Training in Neurotherapeutics 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 针对教员和高级博士后研究员的发展，以为期4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 神经治疗剂--无论是小分子还是生物--用于IND。该课程与 美国实验神经治疗学会(ASENT)。这项培训旨在 适用于各种神经系统疾病，将使学生对神经系统疾病有广泛的了解 神经治疗药物发现和开发过程中的各个组成部分。学生们将 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；药物的要素 化学；如何进行动物药效试验；ADME研究、安全试验和 配方；开发生物制品，包括单抗的特别考虑， 寡核苷酸和病毒载体基因疗法；准备IND文件和 与FDA互动的原则；与之相关的知识产权原则 神经治疗学的发现和发展；以及如何为学术药物发现寻求资金 研究。他们还将接受负责任地进行研究的培训。学生们将被配备 开发和协调整个药物发现和开发工作的技能，以及 与每个组成部分领域的专家协作。培训将结合说教讲座和 主动参与的活动，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4天的短期课程 将每年举办一次，共五次。参加完短期课程后，学员将参加 持续的活动，提供持续的专业发展，通过与美国职业教育协会的接触。

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 4-day short course that will provide the trainees with the various knowledge elements required to discover and advance a neurotherapeutic agent – either small molecule or biological – to IND. The course is offered in conjunction with the American Society for Experimental Neurotherapeutics (ASENT). 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; special considerations for development of biological products, including monoclonal antibodies, oligonucleotides and viral vector gene therapies; 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 4-day short course will be offered annually, a total of five times. After attending the short course, trainees will participate in ongoing activities that provide continuing professional development through engagement with ASENT.