Research Triangle Center of Excellence in Regulatory Science and Innovation

监管科学与创新卓越研究三角中心

• 批准号: 10756714
• 负责人: SUSAN HALABI
• 金额: $ 486.35万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10756714
• 关键词: Research; Triangle; Center; Excellence; Regulatory

ABSTRACT The rapid emergence of innovative technologies, therapeutics, and other FDA-regulated products have outpaced the ability to effectively appropriate them for public benefit. Doing so hinges on the capability to expeditiously evaluate these products and effectively monitor them once on the market. However, methodologies for pre- market evaluation through laboratory testing and clinical trials for drugs, devices, and biologics and for post- marketing surveillance of all FDA-regulated products have not kept pace, and key gaps in knowledge exist that would inform regulatory decision making in many areas. In the face of these pressing needs, the Research Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI) will provide a one-stop- shop accelerator to meet FDA’s current and evolving needs in regulatory science and a generative community for regulators, academia, industry, and other stakeholders. A collaboration of the University of North Carolina at Chapel Hill, Duke University, North Carolina State University, and North Carolina Central University, all in close proximity, the Triangle CERSI represents a broad network of investigators and national and international collaborators that bring unique and diverse expertise and resources for regulatory science, including but not limited to novel approaches in statistical methodologies, machine learning and artificial intelligence, imaging, in silico trials, pediatric pharmacology, patient reported outcomes (PRO), population science, and safety assessment across the lifespan, and other areas. The Triangle CERSI includes two Schools of Medicine, a School of Pharmacy, two Schools of Nursing, a School of Public Health, a College of Veterinary Medicine, a leading historically Black university, a national Center for Virtual Imaging Trials, and the Duke Clinical Research Institute, and leverages relationships with nearby companies and organizations in the Research Triangle Park. The Triangle CERSI has three specific aims: 1. Conduct regulatory science projects in collaboration with FDA to deliver major advances in regulatory science and rapidly address a broad range of major, specific, and emerging challenges in response to FDA needs. 2. Establish robust CERSI Core infrastructure to develop, propose, support, enable, and monitor execution of CERSI research projects to facilitate rapid achievement of project deliverables; partner Oak Ridge National Laboratory provides support for data access, computation, and resource sharing. 3. Expand support of the Triangle CERSI and extend its impact through regulatory science information sharing activities, including efforts to diversify the regulatory science workforce. The Triangle CERSI will actively share results and newly developed tools and resources with the FDA, research community, stakeholders, and our institutions’ students and trainees. Together, our overarching goal is to provide an abundance of essential new information, infrastructure, and tools to shorten the drug and device development process, to advance public health, and to inform FDA activities in ways that complement other CERSIs and contribute to achieving the goals of the national CERSI program.

抽象的 创新技术、疗法和其他 FDA 监管产品的迅速出现已经超过了 有效地将其用于公共利益的能力。这样做取决于能否迅速 评估这些产品并在其上市后对其进行有效监控。然而，预 通过实验室测试和临床试验对药物、设备和生物制品以及后期进行市场评估 对所有受 FDA 监管的产品的营销监督并未跟上步伐，并且存在以下关键知识空白： 将为许多领域的监管决策提供信息。面对这些迫切的需求，研究 三角监管科学与创新卓越中心（Triangle CERSI）将提供一站式- 商店加速器，以满足 FDA 在监管科学和生成社区方面当前和不断变化的需求 对于监管机构、学术界、行业和其他利益相关者。北卡罗来纳大学的合作 教堂山、杜克大学、北卡罗来纳州立大学和北卡罗来纳中央大学都在附近 由于距离较近，CERSI 三角代表了广泛的调查人员网络以及国家和国际 为监管科学带来独特且多样化的专业知识和资源的合作者，包括但不包括 仅限于统计方法、机器学习和人工智能、成像等方面的新方法 计算机模拟试验、儿科药理学、患者报告结果 (PRO)、人口科学和安全性 整个生命周期和其他领域的评估。 CERSI 三角包括两所医学院， 药学院、两所护理学院、一所公共卫生学院、一所兽医学院、一所 历史上领先的黑人大学、国家虚拟成像试验中心和杜克临床研究中心 研究所，并利用与三角研究园附近公司和组织的关系。 CERSI 三角有三个具体目标： 1. 与 FDA 合作开展监管科学项目， 在监管科学领域取得重大进展，并迅速解决广泛的主要、特定和新兴问题 应对 FDA 需求的挑战。 2. 建立强大的 CESI 核心基础设施来开发、提出、 支持、启用和监控 CERSI 研究项目的执行，以促进项目的快速实现 可交付成果；合作伙伴橡树岭国家实验室提供数据访问、计算和分析支持 资源共享。 3. 扩大对 CERSI 三角的支持并通过监管科学扩大其影响 信息共享活动，包括努力实现监管科学劳动力的多元化。三角CESI 将积极与 FDA、研究界分享成果以及新开发的工具和资源， 利益相关者以及我们机构的学生和实习生。我们的总体目标是共同提供 丰富的重要新信息、基础设施和工具，可缩短药物和设备的开发时间 流程，以促进公共卫生，并以补充其他 CERSIS 和 为实现国家 CERSI 计划的目标做出贡献。