Jacob Mekhael's questions to Galapagos NV (GLPG) leadership • Q1 2025
Question
Jacob Mekhael asked how recent leadership changes at the FDA might impact the agency's perspective on point-of-care CAR-T manufacturing and its openness to innovative cell therapy delivery methods.
Answer
CEO Paulus Stoffels expressed confidence that regulators will continue to prioritize and support therapies for high unmet medical needs. He mentioned recent positive interactions with the FDA and noted that European and U.K. regulators are also showing a strong desire to drive innovation in the cell and gene therapy space, suggesting global support for their approach.