Reshoring Pharmaceuticals

Building a Global Cluster of Advanced Pharmaceutical Manufacturing in Central Virginia

VCU College of Engineering

Final Report to GO Virginia under Enhanced Capacity Building Grant Contract 20-GOVA-04A March 31, 2021 

EXECUTIVE SUMMARY

Purpose of the Enhanced Capacity Grant  

At the direction of Dean Barbara Boyan, the VCU College of Engineering sought and received a GO Virginia Enhanced Capacity grant to conduct a strategic analysis and prepare a plan for harnessing the breakthrough technologies developed at VCU’s Medicines for All Institute (M4ALL) to develop a world class advanced pharmaceutical manufacturing cluster that can drive job growth and economic development in the Richmond-Petersburg region. The emerging cluster’s focus is development and use of advanced manufacturing platforms, including continuous processing, for approved, in-market, small- molecule active pharmaceutical ingredients. This focus is narrow enough to reflect the region’s competitive advantages, yet broad enough to support remarkable development and growth.  

Method

VCU convened a wide range of stakeholders and leaders in relevant business, local, regional and state economic development organizations, and higher education to examine the potential of the cluster, to identify key determinants of success, to address major obstacles to its development, and to make action-oriented recommendations that would help the cluster fulfill its great promise. Work groups formed in the process addressed the following key issues: infrastructure, workforce,

communications/branding, and a set of leadership issues (organization/coordination of the cluster, government relations and inter-university and university-industry collaborations).  

Key Work Group Findings  

Infrastructure  

The work group noted that the collaboration led by Richmond-based startup Phlow Corp. with M4ALL,

Petersburg-based AMPAC Fine Chemicals and Civica Rx to lead a multiyear effort to create a supply and national stockpile of active pharmaceutical ingredients for essential medicines and to create new continuous processing manufacturing capability gives the cluster a competitive advantage and genuine jumpstart. The work group noted that continued attention to utility issues and site readiness in the manufacturing footprint and expanding lab and pilot space throughout the region are essential to the cluster’s success, as well as the importance of exploring the potential for developing a signature pilot and scale up “development park”.  

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Workforce  

The work group noted that workforce issues are increasingly a key determinant of economic development success and site decisions of businesses considering relocation or expansion. The advanced pharmaceutical manufacturing cluster can take advantage of the pioneering undergraduate and advanced degree programs at the VCU College of Engineering, and science and engineering programs at Virginia State University and at other universities around the Commonwealth. In addition, the unique nature of the venture and its societal implications can attract advanced degree holders nationally and internationally. Programs led by the Virginia Economic Development Partnership, the Community College Workforce Alliance, and Commonwealth Center for Advanced Manufacturing position the region to meet manufacturing production needs. At the same time, the national and regional challenge in recruiting and retaining an experienced and highly skilled manufacturing workforce remains a challenge. The cluster holds great promise to produce a wide array of high paying jobs across the region.  

Communications/Branding  

The work group noted that the emergence of this advanced pharmaceutical manufacturing cluster is an extraordinary story because it uniquely addresses a confluence of urgent national interests such as the reshoring of U.S. manufacturing, and critical unmet social needs such as assuring a reliable, safe and affordable supply of essential medicines to hospitals and patients in the U.S. and around the world. The work group identified a set of “internal” audiences in the region and the state from whom the cluster will need participation and support, including its businesses, innovators and policy leaders. The work group also addressed the importance of collaboration among regional and state economic development agencies in marketing and recruitment efforts directed toward companies and talent that can gain from and strengthen the cluster in R&D, manufacturing and completing the supply chain the new industry will require.  

Leadership  

The leadership work group addressed the future organization and coordination of the cluster, government relations needs, and inter-university and university-industry collaborations. The work group noted that studies of cluster development initiatives point to the difficulty of sustaining early momentum and emphasize the imperative of establishing a coordinating entity dedicated to its formation and buildout. It noted the unique regional footprint of the emerging cluster, spanning  

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Richmond to Petersburg. The leadership work group also identified immediate government relations opportunities because of the federal government’s current interest in making investments in infrastructure, reshoring manufacturing, securing the nation’s supply of medicine and other interests served by the cluster. The work group detailed how VCU can become a model for university-industry collaboration and the potential for VCU partnering with VSU, local community colleges and colleges/universities across the Commonwealth.  

Recommendations  

The report contains 16 major recommendations across 8 categories. The report highlights the importance of establishing an Advanced Pharmaceutical Manufacturing Council with broad stakeholder representation as an action group that can implement both the short-term and longer-term initiatives required for the buildout of the cluster.  

Specific recommendations address the issues and challenges that the individual work groups identified. These include the call to develop a process for addressing lab space needs across the region; addressing workforce and talent needs by coordinating with the best-in-class programs offered by VEDP, community colleges, and regional organizations; and a communications campaign with set objectives. In addition, the recommendations provide guidance for building out the ecosystem and supply chain for an advanced pharmaceutical manufacturing cluster and pursuing federal support for the transformational opportunities.  

As a whole the recommendations convey a tone of urgency and importance, reflecting the momentum of impressive recent accomplishments and the unusual confluence of important and unifying goals and interests which this emerging cluster brings to the region. Continued partnership with GO Virginia will be vital in sustaining the enthusiasm and momentum that has been built by this planning process and realizing this enormous opportunity.  

 

To view the full report, click here.