The international Standards Coordinating Body (SCB) was established in 2016 and formally launched on January 18, 2017 to advance process, measurement, and analytical techniques to support the global availability of regenerative medicine products and services. The SCB will help to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence in the field of regenerative medicine through support of the development of consensus standards and other standards-related output, as well as reference materials. Led by industry and academic experts, the SCB facilitates stakeholder coordination and prioritization to provide expertise to Standards Setting Organizations (SSOs) and Standards Development Organizations (SDOs) in the pre-standards phase to inform technology development.
The SCB began as an initiative of the Alliance for Regenerative Medicine's (ARM) Science and Technology Committee, which includes stakeholders from all parts of the regenerative medicine community: therapeutic developers, platform and service companies, professional societies in the regenerative medicine sector, academic research institutions, manufacturers, and accrediting organizations such as the AABB and FACT. ARM, dating back to its earliest interactions with regulators in 2009 and with NIST shortly thereafter, committed itself to supporting development of consensus standards for cell and gene therapy and other regenerative medicine products. It continues to work closely with the SCB to ensure that the SCB mission is both supported by industry leaders and influential in leading to adoption of standards that will support approval of regenerative medicine products. The SCB is an independent organization with 501c3 nonprofit status and composed of a variety of vested independent stakeholders and leaders in the regenerative medicine community.
SCB connects the regenerative medicine community to the standards development process. As an unbiased non-profit organization, SCB is dedicated to ensuring that the community has a say in the standards that will impact them. With buy-in from a range of stakeholder organizations across the regenerative medicine community, SCB will pursue its mission to:
Coordinate the accelerated advancement and improved awareness of the standards and best practices that address the rapidly evolving needs of the global regenerative medicine advanced therapy community
The SCB is organized as a consortium of non-government stakeholders that operates through public-private partnerships with government agencies, regulatory bodies, and other government organizations involved in establishing consensus standards for regenerative medicine and other advanced therapy products. Following the language that outlined a framework for standards development in the 21st Century Cures legislation, the SCB public-private partnership is enabled through a Memorandum of Understanding with the National Institute of Standards and Technology (NIST) Material Measurement Laboratory, which was executed in September 2016. The MOU lays out a framework for NIST, while also working with the FDA, Department of Defense, and other federal agencies, to work cooperatively with industry, standards development organizations, and other stakeholders through the SCB to advance and accelerate standards development.
The SCB charter entities identify specific needs for consensus standards development and reference guidelines within the regenerative medicine community and direct project development accordingly. The SCB directly benefits the scientists and engineers who have day-to-day responsibility for creating and managing scalable and reproducible processes, as well as the assays needed to ensure indisputable quality. Through SCB helmed projects, expertise knowledge, networking events, and educational workshops, professionals can access and share the techniques and best practices needed for safe, effective, and consistent products.
The interdisciplinary value proposition of the SCB lies in the strength of its stakeholder’s institutional expertise and the powerful network aggregation of knowledge of the relevant technology, standards, regulations, and the processes to establish them. Given the heterogeneity and dispersion of the regenerative medicine community, significant technological complexities, and the exponential growth of the innovations, there is a perception (partly true) that reference guidelines and consensus standards are lacking or not sufficiently harmonized.