FDA-PDS Symposium V: Growing Dimensions of Big Data in Cancer Research

Executive Summary


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 Excellence, and Founding director, Information Exchange and Data Transformation

Main Sessions

Unlocking Insights Through Open Science and Crowdsources Solutions

  • James Costello, PhD, University of Colorado
  • Addison Howard, Kaggle
  • Gustavo Stolovitzky, PhD, IBM 

Project Data Sphere Initiative Update

  • Steven Cohen, Research Triangle Institute
  • John Dornan, Project Data Sphere
  • Dave Handelsman, Project Data Sphere
  • Paul Kluetz, MD, FDA

Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials

  • Gideon Blumenthal, MD, FDA

The Path Forward: Enabling Immuno-Oncology Research Innovation, Understanding Rare but Serious Immune-Related Adverse Events

  • Laleh Amiri-Kordestani, MD, FDA


Alliance for Clinical Trials in Oncology


Celgene Corp.

Helsinn Therapeutics U.S., Inc.

Hogan Lovells US LLC

Kaggle, Inc.

National Cancer Institute, NIH


NQ Oncology

Pancreatic Cancer Action Network

Parker Institute for Cancer Immunotherapy

Pfizer, Inc.



Tulane University School of Medicine

University of Colorado