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

这项授予弗吉尼亚生物技术研究园区公司(VBRPC)dba激活资本的NSF发动机开发奖将通过创建更好医学联盟(Alliance)来支持强大的制药集群发展计划。该联盟正在弗吉尼亚州中部陷入困境的里士满/彼得堡地区推进先进的制药制造和研发发动机(发动机)。为了建立这一引擎，Activation Capital将在18个月的开发阶段与23个核心合作伙伴(包括所有14个联盟成员)合作，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制造(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一体化的翻译、商业化和劳动力发展活动至关重要，这些活动可以帮助安全和负担得起的药品重新上岸，并对全美和其他地区的个人产生广泛影响。在23个核心合作伙伴中，有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)和英联邦先进制造中心(CCAM)。该项目解决了这样一个挑战，即几乎所有药物都依赖于海外生产的关键起始原料、活性药物成分(原料药)、成品剂量配方，而且往往是全部这三种。FDA注册的原料药生产工厂中有73%位于海外，优质药品的供应不均衡，存在风险，难以监管和监测。自2014年以来，VCU的全民药物研究所一直在研究和开发优化原料药生产以创造更清洁、更快和更便宜的APM方法方面领先于美国。这些创新导致直接向制造商传播工艺以扩大和实施，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。为了加速创建端到端的翻译APM引擎，以推动国家确保高质量负担得起的药品供应的努力，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、合格和多样化的引擎治理委员会和领导团队；2)建立一个基础性的战略实施计划；为战略合作伙伴创建一个全面的招聘和管理战略；4)制定一个全面的劳动力发展计划；以及5)加强多样性、公平、包容性和可获得性(DEIA)计划，并使其与联邦标准保持一致。这一方法将使联盟在未来建立一个长期可持续的区域创新引擎。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.