Translational Incubator Core

转化孵化器核心

• 批准号: 8643875
• 负责人: DARIA MOCHLY-ROSEN
• 金额: $ 32.9万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-10 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8643875
• 关键词: Address; Adopted; Antiviral Agents; Antiviral Therapy; Area; Clinic; Clinical; Clinical Research; Communities; Development; Development Plans; Drug Kinetics; Emerging Communicable Diseases; Ensure; Excretory function; Future; Goals; Incubators; Investigational New Drug Application; Metabolism; Methodology; Monitor; National Institute of Allergy and Infectious Disease; Pathway interactions; Performance; Pharmaceutical Preparations; Pilot Projects; Quality Control; Research Contracts; Research Project Grants; Science; Services; Technology; Therapeutic; Translational Research; Translations; Universities; Virus; Work; absorption; commercialization; in vitro Assay; in vivo Model; new technology; next generation; novel strategies; pathogen; pre-clinical; preclinical safety; preclinical study; safety study; success

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

转化孵化器核心（核心 C）的广泛、长期目标是加强和加速该中心目标的转化，开发新型宿主靶向抗病毒疗法，能够治疗多种 NIAID 新兴和重新出现的疾病优先病原体病毒，单独使用或与其他可用制剂联合使用时。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。该核心将协助项目建立目标产品概况和开发计划，以将其治疗方法推向临床。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。在适当的情况下，转化孵化器核心将在需要进一步推进项目时提供有关商业化选项的建议。此外，每年核心都会选择试点项目并提供指导，以开发治疗方法或支持技术，以解决新出现或重新出现的传染病，并且既符合该中心的转化研究主题，又能够加强现有项目。转化孵化器核心将寻求通过以下具体目标来实现这些目标： 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) 为中心项目的转化提供战略建议、专业知识和实际支持，从而加快完成临床前开发活动的进展。 3) 确定斯坦福大社区内的研究项目和技术，这些项目和技术可以直接加强该中心的项目和转化工作，以开发新型宿主靶向抗病毒疗法