Director, Clinical Biomarkers
Prothena Biosciences, Pennsylvania
Karen J. Quadrini, Ph.D. has over 15 years of industry experience in biomarkers and translational research. She currently serves as Director of Clinical Biomarkers at Prothena Biosciences, where she is responsible for biomarker strategy and implementation, including assay development and validation, across the company’s portfolio. Prior to joining Prothena Biosciences, she spent three years at Passage Bio focused on biomarker strategic planning and assay development to support clinical development of the company’s investigational gene therapy products. Earlier in her career, she held roles of increasing responsibility in R&D at IRX Therapeutics (now Brooklyn Immunotherapeutics) and ICON Laboratory Services, where she provided predominantly tissue- and cell-based assay development and validation support across multiple therapeutic areas. Dr. Quadrini received her Ph.D. in Biomedical Sciences from the Icahn School of Medicine at Mount Sinai, formerly Mount Sinai School of Medicine of New York University (NYC). She is an active volunteer for the American Association of Pharmaceutical Scientists (AAPS) and has been a member of the leadership team for the AAPS Biomarkers and Precision Medicine (BPM) Community since 2019. She is the current Chair of the AAPS BPM Community.
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Hot Topic: 2025 FDA Guidance BMV for Biomarkers: Impact and Path Forward
Tuesday, November 11, 2025
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