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

NSF 引擎开发奖：提高美国 (VA) 先进且价格实惠的药品的质量制造

• 批准号: 2315165
• 负责人: Mariam Crow
• 金额: $ 100万
• 依托单位: VIRGINIA BIOTECHNOLOGY RESEARCH PARK
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2315165&HistoricalAwards=false
• 关键词: NSF; Engines; Development; Award; Enhancing

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.

弗吉尼亚生物技术研究公园公司（VBRPC）DBA激活资本将通过建立建立更好的医学联盟（Alliance）来支持强大的药物集群开发计划。该联盟是弗吉尼亚州中部苦恼的里士满/彼得斯堡地区的先进制药制造和研发发动机（发动机）。为了建立这款引擎，激活资本将与23个核心合作伙伴（包括所有14个联盟成员）在18个月的开发阶段合作，以完成25种规划和能力建设活动，这将使联盟定位，以建立成熟的先进制药（APM）创新生态系统，能够在该地区创造重要的就业和投资。这些计划活动对于联盟实施综合的翻译，商业化和劳动力开发活动至关重要，这些活动可以帮助重新销售安全，负担得起的药物，并对美国及其他地区的个人产生广泛的影响。在23个核心合作伙伴中，有3个将是直接的亚招对 - 弗吉尼亚联邦大学（VCU）；美国药房（USP）；和英联邦高级制造中心（CCAM）。该项目解决了一个挑战，即几乎所有药物都依靠海外生产来用于关键的起始材料，主动药物归纳（API），成品剂量配方，通常三种。有73％的FDA注册API制造设施位于海外，优质药物的供应处于不平衡状态，风险很高，并且难以调节和监测。自2014年以来，VCU的所有研究所的药品一直领导美国的研发，以优化API生产，以创建更清洁，更快和廉价的APM方法。这些创新导致了对制造商进行扩展和实施的直接传播，并使该地区成为创新混合和连续流量制造（CFM）的领导者，这是FDA认可的新兴技术。为了加快端到端翻译APM发动机的创建，该发动机将推动该国确保其优质的负担得起药物的供应，该发动机将在此开发阶段实现五个战略目标：1）组装一个健壮，合格和潜水员的发动机委员会委员会和领导力团队； 2）制定基础战略实施计划；为战略合作伙伴创建全面的招聘和管理策略； 4）制定一项全面的劳动力发展计划； 5）加强和调整多样性，公平，包容性和可访问性（DEIA）计划与联邦标准。方法将定位联盟将来建立长期可持续的区域创新引擎。该奖项反映了NSF的法定使命，并使用基金会的知识分子优点和更广泛的影响评估标准，被视为通过评估而被视为珍贵的支持。