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Thomas W. Arroll, Ph.D.

Sr. Consultant


Dr Arroll has over 18 years of industry experience developing and implementing cell-based and immunoassays to support process development, GXP potency release and stability testing. Through his experience leading development, GLP and GMP laboratories Dr. Arroll has gained deep knowledge of the technical and operational requirements to effectively implement robust and reproducible potency assays in the GXP environment. With an academic background in immunology Dr. Arroll has strong expertise in the development of bioassays to support drugs with immuno-oncology modalities including T cell activation, checkpoint inhibition and Fc-mediated effector functions. In addition to his experience leading potency and impurities assay groups he has served as CMC Team lead for multiple clinical stage programs responsible for process development, internal and external manufacturing and clinical drug product supply. Dr. Arroll is the Owner and Principal Consultant of Seawolf CMC Consulting, a firm focused on providing strategic and technical guidance on the development and implementation of drug potency release and biological characterization assays for the support of CMC activities. Prior to joining Pharmafex Dr. Arroll was Director of Potency and Impurities Assays at Seattle Genetics as well as leader of Potency and Biological Characterization functions at Amgen. Dr. Arroll received his PhD from the University of Washington (UW) School of Public Health and was a Postdoctoral Fellow in Immunology at the UW Howard Hughes Medical Institute.

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