Amy Shaw

Head of Process and Product Development at Takeda, USA

Speaker

Amy Shaw is the Head of Process and Product Development at Takeda Pharmaceuticals, where she leads a multidisciplinary team advancing the design and development of Takeda’s portfolio of allogeneic cell therapy platforms. With over a decade of experience in cell and gene therapies, Amy has established herself as a leader in the field, driving innovation from early-stage process development through clinical translation.Amy began her career at Novartis, where she contributed to key process improvements for the commercial manufacturing of Kymriah, the first FDA-approved CAR-T therapy. She was among the early scientific leaders at Repertoire Immune Medicines, spearheading the development of a novel autologous T-cell manufacturing process targeting tumor-associated antigens for Phase I clinical trials.At Beam Therapeutics, Amy played a critical role in the development of an allogeneic CAR-T platform, leveraging CRISPR-based gene editing technologies to advance next-generation cellular therapies. Since joining Takeda, she has led efforts across multiple pipeline programs, overseeing the end-to-end development of both viral vector and cell therapy processes. Her work integrates small-scale modeling, automation, digital data strategies, and the generation of IND-enabling data packages, positioning Takeda at the forefront of scalable, next-generation cell therapy manufacturing.