Training in Neurotherapeutics Discovery and Development for Academic Scientists

描述(由申请人提供)： 该项目将为教职员工和高级博士后研究员制定和实施神经治疗学发现和发展方面的培训计划，以为期3天的短期课程为中心，为受训者提供发现神经治疗剂并将其提升到IND所需的各种知识要素。在短期课程结束后，培训计划将持续两年，在此期间，学生将接受个性化的指导和评估。该培训适用于各种神经系统疾病，将使学生对神经疗法药物发现和开发过程中的各个组成部分有广泛的了解。学生将学习如何确定一个好的药物发现目标；如何构建化验；药物化学的要素；如何进行动物疗效测试；ADME研究、安全测试和配方的原则；实验医学和生物标记物的原则；准备IND文件所需的步骤和与FDA互动的原则；与神经疗法发现和开发有关的知识产权原则；以及如何为学术药物发现研究寻求资金。他们还将接受负责任地进行研究的培训。学生将具备发展和协调整个药物发现和开发工作的技能，并与每个组成部分领域的专家合作。培训将教学讲座与积极参与活动相结合，在这些活动中，学生将接受挑战，在该领域专家的指导下，利用讲座材料完成他们自己的药物发现项目计划。为期3天的短期课程(随后是两年的指导和评估)将每年提供，共五次。

DESCRIPTION (provided by applicant): This project will develop and implement a training program in neurotherapeutics discovery and development for faculty members and advanced postdoctoral fellows, centered around a 3-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 3-day short course (followed by two-years of mentorship and assessment) will be offered annually, a total of five times.