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中文摘要
翻译
转化孵化器核心(Core C)的广泛、长期目标是加强和加速中心目标的转化方面,即开发新型靶向宿主的抗病毒治疗药物,能够治疗多种NIAID新出现和再出现的优先病原体病毒,无论是单独使用还是与其他可用药物联合使用。转化孵化器核心将负责为所有U19研究项目提供战略科学、监管、临床前和临床指导。核心将协助项目建立目标产品概况和开发计划,以推进其治疗方法走向临床。该核心将在适当使用体外测定和体内模型等领域提供指导,以证明疗效、药代动力学、ADME(吸收、分布、代谢和排泄)和临床前安全性。在适当的时候,翻译孵化器核心将提供有关商业化选择的建议,以进一步推进项目。此外,核心每年将选择试点项目并为其提供指导,以开发治疗新出现或再出现的传染病的治疗方法或辅助技术,这些技术既符合中心的转化研究主题,又能够加强现有项目。转化孵化器核心将通过以下具体目标寻求实现这些目标:1)为所有参与的研究项目提供监管科学专业知识和支持。2)就中心项目的转化方面提供战略建议、专业知识和实际支持,从而加快完成临床前开发活动的进度。3)在更大的斯坦福社区内确定研究项目和技术,这些项目和技术可以直接增强中心的项目和转化工作,以开发新型靶向宿主的抗病毒疗法
英文摘要
The broad, long-range objective of the Translational Incubator Core (Core C) is to enhance and accelerate the translational aspects of the Center's goals to develop new classes of host-targeting antiviral therapeutics that are capable of treating multiple NIAID Emerging and Re-emerging Priority Pathogen viruses, when used alone or in combination with other available agents. The Translational Incubator Core will be responsible for providing strategic scientific, regulatory, preclinical and clinical guidance to all U19 research projects. The Core will assist projects in establishing Target Product Profiles and Development Plans for advancing their therapeutics towards the clinic. The Core will provide guidance in areas such as appropriate use of in vitro assays and in vivo models to demonstrate efficacy, pharmacokinetics, ADME (absorption, distribution, metabolism, and excretion), and preclinical safety. When appropriate, the Translational Incubator Core will provide advice regarding commercialization options when this is required to further advance the project. In addition, each year the Core will select and provide guidance to pilot projects to develop therapeutics or supportive technologies that address emerging or re-emerging infectious diseases and are both consonant with the translational research theme of the Center and capable of enhancing existing projects. The Translational Incubator Core will seek to achieve these objectives via the following specific aims: 1) To provide regulatory science expertise and support to all participating research projects. 2) To provide strategic advice, expertise and practical support on the translational aspects of the Center's projects, thereby accelerating progress in accomplishment of preclinical development activities. 3) To identify research projects and technologies within the greater Stanford community that could directly enhance the Center's projects and translational efforts to develop new classes of host-targeting antiviral therapies
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ALDH Activation to treat Fanconi Anemia
  • 批准号:
    10178078
  • 项目类别:
  • 资助金额:
    $48.26万
  • 财政年份:
    2018
  • 负责人:
    DARIA MOCHLY-ROSEN
  • 依托单位:
ALDH Activation to treat Fanconi Anemia
  • 批准号:
    9980975
  • 项目类别:
  • 资助金额:
    $48.33万
  • 财政年份:
    2018
  • 负责人:
    DARIA MOCHLY-ROSEN
  • 依托单位:
Development of a novel treatment for hyperbilirubinemia-induced kernicterus
  • 批准号:
    9926721
  • 项目类别:
  • 资助金额:
    $32.94万
  • 财政年份:
    2016
  • 负责人:
    DARIA MOCHLY-ROSEN
  • 依托单位:
Mechanisms of Ethanol-Induced Cardiac Protection
  • 批准号:
    7860783
  • 项目类别:
  • 资助金额:
    $23.08万
  • 财政年份:
    2009
  • 负责人:
    DARIA MOCHLY-ROSEN
  • 依托单位:
海外基金