Digital Pathology & Augmented Intelligence are Enablers of Biomarker Testing – A Panel Discussion by the Digital Pathology Association
Moderator: Marilyn M. Bui, MD, PhD, Senior Member and Professor of Pathology, Scientific Director of Analytic Microscopy Core, Section Head of Bone and Soft Tissue Pathology, Program Director of Cytopathology Fellowship, Moffitt Cancer Center, Tampa, FL
Panelists: Mike Montalto, PhD, Chief Scientific Officer, PathAI; Anil Parwani, MD, PhD, Professor of Pathology and Biomedical Informatics, Vice-Chair of Anatomic Pathology, Director of Pathology Informatics, Director, Digital Pathology Shared Resources, Principal Investigator, Cooperative Human Tissue Network (CHTN) Midwestern Division, Wexner Medical Center – Department of Pathology, The Ohio State University
Digital Pathology (DP) and Augmented Intelligence (AI) are gaining momentum in the practice of pathology and laboratory medicine. The FDA has approved multiple whole slide imaging systems for primary diagnosis in recent years and an AI algorithm for prostate cancer diagnosis in 2021. Pathology based biomarkers play an important role along early and late phase biopharmaceutical drug development including mechanism of action, indication selection, enrollment, and harmacodynamics, as well as patient selection and stratification. In the era of precision medicine, traditional microscope-based pathology may fall short of the needed precision, reproducibility and accuracy that are needed to enhance the probability of technical and regulatory success (PTRS) of new drug applications.
The Digital Pathology Association (DPA) is leading the way in advancing DP and AI through education, advocacy, and collaboration. This expert panel will share with the scientific community of precision medicine and the public how DP and AI enable biomarker testing and address some commonly asked questions.
Dr. Parwani, in his presentation entitled “Clinical Implementation of Digital and Computational Pathology: Lessons learnt and the Path Forward”, will provide a practical perspective of an Academic Medical Center’s decision on implementing digital pathology, the lessons learned, and future directions. The objectives are to provide an overview of the current state of Digital Pathology at The Ohio State University, to identify the components for a successful transition into a digital workflow and an integration with the LIS, and to discuss the positive impact of digital pathology on improved pathology workflow and patient care, especially during the pandemic.
Dr. Montalto will address “Applications of AI-powered Pathology in Clinical Stage Drug Development”. His talk will explore the application of machine learning and artificial intelligence in pathology across the entire continuum of the clinical drug development process, with emphasis on translational applications. Examples will be presented in oncology and non-oncology therapeutic areas where AI-based pathology provides superior performance over traditional microscope methods on patient samples from randomized controlled clinical trials. Improved biomarker selected prevalence, hazard ratios between drug and control and enhanced statistical significance of endpoint analysis will demonstrated using AI-powered pathology. Regulatory considerations of using AI-based pathology in drug development will also be discussed.