Overview

The Standards Coordinating Body (SCB) began as an initiative of the Alliance for Regenerative Medicine (ARM) and other regenerative medicine stakeholders and industry to facilitate the development of standards for the nescient regenerative medicine industry. The first of advanced therapies, including cellular and gene therapies, are on the cusp of approval and standards are urgently needed to manufacture and test these new therapies. In September 2016, the National Institute of Standards and Technology (NIST) and SCB established a Memorandum of Understanding (MOU), forming a partnership to jointly advance standards for the regenerative medicine community’s need. This MOU provides a mechanism for more cooperation with other U.S. agencies to work with industry, standards development organizations, and other stakeholders. SCB’s primary office is located on the NIST Gaithersburg campus to enable this coordination.

Formally launched in January 2017, SCB is now a fully independent, functioning non-profit organization committed to coordinating standards activities to accelerate standards advancement; engaging the broader regenerative medicine community in the identification and advancement of potential standards to incorporate a broad range of perspectives and expertise; and educating the community about available standards and their benefits, standards development processes, and standards implementation. During the same year, the U.S. Food and Drug Administration (FDA) awarded a one-year contract to Nexight Group and the SCB to engage with experts to recommend processes and outline a strategic plan for developing standards in regenerative medicine and advanced therapies. This work has helped to lay the foundation for standards development in regenerative medicine research and product development.

Mission

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

Why SCB?

Regenerative medicine therapies present complex challenges related to scientific protocols, product testing, and product quality and performance specifications. The field of regenerative medicine also faces challenges common to emerging industries, including fragmentation of knowledge, insufficient communication and coordination, and unpredictable advancement of innovation. Improving the development and use of standards and best practices in regenerative medicine has the potential to help overcome some of these challenges. However, for the regenerative medicine field to thrive, these standards and best practices must address the diverse needs of a variety of stakeholder groups, including government agencies, regulatory agencies, researchers, raw material providers, product developers, equipment manufacturers, and clinicians and healthcare professionals.

SCB connects the regenerative medicine community to the standards development process and occupies a unique niche within the regenerative medicine ecosystem: with no vested interest in a particular scientific, commercial, clinical, or policy approach, SCB is focused on facilitating the use and development of standards in response to demonstrated need expressed by a range of stakeholders.


“The SCB’s long-term mission is to efficiently and effectively support sector standards development to accelerate product development and scalability, and streamline regulatory submission review and approval.”
— Dr. Robert A. Preti, Chairman of ARM; President of PCT, a Caladrius Company; and CTO & SVP of Manufacturing & Technical Operations at Caladrius Biosciences