Clinical Pharmacology Training Program

Thomas Jefferson University, Philadelphia PA

Investigators

Linked publications & trials

Abstract

? DESCRIPTION (provided by applicant): This is a proposal to evolve postdoctoral training in clinical pharmacology at Thomas Jefferson University (TJU) into a collaborative program in pediatric and adult therapeutics with the Children's Hospital of Philadelphia (CHOP). The goal is to realize one key objective of the NIGMS-NICHD collaboration in clinical pharmacology to create the first program training clinician investigators to translate novel discoveries into therapeutic paradigms that transform disease management for children and adults. The program is designed for four postdoctoral fellows, including MDs and MD-PhDs, PharmDs, and PhDs focused on human pharmacology and therapeutics. While training integrates therapeutics across the developmental continuum for fellows, half will pursue careers in pediatric or adult clinical pharmacology, respectively, 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 the well-established curriculum of didactic coursework, conferences, and rotations (20% effort) and research (80% effort), to compare and contrast pediatric and adult therapeutics. 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 include adult and pediatric clinical pharmacology, clinical trials design, statistics, pharmacoepidemiology, pharmacometrics, drug development, ethics, management, leadership, grant writing and presentation skills. Conferences include journal club in human therapeutics, adult and pediatric 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; and special issues in pediatric therapeutics on the CHOP formulary and investigational new drug (IND) committees. Trainees 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 45 preceptors representing 8 areas of distinction within the TJU-CHOP collaborator, including cancer, cardiopulmonary medicine, neurosciences, virology and immunology, connective tissue biology, pharmacometrics, genomics, and pediatric therapeutics. Preceptors represent a spectrum of disciplines and methodologies to ensure broad training opportunities. They are selected on the basis of their productive extramurally-funded research related to therapeutics, training success, and commitment to train fellows. This evolution of the program will build upon an exemplary record of recruiting qualified diverse trainees who have been uniformly successful in academia, the biopharmaceutical industry, and FDA.