PPD Awarded U.S. Army and BARDA Research Contracts
News Oct 16, 2015
Pharmaceutical Product Development, LLC (PPD) has announced that 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.