Projects

SCB is dedicated to supporting the advancement of standards and best practices that enhance the entire regenerative medicine community and accelerate innovation. 

Current Projects

The success of SCB's efforts to coordinate standards development depends on your participation. To contribute to an SCB project, please contact SCB Senior Technical Program Manager, Dawn Henke (dhenke@regenmedscb.org).

Standards Advancement Projects

Outreach and Education Activities

Landscape Report

Compared with more mature medical fields that feature a greater number of marketed products and a fully developed infrastructure (e.g., traditional pharmaceutical drugs, medical devices), the regenerative medicine field currently has few finalized standards. Analyzing the standards that currently exist and identifying areas of additional standards development opportunities is crucial to facilitate coordinated efforts to advance regenerative medicine therapies from the laboratory to widespread use in patient care.

To this end, Nexight Group LLC and SCB co-authored The Regenerative Medicine Standards Landscape report with funding from the U.S. Food and Drug Administration (FDA). This report provides an overview of nearly 200 existing standards relevant to the cell therapy, gene therapy, or tissue engineering sectors of regenerative medicine and assesses the needs and opportunities for standards development in regenerative medicine as identified by key stakeholders.

This report will be regularly updated to provide the most comprehensive list of existing regenerative medicine standards and to identify emerging standards needs in response to the rapidly developing regenerative medicine field.

Project Proposal Process

SCB reviews and accepts projects that span the priorities of the SCB consortium under the four working groups: cell-based drug discovery, cell therapy, gene therapy, and tissue engineering. Each working group seeks to identify and assess needs for standards or best practices that can support advances in enabling technologies and infrastructure, clinical development, and commercialization. Learn more: