Yoko Momonoi is a biotechnology executive with deep expertise in CMC development. Currently at Takeda, she leads the Cell & Gene Therapy group in Global Regulatory CMC. In this role, Yoko oversees CMC regulatory strategy of ex vivo genetically modified allogeneic cell therapies (e.g. NK cells, iPSCs, T cells) and in vivo gene therapies in early development, as well as a commercial allogeneic cell therapy. Previously, Yoko was Director of Regulatory CMC at Celgene and oversaw an autologous CAR-T product through its global pivotal phase clinical trial rollout, multiple Health Authority interactions, and commercial submissions. Before Celgene, she led the preparation of CMC sections for a successful Japanese NDA of a monoclonal antibody as part of Novartis Japan and later became the Head of Late Stage Process Development in Cell and Gene Therapies at Novartis in the US and supported the initial BLA for Kymriah. She originally started out in a plant molecular biology lab at RIKEN and subsequently at Genentech where she built a strong understanding of GMP manufacturing.
Yoko holds a Master’s degree from the University of Pennsylvania in Biotechnology and a Bachelor of Liberal Arts – Biology degree from the International Christian University in Tokyo, Japan.