North Carolina Collaborative PPRU Network

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DESCRIPTION (provided by applicant): The North Carolina Collaborative Pediatric Pharmacology Research Unit (NCC-PPRU) will be composed of personnel from Duke University and the University Of North Carolina (UNC). The NCC-PPRU will help develop new medications with pediatric indications and increase the availability of pediatric pharmacokinetic data. Faculty leadership will ensure the integration of the infrastructure of the 2 institutions. The NCC-PPRU program will have 6 specific aims: 1) To conduct studies in bioavailability, metabolism pharmacokinetics, pharmacodynamics, and the safety and efficacy of new and licensed drugs. These studies, led by Dr. Pollack (UNC), will rely on the infrastructure of the UNC School of Pharmacy Quantitative Chromatography and PKIPD Laboratories. 2) To form partnerships with industry and gather the necessary clinical data to support FDA approval of pediatric indications for new and previously licensed medications. The accrual of patients into collaborative studies developed by the PPRU Network will be led by Dr. McKinney (Duke) and will grow from a mature interdisciplinary clinical trials group at Duke University-the Pediatric Clinical Research Program. Dr. McKinney, assisted by Drs. Benjamin (Duke) and Retsch-Bogart (UNC), will integrate the clinical departments of both institutions. Drs. Schulman (Duke) and Retsch-Bogart will lead the effort to coordinate the General Clinic Research Centers' resources. Drs. Benjamin and Li (Duke) will integrate the coordinating center resources within the Duke Clinical Research institute. 3) To develop novel approaches and innovative technique in pediatric pharmacology. Dr. Pollack will lead these efforts; Dr. Walson (Senior Consultant, Cincinnati) will facilitate a partnership with the Center for Education and Research in Therapeutics to achieve this aim. 4) To conduct studies on the developmental characteristics of drug-metabolizing enzymes, transporters, and receptors. Dr. LeCluyse (UNC) will lead these efforts in the Drug Metabolism/Transport Laboratory. 5) To apply pharmacogenomic and proteomic tools in pediatric clinical studies. Dr. Mangum (Duke) will lead this collaborative effort in conjunction with the genomics institutes of Duke and IJNC. 6) To train physicians and pharmacologists in clinical and developmental pharmacology: the centerpiece will be a 3-year pediatric pharmacology fellowship. Drs. Brouwer and Lindley (UNC) will lead this program.