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SEVENTH FRAMEWORK PROGRAMME


Duke University (DUKE)

Duke University (DUKE)
324 Blackwell St. Suite 920
NC 27701 Durham

United States of America

Duke University www.duke.edu



Teamleader


Prof. Barry Mangum Prof. Barry Mangum
Associate Professor of Clinical Pharmacology and Pediatrics 
Phone: +1 919 668 8880 
Fax: +1 919 668 7057 
E-Mail to Prof. Barry Mangum Contact  
 



Institute Presentation


The Duke Clinical Research Institute (DCRI), which is part of Duke University, is the world's largest academic clinical research organization. The DCRI combines the clinical expertise and academic leadership of a premier teaching hospital with the full-service operational capabilities of a major contract research organization. With nearly 1,000 faculty and staff, the DCRI is capable of conducting any clinical research project, from the smallest pilot study to truly global mega trials, medical device trials to outcomes and quality of life analyses. Our experience stretches from Phase I to Phase IV and beyond, encompassing post approval analyses and health economics. We have successfully conducted a series of Data Safety Monitoring Board reviews for pediatric pharmaceutical compounds. The full portfolio of abilities means our partners, who include pharmaceutical and medical device makers, biotech companies, and government agencies, can find a tailored research plan that meets their needs. The DCRI conducts studies in more than 20 therapeutic areas. Our faculty are all practicing clinicians in these specialties, applying cutting-edge research in their own patient care. We focus strongly on disseminating research results, publishing more than 500 articles per year in peer-reviewed journals. Their effects on patient care and the state of medicine are felt around the world.

Barry Mangum has an extensive background in neonatal and pediatric pharmacology and is the co-author of the leading drug dosing manual, NeoFax: A Manual of Drugs Used in Neonatal Care. He has been involved as a SC and co-SCI in numerous pediatric clinical trials in the United States and globally related to pediatric exclusivity. He led a team as the Executive Director for a small biotechnology company to seek approval for a novel anti-staphyloccal compound in the neonatal patient population. His efforts included establishing a core Data Safety and Monitoring Board to oversee the conduct of the clinical trial and support patient safety. These efforts resulted in FDA Orphan drug approval, Fast Track designation, and completion of the Phase I portion of the development program. Dr. Mangum also serves as principal investigator for many pharmaceutical industry Data Safety and Monitoring Boards as well as Institutional Ethics Committees.


Duke University (DUKE)