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The Frederick National Laboratory for Cancer Research (FNLCR), operated for the National Cancer Institute by Leidos Biomedical Research, is the Core and coordinating hub for the Immune Cell Network (ICN), supporting the Cancer Adoptive Cellular Therapy Network (Can-ACT), a series of National Institutes of Health-funded centers that advance the application of cell therapies for clinical trials.

Each Can-ACT Network Center conducts research using an adoptive cell therapy approach with the manufacturing of cell therapy products at their site under current Good Manufacturing  Practice (cGMP) conditions, or at the Biopharmaceutical Development Program (BDP), for pilot trials.

Within the ICN Core, FNLCR’s Clinical Monitoring Research Program Directorate (CMRPD) and Biopharmaceutical Development Program (BDP) Directorate:

• Ensure adherence to current Good Clinical Practice (cGCP) regulations, filings, and patient enrollment, and coordinate transport of apheresis materials and cell products between the FNLCR manufacturing site and the Centers.
• Provide guidance on quality systems and regulatory affairs; ensure cGMP compliance at manufacturing facilities and maintenance of quality systems; provide expertise and guidance in preparing Chemistry, Manufacturing, and Controls (CMC) documentation and interacting with the Food and Drug Administration (FDA) throughout the Investigational New Drug (IND) process; establish/qualify analytical procedures to characterize critical quality attributes of cell therapy products and make standardized procedures available to ICN Centers and other collaborators via technology transfer processes.
• Provide centralized cGMP manufacturing for multi-site clinical trials.
• Provide comprehensive project management and reporting.

For more information about the Biopharmaceutical Development Program (BDP) and its capabilities, please contact the BDP Director, Mr. John Roach (john.roach@nih.gov), or the Program Manager, Cindy Roope, MBA (cindy.roope@nih.gov).