Booz Allen Hamilton

Long-term Partnership Enhances Public Health and Safety

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Each year, millions of Americans rely on vaccines and other biological products to help heal or prevent a variety of human diseases, conditions, or injuries. But before these products reach physicians and consumers, they must be approved by the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER). As congressional mandates and electronic submission standards evolve, and as clinical genomics-based data expands, the center requires robust IT systems, platforms, and tools to meet its critical regulatory and public health mission.

Over the past 16 years, Booz Allen has partnered with CBER to modernize its IT portfolio and give reviewers the post-market data and advanced analytical capabilities they need to evaluate new biological products and respond quickly to emerging public health threats. Together with CBER, we continue to transform its response capabilities through an updated IT infrastructure and integrated systems. As a result, industry partners can submit applications electronically, reviewers can access industry submissions from an electronic document repository, and analysts can use innovative post-market surveillance tools to monitor product safety. Our role in supporting the center’s shift from paper-based to electronic submissions allows CBER to receive submissions within hours rather than days, making the review cycle more efficient.

In 2014, Booz Allen continues to position CBER as a leader in supporting public safety through regulatory science and IT solutions. These include accepting vaccine adverse event submissions in the HL7 international data standards format, using genomics data to detect adverse events, and designing text mining tools to enhance adverse event surveillance. We’ve also engaged our Strategic Innovation Group and functional experts to apply a broad range of expertise, including business process improvement, IT modernization, and big data analytics. We look forward to continuing our long-term partnership with CBER to provide innovative and efficient IT solutions to shape the organization’s future.