Wilmington-based pharmaceutical giant PPD has been awarded a lucrative contract by the U.S. Army to support biodefense and vaccine development programs.

The U.S. Army Medical Research contract is a multi-year, indefinite delivery, indefinite quantity contract with a ceiling value of $45.5 million payable over a five-year period.

Under the contract, PPD will provide global regulatory and biostatistical services for a range of drug development initiatives. Currently PPD has offices in 44 countries, giving the company an in-depth knowledge of regulatory requirements worldwide.

PPD will assist the U.S. Army in preparing and filing clinical trial submissions to the U.S. Food and Drug Administration and regulatory authorities in other nations.

To ensure regulatory compliance for clinical programs and to support biodefense, biopreparedness and vaccine development aimed at protecting military personnel, PPD’s research team will work  with its quality assurance and medical writing professionals.

In addition to regulatory strategies and compliance, PPD will also provide statistical consulting, statistical study design and analytical support at every stage of the drug and vaccine development and testing process.

PPD has a history of delivering clinical support services to U.S. government research and development programs. Over the past 21 years, the company has worked on more than 900 government and public health drug development projects. In the past, it has addressed infectious diseases, vaccines, autoimmune and allergic diseases, as well as prior forays into biodefense.

"This contract enables us to deliver on our breadth of global regulatory and biostatistics services and assist the U.S. Army in advancing clinical programs that improve the health of men and women serving in our armed forces," said Henrietta Ukwu, senior vice president of global regulatory affairs for PPD. "We are pleased to partner with the U.S. Army in this effort and to continue to extend our long history of partnering with the U.S. Government on clinical research and development."