Jorge Garcia, founder and chief scientific officer of ISIS Services, the contract research organization, welcomes Alex LaBeaux as its director of sales and marketing. LaBeaux, based out of ISIS Services’ San Carlos facility, will be responsible for spearheading business development efforts. “We are pleased to have Alex on the ISIS team and are confident that his extensive experience in the medical device industry, combined with his strong sales and management background, will enable him to provide the solutions that our current and new clients need to expedite their products to the marketplace,” said Garcia. Here’s the release.

Parexel International will release quarterly financial results on Monday, October 27, 2008 after the close of the stock market. The announcement will be available on Parexel’s website and on the PR Newswire website. Parexel will host a conference call and live webcast at 10:00 a.m. EDT on Tuesday, October 28, 2008.

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PPD has been selected as a full-service preferred provider for translational clinical development services by the Juvenile Diabetes Research Foundation (JDRF) and will share its expertise with academic investigators who are conducting JDRF-funded, early phase clinical trials for type 1 diabetes. PPD will help JDRF review clinical development proposals, collaborate with JDRF-funded investigators to optimize clinical trial designs and help execute components for some of those trials. “As many as three million Americans may have type 1 diabetes, an autoimmune disease that impacts both children and adults,” said Randy Anderson, VP of development at PPD. “We are pleased and honored to partner with JDRF to help speed development of curative therapies for this debilitating disease, which can have devastating complications like kidney failure, blindness, heart disease, stroke and amputation.”

Johnson & Johnson announces call for nominations for the 2009 Paul Janssen Award for Biomedical Research, which recognizes scientists in basic or clinical research who have made significant transformational contributions toward the improvement of human health. An independent selection committee will accept nominations online until December 15, 2008. The winner(s) will be announced in May 2009. The Award includes a $100,000 prize.

SNM has created the Molecular Imaging Clinical Trials Network. The network is a response to the need for streamlined processes to utilize imaging biomarkers in clinical research and clinical practice. According to SNM president Robert Atcher: “The plan specifically includes creation of a biomarker use pathway, which will provide SNM-sponsored centralized investigational new drugs (INDs) that pharmaceutical manufacturers can cross-reference for their multicenter trials. Large trials of investigational therapeutics can often demonstrate safety and efficacy more efficiently if imaging biomarkers are included in the protocols. SNM is taking the lead to establish FDA-friendly imaging biomarker protocols via approved INDs.”

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Integrated BioTherapeutics (IBT) have been awarded a multiyear contract for advanced development of a vaccine to protect against Ebola and Marburg viruses from the National Institute of Allergy and Infectious Diseases (NIAID). The contract is valued at approximately $22 million. Ebola and Marburg lead to death in 30-90 percent of cases. “We are very pleased that NIAID has awarded such a significant contract to fund the advanced development activities for our virus-like particle vaccine against Ebola and Marburg viruses. This is a significant step forward in our mission to improving public health and developing medical countermeasures for biodefense,” said Javad Aman, IBT President and chief scientific officer.

A lawsuit in Boston provides a rare public window into clinical trial design and publication. Pfizer is being sued for off-label promotion of Neurontin (gabapentin). The company already paid $430 million in fines, but now insurers and consumers are seeking billions more. One issue is the alleged manipulation of data from several trials. The suit charges some trial data thought to be damaging to sales were kept inside Pfizer; other aspects of the studies were tweaked by European consultants to be used for marketing. The litigation highlights the still-unregulated area of scientific publication and the broad latitude of sponsors in deciding which trials to put in the scientific literature—and which to put in a locked filing cabinet. Email from the depositions could be as damaging as what emerged in the Vioxx saga. An example: “I think we can limit the potential downsides of the ... study by delaying the publication for as long as possible,” the Wall Street Journal quotes Michael Rowbothan, Neurontin’s marketing team leader, as saying. “It will be more important to how WE write up the study.” Here’s a link to a subscription-only Wall Street Journal story.

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