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; 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，治疗和其他FDA调节产品的快速出现已经超过 有效拟合公共利益的能力。这样做会促进迅速的能力 评估这些产品，并有效地监视它们。但是，预先的方法 通过实验室测试和药物，设备和生物制剂的临床试验以及后的市场评估 所有FDA调节产品的营销监视尚未保持步伐，并且存在关键的知识差距 将为许多领域的监管决策提供信息。面对这些紧迫的需求，研究 三角监管科学与创新卓越中心（三角CERSI）将提供一站式 购物加速器以满足FDA当前和不断发展的监管科学需求和通用社区 用于监管者，学术界，工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州中央大学，均接近 接近性，三角cersi代表了一个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而多样的专业知识和资源的合作者，包括但不是 仅限于统计方法，机器学习和人工智能，成像的新颖方法 硅试验，小儿药理学，患者报告的结果（PRO），人口科学和安全性 整个生命周期和其他领域的评估。三角形的CERSI包括两所医学院，一个 药学院，两名护理学校，一所公共卫生学校，一所兽医学院 领先的历史黑人大学，国家虚拟成像试验中心和杜克临床研究 研究所，并利用研究三角公园的附近公司和组织的关系。 三角Cersi具有三个具体目标：1。与FDA合作进行监管科学项目 在监管科学方面取得重大进展，并迅速解决广泛的主要，特定和新兴 应对FDA需求的挑战。 2。建立强大的CERSI核心基础设施来开发，提案， 支持，启用和监控CERSI研究项目的执行，以促进项目快速实现 可交付成果；合作伙伴橡树岭国家实验室为数据访问，计算和 资源共享。 3。扩大三角核心的支持，并通过监管科学扩展其影响 信息共享活动，包括使监管科学劳动力多样化的努力。三角形cersi 将与FDA，研究社区，积极分享结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学员。在一起，我们的总体目标是提供 基本新信息，基础架构和工具的抽象以缩短药物和设备开发 过程，进步公共卫生，并以补充其他Cersis和 为实现国家CERSI计划的目标做出贡献。