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

基本信息

  • 批准号:
    10756714
  • 负责人:
  • 金额:
    $ 486.35万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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.
摘要

项目成果

期刊论文数量(0)
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SUSAN HALABI其他文献

SUSAN HALABI的其他文献

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{{ truncateString('SUSAN HALABI', 18)}}的其他基金

Sieve based full likelihood approach for the Cox proportional hazards model with applications to immunotherapies trials
基于筛法的 Cox 比例风险模型的完全似然法及其在免疫治疗试验中的应用
  • 批准号:
    10577723
  • 财政年份:
    2023
  • 资助金额:
    $ 486.35万
  • 项目类别:
Interactions of Androgen Production, Uptake and Metabolism on outcome in Castration Resistant Prostate Cancer
雄激素产生、摄取和代谢的相互作用对去势抵抗性前列腺癌预后的影响
  • 批准号:
    10460400
  • 财政年份:
    2021
  • 资助金额:
    $ 486.35万
  • 项目类别:
Interactions of Androgen Production, Uptake and Metabolism on outcome in Castration Resistant Prostate Cancer
雄激素产生、摄取和代谢的相互作用对去势抵抗性前列腺癌预后的影响
  • 批准号:
    10908110
  • 财政年份:
    2021
  • 资助金额:
    $ 486.35万
  • 项目类别:
Serum Androgens as Predictors of Survival in Metastatic Prostate Cancer
血清雄激素作为转移性前列腺癌生存的预测因子
  • 批准号:
    8881946
  • 财政年份:
    2015
  • 资助金额:
    $ 486.35万
  • 项目类别:
Prognostic Models of Clinical Outcomes In Men With Castration Resistant Prostate
去势抵抗性前列腺男性临床结果的预后模型
  • 批准号:
    8298156
  • 财政年份:
    2011
  • 资助金额:
    $ 486.35万
  • 项目类别:
Prognostic Models of Clinical Outcomes In Men With Castration Resistant Prostate
去势抵抗性前列腺男性临床结果的预后模型
  • 批准号:
    8188071
  • 财政年份:
    2011
  • 资助金额:
    $ 486.35万
  • 项目类别:
Prognostic Models of Clinical Outcomes In Men With Castration Resistant Prostate
去势抵抗性前列腺男性临床结果的预后模型
  • 批准号:
    8471668
  • 财政年份:
    2011
  • 资助金额:
    $ 486.35万
  • 项目类别:
Prognostic Models of Clinical Outcomes In Men With Castration Resistant Prostate
去势抵抗性前列腺男性临床结果的预后模型
  • 批准号:
    8681186
  • 财政年份:
    2011
  • 资助金额:
    $ 486.35万
  • 项目类别:

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Conference: Triangle Lectures in Combinatorics
会议:组合学三角讲座
  • 批准号:
    2416639
  • 财政年份:
    2024
  • 资助金额:
    $ 486.35万
  • 项目类别:
    Continuing Grant
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EAGER:研究三角区的集成光纤传感和通信生活实验室
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    2330333
  • 财政年份:
    2023
  • 资助金额:
    $ 486.35万
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    Standard Grant
SBIR Phase I: Autonomous Warning Triangle System (aWTS) for Emergency Stopping
SBIR 第一阶段:用于紧急停车的自主警告三角系统(aWTS)
  • 批准号:
    2222996
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    Standard Grant
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FET:小:量子数学、计算复杂性和几何的三角关系
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