FDA-PDS Symposium III: Intermediate Endpoints in Immuno-Oncology


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, PhD, Millennium Pharmaceuticals
  • Antonio Fojo, MD, PhD, Columbia University
  • Martin Murphy, DMedSc, PhD, FASCO, Project Data Sphere
  • Mace Rothenberg, MD, Pfizer Oncology
  • Oliver Sartor, MD, Tulane Cancer Center

Information Exchange and Data Transformation (INFORMED) Initiative Update

  • Sean Khozin, MD, MPH, FDA
  • Adrian Myers, FDA
  • Anand Shah, MD, FDA
  • Vahan Simonyan, PhD, FDA

Research on Intermediate Endpoints in Immuno-Oncology

  • Jeff Allen, PhD, Friends of Cancer Research
  • Gideon Blumenthal, MD, FDA
  • Ellen Sigal, PhD, FDA
  • Rajeshwari Sridhara, PhD, FDA



Alliance for Clinical Trials

Alliance for Clinical Trials in Oncology


Breast Oncology Center | Dana-Farber Cancer Institute

Carmine Research


Center for Biomedical Informatics & Information Technology, NCI

Columbia University Medical Center


EMD Serono

Flatiron Health

Focused Ultrasound Foundation

Friends of Cancer Research

Hogan Lovells

James J. Peters VA Hospital Cancer Center

Johns Hopkins University

Merck and Co., Inc.

Memorial Sloan Kettering Cancer Center

National Cancer Institute, NIH

NeoImmuneTech, Inc.


Pfizer, Inc.

RA Capital Management


Takeda Oncology

Tulane University

U.S. Department of Health and Human Services