Executive Summary

Goals and Objectives

Five years ago the CEO Roundtable on Cancer’s Project Data Sphere® (PDS), in partnership with the FDA, founded a series of symposia devoted to areas fertile for fresh attention in the realm of cancer clinical trials. Fostered by Rick Pazdur, Rob Califf, Scott Gottlieb and now Ned Sharpless, this series has consistently elevated the conversation, often deriving major new thrusts from academia, industry as well as from our FDA.

The primary mission of FDA-PDS Symposium VIII is to discuss the development of machine learning algorithms, based on computerized tomography (CT) images, to improve the efficiency and consistency of CT tumor measurements and to augment/eliminate the adjudication of CT readings. CT scans offer a consistent methodology of use across research institutions to develop a common AI solution for big data, applicable for 90% of solid tumors.

Hosted by Stanford University School of Medicine, the Symposium will focus on PDS’ Images and Algorithms Program devoted to machine learning image-recognition algorithms. These algorithms may be used for continuous and categorical measurement of cancer tumor dynamics.

Welcome & Call to Order

• Lloyd Minor, MD; Dean, School of Medicine, Stanford University
• Martin Murphy, DMedSc, PhD, FASCO; Chief Executive Officer, Project Data Sphere

Life Sciences Consortium of the CEO Roundtable on Cancer

• David Reese, MD; Executive Vice President, Research and Development, Amgen; Co-Chair, Life Sciences Consortium

Project Data Sphere: Convener, Collaborator, Catalyst

• Bill Louv, PhD; President, Project Data Sphere

Images & Algorithms Program Overview

• George Demetri, MD; Co-Director, Ludwig Center; Co-Chair, Images & Algorithms Task Force

Fireside Chat: Evolution of Cancer Imaging Technology in Research

• Robert Califf, MD; Advisor and Board Member, Verily; Vice Chancellor for Health Data Science, Duke University
• Lloyd Minor, MD; Dean, School of Medicine, Stanford University

Spotlight Talks – Panel 1: Filling Current Gaps in Radiologic Image Processing

• Moderator: Anshu Jain, MD; NCI/FDA Senior Fellow in Oncology Innovation, National Cancer Institute
• Curtis Langlotz, MD, PhD; Professor of Radiology and Biomedical Informatics, Stanford University
• Daniel Rubin, MD; Professor of Biomedical Data Science, Radiology, and Medicine, Stanford University
• Firas Ahmed, MD, MPH; Assistant Professor, Department of Radiology, Columbia University Medical Center

Spotlight Talks – Panel 2: Advancements in Image Recognition in Medical Imaging, Cancer Imaging, and Beyond

• Moderator: Pratik Shah, PhD; Principal Investigator, MIT Media Lab
• Courtney Ambrozic, MS; Senior Associate Staff Scientist, SAS Institute
• Shravya Shetty, MS; Senior Staff Engineer, Google Health
• Gregory Goldmacher, MD, PhD, MBA; Executive Director, Translational Biomarkers, Merck Research Laboratories
• Tito Fojo, MD, PhD; Professor of Medicine, Columbia University Medical Center
• Matt Lungren, MD, MPH; Associate Director, Stanford Center for Artificial Intelligence in Medicine and Imaging, Stanford University

Keynote: Insights to Accelerate Progress in Assessment of Drug Effect – Including Cancer Imaging Technology

• Robert Califf, MD; Advisor and Board Member, Verily; Vice Chancellor for Health Data Science, Duke University

Expert Panel: Artificial Intelligence in Image Processing – Needs, Requirements, and Challenges

• Moderator: Lawrence Schwartz, MD; Chairman, Department of Radiology, Columbia University Medical Center; Co-Chair, Images & Algorithms Task Force
• Tito Fojo, MD, PhD; Professor of Medicine, Columbia University Medical Center
• Mace Rothenberg, MD; Chief Medical Officer, Pfizer, Inc.
• Pratik Shah, PhD; Principal Investigator, MIT Media Lab
• Sam Gambhir, MD, PhD; Chairman of the Department of Radiology, Stanford University
• Karla Childers, MS; Senior Director, Office of the Chief Medical Officer, Johnson & Johnson

Call for Action & Next Steps

• Sean Khozin, MD, MPH; Founding Director, Information Exchange and Data Transformation (INFORMED), Associate Director, Oncology Center of Excellence, FDA; Member, Images and Algorithms Task Force
• Robert Califf, MD; Advisor and Board Member, Verily; Vice Chancellor for Health Data Science, Duke University

Closing Remarks

• Mace Rothenberg, MD; Chief Medical Officer, Pfizer, Inc., Co-Chair, Life Sciences Consortium
• Lloyd Minor, MD; Dean, School of Medicine, Stanford University
• Reed Jobs, MA; Managing Director, Health, Emerson Collective
• Greg Simon, JD; Former President, Biden Cancer Initiative