WILMINGTON, N.C.--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.
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 13,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about PPD's BARDA contract, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; competition in the outsourcing industry; the ability to attract, integrate, retain and train key personnel; rapid technological advances that make our services or capabilities less competitive; compliance with drug development regulations; changes in the regulation of the drug development process; PPD's ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; consolidation in the pharmaceutical and biotechnology industries; risks associated with and dependence on strategic relationships; actual operating performance; risks associated with acquisitions and investments; and the ability to control SG&A spending. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD's estimates or views as of any date subsequent to the date hereof.