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September 9, 2025

Kelly Gordon, Ph.D.

Dr. Gordon is a regulatory translational scientist and the founder of Boudicca DXTM, a global precision medicine consulting firm that supports global translational science and regulatory strategies for innovative precision medicine products. She received a BS magna cum laude in Molecular and Cellular Biology from the University of Arizona and a PhD in Pharmacology from Duke University.  After completing two years of postdoctoral training in translational oncology at the Translational Genomics Research Institute (TGen) and Arizona Cancer Center, she worked at the Southern Arizona Veterans Affairs (VA) hospital’s CAP-certified and CLIA-accredited laboratory developing molecular diagnostic Laboratory Developed Tests (LDTs) hands-on as an ASCP-certified molecular technologist. Dr. Gordon holds a Regulatory Affairs Certification (RAC) in Medical Devices from the Regulatory Affairs Professional Society (RAPS) and is knowledgeable in global In Vitro Diagnostic (IVD) and Medical Device regulations. Dr. Gordon developed Companion Diagnostic (CDx) and Complementary Diagnostic IVDs for oncology therapies working at Ventana/Roche Tissue Diagnostics, Loxo Oncology & Kura Oncology and has supported over 140 precision medicine clients with both non-oncology and oncology product development and regulatory affairs as a consultant.