Immune Tolerance Network

免疫耐受网络

• 批准号: 10471497
• 负责人: GERALD T NEPOM
• 金额: $ 450万
• 依托单位: BENAROYA RESEARCH INST AT VIRGINIA MASON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10471497
• 关键词: Address; Adopted; Affect; Allergic Disease; Area; Autoimmune Diseases; Autoimmunity; California; Clinical Research; Clinical Sciences; Clinical Trials; Clinical assessments; Communities; Development; Discipline; Disease; Fostering; Freedom; Funding; Future; Genetic; Goals; Health; Health Care Costs; Hypersensitivity; Immune Tolerance; Immunologics; Immunology; Industry; Institution; Intervention; Knowledge; Laboratories; Lead; Leadership; Life; Medical; Mission; National Institute of Allergy and Infectious Disease; Organ failure; Phase; Population; Process; Quality of life; Research Design; Research Institute; Research Personnel; Resource Sharing; Resources; Role; Sampling; San Francisco; Savings; Structure; Therapeutic; Therapeutic immunosuppression; Transplantation; United States; Universities; base; burden of illness; clinical application; clinical research site; data integration; data management; data sharing; design; drug withdrawal; empowered; experience; flexibility; improved; innovation; next generation; novel; operation; preclinical study; programs; response; success; tool

Project summary / ABSTRACT The mission of the ITN is to advance the clinical application of immune tolerance by performing high quality clinical trials of emerging therapeutics based upon testable mechanistic hypotheses. The ITN is structured in order to interrogate different diseases across the immunologic spectrum, with integration of innovative clinical studies and cutting edge immunology laboratory analysis. The ITN approach—clinical assessment of novel tolerance therapeutics, while we simultaneously evaluate the cellular, genetic, and immunologic mechanisms of disease and how they are altered in response to therapy—creates a framework for advancing cross-disease and cross-discipline knowledge, all designed to accelerate therapeutic options for major diseases. In this renewal application, we describe the scientific and operational framework that will enable the ITN to successfully enhance the development of tolerance therapies in transplantation, autoimmunity, and allergy. We outline a process to evolve our current strategies into the next generation of planned trials, as well as how we plan to operate a nimble, future-focused organization, poised to lead and adopt innovations that are currently unknown. We propose a collaborative structure involving hundreds of investigators, advisors, and clinical sites working in tandem with a core group of ITN staff, operating a program that is both scientifically and financially efficient. Several new innovations recently adopted by the ITN will encourage widespread involvement from academic investigators, including expanded resource sharing and data sharing operations. With lead institutional commitment from the Benaroya Research Institute and the University of California San Francisco, and participation of more than 20 other major institutions represented in leadership and major advisory roles, the ITN strives to continue to successfully pioneer high impact clinical trials and mechanistic studies in areas of unmet medical need.

项目概要/摘要 ITN的使命是推进免疫耐受的临床应用， 基于可检验的机制假设的新兴疗法的高质量临床试验。 ITN的结构是为了询问不同的疾病在免疫学 光谱，与创新的临床研究和尖端的免疫学实验室相结合 分析. ITN方法-新型耐受性治疗的临床评估，而我们 同时评估疾病的细胞，遗传和免疫机制，以及如何 它们在对治疗的反应中被改变--为推进交叉疾病创造了一个框架， 跨学科知识，所有这些都旨在加速重大疾病的治疗选择。 在此更新申请中，我们描述了科学和操作框架， ITN成功地促进了移植耐受疗法的发展， 自身免疫和过敏。我们概述了一个过程，以发展我们目前的战略， 一代计划的试验，以及我们计划如何运作一个灵活的，以未来为重点的 组织，准备领导和采用目前未知的创新。我们提出了一个 涉及数百名研究者、顾问和临床研究中心的协作结构， 与ITN工作人员的核心小组合作，经营一个既科学又 财务效率。ITN最近采用的几项新创新将鼓励 学术研究人员的广泛参与，包括扩大资源共享， 数据共享业务。在Benaroya研究所的领导机构承诺下， 研究所和加州大学旧金山弗朗西斯科，以及其他20多个参与 作为主要机构的领导和主要咨询角色，ITN努力继续 在未满足的领域成功地开创高影响力的临床试验和机制研究 医疗需求。