There is a widely recognized shortage of scientists with formal training in clinical pharmacology, a discipline ideally suited to our nation's current efforts to translate new therapies into clinical practice and to ensure safe and effective use. This application is a competitive renewal of the Indiana University (IU) Comprehensive Training Program in Clinical Pharmacology, currently in the 24th year, to continue train exceptional clinical pharmacologists for leadership. The training program provides fellows (MD, PharmD, MD/PhD, PhD or equivalent) with comprehensive, integrative and cutting-age training in two key areas. 1) Trainee will conduct research (laboratory and/or clinical) under the mentorship of one of the program preceptor. Fellows have access to diverse and outstanding preceptors (20 senior and 5 junior) from the Division and other basic and clinical departments, which were selected based on research quality, peer-reviewed funding, collaborative relationships, and mentoring commitment. Five junior mentors are included to provide the continuum of mentorship and leadership development. Collaborations among the preceptors within the Division and beyond has been well established and include pharmacogenomics, adverse drug reactions, drug-drug interactions, drug disposition, quantitative pharmacology, pediatric pharmacology, precision medicine, biomarker of drug response and therapeutic outcomes. 2) Trainee will receive formal training in broad clinical pharmacology issues and skills and in research ethics and responsible conduct of research to prepare trainees for the complexities involved in the research and practice of translational therapeutics. Fellows attend weekly team journal clubs specifically organized to break down silos, seminars in clinical pharmacology and personalized medicine, and an organized weekly didactic program. The didactic training concentrates on pharmacokinetics/pharmacokinetics, drugs and metabolites analysis, pharmacogenomics, quantitative pharmacology, drug development, biostatistics, clinical trial design, research ethics and responsible conduct of research. The training occurs at an exceptionally rich, synergetic and complementary training environment. The School of Medicine and the Department Medicine at IU have significantly increased flexible funds to enhance the training experience. The training program continue to generate diverse clinical pharmacologists, including women and underrepresented minority, which assumed prominent roles in academia, the pharma industry and the FDA, and it has significantly evolved such that it now represents one of the strongest, most comprehensive and cutting-age training program in the country. Since first funded in 1992, a robust applicant pipeline existed and qualified applicants have always filled the training grant slots. We receive substantially more qualified applicants than available positions. All of these factors make the Division an ideal site to continue training future leaders in the discipline. We request support for two additional slots in this application.
The Indiana University Research Training Program in Clinical Pharmacology proposed in this application is designed to generate new leaders able to implement the science of Clinical Pharmacology and Therapeutics in academic, industry or drug regulatory settings. The availability of a well-established Division of Clinical Pharmacology with a documented track record in accomplishing the goals of this training grant for many years, multiple well-funded and experienced investigator teams assembled to mentor trainees, a robust pipeline of applicants and an outstanding institutional training environment and new institutional support will continue to provide trainees the highest possible quality of training in this critical translational field.
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