Innovation Panel - Panelist
Esther Abels, MSc, VP Regulatory & Clinical Affairs and Strategic Business Development, PathAI
Esther Abelsis is VP of Regulatory & Clinical Affairs and Strategic Business Development at PathAI. She 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 both pharma and biotech. Worked and lived in NL as well as USA prior to relocating to Boston USA to join PathAI in 2018. She played a crucial role in the Digital Pathology Association (DPA) Regulatory and standards 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 and led the entire regulatory, clinical and medical affairs trajectory within Philips Digital Pathology Solutions (DPS) for Whole Slide Imaging devices to be marketed for “HER-2” as well as for “Primary Diagnosis” in as well US as in EU, CAN, Singapore and part of APAC. Esther is currently Chair of the DPA Regulatory and Standards Taskforce where she is spearheading regulatory and standards clarifications for interoperability and computational pathology as well as working on reimbursement in DP.