Kathy Lee joined the Acumen team in October 2024 as Senior Director, CMC Regulatory, bringing over 25 years of experience in CMC Regulatory. She has an extensive background in global regulatory affairs and has expertise in global regulatory CMC submissions, both pre- and post-approval. She has served in various roles over the years, including as a reviewer at the US FDA and CMC policy at Merck. Before joining Acumen, Kathy worked at Genentech, where she was responsible for managing a post-approval portfolio of over 20 products. She also represents BIO on the International Council of Harmonization (ICH) M4Q (R2) “The Common Technical Document for the Registration of Pharmaceuticals for Human Use” Quality Expert Working Group for the revision of M4Q (R1) as an expert in biologic products.

Kathy has worked at several large pharmaceutical companies, including Genentech as an Executive Director of Global Regulatory Affairs and at Merck as an Interim Director of CMC Regulatory Policy. She also spent eight years at Eli Lilly as a Senior Research Advisor in Global Regulatory Affairs, mainly responsible for the global change agenda of the post-approval E. coli drug substance platform.

Before joining Eli Lilly, Kathy worked at the US FDA in the Office of Biotechnology, where she was a Lead Interdisciplinary Scientist reviewing and supervising reviewers in the quality (CMC) review of biological products.

Drawing on over 25 years of experience in global regulatory affairs, CMC at the US FDA and large pharma, Kathy continues to focus on CMC regulatory affairs for Acumen.  Kathy holds a Master’s Degree from Johns Hopkins University, Baltimore, Maryland.