Objectives of the meeting
This meeting will bring together an outstanding and diverse group of speakers from regulatory agencies, industry, and academia, all of whom are at the forefront of the cell therapy (CT) field. The major objective of the meeting is to make continuous efforts toward international convergence of core scientific elements and evaluation for ensuring quality and safety of human cell therapy products (hCTPs).
The 5th IABS CT meeting will build further considerations on outcomes of previous meetings and relevant papers with respect to the scientific basis for the research, development, evaluation, and standardization of hCTPs derived from substantially manipulated human cells, which include stem cells and stem cell line derived products and CAR-T cell products. Core scientific elements for CMC, nonclinical, and clinical studies will be identified and addressed so that they can be commonly employed among interested parties as a basic consensus package for product development and assessment. In addition, some issues that are derived unique structural and biological features of hCTPs and need to further studies and discussions continuously in order to improve, solve or even break through will be covered. These include: characterization of cells and determination of their critical quality attribute (CQA); relationship between CQA and safety/efficacy of the final products; potency measurement; setting specifications; comparability study; tumorigenicity testing; development of new analytical methodologies among others.