Workshops of the National Academies Roundtable on Science and Welfare in Laboratory Animal Use (ILAR Roundtable)

项目概要/摘要 申请名称：国家科学院科学与福利圆桌会议研讨会 实验动物使用（ILAR圆桌会议） 资助机会标题：FDA科学会议资助计划（R13）; PAR-19-306。 这一请求是为了获得林业发展局局长办公室（OC/OCS/OCET）的资金。 美国国家科学院实验动物研究所（ILAR）， 工程和医学成立了实验室科学与福利圆桌会议 2013年秋季的动物使用。圆桌会议的目的是促进交流 和解决问题之间的许多不同的选区有强烈的兴趣在使用 研究和试验中的实验动物福利，包括政府机构， 制药和消费品公司，供应商，动物保护组织， 专业协会和学术机构，包括科学家和兽医。的 研讨会将向公众开放，并通过网络直播，参加研讨会将不收取任何费用 或通过网络查看研讨会。 本申请要求美国食品和药物管理局提供部分资金， 支持从2020年开始每年举办两次讲习班，为期五年， 在圆桌会议的主持下，每个讲习班将侧重于一个关键问题， 实验动物使用的科学和福利，如微生理系统， 有效性和安全性研究：器官芯片技术进展研讨会 动物;第四个R：研究用非人类灵长类动物的回归和退休; 异种移植中遗传修饰的伦理学和使用;以及实验动物的使用和 一种健康模式。讲习班提供了以下机会：（1）外联和对话 与所有对在研究中使用实验室动物感兴趣的社区; 2）分享 尖端科学信息;和3）增加对主题的理解， 确定可能的后续活动，以提高生物医学研究的质量， 实验动物福利 基于动物的研究是临床前研究和开发的基本组成部分 以及药物、生物制品和医疗器械的概念验证研究。确保最高 这些研究的质量，同时保持适当的护理和使用所使用的动物取决于 关于在研究、科学和 兽医医学社区。因此，圆桌会议及其讲习班的目的是 与FDA的使命一致：“.通过确保安全性来保护公众健康， 人用和兽药、生物制品、医疗器械、我们的 国家的食品供应、化妆品和放射性产品”。

PROJECT SUMMARY/ABSTRACT Application Title: Workshops of the National Academies' Roundtable on Science and Welfare in Laboratory Animal Use (ILAR Roundtable) Funding Opportunity Title: FDA Scientific Conference Grant Program (R13); PAR-19-306. This request is for funding from the Office of the FDA Commissioner (OC/OCS/OCET). The Institute for Laboratory Animal Research (ILAR) of the National Academies of Sciences, Engineering, and Medicine established the Roundtable on Science and Welfare in Laboratory Animal Use in the Fall of 2013. The purpose of the Roundtable is to foster communication and problem solving among the many different constituencies with strong interests in the use and welfare of laboratory animals in research and testing, including, government agencies, pharmaceutical and consumer product corporations, vendors, animal advocacy groups, professional societies, and academic institutions , including scientists and veterinarians. The workshops will be open to the public and webcasted, and there will be no fee charged to attend or view the workshop via the web. This application requests funds from the U.S. Food and Drug Administration to provide partial support toward convening up to two workshops a year, beginning in 2020 for a period of five years under the auspices of the Roundtable. Each workshop will focus on a critical issue related to the science and welfare of laboratory animal use, such as Micro-Physiological Systems for Efficacy and Safety Studies: A Workshop on Advances in Organs-On-Chip Technologies for Animals; The 4th R: Rehoming and Retirement of Non-Human Primates Used in Research; the Ethics and Use of Genetic Modifications in Xenotransplantation; and Laboratory Animal Use and the One Health Paradigm. The workshops present opportunities for 1) outreach to and dialogue with all communities who share an interest in the use of laboratory animals in research; 2) sharing of cutting-edge scientific information; and 3) increased understanding of the topics and identification of possible follow-on activities to improve the quality of biomedical research and laboratory animal welfare. Animal-based research is a fundamental component of the preclinical research and development and proof-of-concept studies of drugs, biologics and medical devices. Ensuring the highest quality of these studies while maintaining appropriate care and use of the animals used depends on building trust and maintaining and information sharing among the research, scientific and veterinary medical communities. As such, the purpose of Roundtable and its workshops is consistent with the mission of the FDA: "…protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation”.