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 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-Bedside Translational Effort: Alexandra-Chloe Villani, PhD, MGH

Attendees
Apricity
Astellas Pharma
AstraZeneca
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
Genentech
Hass and Partners
Johns Hopkins University
Massachusetts General Hospital
MD Anderson Cancer Center
MedImmune
Memorial Sloan Kettering Cancer Center
Merck and Co., Inc.
National Cancer Institute
National Institutes for Health
Novartis
Oracle Health Sciences
Palantir
Pfizer, Inc.
Regeneron
Replimune, Inc.
University of Michigan
Vanderbilt University