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Regenerative medicine, including cell and gene therapy, provides an unprecedented potential to treat or cure previously intractable diseases, such as cancer and rare genetic diseases. Advances in diagnostics and manufacturing technologies, measurements, and standards are needed to ensure the safety, quality, and consistency of this new class of therapies and to reduce cost. NIST in collaboration with FDA has been working with the broader industry and stakeholders to develop global standards underpinned by a robust measurement infrastructure. NIST hosts multiple technical Consortia to jointly develop precompetitive technologies, measurement solutions, and standards to accelerate technology development and translation.
At the Workshops on Measurements and Standards for Advanced Therapy, stakeholders from federal agencies, industry, and academia will provide perspectives on identifying measurement challenges and innovative technology solutions, as well as standards to accelerate R&D (including the use of ML/AI for biological data), promote manufacturing innovation, improve supply chain resilience, and support characterization and testing to facilitate regulatory approval.
The workshops will include:
Genome Editing Consortium Workshop (March 24-25, 2025)
Cell Characterization Standardization Workshop (March 25, 2025)
AI and Flow Cytometry Workshop (March 26-27, 2025)