Esther Abels, MSc, Dir Regulatory, Clinical and Medical Affairs Philips Digital Pathology Solutions. Graduated in Biomedical Health Science, toxicology. Experienced in clinical validation studies used for regulatory purposes in USA, Europe and Asia. Has a background in bridging R&D, Proof of Concept and socio economics studies. Was Clinical Research Scientist and Global Clinical Trial Manager for pivotal regulatory studies in pharma. Worked and lived in NL as well as USA prior to joining Digital Pathology Solutions in 2011. She played a crucial role in the Digital Pathology Association (DPA) Regulatory Taskforce and FDA collaborations. The successful outcome was that WSI for primary diagnosis was recommended to become a class II instead of class III device in the United States. She also played an integral role in the legally marketed Philips’ HER2 manual digital read device and led the entire regulatory de novo process for WSI “Primary Diagnosis” with the successful outcome for DPS. Esther is currently Chair of the DPA Regulatory and Standards Taskforce.
