Nexight helped Georgia Tech and the Georgia Research Alliance, through funding from the National Institute of Standards and Technology (NIST) Advanced Manufacturing Technology Consortia (AMTech) program, to develop a roadmap for the large-scale, cost-effective reproducible manufacturing of a variety of human cell types. The roadmap’s pathway for advancing cell manufacturing technologies and infrastructure aims to help facilitate widespread access to life-changing cell therapies, engineered tissues, medical devices, and drug discovery and testing platforms.
Cell-based therapies—especially stem cell therapies, regenerative medicine, and immunotherapies—and cell-based devices and diagnostics could have significant public health and economic benefits but will require the cost-effective, large-scale, reproducible manufacturing of high-quality cells to realize their potential. To define the pathway for advancing cell manufacturing, the Georgia Research Alliance and Georgia Tech needed to bring together key stakeholders, including members of industry, academia, and government, to build a consensus strategy for developing and implementing next-generation cell manufacturing technologies.
Nexight Group helped facilitate discussions with these stakeholders to establish a coordinated approach for advancing cell manufacturing technologies. We facilitated four in-person workshops and three working group teleconferences with more than 100 cell manufacturing experts representing more than 60 organizations. During these workshops, participants identified current cell manufacturing challenges and needs, identified and prioritized research and development activities that address these challenges, and defined the vision and mission for a national consortium—the National Cell Manufacturing Consortium (NCMC)—that could facilitate continued coordination across these groups. Following these meetings, we led the writing and design of a national roadmap that identifies current industry barriers and more than 150 research and development activities needed to implement next-generation cell manufacturing technologies in the United States. The roadmap includes an overarching graphic that outlines key activity areas for research and development, standardization and regulatory support, and workforce development. To help Georgia Research Alliance and Georgia Tech attract additional consortium members to accelerate progress, we also developed and designed a four-page marketing piece.
Achieving Large-Scale, Cost-Effective, Reproducible Manufacturing of High-Quality Cells, which was announced in June 2016 at the White House Organ Summit, outlines specific actions for advancing cell manufacturing in the next 10 years. To implement the roadmap activities and enable continued cell manufacturing advances, NCMC has already secured more than $20 million in funding for The Marcus Center for Therapeutic Cell Characterization and Manufacturing at Georgia Tech. Nexight worked with Georgia Tech and the Georgia Research Alliance to develop a 2017 Roadmap Update in response to recent cell manufacturing advances, the industry and clinical outlook, and emerging needs in the cell manufacturing industry.