Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently represents PhRMA in the ICH Cell and Gene Therapy Discussion Group. In addition, she is an active member of the PhRMA Global Quality and Manufacturing Work Group, the BIO Manufacturing/Quality and Distribution Committee, and the IFPMA Quality/Manufacturing Working, the Co-Chair of BIO Regenerative Medicine Committee and a member of the ARM US Policy Advisory Group driving harmonization efforts, regulatory efficiency, and policies that enhance patient access.