FDA-PDS Symposium I: Prostate Cancer DREAM Challenge Keynote Thoughts on the Future of Medical Evidence Generation Robert M. Califf, MD, Deputy Commissioner, FDA Main Sessions Project Data Sphere Initiative, Overview & Demonstration Charles Hugh-Jones, MD, Sanofi Joseph Morrell, Project Data Sphere Martin Murphy, [...]

FDA-PDS Symposium II: From Silos to Solutions Keynote Advancing Cancer Research Through Collaborations between Academia, Industry and Regulatory Science Richard Pazdur, MD, Director, Office of Hematology & Oncology Products, FDA Main Sessions Project Data Sphere Initiative Update Monica Bertagnolli, MD, Alliance for […]

FDA-PDS Symposium III: Intermediate Endpoints in Immuno-Oncology Keynote The Role of Data Sharing in Fulfilling FDA’s Vision of an Evidence Generation System Robert M. Califf, MD, Commissioner, FDA Main sessions Project Data Sphere Initiative Update: Outcomes Since Symposium II Dean Bottino, […]

FDA-PDS Symposium IV: Project Data Sphere, LLC & NCTN Data Archive Initiative Keynote The Promise of Shared Data Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA Main Sessions Leveraging the Power of Collaboration: FDA's New Oncology Center of Excellence […]

FDA-PDS Symposium V: Growing Dimensions of Big Data in Cancer Research Executive Summary Keynote The Potential and Reality of Data Sharing in Fulfilling the FDA Vision of an Evidence-Generation System Sean Khozin, MD, MPH, Associate Director (Acting), FDA Oncology Center of […]

Symposium VI: Small Cell Lung Cancer (SCLC) External Control Arm: A Paradigm Shift in Cancer Drug Evaluation/Registration Executive Summary Keynotes Patient-Centered Datasharing:  An Imperative for Agile Innovation Paul Howard, PhD, Senior Advisor to the Commissioner, FDA NCI Clinical Data Initiatives: Building […]

FDA-PDS Symposium VII: Immune-Related Adverse Events and Checkpoint Blockade Combination Therapies Keynote Current Clinical Challenges in Immune-Related Adverse Events and Emerging Opportunities: The MGH Experience Kerry Reynolds, MD, Director of the Severe Immunotherapy Complications Service and Clinical Director, Massachusetts General […]

FDA-PDS Symposium VIII: Artificial Intelligence in Tumor Imaging: Needs, Opportunities & Challenges 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 […]

Executive Summary PDS Symposium IX on rare cancer registries was a virtual meeting held on Oct. 7, 2020. For the first time in our annual symposia series, we are met online. As a result, more of you were able to engage which will help advance […]

Executive Summary Overview: For the last 6 years, the CEO Roundtable on Cancer’s Project Data Sphere (PDS) has actively partnered with the FDA through a series of symposia focused on building consensus within the scientific community in support of advanced cancer […]