Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy and CMC across all modalities and oversees U.S. regulatory policy for Rare Diseases and New Approach Methodologies. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and Gene Therapy Discussion Group—contributing to continuous manufacturing training and regulatory science. She chairs the BIO Regenerative Medicine Committee and serves on the ARM U.S. Policy Advisory Group and the ASGCT Regulatory Committee, advancing harmonization, regulatory efficiency, and policies to improve patient access.