PROJECT SUMMARY This is a competitive renewal application for the continuation of a highly collaborative and successful pediatric clinical pharmacology training program at Cincinnati Children's Hospital Medical Center and the University of Cincinnati. The program will train a new generation of pediatric investigators to assume leadership roles in the application of innovative, high impact quantitative clinical pharmacology approaches to improve the development, rational use and tailoring of new and existing drug therapies for neonates, infants, children, adolescents and young adults. The need for pediatric clinical pharmacology research and training has never been greater. The T32 Training Program in Pediatric Clinical Pharmacology at Cincinnati Children's Hospital Medical Center (CCHMC) is designed specifically to address this critical need. The program is based in the Division of Clinical Pharmacology, which is jointly a unit within the Department of Pediatrics and the University of Cincinnati, College of Medicine (UCCoM). The program outlined in this renewal application draws on strong leadership and a diverse group of well-established faculty mentors actively involved in subspecialty clinical pharmacology research, representing 18 divisions within the Department of Pediatrics, the Departments of Pharmacology & Systems Physiology and Biomedical Informatics at the UCCoM, and the James L. Winkle College of Pharmacy. The program has tremendous institutional support and takes advantage of broad areas of distinction and resources within a uniquely collaborative environment. The T32 training program is innovative and well aligned with the objectives outlined in the program announcement as it: (1) has a focus in early and later phase studies in multiple and diverse pediatric populations through ongoing research collaborations with all major pediatric subspecialties; (2) involves the application and development of innovative quantitative methodologies such as PK/PD modeling and pharmacometrics, quantitative systems pharmacology modeling and simulation and model-informed clinical trial design; (3) is embedded in the institutional and UCCoM pharmacogenetic/genomics research and training endeavors through the Center for Pediatric Genomics; (4) is closely integrated with Bioinformatics and Health Services and Outcomes Research; and (5) can rely on over 10 years of a well-established curriculum after two funding cycles as a successful training program. The program provides a unique training experience to MDs, PharmDs, and PhDs to become the next generation of leaders whose work will advance pediatric clinical pharmacology and to have an extraordinary impact on pediatric therapeutics and health outcomes for children. The program has successfully opened new avenues to enlarge the pool of talented young clinical investigators with a career interest in pediatric therapeutics.