Providing global regulatory and biostatistical services for broad range of drug development initiatives
WILMINGTON, N.C.--(BUSINESS WIRE)-- PPD, Inc. (Nasdaq: PPDI) today announced it has been awarded the U.S. Army Medical Research Acquisition Activity: Regulatory Affairs & Compliance Support contract to provide global regulatory and biostatistical services for a range of clinical development programs funded by the U.S. Army.
The award is a multi-year, indefinite delivery, indefinite quantity (IDIQ) contract with a ceiling value of $45.5 million over a five-year period beginning April 15, 2011.
PPD brings strong operational regulatory capacity, regulatory affairs consulting expertise, and an in-depth understanding of global regulatory requirements and submission strategies to aid the U.S. Army in preparing and filing clinical trial submissions to the U.S. Food and Drug Administration and other regulatory authorities worldwide. PPD’s quality assurance and medical writing professionals will ensure regulatory compliance for the U.S. Army’s clinical programs and support biodefense, biopreparedness and vaccine development initiatives aimed at protecting military personnel.
In addition, PPD’s team of global biostatisticians will provide statistical consulting, study design and statistical analysis support.
“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, M.D., 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.”
PPD has delivered global clinical support services to U.S. Government research and development programs for 21 years. The company has collaborated on more than 900 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 and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 11,000 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 contract award by the U.S. Army, 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 which could cause future results to differ materially include the following: risks that the U.S. Army may not request services for the entire value of this contract; the conversion of this contract into revenue; PPD’s ability to win new business; actual operating performance; the ability to attract, integrate and retain key personnel, including a new CEO; risks associated with and dependence on strategic relationships; risks associated with fixed price contracts and cost overruns; overall global economic conditions; economic conditions in the pharmaceutical, biotechnology and government-sponsored research sectors; research and development spending in the pharmaceutical, biotechnology and government-sponsored research sectors; outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; consolidation in pharmaceutical and biotechnology industries; competition in the outsourcing industry; loss, delay or modification of large contracts; higher-than-expected cancellation rates; fluctuations in currency exchange rates; rapid technological advances that make our services less competitive; compliance with drug development regulations; changes in the regulation of the drug development process; international economic and political risks; and the ability to control SG&A spending. These and other PPD risk factors are set forth in more detail from time to time in our SEC filings, copies of which are available free of charge upon request from PPD’s investor relations department. 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.
KEYWORDS: United States North America North Carolina
INDUSTRY KEYWORDS: Technology Data Management Health Biotechnology Cardiology Clinical Trials Medical Devices Pharmaceutical Defense Contracts Research Science