PROJECT SUMMARY/ABSTRACT During the past 20 years, Congress, the National Institutes of Health (NIH), and the Food and Drug Administration (FDA) have made it clear that safe drug therapy for children is a high priority. With the rapidly changing health care and research environments, it has become essential to focus on the training of the next generation of leaders in Pediatric Clinical Pharmacology who are involved in the design and conduct of hands- on drug studies in children to augment the translation of new and effective therapies for children. The proposed Cincinnati Children’s Pediatric Clinical Pharmacology K12 program aims to provide the resources for a diverse group of junior faculty to become the next leaders in Pediatric Clinical Pharmacology. This includes training in the principles of Pediatric Clinical Pharmacology to those who may never had previous clinical pharmacology experience while also facilitating the transition from fellowship to junior faculty to independent investigator for those who have had previous fellowship training in Pediatric Clinical Pharmacology. The training program we propose in this application for K12 Scholars will leverage the outstanding research infrastructure that exists within Cincinnati Children’s Hospital Medical Center and the University of Cincinnati Academic Health Center, the strong research training activities that we have built within the Cincinnati Children’s Division of Clinical Pharmacology, and the robust collaborations that our Division has developed with other Clinical Pharmacology T32 sites and Clinical Pharmacology programs throughout the nation. Through our rigorous training program, we expect Scholars to achieve the following five core competencies: 1) Foundational Knowledge and Skill in Pharmacometrics, 2) Foundational Knowledge and Skills in Pharmacogenetics, 3) In-depth Understanding of the Impact of Developmental Pharmacology Principles on Drug Action and Toxicity, 4) Ability to Conduct Studies in a Variety of Pediatric Patient Populations, and 5) Collaborative Skills in Interdisciplinary Team Research. The four pillars of training to achieve these core competencies will be focused on 1) research training, 2) responsible conduct of research, 3) teaching/research mentorship and 4) leadership and career development through both experiential learning and didactic courses with knowledge and skills to be attained and expected outcomes in each of these areas. Intended Scholar outcomes include high impact manuscripts describing research in Pediatric Clinical Pharmacology, submission of independent K career development awards or R awards, delivery of lectures and presentations on clinical pharmacology topics in local forums and national conferences, experience in mentoring trainees locally and nationally, and leadership positions in national committees in Clinical Pharmacology societies. We intend to have two junior faculty Scholars appointed at any time with the anticipated appointments being 2 to 3 years, depending on external grant funding. This program will expand the critically small pool of Pediatric Clinical Pharmacology investigators who will advance personalized therapeutics in pediatrics to improve the health outcomes of children.

NARRATIVE The Cincinnati Children’s K12 Pediatric Clinical Pharmacology Program will provide the essential resources to expand the critically small pool of pediatric clinical pharmacologists by training a diverse group of junior faculty to become the next generation of independent investigators in the field of Pediatric Clinical Pharmacology. The K12 Scholars will be equipped to lead the development of innovative clinical pharmacology approaches that transform the use of medications in pediatrics. The program will further advance the mission to implement personalized pediatric therapeutics to improve clinical outcomes of children.