Session – Drug-Device Combination Treatments & Diagnostics Angela N. Johnson, MSE, PMP, RAC, is the Senior Director Regulatory Affairs at Sigilon Therapeutics, and previously held roles as Director of Regulatory Strategy at IQVIA (Quintiles) and Senior Manager of Global Clinical Affairs Operations at GE Healthcare. Angela has over 20 years of global regulatory strategy and clinical development experience in a novel drug delivery devices, diagnostics, digital therapeutics, and combination biologic products— with expertise in new technologies that challenge traditional regulatory frameworks. She is affiliated with Texas Tech University’s communication research program with multiple peer-reviewed publications in regulatory strategy, and has authored multiple chapters on medical devices and advanced therapies for the best-selling Regulatory Affair Professionals Society (RAPS) Fundamentals textbook series.