TRAINING IN NEUROTHERAPUETICS AND DEVELOPMENT FOR ACADEMIC SCIENTISTS

项目摘要/摘要 该项目将开发和实施一项神经疗法发现和培训计划 教师和高级博士后研究员的发展，以3.5天的短期课程为中心 这将为学员提供所需的各种知识元素，以发现和提高 IND的神经治疗剂。短期课程结束后，培训计划将持续两年 学生将接受个性化指导和评估的时期。培训，这是专门设计的 适用于各种神经系统疾病，将使学生对此有广泛的认识。 神经疗法药物发现和开发过程中的各个组成部分步骤。 学生将学习如何确定一个好的药物发现目标；如何构建一种分析方法； 药物化学；如何进行动物药效试验；ADME研究的原则，安全性试验， 和配方；实验医学和生物标记物的原理；制备 IND文件和与FDA互动的原则；知识产权原则 与神经治疗学的发现和发展有关；以及如何为学术药物寻求资金 发现性研究。他们还将接受负责任地进行研究的培训。学生们将成为 具备开发和协调整个药物发现和开发工作的技能，并 与每个组件领域的专家协作。培训将结合说教讲座。 通过积极参与的活动，学生将被要求利用讲课材料进行工作 通过自己的药物发现项目计划，在地区专家的指导下完成。为期3天半的短期课程 (随后为期两年的指导和评估)将每年提供，总共五次。

Project Summary/Abstract This project will develop and implement a training program in neurotherapeutics discovery and development for faculty members and advanced postdoctoral fellows, centered around a 3½-day short course that will provide the trainees with the various knowledge elements required to discover and advance a neurotherapeutic agent to IND. Following the short course, the training program will continue for a two-year period in which students will have individualized mentoring and assessment. The training, which is designed to be applicable to diverse diseases of the nervous system, will equip students with a broad understanding of the various component steps in the neurotherapeutics drug discovery and development process. Students will learn how to identify a good drug discovery target; how to construct an assay; the elements of medicinal chemistry; how to conduct animal efficacy testing; the principles of ADME studies, safety testing, and formulation; the principles of experimental medicine and biomarkers; the steps required to prepare an IND document and the principles for interacting with the FDA; the principles of intellectual property as they relate to neurotherapeutics discovery and development; and how to seek funding for academic drug discovery research. They will also receive training in responsible conduct of research. Students will be equipped with the skills to develop and coordinate an entire drug discovery and development effort, and to work collaboratively with experts in each of the component areas. The training will combine didactic lectures with active engagement activities in which the students will be challenged to utilize the lecture material to work through their own drug discovery project plan with the guidance of the area experts. The 3½-day short course (followed by two-years of mentorship and assessment) will be offered annually, a total of five times.