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Mike Wierzba, PhD

Director, Global Regulatory Affairs, Precision Medicine and Digital Health
GSK

Mike Wierzba, PhD is Director, Precision Medicines, Global Regulatory Affairs at GSK where he is the diagnostic regulatory lead for multiple development programs and leads efforts related to IVDR. Mike is a participant in EFPIA Precision Medicine Working Group and MedTech Europe initiatves around IVDR. Prior to moving to Pharma, Mike was the global regulatory lead for multiple companion diagnostics programs for IHC and ISH devices at Roche Diagnostics (Ventana Medicial Systems, Inc.). Before his work in Regulatory, Mike was a Scientist in CDx Assay Development and spent 15 years in academic research focusing on cell signaling pathways. Mike has a PhD in Molecular and Cellular Biology from the University of Arizona, is passionate about diversity, equity, and inclusion initiatives and, when not working, enjoys cultivating native landscaping on his desert property and cooking.

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