DESCRIPTION (provided by applicant): A critical need continues to exist for a robust supply of clinician scientists with formal training in pediatric clinical pharmacology. Without trained investigators the goal of optimizing use of medications for individual children cannot be realized. The Indiana University Department of Pediatrics and Division of Clinical Pharmacology are uniquely positioned to address this need. A strong, well-established group of clinical pharmacology investigators has the advantage of being located directly adjacent to one of the strongest pediatric research environments in the US: Riley Hospital for Children, with a Department of Pediatrics consistently ranked in the top 10 in NIH funding. This renewal seeks to continue a formal pediatric clinical pharmacology and therapeutics training program in parallel with their long-standing clinical pharmacology training program, which has a track record of excellence in training successful translational clinician scientists. There are three main components to the Indiana University Postdoctoral Research Training in Pediatric Clinical and Developmental Pharmacology: 1) completion of a two to three year formal didactic curriculum, at the end of which the trainee may receive a master's degree in clinical research; 2) organized pediatric participation in a personalized therapeutics seminar series and weekly journal club; and 3) active involvement in pediatric therapeutics research under the mentorship of one of the faculty members associated with the program. The program faculty selects trainees for the 2 to 3 year program based on their potential as clinician scientists from candidates with MD or MD/ PhD degrees who qualify for primary specialty certification. Exceptional PhD or PharmD candidates with experience and goals related to the objectives of the program may be selected. We propose to continue supporting a total of three postdoctoral fellows at any given time. Those who complete the program will develop core competencies in clinical and translational research methods, biostatistics, clinical trials, research ethics, scientific writing, and grant writing. Thy will also be provided with a structured research mentoring program with an explicit timeline and benchmarks. In depth training focusing on pharmacokinetics, pharmacogenomics, drug development, individualized therapeutics, clinical trial design, modeling and bioethics is included in a didactic lecture series required of all trainees. Trainees may also participate in the Clinica Investigator Training Enhancement program supported by the Indiana CTSI and resulting in an MS in Clinical Investigation. Coursework combined with supervised research experience will result in development of a highly trained cadre of investigators with broad, deep, cutting edge training experiences preparing them for successful careers in pediatric clinical and translational pharmacology. A large, diverse patient population coupled with the dept...