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 a snapshot of the current landscape for regenerative medicine standards. It outlines existing and in-development standards, providing a reference that individual organizations can use to identify available standards to improve their operations.

The first iteration of this report was developed in an accelerated 3-month timeframe and published in December 2017, with updates in February 2018 and in this Spring 2019 edition. Given the constantly-evolving nature of the field of regenerative medicine, SCB will continue to engage stakeholders to build on and refine this document in support of its missio

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: