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：UCSF-史坦福大学监管科学与创新卓越中心（CERSI） UCSF史丹福德史坦福大学监管科学与创新卓越中心（CERSI）汇集了一个 来自两个杰出学术机构的世界一流的科学家团队，目的是合作 支持FDA保护公众健康的使命。我们的CERSI于2014年启动，专注于任务 - 驱动的监管科学研究 - 生成新知识，以帮助FDA进行监管决策 - 制作。我们的研究为与评估有关的监管过程，指导和政策提供了信息 监视安全有效的医疗产品。这两年竞争的续约的主要目标 应用是通过协作研究项目提高监管科学的主要 UCSF和斯坦福大学的FDA和教职员工的科学家。第二个目标是提供教育和培训 对于医学产品开发的学生，博士后和科学家。研究策略包括四个 成分。第一个组件集中于我们的基础架构CERSI核。 CERSI-CORE的目标是 通过有效的管理和对CERSI活动的监督，支持CERSI的活动 财务交易，向FDA和主要利益相关者报告信息，并安排交互式 会议。研究策略的第二和第三组成部分集中在研究上。通过 学术和FDA科学家之间的战略合作研究，我们CERSI研究的总体目标是 解决关键科学问题，以推进FDA保护公共卫生的使命。第二个 组成部分主要由UCSF和 斯坦福大学针对CERSI计划的FDA优先领域。这些研究项目是为 在续签时期的倡议中资金。第三部分包括20个半页研究建议 这可以在两年续期期间资助。一页和一半的区域 页面建议包括数据分析，临床试验设计和数字健康，包括广泛的研究 建议。第四部分包括一个计划，用于利用FDA投资并采购非 来自私人捐助者，我们的机构，行业以及通过我们的教育产品的联邦资金。最后，我们 包括有关我们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，拟议的继续 UCSF-Stanford Cersi的更新应用将促进FDA的监管科学目标。