NSF engines development award: enhancing the quality manufacturing of advanced and affordable pharmaceuticals in the U.S. (VA)

This Cooperative Agreement award from the National Science Foundation (NSF) Technology, Innovation, and Partnerships (TIP) program (CFDA 47.084) provides $1,000,000 in funding to the Virginia Biotechnology Research Park Corporation (dba Activation Capital) to develop a robust pharmaceutical cluster program called the Alliance for Building Better Medicine in the Richmond/Petersburg region of Virginia. Over an 18-month period, the awardee will work with 23 core partners, including three direct sub-recipients (Virginia Commonwealth University, US Pharmacopeia, and the Commonwealth Center for Advanced Manufacturing), to execute 25 planning and capacity-building activities. This will position the Alliance to establish an advanced pharmaceutical manufacturing (APM) innovation ecosystem capable of re-shoring the production of safe, affordable medicines and creating significant regional jobs and investment. The project aims to address the challenge of overseas API and pharmaceutical production by leveraging VCU's Medicines for All Institute's innovations in optimized API production methods.

Abstract

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.- subawards are planned for this award.