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Expertise to aid development of novel therapies to respond to terrorist attacks, pandemics
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.