Training in Neurotherapeutics for Academic Scientists

学术科学家神经治疗学培训

• 批准号: 10666685
• 负责人: MICHAEL A. ROGAWSKI
• 金额: $ 26.84万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666685
• 关键词: ADME Study; Academia; Address; Advocacy; American; Antibodies; Area; Binding; Biological; Biological Assay; Biological Products; Biological Response Modifier Therapy; Brain; Brain Diseases; Breathing; Communities; Continuing Education; Critiques; Development; Development Plans; Educational Curriculum; Elements; Event; Faculty; Formulation; Funding; Future; Gene Transduction Agent; Goals; Government; Individual; Industry; Intellectual Property; Knowledge; Lead; Learning; Legal patent; Mentors; Monoclonal Antibodies; Nervous System; Oligonucleotides; Participant; Pharmaceutical Chemistry; Postdoctoral Fellow; Process; Quality of life; Research; Research Personnel; Rotation; Scientist; Series; Societies; Special Event; Specialist; Students; Teacher Professional Development; Toxicology; Training; Training Programs; Viral Vector; Vision; Work; animal efficacy; apprenticeship; base; biological development; career; commercialization; community building; design; disability; drug development; drug discovery; efficacy testing; experience; improved; instructor; interest; lecturer; lectures; meetings; member; nervous system disorder; responsible research conduct; safety testing; skills; small molecule; student participation; success; teacher

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.

项目总结/摘要 该项目将开发和实施神经治疗学发现和 教师和高级博士后研究员的发展，围绕4天的短期课程 这将为学员提供发现和推进一个 神经治疗剂-无论是小分子或生物-IND。该课程是结合提供 美国实验神经治疗学会（ASENT）培训的目的是 适用于神经系统的各种疾病，将使学生广泛了解 神经治疗药物发现和开发过程中的各种组成步骤。学生将 学习如何确定一个好的药物发现目标;如何构建一个分析;医药的元素 化学;如何进行动物有效性试验; ADME研究的原则，安全性试验， 制剂;开发生物制品的特殊考虑，包括单克隆抗体， 寡核苷酸和病毒载体基因疗法;准备IND文件所需的步骤和 与FDA互动的原则;知识产权原则，因为它们涉及 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 research.他们还将接受负责任地开展研究的培训。学生将配备 开发和协调整个药物发现和开发工作的技能， 与每个组成部分领域的专家合作。培训将结合联合收割机教学讲座， 积极参与活动，学生将受到挑战，利用讲座材料工作 通过他们自己的药物发现项目计划与该地区专家的指导。4天短期课程 每年举办一次，共举办五次。参加短期课程后，学员将参加 通过与ASENT的合作提供持续专业发展的持续活动。