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Keeping the public healthy

Business analytics software is helping the U.S. Food and Drug Administration analyze data about adverse reactions to vaccines and biological products in order to improve regulatory oversight.

The FDA's Center for Biologics Evaluation and Research (CBER) provides data tracking and analysis to support its mission of protecting and enhancing public health. A data integration platform from Informatica acts as the infrastructure for the Center's Vaccine Adverse Event Reporting System and a broader-based Adverse Event Reporting System, which track known adverse medical reactions to FDA-approved vaccine and biological products.

Philip Perucci, project officer for software development at the Center, says, "The ability to access and analyze high-quality data about adverse reactions to vaccinations is essential to protecting public health. Having the means to leverage all of our Center's data is critical to carrying out our regulatory responsibilities.

"The data integration platform supports our need for up-to-date access to critical adverse reporting information, and increases our productivity through streamlined maintenance."

The Center's goal has been complicated by rapid change in the healthcare and biotechnology fields. Because of merger and acquisition activity, for instance, names of companies and products frequently change, exacerbating the challenge of keeping data consistent and reliable. The new platform addresses that concern and others by automating integration of data and replacing some of the Center's legacy methods of hand coding.

The mission of the Center for Biologics Evaluation and Research is "to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, tissue, gene therapy products, allergenics and biological therapeutics." That mission is deemed more important than ever because of increased concern about pubic health and bioterrorist activity.

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