MsRI-EW: Planning the Infrastructural Needs to Meet National Research Demand and Support the United States’ Leadership in Biomanufacturing

最近的全球大流行突出了在提供安全有效治疗方面需要改进的一些关键领域。一个能够快速、按需生产新兴疗法的基础设施对于维持美国人民的健康至关重要。这次会议将汇集来自公共和私营部门的代表。会议将调查疫苗和治疗药物开发和生产的所有主要方面。目标是制定一个路线图，以推动创新的生物制造研究和开发。需要解决的问题包括用于临床试验和监管批准的产品特征的基础设施；提供安全通讯和储存研究数据的网络基础设施；人工智能和机器学习工具加速研究进展；自动化技术为疫苗和治疗提供了新的、颠覆性的制造技术。会议将举行虚拟会议，内容包括(1)细胞/基因制造，(2)新兴疫苗制造，以及(3)数据整合、分析、安全和管理。每届会议的专家将代表临床研究和应用、学术界、政府机构和产业价值链。将从支持加速和扩大研究工作所需的基础设施方面讨论跨领域主题。这些交叉主题包括规模扩大、自动化、供应链、教育和劳动力。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The recent global pandemic has highlighted some critical areas for improvement in delivering safe and effective therapeutics. An infrastructure that enables rapid, on-demand manufacturing of emerging therapies is critical to maintaining the health of the American people. This conference will bring together representatives from the public and private sectors. The conference will investigate all major aspects of vaccine and therapeutic development and production. The objective is to develop a roadmap to drive innovative biomanufacturing research and development. Issues to be addressed include infrastructure to characterize products for clinical trials and regulatory approval; cyberinfrastructure to provide secure communication and storage of research data; artificial intelligence and machine learning tools to accelerate research progress; and automation technologies to enable new, disruptive manufacturing technologies for vaccines and therapeutics. The conference will have virtual sessions covering (1) cell/gene manufacturing, (2) emerging vaccine manufacturing, and (3) data integration, analytics, security, and management. Experts within each session will represent clinical research and application, academia, governmental agencies, and the industrial value chain. Cross-cutting topics will be discussed in terms of needed infrastructure to support accelerated and expanded research efforts. These cross-cutting topics include Scale-up, Automation, Supply Chain, and Education and Workforce.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.