Research Triangle Center of Excellence in Regulatory Science and Innovation

摘要 创新技术、治疗药物和其他FDA监管产品的迅速出现， 有能力有效地将其用于公共利益。这样做取决于迅速 对这些产品进行评估，并在上市后对其进行有效监控。然而，预处理方法 通过药物、器械和生物制品的实验室测试和临床试验以及 对所有FDA监管产品的营销监督没有跟上步伐，存在知识方面的关键差距， 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 Triangle Center of Excellence in Regulatory Science and Innovation（Triangle CERSI）是一个一站式的监管科学和创新中心。 购物加速器，以满足FDA在监管科学和生成社区方面的当前和不断发展的需求 为监管机构、学术界、工业界和其他利益相关者提供服务。北卡罗来纳州大学的一项合作， 查佩尔山、杜克大学、北卡罗来纳州州立大学和北卡罗来纳州中央大学，都在附近 三角CERSI代表了一个广泛的调查人员网络， 为监管科学带来独特和多样化的专业知识和资源的合作者，包括但不限于 局限于统计方法、机器学习和人工智能、成像、 计算机模拟试验、儿科药理学、患者报告结局（PRO）、人群科学和安全性 整个生命周期的评估，以及其他领域。三角CERSI包括两个医学院，一个 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，并利用与附近的公司和组织在三角研究园区的关系。 三角CERSI有三个具体目标：1。与FDA合作开展监管科学项目， 在监管科学方面取得重大进展，并迅速解决一系列重大的、具体的和新兴的问题。 以满足FDA的需求。2.建立强大的CERSI核心基础设施，以开发，提出， 支持、促进和监督CERSI研究项目的执行，以促进项目的快速完成 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.扩大对Triangle CERSI的支持并通过监管科学扩大其影响力 信息共享活动，包括努力使监管科学工作人员队伍多样化。三角CERSI 将积极与FDA、研究界、 持份者及院校的学生和学员。总之，我们的首要目标是提供一个 丰富的基本新信息、基础设施和工具，以缩短药物和器械的开发 过程，以促进公共卫生，并以补充其他CERSIs的方式通知FDA活动， 有助于实现国家CERSI计划的目标。

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.