UCSF-Stanford Center of Excellence in Regulatory Science and Innovation

加州大学旧金山分校-斯坦福大学监管科学与创新卓越中心

• 批准号: 10610497
• 负责人: RUSS BIAGIO ALTMAN
• 金额: $ 43.53万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10610497
• 关键词: UCSF; Stanford; Center; Excellence; Regulatory

Abstract: The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) brings together a world-class team of scientists from two outstanding academic institutions, with the goal of collaboratively supporting the FDA’s mission to protect the public’s health. Launched in 2014, our CERSI focuses on mission- driven regulatory science research—generating new knowledge that helps the FDA in its regulatory decision- making. Our research informs regulatory processes, guidances and policies relevant to the evaluation and monitoring of safe and effective medical products. The major goal of this two-year competing renewal application is to advance regulatory sciences primarily through collaborative research projects between scientists at the FDA and faculty at UCSF and Stanford. A secondary goal is to provide education and training to students, postdocs and scientists in medical product development. The research strategy includes four components. The first component is focused on our infrastructure, CERSI-Core. The goal of CERSI-Core is to support activities of the CERSI through effective management and oversight of the CERSI activities, monitoring financial transactions, reporting information to the FDA and key stakeholders, and scheduling interactive meetings. The second and third components of the research strategy is focused on research. Through strategic collaborative research among academic and FDA scientists, the overall goal of our CERSI research is to address key scientific issues for advancing FDA’s mission in protecting the public health. The second component consists largely of eight one-page proposals for research projects from investigators at UCSF and Stanford that address FDA’s priority areas for the CERSI program. These research projects are proposed for funding at the initiation of the renewal period. The third component includes 20 half-page research proposals that may be funded during the course of the two-year renewal period. Areas covered by one-page and half- page proposals include data analytics, clinical trial design, and digital health, among a broad range of research proposals. The fourth component consists of a plan for leveraging the FDA investment and procuring non- federal funds from private donors, our institutions, industry, and through our educational offerings. Finally, we include a short section on educational and outreach activities of our CERSI, which includes fellowship and scholarship programs, courses, workshops, meetings and other events. Collectively, the proposed continuing renewal application of the UCSF-Stanford CERSI will advance the FDA’s regulatory science goals.

摘要：加州大学旧金山分校-斯坦福大学监管科学与创新卓越中心 (CERSI) 加州大学旧金山分校-斯坦福大学监管科学与创新卓越中心 (CERSI) 汇集了 来自两个杰出学术机构的世界级科学家团队，其目标是合作 支持 FDA 保护公众健康的使命。我们的 CERSI 于 2014 年启动，重点关注以下使命： 驱动监管科学研究——产生新知识，帮助 FDA 做出监管决策—— 制作。我们的研究为与评估和相关的监管流程、指南和政策提供了信息 监控安全有效的医疗产品。此次两年竞争性更新的主要目标 应用程序主要是通过合作研究项目来推进监管科学 FDA 的科学家以及加州大学旧金山分校和斯坦福大学的教师。第二个目标是提供教育和培训 面向医疗产品开发领域的学生、博士后和科学家。研究策略包括四个 成分。第一个组件专注于我们的基础设施 CERSI-Core。 CERSI-Core 的目标是 通过对 CERSI 活动的有效管理和监督、监测来支持 CERSI 的活动 金融交易、向 FDA 和主要利益相关者报告信息以及安排互动 会议。研究策略的第二个和第三个组成部分侧重于研究。通过 学术界和 FDA 科学家之间的战略合作研究，我们 CESI 研究的总体目标是 解决关键科学问题，以推进 FDA 保护公众健康的使命。第二个 组成部分主要由加州大学旧金山分校研究人员提出的八页一页的研究项目提案组成， 斯坦福大学解决了 FDA 的 CESI 计划的优先领域。这些研究项目的提议是为了 续订期开始时提供资金。第三部分包括 20 份半页研究提案 可以在两年续展期间提供资金。一页半页覆盖的区域 页面提案包括数据分析、临床试验设计和数字健康等广泛的研究 提案。第四部分包括一项利用 FDA 投资和采购非 来自私人捐助者、我们的机构、行业以及我们的教育产品的联邦资金。最后，我们 包括一个关于我们 CERSI 的教育和外展活动的简短部分，其中包括奖学金和 奖学金计划、课程、研讨会、会议和其他活动。总的来说，拟议的持续 加州大学旧金山分校-斯坦福大学 CERSI 的更新申请将推进 FDA 的监管科学目标。