RESEARCH TRIANGLE PARK, NC - March 15, 1999 - Quintiles Transnational Corp. (Nasdaq: QTRN) today announced the formation of Quintiles Pediatric and Adolescent Care Group to specialize in clinical development services for drugs used in neonatal, pediatric and adolescent care. "Having worked on more than two dozen national and international pediatric studies involving almost 30,000 patients, we have a great deal of experience in helping customers develop medicines for infants, children and teenagers," said Ludo Reynders, Chief Executive Officer of Quintiles CRO services group. "This group's formation is the result of two main factors: Quintiles' critical mass of experience and staff expertise in this patient group, and the need for more and better clinical evaluations of drugs intended for use in infants and children."
Driving that need is the FDA Modernization Act of 1997, which mandates pediatric clinical trials to provide a scientific basis for labeling information regarding dosing levels for medications used in pediatric patients.
"The Quintiles Pediatric and Adolescent Care Group brings what I believe is unsurpassed focus, experience and excellence to this critical area of drug development," said Senior Director Barry Mangum, Pharm.D., who will lead the group.
"Our research experience includes such areas as respiratory distress syndrome, pertussis, neonatal sepsis, cerebral palsy, pyelonephritis, epilepsy, depression and numerous other diseases. "Combined with our strong relationships with leading academic centers and community professionals specializing in pediatric care, we have a unique mix of resources to quickly gather high-quality information about medications used in the pediatric patient population."
Quintiles Pediatric and Adolescent Care has a close collaborative arrangement with the Duke University Medical Center Department of Pediatrics and its 14 clinical divisions. Quintiles also has strategic alliances with other leading medical centers that will benefit customers working with the Quintiles Pediatric and Adolescent Care Group.
Dr. Mangum is an associate clinical professor of pediatrics and pharmacy at The University of North Carolina-Chapel Hill and a consultant to the U.S. Food and Drug Administration on issues involving pediatric medicine. He is co-author of NeoFax: A Manual of Drugs Used in Neonatal Care, the leading manual for neonatal dosing in the U.S. and China, and is a member of the American Academy of Pediatrics, American College of Clinical Pharmacists, and American Society of Health System Pharmacists. He has pioneered the use of syringe infusion systems in neonatal intensive care and designed an innovative fluid delivery system called "The Mangum Set." He has also patented multiple aerosol drug delivery technologies for delivery of medications to the pulmonary systems.
Prior to joining Quintiles, Dr. Mangum served as the operational head of the WakeMed Clinical Research Institute in Raleigh, N.C., where he was an investigator in more than 50 Phase II and Phase III clinical trials. Dr. Mangum earned his bachelor's and doctoral degrees in pharmacy at the Medical University of South Carolina and a bachelor's degree in chemistry from the University of North Carolina-Wilmington.
Quintiles Transnational Corp. is the market leader in providing a full range of integrated product development and commercialization services to the pharmaceutical, biotechnology and medical device industries. Quintiles also provides healthcare policy consulting and health information management services to healthcare and governmental organizations worldwide. Quintiles is headquartered near Research Triangle Park, North Carolina. Quintiles operates through specialized work groups dedicated to meeting customers' individual needs and has more than 15,000 employees worldwide and offices in 30 countries.