Clinical Pharmacology Training Program

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PROJECT SUMMARY/ABSTRACT This is a proposal to continue the evolution of postdoctoral training in clinical pharmacology as a collaborative program in pediatric and adult therapeutics in the joint program between Thomas Jefferson University (TJU) with the Children’s Hospital of Philadelphia (CHOP). The goal is to realize one key objective of the NIGMS-NICHD collaboration in clinical pharmacology as a leading joint program training clinician investigators to translate novel discoveries into therapeutic paradigms that transform disease management for children and adults. The program is designed for eight postdoctoral fellows, including MDs and MD-PhDs, and PharmDs, focused on human pharmacology and therapeutics. While training integrates therapeutics across the developmental continuum for fellows, half pursue careers in pediatric and half in adult clinical pharmacology to address shortages in these communities of practice nationally. The program, which is two years with the potential to extend for a third year, expands a well-established curriculum of didactic coursework, conferences, and rotations (20% effort) and research (80% effort). The breadth of pediatric and adult clinical pharmacology is delivered using a framework built on the TJU Training Program in Human Investigation (former NIH K30 Program). Courses cover clinical pharmacology, clinical trials design, statistics, pharmacoepidemiology, pharmacometrics, drug development, ethics, management, leadership, grant writing and presentation skills. Advanced training in academic and industrial pharmacometrics is an elective offering. Conferences include journal club in human therapeutics, research ethics, and seminars in human therapeutics. Rotations provide experience in the critical analysis of the scientific literature on the editorial board of the Annals of Internal Medicine; critical review of pediatric (CHOP) and adult (TJU) human subjects research on institutional review boards (IRBs); clinical trial execution in the TJU Clinical Research Unit; special issues in pediatric therapeutics on the CHOP formulary and investigational new drug (IND) committees, or analytic method development to support trainee pharmacokinetic studies. Fellows customize their education by selecting electives congruent with career aspirations, including drug development at Merck and/or rotation at the Food and Drug Administration (FDA). The majority of fellows’ time is focused on independent, hypothesis-driven research. Opportunities in pediatric and adult experimental therapeutics are offered by 54 preceptors representing 9 broad areas of distinction, including cancer, cardiopulmonary medicine, neurosciences, virology and immunology, connective tissue biology, pediatric oncology, systems and clinical pharmacology, gastroenterology, and pediatric therapeutics. Preceptors are selected based on their productive research programs related to therapeutics, training success, and commitment to train fellows. This program will continue to build upon an exemplary record of recruiting qualified diverse trainees who have been uniformly successful in academia, the biopharmaceutical industry, and FDA.