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Pharmaceutical Product Development, LLC (PPD) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has chosen the company as one of a select group to design and conduct clinical studies needed to develop medical countermeasures – drugs, vaccines and diagnostic tests – that help protect health against bioterrorism, pandemic influenza and other public health emergencies.
BARDA, part of the U.S. Department of Health and Human Services (HHS), selected PPD as a contractor for the Medical Countermeasure Clinical Studies Network (MCM CSN). PPD will support BARDA and its development partners in planning, performing, monitoring and interpreting Phase I-IV clinical studies. Services include performing clinical studies that are required by the U.S. Food and Drug Administration for the approval of a product for human use, comparing the properties of multiple products or evaluating the potency of products stored in U.S. government stockpiles.
“PPD’s inclusion in this vital network highlights our industry-leading efforts to support government research and development programs through our robust, end-to-end clinical research services,” said Paul Colvin, PPD’s executive vice president of clinical development. “We are excited at the prospect of deploying our world-class scientific expertise, innovative solutions, cutting-edge technology, flexible resources and operational efficiencies to help protect public health and the nation’s health security.”
As a leading global contract research organization, having worked with all of the world’s top 50 pharmaceutical companies and conducting hundreds of clinical trials annually, PPD has provided a full range of study services on more than 1,300 government and public health projects in multiple indications, including infectious diseases, vaccines, biodefense, and autoimmune and asthma/allergic diseases.
PPD’s contract with BARDA is an indefinite-delivery, indefinite-quantity (IDIQ) agreement for clinical study services, with a minimum period of performance of two years and maximum period of performance of five years.