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CenterWatch Monthly November 2007 Issue

Friday, November 16, 2007

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 region’s power as a bloc. CenterWatch surveyed 156 investigative sites from more than a dozen Asia-Pacific countries in its first ever survey of 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.

Competition Challenges 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. CenterWatch data show that pharmaceutical and biotech R&D spending has risen rapidly since 2005 and will continue to rise at least through 2009. In 2005, spending totaled $95.1 billion; next year’s spending is expected to reach nearly $130 billion. If trends continue, by 2010, R&D investment will have increased 50% in five years.

EU Phase I Programs Respond to Northwick Park Incident

The first human trial of TeGenero’s TG1412 catapulted volunteer studies into the headlines for all the wrong reasons in March 2006. None of the six volunteers dosed with TG1412 at the Northwick Park site died, but they were seriously injured. The long-term effect of their injection with the anti-CD28 monoclonal antibody remains unknown. The lasting impact of the Northwick Park incident on the clinical trials industry in Europe is difficult to quantify.

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. CenterWatch has identified a pipeline of 15 drugs in various stages of development for depression. Many of these affect central neurotransmitters, whereas some have novel mechanisms of action.

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