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?

 Session Chair Profile

Ph.D., Independent consultant in Translational Science & Medicine

Biography
John is a biotechnology Translational Science & Medicine consultant with a comprehensive and deep understanding of the development and application of pioneering molecular procedures to the translation of research-grade biomarker assays into clinical-grade clinically adopted diagnostic tests. John oversaw the translation of an early stage research Next Generation sequencing test to a US government reimbursed and now widely adopted Laboratory Developed CLIA-CAP test for transplanted kidney rejection. He advises commercial translation efforts at Stanford University (SPARK) and University of California in San Francisco (CATALYST).


 Speaker Profile

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

Biography
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.


 Speaker Profile

Ph.D., Chief Scientific Officer, Covance, Sr VP, LabCorp

Biography
Dr Anderson has been with the LabCorp organization for 26 years and has held a variety of positions including director of operations for ViroMed Laboratories, director of operations for Monogram Biosciences, director of operations for the Center for Molecular Biology and Pathology, director of operations for Integrated Oncology and Genetics, national director of Research and Development, and global head of LabCorp Clinical Trials. Dr Anderson is a member of a variety of professional societies including the American Association for Cancer Research, the American Society of Clinical Oncology and the Association for Molecular Pathology. Dr Anderson’s research interests are in the development and applications for molecular diagnostics, including several examples of companion diagnostics and pharmacogenomics assays. He has authored more than 175 articles and abstracts published in such journals as Genetics, Proceedings of the National Academy of Sciences, Clinical Chemistry, the Journal of Infectious Disease, Human Pathology, American Journal of Obstetrics and Gynecology, Oncogene, the Journal of the National Cancer Institute, Clinical Cancer Research, Breast Cancer Research, BMC Cancer, the Journal of Molecular Diagnostics, Archives of Pathology and Laboratory Investigation and Expert Reviews in Molecular Diagnostics.


 Speaker Profile

M.D., Ph.D., Professor of Medicine, Stanford University; Chief Data Scientist, Stanford Health Care

Biography
Dr. Nigam Shah is Professor of Medicine (Biomedical Informatics) at Stanford University, and serves as the Associate CIO for Data Science for Stanford Health Care. Dr. Shah's research focuses on bringing machine learning to clinical use safely, ethically and cost-effectively. Dr. Shah was elected into the American College of Medical Informatics (ACMI) in 2015 and was inducted into the American Society for Clinical Investigation (ASCI) in 2016. He holds an MBBS from Baroda Medical College, India, a PhD from Penn State University and completed postdoctoral training at Stanford University.


 Speaker Profile

M.D., Chief Research Informatics Officer; Division Chief Trauma/Critical Care surgery, UC Davis Health

Biography
Dr. Callcut is a nationally recognized expert in data science, is the current Vice Chair of Clinical Sciences in the Department of Surgery, Division Chief, and is the Chief Research Informatics Officer at the University of California- Davis Health. She is a practicing clinician double board certified in General Surgery and Surgical Critical Care. Dr. Callcut has a long track record of extensive extramural research support including from the NIH, DoD, and industry sources. She is also the recipient of funding from the California Institute of Regenerative Medicine. Dr. Callcut has published more than 100 peer reviewed publications, holds several provisional patents in artificial intelligence, has brought a number of products through FDA approval, and her research featured in over 50 news media publications in the last few years. Dr. Callcut is also the co-Founder of BeeKeeperAI, Inc.