François Gianelli

François Gianelli is the Head of Regulatory and Quality at Treefrog Therapeutics, a Cell Therapy biotech based in Bordeaux (FR) with laboratories in Cambridge (MA) and Kobe (JP). François has been working on cell and gene therapy development for 15 years, including 10 years as a CMC-Regulatory expert, working on multiple IMPDs/INDs, MAAs/BLAs as well as other agency interactions, including scientific advice and Life Cycle Management. Previously, François was involved in the establishment of recommendations on Cell Therapies at the French competent authority (ANSM) and he was a resident in cell therapy production for the French Army Health Services.

Company: TreeFrog Therapeutics advances a pipeline of allogeneic cell therapies based on human induced pluripotent stem cells (hiPSCs) and develops a breakthrough technology – C-Stem – allowing to scale-up cell therapy manufacturing in bioreactors thus reducing cell therapy costs, to improve cell quality to ensure the genomic safety of cell therapy products, and to enhance the efficacy of cellular therapies through a delivery approach based on 3D microtissues containing mature cell phenotypes (in contrast with cell therapies based single-cell suspensions of progenitors). C-Stem enables exponential iPS cell amplification with high viability, pluripotency and genomic integrity in large-scale stirred-tank bioreactors, thus producing commercial-size single-batches of iPS of over 10 billions cells. Our iPS platform also enables direct differentiation of human pluripotent stem cells into the desired cell type in a ready-to-graft 3D microtissue format.