Speaker Profile

Ph.D., Vice President, Clinical Development and Regulatory Affairs, PathAI

Katy has been leading clinical and regulatory at PathAI for the last two years. One of her main focuses has been the NASH program, where she works to develop and qualify PathAI's unique drug development tools to advance NASH therapeutics with a consortium of close industry and academic partners. Katy has over a decade of clinical research and regulatory experience in digital pathology, diagnostics, and drug development, as well as an extensive background in liver research in tissue engineering, liver regeneration, and toxicology. Since 1998, Katy has been focused on harnessing quantitative imaging to unlock the intricate structure/function relationship in pathology, with the help of close, interdisciplinary collaborations.

 Session Abstract – PMWC 2022 Silicon Valley

Track 2, June 28

AI/ML-related healthcare products/services have begun changing the healthcare landscape. Watershed events in AI diagnostics include recent FDA approvals in imaging and data integration and guidance for Software as a Medical Device. What role will AI/ML play and what should criteria be for reimbursement as healthcare pivots to value-base models?