The print issue of Nature Reviews Drug Discovery has an article by Dan Jones that explores the risks and potential of meta-analyses. Some academics are urging the industry to anticipate that any trial may later be used in a meta-analysis. The Annals of Internal Medicine also addressed the issue in this article about Serevent (salmeterol), an inhaled GlaxoSmithKline (GSK) drug for asthma.
Are one in nine emergency room visits related to medication issues? That’s the word from Tom Lamb’s website.
Axio Research said scientific director Ruth McBride has been named a fellow of the Society for Clinical Trials. McBride has served on the board of the organization. Here’s the release.
With a presumptive fall presidential race now under way, it’s worth noting the pharmaceutical industry has abandoned its friends in the Republican Party, no doubt hoping to ingratiate itself with their opponents. Overall donations by the industry are sharply down now that the FDAAA legislation has cleared Congress. Of the money that is being given to presidential candidates, industry-linked contributions to Democrat Barack Obama are running at three times the level of John McCain, a Republican who has half as much cash on hand as his rival. Here’s some data.
Moody’s has soured on the finances of the sponsor community, the Wall Street Journal blog says. Sample quotation: “The adjusted debt level for the nine biggest companies in the sector rose to $94 billion at the end of ‘07 from $75 billion at the end of ‘06.”
At the 2nd Annual Global R&D Congress held May 29–30 in Washington, DC, Paul D’Sylva, CEO of Commonwealth Biotechnologies, presented a process to help pharmaceutical companies select the best contract research organization (CRO). “Companies are increasingly looking to CROs to provide more value by operating as full collaborators, with integrated service offerings, the ability to innovate and solve problems, and managers with extensive Western pharmaceutical research and development experience. Simply adding affordable capacity by outsourcing to Asia is no longer sufficient,” he said.
PharmaLink appointed Frank Santoro as chief medical officer. Santoro joins PharmaLink from Protherics, a UK-based biopharmaceutical company specializing in oncology and critical care products, where he served as VP, clinical development and medical affairs. Prior to Protherics, Dr. Santoro worked in the contract research organization (CRO) industry for more than seventeen years, including tours of duty at Innovex, Kendle International and Covance. “We are delighted Dr. Santoro joined our team. Dr. Santoro’s experience working for global CROs and biotech companies gives him a unique skill set to address our sponsor’s outsourcing needs. He will be a tremendous asset for our company and our clients,” commented Richard Staub, president and CEO. Here’s the release.
Synergy Research, a Russia-based CRO, presented the current issue of its orange paper, a regular report on the clinical trial landscape in Russia.
The FDA may be losing key employees to industry and retirement, according to USA Today. The average age of the FDA workforce is now 54; some staffers are leaving because of renewed efforts to silence internal scientific debate at the agency. The newspaper says the FDA may have difficulty recruiting the thousands of new employees for which it has finally been given funding. Here’s the article.
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