Significant Efforts Underway to Lay the Foundation for Standards Development in Regenerative Medicine Therapies
Washington, D.C. (October 25, 2017) – On September 27, 2017, the U.S. Food and Drug Administration awarded a one-year contract to Nexight Group to engage with experts to recommend processes and outline a strategic plan for developing standards in regenerative medicine and advanced therapies. The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-based Drug Discovery (SCB) has partnered with Nexight to provide subject matter technical support for this effort.
Newly Created Standards Coordinating Body Seeks to Advance Development and Establishment of Regenerative Medicine Standards
Washington, D.C. (Marketwired - Jan 19, 2017) – The international Standards Coordinating Body for regenerative medicines (SCB), in coordination with the Alliance for Regenerative Medicine (ARM), today announced its formal launch as a public-private partnership for coordinating, prioritizing and supporting standards that advances process, measurement and analytical techniques to support the global availability of products across the gene and gene-modified cell therapy, cell therapy, cell-based drug discovery, tissue engineering and biomaterials sectors.
Washington, D.C. (September 19, 2016) – The Standards Coordinating Body for Gene, Cell and Regenerative Medicines and Cell-based Drug Discovery (SCB) announced today it has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology’s (NIST) Material Measurement Laboratory (MML) to advance the development of industry-wide standards for cell therapy, gene therapy, regenerative medicine and cell-based drug discovery.