A group of companies that specialize in cardiac safety testing have joined forces to create a comprehensive and technologically advanced solution for determining how drugs affect the heart. The Cardiac Safety Network integrates preclinical and clinical cardiac safety analysis services from Spacelabs Healthcare, iCardiac Technologies, and Charles River Laboratories. The Cardiac Safety Network will offer drug developers a complete solution with services that include recruitment and monitoring of clinical trial subjects to the submission of cardiac safety data to the FDA. “The Cardiac Safety Network combines the industry’s most precise Thorough QT analysis services with insight derived from advanced ECG-based biomarkers,” said Jim Roop, president of clinical services at Spacelabs Healthcare. “Without spending any more than they would for a traditional Thorough QT study, drug developers now will be able to meet FDA requirements while significantly improving the quality and depth of their cardiac safety data.”

An attempt to quickly pass the Wired for Health Care Quality Act, which the Senate could not agree on, was delayed. Some small quantity of Washington momentum to modernize hospital IT systems has now quietly dissipated in the usual partisan bickering. The American Medical Association and 35 other physician organizations sent a letter expressing their concerns about the bill’s quality measurement, patient privacy and funding provisions to the legislation’s main sponsors, Hillary Clinton, Edward Kennedy, Michael Enzi and Judd Gregg. The most serious concern was whether the Senate’s health information technology bill contained adequate patient privacy protections. The bill would have established a board to determine HIT interoperability standards and require federal agencies to adopt them. It would give the Health and Human Services (HHS) secretary the authority to create quality measures and doctor-specific reports on performance on the measures.“The Secretary and Federal Government are not equipped to unilaterally mandate the practice of medicine,” the physician letter stated. Without adequate stakeholder input, “there is a significant risk that the measures will not be appropriate or valid for the services that are to be measured, and therefore, will not be useful to patients or could even harm patients.”

Pfizer is planning to cut costs by increasing outsourcing of its manufacturing capabilities from 15 percent to 30 percent to facilities in Asia, particularly in India and China.  In addition it will expand its research and development investments in China, India, Japan and South Korea.

InferMed, a provider of advanced software solutions for clinical research and practice, announced the appointment of a seasoned IT executive, Martin Rouen, to director of product development. Rouen will report directly to InferMed’s chief executive officer, Duane Lawrence. His focus will be product development and enhancements in development processes to improve customer satisfaction. Rouen joins InferMed from Alphameric Solutions, where he held the role of program and development manager with responsibility for the full software development life cycle for a series of products through to ensuring their successful deployment.

“The nation is at risk if FDA science is at risk,” says a grim new report on systemic underfunding at the FDA. The report adds: “The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations.” The report also notes serious research, staffing and collaboration inadequacies in the agency that will be hard to fix in a decade or more. Instead, politicians from both parties will continue to berate the FDA—but not pony up the money to fix it. For the stout of heart, here’s a story and a link to the full report from the FDA Science Board.

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