The Children's Mercy Hospital (CMH), through its Division of Pediatric Clinical Pharmacology and with collaboration from both Duke University and the Children's Hospital of Philadelphia, is ideally suited to provide a comprehensive T32 research fellowship program in Pediatric Clinical/Developmental Pharmacology. The CMH program in Pediatric Clinical Pharmacology, the largest (n=36 members which includes 16 full time faculty members, 5 of whom have been certified by the American Board of Clinical Pharmacology) and most productive such program in the U.S., has developed a world-class reputation as one of the leading programs in this discipline. The outstanding resources (both faculty and facilities) and rich research environment of this program has produced several internationally recognized areas of research excellence which include developmental pharmacogenomics, pharmacokinetics, pharmacodynamics, and early phase clinical trial design/execution. Evidence of this success is reflected by sustained funding of program faculty from NIH, numerous highly cited peer-reviewed publications, the provision of exemplary education/training to a large number of postdoctoral trainees (10 total including those in training;9 MD, 1 PharmD;5 currently in academic positions) from diverse backgrounds and continuous leadership in making scientific contributions through the NICHD-sponsored Pediatric Pharmacology Research Unit Network. This program is the only one in the U.S. solely dedicated to Pediatric Clinical Pharmacology that has been accredited by the American Board of Clinical Pharmacology. It has been recently adopted as a """"""""model program"""""""" for a ,12million E.C. initiative (GRIP initiative) to develop Pediatric Clinical Pharmacology training across Europe. The program proposed in this T32 application combines didactic and experiential training in subject areas germane to Pediatric Clinical/Developmental Pharmacology (e.g., PK, PD, pharmacogenomics, bioinformatics, modeling/simulation, pharmacoepidemiology, treatment adherence, drug delivery systems, clinical trial design). All teaching will be accomplished by experienced faculty (both clinical and basic scientists) who have significant research experience in their subject area(s). This will be augmented by fellow's participation in a M.S. degree program in Bioinformatics offered by the University of Missouri - Kansas City School of Medicine. Over a 3 year total training period, all fellows (with faculty mentors) will complete an investigation that is laboratory-based (translational), clinical-based (phase I/II PK/PD trial) and pharmacoepidemiology-based;all of which will produce a publication. Their transition to independence will be fostered in the 3rd year by preparation of a K-award grant application. Finally, the program at CMH contains a proven, multiple-input method for evaluation of trainees and trainers, and a comprehensive approach for recruiting fellows from diverse professional, cultural and ethnic backgrounds. The longstanding, documented record of excellence of this program will provide applicants with exemplary training in Pediatric Clinical/Developmental Pharmacology.
Regulations in the United States and Europe now require that drugs that have the potential to be used in children actually be evaluated in them;a task undertaken by professionals trained in clinical pharmacology. While there are over 700 clinical pharmacologists trained in adult medicine in the U.S., only 20 have been trained in pediatric clinical pharmacology over the last decade. This disparity, with its profound negative implications for the health of children, will be squarely addressed by proposed pediatric clinical pharmacology training program at the Children's Mercy Hospital;a large academic pediatric medical center located in Kansas City, Missouri.
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