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: 10755484
• 负责人: RUSS BIAGIO ALTMAN
• 金额: $ 191.3万
• 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 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10755484
• 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) supports FDA’s mission of protecting the public health through collaborative research, as well as training and outreach activities. Our CERSI, launched in 2014, brings together a world-class team of scientists from two outstanding academic institutions to focus on innovative regulatory science research in collaboration with FDA scientists—generating new knowledge, tools and standards that help 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 five-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. Our CERSI offers research projects grounded in the enormous research breadth of the two academic institutions: UCSF and Stanford. Eight projects are included in the first year of funding (selected from over 30 submitted proposals). Several of the eight projects are focused on the use of artificial intelligence and real-world data, a major strength of both institutions, to advance the FDA mission. In addition, we include research focused on novel clinical trial design in diverse populations, a multiscale research project that uses AlphaFold on highly polymorphic pharmacogenes to model adverse drug events, and projects focused on advancing digital health tools and vaccine surveillance. These eight projects address research priorities at the FDA including those of the Center for Drug Evaluation and Research (CDER); the Center for Biologics Evaluation and Research (CBER); and the Center for Devices and Radiological Health (CDRH). We also include 18 half-page research proposals that may be funded after the first year; these projects will advance research in data analytics, clinical trial design, digital health, biologics, and special populations. We include a range of education and outreach activities of our CERSI, which include fellowship and diversity scholarship programs, courses, workshops, and summits. We describe top-level scientific advisory board and management and financial teams which have guided our CERSI over almost 10 years in collaborative research, training, and outreach interactions with the FDA. The UCSF-Stanford CERSI provides a West Coast hub for FDA collaborative science and has facilitated the growth of regulatory science at UCSF and Stanford University.

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) 支持 FDA 的使命 通过合作研究以及培训和外展活动保护公众健康。我们的 CERSI 成立于 2014 年，汇集了来自两位杰出学者的世界级科学家团队 机构与 FDA 科学家合作专注于创新监管科学研究——产生 帮助 FDA 进行监管决策的新知识、工具和标准。我们的研究告诉我们 与安全有效的评估和监测相关的监管流程、指南和政策 医疗产品。这项为期五年的竞争性续展申请的主要目标是推进监管 科学主要通过 FDA 科学家和 UCSF 教师之间的合作研究项目 和斯坦福大学。第二个目标是为学生、博士后和科学家提供教育和培训 医疗产品开发。我们的 CERSI 提供基于广泛研究广度的研究项目 两个学术机构：加州大学旧金山分校和斯坦福大学。第一年资助包括八个项目 （从 30 多个提交的提案中选出）。八个项目中有几个重点关注人工技术的使用 情报和真实世界数据是这两个机构的主要优势，可以推进 FDA 的使命。此外， 我们包括专注于不同人群的新颖临床试验设计的研究，这是一个多规模的研究项目 使用高度多态性药物基因的 AlphaFold 来模拟药物不良事件，项目重点 推进数字健康工具和疫苗监测。这八个项目涉及以下领域的研究重点： FDA，包括药物评价和研究中心 (CDER) 的机构；生物制品中心 评估与研究（CBER）；以及设备和放射健康中心 (CDRH)。我们还包括 18 份半页研究提案，第一年后可能获得资助；这些项目将推进以下方面的研究 数据分析、临床试验设计、数字健康、生物制品和特殊人群。我们包括一系列 我们 CERSI 的教育和外展活动，包括奖学金和多元化奖学金计划， 课程、研讨会和峰会。我们描述顶级科学顾问委员会和管理层， 近 10 年来指导我们的 CERSI 合作研究、培训和培训的财务团队 与 FDA 的外展互动。加州大学旧金山分校-斯坦福大学 CERSI 为 FDA 合作提供了西海岸中心 科学，并促进了加州大学旧金山分校和斯坦福大学监管科学的发展。