WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD) today announced it has been awarded two separate United States government contracts to improve health outcomes for armed forces service members and to help test the effectiveness of the nation’s stockpile of avian influenza vaccine to safeguard the public.
In one agreement, the U.S. Army selected PPD to provide medical product research and development services to enhance readiness, to ensure the provision of the highest quality medical and preventative care and to maximize the survival of armed forces personnel on the battlefield. In the second agreement, PPD will leverage its robust vaccines capabilities as part of its association with the Biomedical Advanced Research and Development Authority (BARDA) Medical Countermeasures Clinical Study Network, a part of the U.S. Department of Health and Human Services.
“PPD is pleased to contribute to the important missions of improving health outcomes for armed services personnel and helping protect the people of the United States against the threat of pandemic influenza,” said Bill Sharbaugh, chief operating officer for PPD. “Our integrated services, including deep clinical and laboratory expertise, enable us to provide the medical and technical knowledge necessary to help ensure these vital programs succeed.”
The contract with the U.S. Army is an indefinite delivery, indefinite quantity (IDIQ) agreement, with a base period of five years with five one-year option periods. PPD will provide medical product development and lifecycle support for the U.S. Army Medical Materiel Development Activity, U.S. Army Medical Research and Materiel Command (USAMRMC), Joint Project Manager and Medical Countermeasure Systems and other USAMRMC subordinate commands.
PPD will provide project management, technical expertise, strategic planning, market analysis and training, along with pharmaceutical testing, assay validation, validated storage and shipment, nonclinical testing and clinical development study support, integrated logistics, equipment maintenance, information technology and other capabilities.
For BARDA, PPD will evaluate the potency and long-term stability of H5N1 influenza (avian influenza) vaccines from the Centers for Disease Control and Prevention’s Strategic National Stockpile. H5N1 influenza is highly pathogenic in poultry. The virus can be transmitted to humans following prolonged contact with infected birds, and rarely has been transmitted between humans. Human infection with H5N1 influenza results in serious disease and a high risk of death. BARDA and the CDC have stockpiled this vaccine because there is a risk the virus could mutate and result in widespread, serious disease in the American population.
The contract with BARDA is an IDIQ agreement for clinical study services, with a minimum period of performance of two years and a maximum period of five years.
PPD has delivered global clinical support services to U.S. government research and development programs on more than 1,500 government and public health drug development projects in multiple indications, including infectious diseases, vaccines, biodefense and autoimmune and asthma/allergic diseases.
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 14,000 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 contracts awarded by the U.S. Army and BARDA 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; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; the ability to attract, integrate, retain and train key personnel; competition in the outsourcing industry; PPD’s ability to win new business; overall global economic conditions; risks associated with and dependence on strategic relationships; risks associated with acquisitions and investments; consolidation in the pharmaceutical and biotechnology industries; rapid technological advances that make our services or capabilities less competitive; the ability to control SG&A spending; compliance with drug development regulations; changes in the regulation of the drug development process; and actual operating performance. 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.