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November 2007 (Volume 14, Issue 11)
November 2007 (Volume 14, Issue 11)

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Changes in Asia-Pacific Regulations Position Region for More Growth

  • Between 2005 and 2006, big pharma and biotech initiated 50% more global clinical trials in the Asia-Pacific region. As regulators in the region continue to improve the approval process in their respective countries, growth should continue. Spearheaded by Japan, regulators in Asia-Pacific countries are becoming more aware of, and tapping into, the regions power as a bloc.CenterWatch surveyed 156 investigative sites from more than a dozen Asia-Pacific countries in its first ever surveyof the region in late 2006. Among its findings, the survey revealed the timeliness with which patients are enrolled and what factors could best prevent future delays.

CompetitionChallenges U.S. Site Profitability

  • Investigative sites continue operating under financial pressures even as contract research organizations have had a very profitable run in 2007.Competition for research sites grows as sponsors and the larger global CROs are placing more studies globally.

EU Phase I Programs Respond to Northwick Park Incident

  • The first human trial of TeGeneros TG1412 catapulted volunteer studies into the headlines for all the wrong reasons in March 2006.

Eye On: Depression

  • Depression, which is one of the most common diseases affecting the brain, is characterized by depressed or saddened mood, loss of interest or pleasure in normally enjoyable activities, changes in weight or appetite, fatigue, and sleep disturbances. According to the World Health Organization, at least 121 million people worldwide suffer from depression.

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