Industry Ecosystem Successful/Robust Industry Cell Banks Tool Developers Services Raw Materials R&D Sponsors Manufacturing Innovations and Standards to Enable the Translations of Cellular and Gene Therapy Products

NIST Laboratory Programs Standards Leadership Bridging the Communication Gap AMTech on CMC Mforesight Open call NNMI MOU discussion SCB Strong interagency partnership Stakeholder engagement Convene workshops ISO/TC 276 leadership Convening of National and International meetings NIST laboratory programs underpin standards development Innovative measurement sciences; enable tools, methods, reference materials, and data Increased industry collaborations

Cell Therapy Gene Therapy Tissue Engineering Enabling Tools Imaging tools for biomarker validation Validation of gene editing tools Validated metrics of 3D scaffolds Reference Materials Fluorescence benchmarking RM Flow cytometry RM Whole genome RM Reference scaffolds Methods & Protocols Cell characterization (ID, quantity, function) Targeted NA quantification Scaffold structure & properties Bioinformatics and Modeling Tools Development of predictive models Bioinformatics pipelines Image analysis and computational tools NIST Laboratory Programs: Measurement infrastructure for Cell and Gene Therapy and other Regenerative Medicine Products

ISO/TC 276: Biotechnology Secretariat: DIN Secretary: Lena Krieger Chairperson: Ricardo Gent 22 participating countries 13 observing countries Terms and Definition Biobanking and Bioresources Analytical MethodsBioprocessing Data Processing and Integration WG3: Analytical Methods: Cell Counting (2 Parts) Characterization of Cells (3 Parts) Quality considerations for targeted nucleic acid quantification methods Methods to determine the concentration of total nucleic acids Methods to evaluate the quality of massive sequencing data WG4: Bioprocessing: Ancillary materials present during the production of cells for therapeutic use (3 Parts) Downstream cell bioprocessing Cell transportation

The T-Cell Warriors “Four years after a tentative but tantalizing breakthrough against leukemia, Carl June and Bruce Levine have gone from the fringes of gene therapy to the center of a revolutionary approach to cancer treatment.” warriors/