AM23-ST-16-O - AM23-ST-16-O: Go for GOLD: A Critical Need for a New GOLD Standard for Blood Cell Recovery and Survival Studies (Enduring)

Measurement of in vivo blood cell recovery and survival (R&S) provides assurance of safety and efficacy of new or modified cell products in transfusion medicine to support scientific proof to regulatory agencies, clinical practitioners, product manufacturers, and patients. The gold standard method required to measure in vivo population of red blood cell (RBC) and platelet kinetics utilizes radioisotopes, including 51‐chromium (51Cr), 99-technetium (99mTc), and 111Indium (111In). There are new major risks to relying on radiolabeling for licensing studies, including regulatory hurdles and instability in radioisotope procurement and regulations for labs conducting research with radioisotopes. Alternative labeling methods are being validated, and a standardized, worldwide available method and protocol needs to be widely adopted by researchers and regulators.Key Thought-provoking Takeaway for attendees: Without global alignment on a standard protocol and without validation of new methods, there is likely to be a major gap in generating critical data needed for licensure of new innovative products in transfusion medicine. This calls for education and action to collaborate on standardization and validation of new methods.In this session we will: 1. Describe the changing regulatory landscape driving the need to replace radiolabeling for blood cell R&S studies and adopt new standardized methods to assure integrity of in vivo efficacy data. 2. Discuss up-to-date research related to alternative labeling methods focusing on the biotin-labeling of RBCs and platelets for in vivo R&S methods and the need for standardized approaches.3. Identify next steps in standardizing, validating, and adopting alternative blood cell labeling methods for in vivo R&S studies This session will also include a Q&A and audience discussion (poll) around global efforts for in vivo R&S studies and standardization.