Kathy Lee

Kathy Lee is an experienced CMC regulatory professional with more than 20 years of experience working for Industry and the US FDA. Kathy has worked on many modalities, both pre- and post-approval. She especially loves helping shape the CMC story for regulatory submissions. Kathy is a member of the ICH M4Q(R2) Expert Working Group representing BIO, where she is helping to shape the future of regulatory CMC submissions for current and future modalities. She currently works for Acumen Pharmaceuticals as a Sr. Director Regulatory CMC.