NSF Engines Development Award: Enhancing the quality manufacturing of advanced and affordable pharmaceuticals in the U.S. (VA)

该NSF发动机开发奖授予弗吉尼亚生物技术研究园公司（VBRPC）dba Activation Capital，该奖项将通过创建“构建更好的医学联盟”（Alliance for Building Better Medicine）来支持强大的制药集群开发计划。该联盟正在推进先进的制药制造和研发引擎（引擎）在陷入困境的里士满/彼得堡地区在弗吉尼亚州中部。为了建立这一引擎，Activation Capital将与包括所有14个联盟成员在内的23个核心合作伙伴合作，在18个月的开发阶段内完成25项规划和能力建设活动，使联盟能够建立一个成熟的先进制药（APM）创新生态系统，能够在该地区创造大量就业机会和投资。这些规划活动对于联盟实施综合转化，商业化和劳动力发展活动至关重要，这些活动可以帮助重新支持安全和负担得起的药物，并为美国和其他地区的个人创造广泛的影响。在23个核心合作伙伴中，三个将是直接的次级接受者-弗吉尼亚联邦大学（VCU）;美国药典（USP）;和联邦先进制造中心（CCAM）。该项目解决了几乎所有药物都依赖于海外生产的关键起始材料、活性药物成分（API）、成品制剂以及通常所有这三种药物的挑战。由于73%的FDA注册API生产设施位于海外，高质量药物的供应不均衡，存在风险，难以监管和监测。自2014年以来，VCU的Medicines for All Institute一直引领美国的研究和开发，以优化API生产，创造更清洁，更快速，更便宜的APM方法。这些创新导致直接向制造商传播工艺，以扩大规模和实施，并使该地区成为创新混合和连续流制造（CFM）的领导者，CFM是FDA认可的新兴技术。为了加速创建一个端到端的翻译APM引擎，以推动国家努力确保其优质廉价药品的供应，该引擎将实现五个战略目标，作为本开发阶段的一部分：1）组建一个强大的，合格的和多样化的引擎治理委员会和领导团队; 2）建立一个基础战略实施计划;为战略合作伙伴制定全面的招聘和管理战略; 4）制定全面的劳动力发展计划; 5）加强多样性、公平、包容和无障碍（DEIA）计划并使其符合联邦标准。该奖项反映了NSF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。

This NSF Engines Development Award to the The Virginia Biotechnology Research Park Corporation (VBRPC) dba Activation Capital will support a robust pharmaceutical cluster development program through the creation of the Alliance for Building Better Medicine (Alliance). The Alliance is furthering an advanced pharmaceutical manufacturing and R&D Engine (Engine) in the distressed Richmond/Petersburg Region in Central Virginia. To establish this Engine, Activation Capital will team with 23 core partners, including all 14 Alliance members, over an 18-month Development Phase period to accomplish 25 planning and capacity building activities that will position the Alliance to build a mature advanced pharmaceutical manufacturing (APM) innovation ecosystem capable of creating significant jobs and investment in the Region. These planning activities are critical for the Alliance to implement the integrated translational, commercialization, and workforce development activities which can help to re-shore safe and affordable medicines and create wide-reaching impact for individuals across the United States and beyond. Of the 23 core partners, three will be direct subrecipients – Virginia Commonwealth University (VCU); US Pharmacopeia (USP); and the Commonwealth Center for Advanced Manufacturing (CCAM). This project addresses the challenge that virtually all medicines rely on overseas production for key starting materials, active pharmaceutical ingredients (APIs), finished dose formulations, and often all three. With 73% of FDA registered API manufacturing facilities located overseas, the supply of quality medicines is uneven, at risk, and difficult to regulate and monitor. Since 2014, VCU’s Medicines for All Institute, has led the U.S. in research and development to optimize API production to create cleaner, faster, and cheaper APM methods. These innovations have led to direct process dissemination to manufacturers for scale-up and implementation and allowed the Region to emerge as a leader in innovative hybrid and continuous flow manufacturing (CFM), an FDA-recognized emerging technology. In order to accelerate the creation of an end-to-end translational APM Engine that will drive the nation’s effort to secure its supply of quality affordable medicines, the Engine will accomplish five strategic goals as part of this Development Phase: 1) assemble a robust, qualified and diverse Engine Governance Board and Leadership Team; 2) build a foundational Strategic Implementation Plan; create a well-rounded recruitment and management strategy for strategic partners; 4) craft a comprehensive workforce development plan; and 5) strengthen and align the Diversity, Equity, Inclusion and Accessibility (DEIA) Plan with federal standards. This approach will position the Alliance to build a long-term sustainable Regional Innovation Engine in the future.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.