UNC Department of Pediatrics announced as member of new global clinical trials network

The UNC Department of Pediatrics named one of eight institutions partnered in new global pediatric clinical trials network formed by Pharmaceutical Product Development, LLC.

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Wednesday, July 1, 2015

Pharmaceutical Product Development, LLC (PPD) today announced the formalization of an international research partnership with the University of North Carolina at Chapel Hill Department of Pediatrics and seven other health institutions. The PPD pediatric investigator network, as it’s touted, will enhance global clinical trials capabilities by aligning pediatric thought leaders and principal investigators around the world with clinical trials that match the needs of their specific patient populations.

Says Jacob Lohr, MD, director of the UNC Department of Pediatrics’ clinical trials initiative, the network partnership will enable UNC to expand clinical trial offerings for conditions from the common to the rare in at least nine pediatric specialty areas: allergy, cardiology, critical care, emergency medicine, endocrinology, gastroenterology, general pediatrics, infectious diseases, and neonatal-perinatal medicine.

“As a member of PPD’s pediatric investigator network, the Department of Pediatrics will grow its newly established clinical trials initiative offerings by as many as 15 trials by the end of the year,” explains Lohr, a professor of pediatrics in the UNC School of Medicine. “Our patients and their families will benefit by having direct access to more clinical trials, and our physicians through additional opportunities to develop safe and effective therapies aimed at helping their very own patients.”

That this partnership is focused on therapies for children from newborn to older adolescents is significant, because pediatric drug development is hindered by a range of unique challenges that cause drug innovations for children to lag far behind pharmaceutical breakthroughs for adults. According to PPD, the pediatric investigator network will accelerate biopharmaceutical companies’ ability to bring new pediatric medications to market through faster trial startup, more predictable patient enrollment, and higher-quality data.

“Drugs intended for use in children require specific evaluation in the age groups where such use is recommended in product labels,” says Mark Sorrentino, MD, executive medical director and chair of PPD’s pediatric practice area. “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. [ . . . ] 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 seven other world-renowned centers of excellence partnered with the UNC Department of Pediatrics in PPD’s international pediatric investigator network are Columbia University, New York; LSU Health Shreveport; National Children’s Research Centre, Ireland; National Institute for Health Research/Wellcome Trust Clinical Research Facility at Central Manchester University Hospitals NHS Foundation Trust, United Kingdom; NHS Research Scotland; Seattle Children’s Hospital; and Schneider Children’s Medical Center of Israel.

“The University of North Carolina has an amazing track record for science and is well known for innovation and cutting-edge research,” says Toni Darville, MD, vice chair of pediatric research at UNC. “The Department of Pediatrics’ participation in this network will enable our investigators to deepen that legacy and make UNC an even more attractive venue to present and future physician researchers who have a passion for improving the lives of children.”



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