PPD Creates Pediatric Investigator Network


Company News Release


Offers clients enhanced startup, enrollment and data quality for pediatric clinical trials

WILMINGTON, N.C. (July 1, 2015) – Pharmaceutical Product Development, LLC (PPD) has formalized relationships with eight investigator sites as part of a pediatric investigator network (PIN) the company has established to further enhance its pediatric clinical development capabilities.

This network-which includes world-renowned centers of excellence among its members-will provide biopharmaceutical companies with faster trial startup, more predictable patient enrollment and higher-quality data. PPD’s clients also will benefit from direct access to pediatric thought leaders and principal investigators across the globe.

The PPD PIN currently includes Columbia University, New YorkLSU Health ShreveportNational Children’s Research Centre at Our Lady’s Children’s Hospital Crumlin, IrelandNational Institute for Health Research/Wellcome Trust Clinical Research Facility at Central Manchester University Hospitals NHS Foundation Trust, United KingdomNHS Research ScotlandSeattle Children’s Research InstituteSchneider Children’s Medical Center of Israel; and University of North Carolina at Chapel Hill Department of Pediatrics. The company plans to continue to expand this network by selecting and partnering with other centers of excellence worldwide that align with particular pediatric populations and research needs.

“Drugs intended for use in children require specific evaluation in the age groups where such use is recommended in product labels. In recent years we have seen increased development in pediatric patients related both to regulatory imperatives and to increased development activity in rare diseases where children and adolescents constitute at least half of those affected,” said Mark Sorrentino, M.D., executive medical director and chair of PPD’s pediatric practice area. “Our network already has been working effectively with our clients to provide state-of-the-art clinical trial delivery across the globe. Building formal relationships with strategically important centers that have significant pediatric clinical trial expertise, a proven track record of superior quality and the ability to recruit pediatric patients demonstrates our commitment to partnering with our clients to bring life-changing medications to market faster and at less cost.”

The network further advances PPD’s already robust pediatric capabilities, including the conduct of more than 300 studies in the past five years, which have enrolled more than 180,000 children and adolescents in a wide variety of indications. PPD also has a well-established pediatric practice area in place that brings together a cross-functional group of experts in pediatric development planning, consent and assent, and clinical trial design and implementation to support state-of-the-art clinical pharmaceutical development in children and adolescents.

About PPD
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceuticalbiotechnologymedical device, academic and governmentorganizations. 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.

PPD Forward-Looking StatementExcept for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about the value of PPD’s pediatric investigator network, 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: risks associated with and dependence on strategic relationships; competition in the outsourcing industry; 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; risks associated with acquisitions and investments; the ability to attract, integrate, retain and train key personnel; compliance with drug development regulations; changes in the regulation of the drug development process; consolidation in the pharmaceutical and biotechnology industries; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; actual operating performance; 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.


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