The Bush White House has shuffled top health officials at FDA. The head of CDER, Steven Galson, will move within the health bureaucracy to a new role as acting surgeon general. Janet Woodcock will be named acting center director of CDER but retain her former (and not exactly part-time) duties as the agency’s deputy commissioner and chief medical officer. Galson’s departure will mean more operational drift at the agency for at least 18 months, until a new presidential administration’s FDA team arrives in January, 2009. Galson joined the FDA in April, 2001 after stints at the Centers for Disease Control and the EPA. He ran CDER during the Vioxx era. ClinPage wishes Galson well. But the surgeon general chair is an impotent yet acutely precarious one; its occupant may state obvious medical facts and be abusively criticized by his own political party. Or the other party. Or both.

Akaza Research, the developer of open source electronic data capture (EDC) software, announced it has been accepted into the National Institutes of Health Commercialization Assistance Program (NIH-CAP). The NIH-CAP is funded by the National Institutes of Health and managed and executed by the Larta Institute, a global consultancy with clients such as IBM, Genzyme, and Allergan. Akaza will work with Larta to expand the presence of its OpenClinica EDC system. Cal Collins, chief executive officer at Akaza, said: “We are pleased to have been accepted into this exclusive program and look forward to collaborating with the Larta Institute and NIH.”

Vasogen, a Canadian pharma, is touting a new trial with an adaptive design. The company’s next phase II trial may need to recruit just 300 patients with chronic heart failure. The company says an earlier trial delivered a 39 percent reduction in risk of death or cardiovascular-related hospitalization. “For the purpose of obtaining U.S. regulatory approval, an adaptive trial design utilizing a Bayesian statistical approach provides us with the possibility of confirming our earlier results with as few as 300 patients,” said Chris Waddick, Vasogen’s president and CEO. “We are now preparing to meet with the FDA, with the objective of obtaining formal FDA agreement with respect to our proposed trial design prior to the end of the year. We continue to be on track for the initial commercialization of Celacade by year-end in the European Union, where Celacade has already received CE Mark regulatory approval for the treatment of NYHA Class II heart failure.” Here’s the release.

China’s pharmaceutical contract research organization (CRO) industry is becoming a hot sector for international players. Novo Nordisk, Pfizer, Novartis, Roche, Bayer, and GSK already have an R&D presence in China. Eli Lilly is increasing its spend there. Zhang Hancheng, president of the Sino-American Pharmaceutical Professionals Association, said: “China and India will become powerhouses for global R&D.” The global CRO market is estimated to be worth $14 billion in 2006, and will grow annually between 14 percent and 16 percent to peak at $24 billion in 2010.

Medidata Solutions, Tessella and United BioSource are to deliver their fourth webinar in a series on adaptive clinical trials. The presenters will be: Hugh Levaux, vice president of product strategy, Medidata; Tom Parke, head of clinical trial solutions, Tessella; and Mike Borkowski, general manager of clinical technologies, UBC. The subject of the conference will be-“Enabling Adaptive Clinical Trials: IVRS/IWRS, Randomization and Drug Supply.” The webinar will explore the critical role of randomization, subject management and drug supply in an adaptive trial. It’s scheduled on October 3, 2007.

ReachBio, a boutique contract research and consulting organization, has announced the official opening of its business operations. The company will focus on providing specialized contract assay and contract research services utilizing in vitro and in vivo stem cell and progenitor cell assays to biopharma, biotechnology, agrichemical, and other related industries. The founding members of ReachBio are all former long-time scientists, managers and executives of the Canadian CRO StemCell Technologies. Rob Chaney, chief operations officer ReachBio, said: “ReachBio removes the technical obstacles and makes the power of sensitive CFC assays available to our clients by allowing them access to highly trained and knowledgeable scientists with many years of experience in performing these assays and interpreting their results.”

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