The Indiana University-Ohio State University Maternal and Pediatric Precision in Therapeutics Data, Model, Knowledge, and Research Coordination Center (IU-OSU MPRINT DMKRCC)

印第安纳大学-俄亥俄州立大学母婴精准治疗数据、模型、知识和研究协调中心 (IU-OSU MPRINT DMKRCC)

• 批准号: 10309155
• 负责人: Lang Li
• 金额: $ 300万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10309155
• 关键词: Acute; Address; Adult; Best Pharmaceuticals for Children Act; Breast Feeding; Child; Childhood; Chronic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Communities; Complex; Consumption; Data; Databases; Development; Drug Kinetics; Drug usage; Educational Activities; Enrollment; Ethics; Exclusive Breastfeeding; FDA approved; Feedback; Fetus; Fostering; Funding; Goals; Guidelines; Health; Incentives; Indiana; Individual; Infant; Infrastructure; Institute of Medicine (U.S.); Knowledge; Knowledge Portal; Label; Lactation; Literature; Logistics; Milk; Mission; Modeling; Modernization; National Institute of Child Health and Human Development; Neonatal; Ohio; Orphan; Outcome; Pediatric Research; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Pharmacotherapy; Physiology; Population; Pregnancy; Pregnant Women; Research; Research Design; Research Support; Resources; Rheumatoid Arthritis; Risk; Science; Source; Therapeutic; Therapeutic Agents; TimeLine; Translational Research; United States Food and Drug Administration; United States National Institutes of Health; Universities; Vulnerable Populations; Woman; Women' s Health; Work; base; cohesion; data sharing; drug development; drug disposition; drug distribution; drug efficacy; improved; infant morbidity/mortality; knowledge base; knowledge integration; maternal morbidity; medication safety; meetings; men; multidisciplinary; neonate; organizational structure; outreach; pediatric patients; personalized medicine; pharmacokinetics and pharmacodynamics; pharmacometrics; physiologically based pharmacokinetics; programs; research study; response; web portal; webinar

Summary (Overall) The Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub will serve as a national resource for multi- disciplinary expertise and knowledge in maternal and pediatric therapeutics. The MPRINT Data, Model, Knowledge, and Research Coordination Center (DMKRCC) will support the MPRINT Centers of Excellence in Therapeutics (CET) and Steering Committee to coordinate and expand research relating to maternal and pediatric therapeutics. The DMKRCC will serve as the administrative component of the MPRINT Hub, coordinate outreach and dissemination of MPRINT Hub activities, and will serve as a conduit between the MPRINT Hub and the broader scientific community. Additionally, the MPRINT DMKRCC will organize annual MPRINT meetings and educational activities, including webinars, to cultivate translational research in maternal and pediatric therapeutics. The DMKRCC will identify, aggregate, and make available data, knowledge, and expertise in maternal and pediatric therapeutics to the wider research, drug development, and regulatory communities. Specifically, the DMKRCC will identify, evaluate, and collate pertinent data in a knowledgebase that will be made available through a web portal; utilize and enhance pharmacometric modeling approaches such as physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD); support clinical trial design; and foster expertise in drug development and personalized therapy for maternal and pediatric populations. The specific aims of this proposal will develop a cohesive organizational structure to support the research of the MPRINT Hub as a whole as well as the individual cores within the DMKRCC. We will develop infrastructure to facilitate data sharing and knowledge dissemination, and work with the CETs and Steering Committee to identify and address changing needs of the maternal and pediatric communities.

摘要（总体） 母婴精准治疗 (MPRINT) 中心将作为多方的国家资源 孕产妇和儿科治疗方面的学科专业知识和知识。 MPRINT 数据、模型、 知识和研究协调中心 (DMKRCC) 将支持 MPRINT 卓越中心 治疗学 (CET) 和指导委员会协调和扩大与孕产妇和 儿科治疗学。 DMKRCC 将作为 MPRINT 中心的行政组成部分，协调 外展和传播 MPRINT 中心活动，并将作为 MPRINT 中心之间的渠道 以及更广泛的科学界。此外，MPRINT DMKRCC 将组织年度 MPRINT 会议和教育活动，包括网络研讨会，以促进孕产妇和儿童方面的转化研究 儿科治疗学。 DMKRCC 将识别、汇总并提供数据、知识和专业知识 在孕产妇和儿科治疗领域向更广泛的研究、药物开发和监管界迈进。 具体来说，DMKRCC 将识别、评估和整理知识库中的相关数据， 可通过门户网站获取；利用和增强药理学建模方法，例如 基于生理学的药代动力学和药效学（PBPK/PD）；支持临床试验设计；和 培养针对孕产妇和儿科人群的药物开发和个性化治疗方面的专业知识。这 该提案的具体目标是建立一个有凝聚力的组织结构来支持研究 MPRINT Hub 作为一个整体以及 DMKRCC 内的各个核心。我们将发展基础设施 促进数据共享和知识传播，并与 CET 和指导委员会合作，确定 并满足孕产妇和儿科社区不断变化的需求。