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: 10615295
• 负责人: RUSS BIAGIO ALTMAN
• 金额: $ 20万
• 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/10615295
• 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 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，目标是合作 支持FDA保护公众健康的使命。我们的CERSI成立于2014年，专注于使命- 推动监管科学研究-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评估相关的监管流程、指南和政策提供信息 监测安全有效的医疗产品。这项为期两年的竞争性续签的主要目标是 应用主要是通过合作研究项目推动监管科学的发展 FDA的科学家以及加州大学旧金山分校和斯坦福大学的教职员工。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。研究策略包括四个方面 组件。第一个组成部分侧重于我们的基础设施--CERSI-Core。CERSI-Core的目标是 通过有效管理和监督欧洲核子研究中心的活动、监测 财务交易，向FDA和主要利益相关者报告信息，以及安排互动 开会。研究战略的第二和第三部分侧重于研究。穿过 学术和FDA科学家之间的战略协作研究，我们CERSI研究的总体目标是 为推进FDA保护公众健康的使命，解决关键的科学问题。第二 这一部分主要由加州大学旧金山分校和加州大学旧金山分校的研究人员提出的八份一页的研究项目提案组成 斯坦福大学解决了FDA在CERSI项目中的优先领域。这些研究项目是为 在续展期开始时提供资金。第三部分包括20个半页的研究提案 这笔资金可在两年续展期内提供。一页半所涵盖的区域- 页面建议包括数据分析、临床试验设计和数字健康，以及广泛的研究 提案。第四个组成部分包括一项利用FDA投资和采购非 联邦资金来自私人捐赠者、我们的机构、行业和我们的教育机构。最后，我们 包括关于我们CERSI教育和推广活动的一小部分，其中包括研究金和 奖学金计划、课程、研讨会、会议和其他活动。总的来说，拟议的继续 加州大学旧金山分校-斯坦福大学CERSI的续签申请将推进FDA的监管科学目标。