The New York Times has a nice piece on the political mess around the nomination of FDA head Andrew von Eschenbach, who’s been doing the job for a year. During the 6 years of the Bush administration, the NYT points out, the FDA has had a confirmed leader for 18 months. Any Senator can block any nomination, and the tussling over a variety of reproductive health issues dear to conservative and liberal hearts has allowed the agency to drift. The prospect of a major renewal of user fee legislation next year makes the FDA job especially important just now, but the NYT ignores that. The juiciest quote is from the diminuitive Sen. Barbara Mikulski of Maryland. “As you know, the F.D.A. is located in my state,” Mikulski said. “There is a crisis of morale at the F.D.A., and I take [von Eschenbach] at his word that he will deal appropriately with this.”

University Hospitals of Cleveland picked Eclipsys as its provider of an electronic health record system. It’s a branch of Case Western Reserve University School of Medicine, which is in a long-running competitive battle with the Cleveland Clinic and its advanced IT infrastructure.

Most U.S. researchers resist financial disclosure requirements when publishing articles in peer-reviewed journals. A new article in the Journal of Law, Medicine and Ethics was part of a $3 million project, centered at the Berman Bioethics Institute at Johns Hopkins, to determine why scientists don’t reveal ties to industry and other organizations that may have a stake in their findings. “The ultimate goal of the project is to provide a framework for establishing sound policy and practices for disclosing conflict of interest in clinical research,” said Kevin Weinfurt, Ph.D., deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute. “We are hoping that the data we’re collecting will benefit officials who are struggling with the best ways of minimizing potential risks to study subjects and advancing the cause of clinical science.”

Kendle International shares have jumped of late. The acquisition of the Charles River Associates assets seems to be encouraging Wall Street.

Cyco Software has software to help the pharmaceutical manufacturing process remain compliant with 21 CFR Part 11. PDL BioPharma and Pfizer are customers, according to the Cyco website.

Are drug companies tracking investigator-initiated trials (IIT)? No, says a new report by Cutting Edge research. “We’re seeing drug companies exposing themselves to lawsuits simply because they don’t have control over their own IIT grant decision-making processes,” says Jon Hess, research team leader at Cutting Edge. “They don’t know what’s going on under their own roof.”

Affymetrix has a deal with translational medicine in China. Zhejiang California Nanosystem Institute (ZCNI) at Zhejiang University will partner with the chip company to study cancer, infectious disease and neonatal conditions. “We are excited about using the Affymetrix GeneChip technology to explore the relationship between genes and human health and to develop clinical applications to improve healthcare in China,” said Professor Jiaan Cheng, director of ZCNI and former vice president of Research at Zhejiang University. “This collaboration will enable us to develop a more personalized form of medicine, which should help improve healthcare in China and around the world.” Affy is also looking forward to the deal. “As an alumnus and a former faculty member of this distinguished University, I am very impressed by the cutting-edge research that is taking place at the ZCNI and the School of Medicine,” said Wei Zhou, vice president, intellectual property and advanced technology and China country manager at Affymetrix. “With this translational medicine strategic partnership and the joint laboratory, we hope to accelerate clinical research and bring better healthcare to patients.”

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