Clinical Pharmacology Training Program

PROJECT SUMMARY/ABSTRACT This is a proposal to continue the support of two pediatric and maternal-fetal clinical pharmacology slots in a long standing collaborative postdoctoral training program in at Children’s Hospital of Philadelphia (CHOP) and Thomas Jefferson University (TJU). These slots have been supported by NICHD for the past 2 cycles under a parent NIGMS T32 grant. Changes to the approach of NICHD to support clinical pharmacology slots prompted this application. The mission of our joint program is to train the next generation of drug development scientists to ensure innovation in therapeutics that transforms disease management. To accomplish this, we seek to identify diverse basic, translational, and clinical investigators and provide a curriculum that prepares trainees for research careers in academia, industry, or regulatory agencies. The program is designed for postdoctoral fellows, including MDs, MD-PhDs, PharmDs, and PhDs, leveraging the exceptional research environment of our two institutions to support training that addresses workforce needs in the field. Our 2-year program pairs a well- established curriculum of didactic coursework, conferences, and rotations with mentored research in mechanism-based discovery, drug development, pharmacometrics, experimental medicine, and drug safety; the majority of fellows’ time is focused on hypothesis-driven research. The breadth of clinical pharmacology is delivered using a framework built on the TJU Training Program in Human Investigation. Courses cover clinical pharmacology, clinical trials design, biostatistics, pharmacoepidemiology, pharmacometrics, regulatory science, research ethics, data 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 review of human subjects research on an institutional review board (IRBs); clinical trial execution in the TJU Clinical Research Unit or within the inpatient setting at CHOP; analytic method development to support trainee pharmacokinetic studies; or the critical analysis of the scientific literature on the editorial board of the Annals of Internal Medicine. Fellows customize their education by selecting electives congruent with career aspirations, including off-site rotations at industrial drug development partners and/or regulatory agencies such as the Food and Drug Administration (FDA). Opportunities in pediatric, maternal, and adult experimental therapeutics are offered by preceptors representing 6 broad areas of distinction, including cancer biology, cardiopulmonary medicine, neurosciences, immunology and infectious diseases, neonatology and maternal therapeutics, and pediatric therapeutics. Preceptors are selected based on their productive research programs related to therapeutics, training success, and commitment to training. This program will continue to build upon an exemplary record of recruiting diverse trainees who have been uniformly successful in academia, the biopharmaceutical industry, and the FDA.