Cell and Gene Therapies (CGT) are transforming not just how humans treat genetic and intractable diseases but are altering the entire pharmaceutical ecosystem. CGT are rapidly becoming established as the new wave of biological therapeutics. Whether using autologous or allogeneic engineered cells as the active therapeutic (Cell Therapy), or the gene delivery system (Gene Therapy; e.g., LNP’s, AAV’s, etc.), CGT is in the process of becoming a mainstream approach. Already, more than 18 CTx or GTx products were approved by US FDA in 2020. Around 990 companies are engaged in R&D and commercialization of next-generation CGT. Resultingly, CGT is now in the process of transitioning from the ‘Wild West’ of a novel therapeutic to the emerging requirements of being a fully realized biotherapeutic. This session will explore considerations and case studies demonstrating strategies of dealing with that transition.