Johns Hopkins Center of Excellence in Regulatory Science and Innovation

项目摘要/摘要 作为世界领先的监管机构和国家最大的研究型大学，美国食品和药物管理局 行政管理部门和约翰霍普金斯大学非常适合扩大和深化他们的高生产率 通过约翰霍普金斯大学监管科学和创新卓越中心(JH-CERSI)建立伙伴关系。 该计划于2014年启动，产生了基础和应用的新知识，影响了广泛的 受监管的产品，从新冠肺炎疗法(药物评估和研究中心)到 电子烟(烟草产品中心)到上肢假肢(器械和放射学中心 健康)。该计划还进行了与许多未被研究的群体有关的至关重要的调查， 包括孕妇、种族和少数民族、儿童和阿片类药物使用障碍的个人。这 FDA已经使用知识来支持规则制定、指导开发和协调 战略优先事项，帮助确保FDA在推进技术和 产品监管的科学基础。自成立以来，JH-CERSI还利用历史上的 FDA和约翰霍普金斯大学之间的密切关系，我们的更新建立在实质性的基础上 过去8年，基础设施共同发展。JH-CERSI的成功反映了许多优势 包括FDA首席科学家办公室和监管科学办公室做出的卓越承诺 和创新，大学在监管科学方面的国际知名奖学金，一个巨大的培训 平台，靠近FDA的地理位置，以及灵活和有机的操作方法。在这次更新中， 我们计划利用这些优势，并利用我们自成立以来所做的大量结构改进 盗梦空间。我们还提出了三个新的方案要素，以扩大影响。首先，我们将任命一名 人工智能副主任和数据科学和信息学副主任将扩大 我们在教职员工、项目、中心和学校，包括世界各地的活动的深度和广度- 著名的怀廷工程学院和约翰霍普金斯应用物理实验室。第二，我们将发展 新的培训，包括防备和公共卫生传播方面的培训，以应对以下重大威胁 错误信息对FDA的监管成功构成了威胁。我们还建议与海外领先的公司进行新的交流 监管机构，从而加强全球监管科学。最后，我们将建立外部合作伙伴关系 通过利用约翰·霍普金斯大学教职员工卓越的科学网络，发挥力量倍增器的倡议 为FDA的使命服务。通过这些努力，约翰霍普金斯大学和FDA将继续 取得显著成果，使FDA能够通过最先进的技术最大限度地提高其有效性和影响力 21世纪的监管。

PROJECT SUMMARY/ABSTRACT As the world’s leading regulatory authority, and the country’s largest research university, the U.S. Food and Drug Administration and Johns Hopkins University are ideally suited to broaden and deepen their highly productive partnership through the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI). This program, launched in 2014, has produced fundamental and applied new knowledge impacting a breadth of regulated products, ranging from COVID-19 therapeutics (Center for Drug Evaluation and Research) to eCigarettes (Center for Tobacco Products) to upper extremity prostheses (Center for Devices and Radiologic Health). The program has also undertaken vitally important inquiries relevant to many understudied groups, including pregnant women, racial and ethnic minorities, children and individuals with opioid use disorder. This knowledge has been used by the FDA to support rule-making, guidance-development, and the alignment of strategic priorities, helping to ensure that the FDA remains a global leader in advancing the technical and scientific foundations of product regulation. Since its inception, JH-CERSI has also leveraged the historically close relationship between the FDA and Johns Hopkins, and our renewal builds upon the substantial infrastructure developed together over the past eight years. JH-CERSI’s successes reflect many strengths including remarkable commitment from the FDA’s Office of the Chief Scientist and Office of Regulatory Science and Innovation, the University’s internationally renowned scholarship in regulatory science, an immense training platform, close geographic proximity to the FDA, and a nimble and organic operational approach. In this renewal, we propose to capitalize on these strengths and on the numerous structural improvements we have made since inception. We also propose three new programmatic elements to amplify impact. First, we will appoint an Associate Director of Artificial Intelligence and an Associate Director of Data Science and Informatics to expand the depth and breadth of our activities across faculty, programs, centers and schools, including the world- renowned Whiting School of Engineering and the Johns Hopkins Applied Physics Lab. Second, we will develop new training, including in Preparedness and Public Health Communications, to address the major threat that misinformation poses to the FDA’s regulatory success. We also propose new interchange with leading overseas regulators, thereby enhancing global regulatory science. Finally, we will institute an External Partnerships Initiative to serve as a force-multiplier by leveraging the remarkable scientific networks of Johns Hopkins faculty in service of the FDA’s mission. Together, through these efforts, Johns Hopkins and the FDA will continue to achieve remarkable gains that allow the FDA to maximize its effectiveness and impact through state-of-the-art regulation in the 21st Century.