FDA-PDS Symposium VII: Immune-Related Adverse Events and Checkpoint Blockade Combination Therapies


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 Hospital Cancer Center

Main Sessions

Summary of the NIH Conference on Cancer, Autoimmunity and Immunology — Elad Sharon, MD, MPH, Senior Investigator, National Cancer Institute (NCI), Cancer Therapy Evaluation Program

Project Data Sphere: Convener, Collaborator, Catalyst — Bill Louv, PhD, President, Project Data Sphere, LLC

Patient Care, Immuno-Oncology Toxicity and Immune-Related Adverse Events (irAEs) — Kerry Reynolds (moderator)

  • Patient experience: Spouse of patient who received ICI therapy at Massachusetts General Hospital (MGH)
  • Colitis Complications in ICI Therapy: Michael Dougan, MD, PhD, MGH
  • Determining the Cause of Acute Kidney Injury in Patients on Checkpoint Inhibitors: Meghan Sise, MD, MS, MGH
  • Neurological Complications in ICI Therapy: Amanda Guidon, MD, MGH
  • Cardiovascular Toxicities and Fatal Events: Doug Johnson, MD, Vanderbilt University
  • FDA Clinical Trial Data and FDA Adverse Event Reporting System (FAERS) Surveillance Data

FDA Clinical Trial Data and FDA Adverse Event Reporting System (FAERS) Surveillance Data — Sean Khozin, MD, MPH, Associate Director, FDA Oncology Center of Excellence; Founding Director, Information Exchange and Data Transformation (INFORMED), FDA (Moderator)

  • Immune-Mediated Adverse Events: A Regulatory Perspective: Victoria Chiou, MD, Medical Officer, Office of Hematology and Oncology Products, FDA
  • Analysis of FAERS Data for Checkpoint Inhibitors and Events in Three MedDRA SOCs: William DuMouchel, PhD, Chief Statistician, Oracle Health Sciences
  • Checkpoint Inhibitors: Highlights of Several Safety Data Mining Techniques Using Clinical Trial and MedWatch Data: Ana Szarfman, MD, PhD, Medical Officer, Diplomate by the American Board of Pathology in both Clinical Pathology and Clinical Informatics, Division of Cardiovascular and Renal Products, FDA
  • ICI Toxicity-Related Biorepositories and Registries

ICI Toxicity-Related Biorepositories and Registries — Elad Sharon (moderator)

  • A NICER Approach to irAEs: Harnessing Experience in PIDD: Kelly Walkovich, MD, University of Michigan
  • Building a Robust “Memory Response” to Immune-Related Adverse Events – The MGH Immunotherapy Toxicity Registry: Laura Petrillo, MD, MGH
  • Finding a Predictor of Toxicity Using Real-World Data: Osama Rahma, MD, Dana-Farber Cancer Institute (DFCI)
  • Alliance-NCI Immune-Related Adverse Events Biorepository: David Kozono, MD, PhD, DFCI
  • Solving the Underpinnings of irAE Through Integrative Bench-to-Bedsite Translational Effort: Alexandra-Chloe Villani, PhD, MGH



Astellas Pharma


Bayer HealthCare Pharmaceuticals Inc.

Bristol Myers-Squibb

Columbia University Medical Center

Dana-Farber Cancer Institute

EMD Serono

Emerson Collective

Evidation Health

Foundation for the National Institutes for Health


Hass and Partners

Johns Hopkins University

Massachusetts General Hospital

MD Anderson Cancer Center


Memorial Sloan Kettering Cancer Center

Merck and Co., Inc.

National Cancer Institute

National Institutes for Health


Oracle Health Sciences


Pfizer, Inc.


Replimune, Inc.

University of Michigan

Vanderbilt University