a mistake,” emphasizes  Pablo Caviedes, Ph.D., CEO, Center for Clinical Research and Pharmacological Studies.

    An additional bonus, he says, is that “The Ameri-Indian racial markers are well spread throughout Chile’s population,” but not throughout the traditional testing sites of North America or Europe. That population is, therefore, valuable in testing therapies intended for widespread use.

    Currently, more than 30 CROs operate in Chile. There are some 300 research sites and 1,274 clinical trial investigators, 56% of whom are dedicated to Phase III trials. Chile is listed among the top 25 nations in terms of clinical trials for infectious disease and nervous system disorders, according to Jorge Guerra, M.D., senior vp, global clinical operations, Biogen Idec. Globally, of the 66,552 clinical trials conducted in 2008, Chile conducted 415. For comparison, Mexico conducted 782, Rácaro says.

    When asked about data reliability, Dr. Guerra, who was at Merck between 1984 and 2008, recalls that “Merck has conducted clinical trials in Chile since 1980. There were no complaints of data unreliability. Merck never had any problems. It was even better than in the U.S.,” he maintains.

    Chile currently is working to “strengthen ethical governance and to improve the function of clinical research through the creation of a central office for administering research in a selected number of public sector sites,” according to Rodrigo Salinas, M.D., Ministry of Health. That includes creating a national register for human subjects. Chile is also in the process of writing clinical trial regulatory guidelines for submission to WHO. In addition, the country has a firm policy of ethical review and informed patient consent.

    Aside from Chile’s intent to increase its participation in clinical trials, its other biotech interests focus on using biotech to enhance its mainstay industries of agriculture, forestry, mining, and aquaculture. It is doing that through incentives to attract foreign investment and by encouraging Chilean businesses to commercialize their products.

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