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 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联活动保护公众健康。我们的 CERSI成立于2014年，汇集了一支世界级的科学家团队，他们来自两位杰出的学者 机构与FDA科学家合作，专注于创新的监管科学研究 帮助FDA制定监管决策的新知识、新工具和新标准。我们的研究告诉我们 与安全和有效的评估和监测有关的监管流程、指南和政策 医疗产品。这项为期五年的竞争性续签申请的主要目标是推进监管 科学主要是通过FDA的科学家和加州大学旧金山分校的教职员工之间的合作研究项目 还有斯坦福大学。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提供基于巨大研究广度的研究项目 两所学术机构：加州大学旧金山分校和斯坦福大学。在第一年的资助中包括八个项目 (从30多份提交的建议书中挑选出来)。在八个项目中，有几个项目的重点是使用人工 情报和真实世界数据，这是两个机构的主要优势，以推进FDA的任务。此外, 我们的研究集中在不同人群中的新型临床试验设计，这是一个多规模的研究项目。 使用AlphaFold对高度多态的药物原产地进行建模，并将项目重点放在 关于推进数字健康工具和疫苗监测。这八个项目涉及研究的优先事项， FDA，包括药品评价和研究中心(CDER)；生物制品中心 评估和研究(CBER)；以及设备和放射健康中心(CDRH)。我们还包括 18个半页的研究提案，可能会在第一年后获得资助；这些项目将在 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，包括奖学金和多样性奖学金计划， 课程、研讨会和峰会。我们描述最高级别的科学顾问委员会和管理层 财务团队指导我们的CERSI近10年来在协作研究、培训和 与FDA的外展互动。加州大学旧金山分校-斯坦福大学CERSI为FDA合作提供西海岸枢纽 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。