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CenterWatch Monthly September 2010

Wednesday, September 1, 2010

“Sunshine law” puts cloud of concern over sponsors, sites

The sunshine law, part of the recent healthcare reform legislation, creates significant new obligations for drug sponsors by requiring that annual reports be submitted detailing their financial relationships with physicians and teaching hospitals. Both sponsors and investigative sites are trying to understand the scope of the law and have questioned whether it’s possible to prevent a variety of unintended consequences that could harm clinical research and competitive confidentiality.

Academic Medical Centers and industry: Friends or foes?

Since drug development began, dysfunction and trouble have plagued the relationship between the commercial side of the industry — sponsors and CROs — and the academic side — AMCs. Industry has long bemoaned that AMCs are too big, too slow, and too bureaucratic, while AMCs have complained that industry doesn’t care about the patient or the science, but just wants to make money. Through the years, this tempestuous relationship has led the pendulum to swing both toward and away from collaboration, leading observers of the drug development process to question whether the two should work together at all. But as the industry matures and economic conditions remain tight, both sides are now striving to create better, more strategic partnerships.

Eye On: AstraZeneca

CenterWatch launches its new Eye On focusing on a single company’s drug development pipeline this month with AstraZeneca, a worldwide biopharmaceutical company involved in discovery, development, manufacturing and marketing prescription drugs for six major therapeutic areas. Its strongest focus in terms of numbers of drugs in its pipeline includes oncology/inflammation, neuroscience and respiratory/inflammation. Other therapeutic areas include cardiovascular, gastrointestinal and infection. Research and development expenditures in 2008 exceeded $5 billion.

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