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IQVIA to Lead Group to Expand Safety/Efficacy Monitoring of Regulated Vaccines and Biologics for the FDA Center for Biologics Evaluation and Research

February 6, 2018

DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- IQVIA Holdings Inc. (NYSE: IQV), a company dedicated to using analytics and science to help healthcare stakeholders find better solutions for patients, is announcing a novel alliance with the FDA Center for Biologics Evaluation and Research (CBER) to combine advanced analytics and unparalleled information assets to monitor and assist in the evaluation of safety and effectiveness of various CBER-regulated vaccines, blood products and other biologics.

As part of this important public health collaboration, IQVIA has teamed up with the Observational Health Data Science and Informatics (OHDSI) initiative and its world-class team of healthcare experts and unique data assets from Columbia University, Stanford University, Georgia Institute of Technology, University of California, Los Angeles (UCLA) and the Regenstrief Institute at the Indiana University School of Medicine to enhance the function and outputs of the initiative.

This agreement launches CBER’s Biologics Effectiveness and Safety (BEST) Initiative as a new component of the ongoing Sentinel Initiative to develop new capacity and capabilities within the following areas: •Boosting blood safety surveillance in support of FDA efforts to further develop a national hemovigilance program; •Evaluating post-market safety and effectiveness for biologic products using innovative approaches such as query tools, machine learning, artificial intelligence and natural language processing; and •Assessing health outcomes and evaluating biologic products use.

We believe biologics surveillance will benefit from IQVIA’s near-real-time data and analytics specific to CBER-regulated vaccines, blood and blood products, tissues and other biologics.

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