Clinical Pharmacology Training Program

项目摘要/摘要 这是一项继续发展临床药理学博士后培训的合作计划。 托马斯·杰斐逊大学(TJU)与托马斯杰斐逊大学(TJU)联合开设的儿科和成人治疗学课程 费城儿童医院(CHOP)。其目标是实现NIGMS的一个关键目标--NICHD 临床药理学合作作为一个领先的联合项目，培训临床医生研究人员翻译小说 转变儿童和成人疾病管理的治疗范例的发现。该计划 是为八名博士后研究员设计的，包括医学博士和医学博士，以及专注于人类的药学 药理学和治疗学。虽然培训将治疗方法整合到整个发育连续体中 研究员，一半从事儿科职业，一半从事成人临床药理学，以解决这些领域的短缺 全国范围内的实践社区。该计划为期两年，有可能延长第三年， 扩展完善的教学课程、会议和轮换课程(20%的工作量)和 研究(80%的努力)。儿科和成人临床药理学的广度使用了一个框架 建立在TJU人类调查培训计划(前NIH K30计划)的基础上。课程涵盖临床 药理学、临床试验设计、统计学、药物流行病学、药物计量学、药物开发、 道德、管理、领导力、奖助金撰写和演示技巧。高级学术和技术培训 工业药物计量学是一门选修课。会议包括人类治疗学杂志俱乐部， 研究伦理学，以及人类治疗学研讨会。轮换提供了批判性分析的经验 《内科医学年鉴》编委会上的科学文献；儿科评论 (CHOP)和成人(TJU)在机构审查委员会(IRBs)上的人体受试者研究；临床试验执行 在TJU临床研究单位；关于CHOP配方表的儿科治疗特刊和 研究新药(IND)委员会，或分析方法开发，以支持学员的药代动力学 学习。研究员通过选择与职业抱负一致的选修课来定制他们的教育，包括 默克公司的药物开发和/或食品和药物管理局(FDA)的轮换。大多数研究员的 时间集中在独立的、假设驱动的研究上。儿科和成人实验中的机会 治疗学由54名导师提供，代表9个广泛的区别领域，包括癌症， 心肺医学、神经科学、病毒学和免疫学、结缔组织生物学、儿科 肿瘤学、系统和临床药理学、胃肠病学和儿科治疗学。教官是 根据他们与治疗学、培训成功和承诺相关的生产性研究计划进行选择 来训练学员。该计划将继续以招聘合格的多样化人才的模范记录为基础 在学术界、生物制药行业和FDA都取得一致成功的受训人员。

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.