The FDA will spend $2.5 billion on better computers over the next ten years. The agency selected large, well-connected IT giants that generally have no specialized biomedical or clinical-trial-specific research systems. “This contract sets the stage for the FDA to have IT to acquire, analyze and act on data critical for import protection, food protection and medical product safety plans,” said Andrew von Eschenbach, head of the agency. “We are creating a high-tech, efficient, data management system designed to meet the needs of those who must accomplish our mission—protecting and promoting the health of the American public,” he said in this statement.

The Susan G. Komen for the Cure charity is distributing a record $100 million in grants. “There’s a tremendous urgency to translate what we’re learning in the lab into treatments for patients, particularly patients with very aggressive cancers who don’t have years to wait,” said Eric Winer, chief scientific advisor, and director of the Breast Oncology Center at Dana-Farber Cancer Institute. “The grants we are funding focus on safely and effectively bringing treatments to cancer patients in a more timely way than we have been able to in the past.”

PPD confirmed that Takeda Pharmaceutical has submitted a new drug application for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, to the Ministry of Health, Labor and Welfare in Japan. PPD partnered with Takeda to develop the compound. “We are very pleased with Takeda’s regulatory strategy in Japan and the achievement of this important regulatory milestone for alogliptin,” said Fred Eshelman, PPD’s CEO. Under PPD’s agreement with Takeda, submission of the NDA in Japan triggered a $3 million milestone payment to PPD.

President and CEO Bob Weiler of Phase Forward will participate in the MassTLC Innovation 2008 unConference at Sun Microsystems’ Burlington, Mass. campus. Designed to foster local entrepreneurship, the unConference brings together four generations of the region’s most successful business leaders. Here’s the release.

DataTrak announced the release of the next version of its eclinical suite. The company says it is offering new functionality for better reports, Japanese trials and site performance tracking. Here’s more information. “Our unified architectural platform continues to allow for efficient and rapid development and expansion of our product suite capabilities, probably more than any other software in this industry,” stated Jeffrey A. Green, CEO. Here’s the release.

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited another nine organizations, including Hope Research Institute of Arizona. Some 138 organizations representing more than 600 entities have earned AAHRPP accreditation. Hope’s accreditation extends AAHRPP’s higher standards to a key sector of the research enterprise: the private research sites that conduct an increasing share of industry-sponsored clinical trials. As an accredited site, Hope now relies exclusively on AAHRPP-accredited institutional review boards (IRBs) to review its clinical trials. “AAHRPP’s goal is to improve protections for research participants by setting uniform, high standards across the research enterprise―in both the private and non-profit sectors,” said AAHRPP president and CEO Marjorie Speers. “The accreditation of Hope Research Institute is a significant step toward achieving that goal. It increases the accredited options available both to industry sponsors and research participants.” Here’s an earlier ClinPage article on AAHRPP.

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