SCB and Nexight Group Publish Landmark Regenerative Medicine Standards Landscape Report

Washington, DC (February 28, 2018) –  With input from more than 30 academic institutions, standards development organizations (SDOs), and other industry experts, Nexight Group and The Standards Coordinating Body (SCB) published a first-of-its-kind report that outlines nearly 200 standards currently relevant to regenerative medicine therapies and identifies opportunities for future standards development in the field.

The Regenerative Medicine Standards Landscape—which was developed with funding from the U.S. Food and Drug Administration (FDA)—is intended to serve as a living document that will be updated as new standards become available and will guide SCB-coordinated efforts to improve and accelerate standards development across the regenerative medicine field.

The landscape report outlines existing standards and opportunities for standards development relevant to the cell therapy, gene therapy, and tissue engineering sectors of regenerative medicine. Specifically, these standards and opportunity areas apply to a range of product development functional areas, including the following:

• Bioprocessing and production standards, including equipment or raw/ancillary materials or ingredient specifications

• Analytical and testing methodologies standards

• Product quality and characterization standards (e.g., identity, potency, or performance characteristics)

• Logistics standards and compliance criteria

• Preclinical study standards

• Clinical trial standards

By providing a foundational understanding of the landscape of existing standards and the potential areas where new standards may be developed, the report will serve as a central reference document for SDOs, researchers, industry members, and other stakeholders in the regenerative medicine field as they work to advance regenerative medicine therapies from the laboratory to widespread use in patient care. Regular updates to the report facilitated by SCB will help ensure that the report remains comprehensive and will enable its use in identifying emerging standards needs in the field.

The landscape report was developed as part of a larger FDA-funded project being conducted by Nexight Group and SCB that aims to identify process recommendations and criteria for identifying, prioritizing, and advancing standards that will have a high impact on the quality and safety of regenerative medicine therapies. Sparked by a directive in the 21st Century Cures Act, the project aims to help realize a future state for regenerative medicine standards development that embodies the following:

• Helps reduce cost and time barriers to regenerative medicine product development, facilitating increased participation from small- and medium-sized businesses

• Ensures safety and quality of products, from raw materials sourcing to clinical administration

• Increases the efficiency of regulatory review processes

• Reduces costs for patients by passing on resources saved during research and development

If you have information on other standards relevant to regenerative medicine or suggestions for improving The Regenerative Medicine Standards Landscape report, please send them to Sarah Lichtner at Nexight Group (slichtner@nexightgroup.com).

Want a say in the development of standards for regenerative medicine therapies?

Nexight Group and SCB are working to engage the regenerative medicine community throughout the standards identification, prioritization, and advancement process. If you are not already engaged in SCB efforts, please contact SCB to be included in outreach.