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  1. News & Events for Human Drugs

FDA Public Workshop: Assessment of Cardiovascular Toxicities in Immuno-oncology Trials

Organized by the:
U.S. Food & Drug Administration (FDA) 
Oncology Center of Excellence (OCE)
with support from the American Association for Cancer Research (AACR),
American College of Cardiology (ACC), American Heart Association (AHA), & American Society of Clinical Oncology (ASCO)

Co-Chairs: Laleh Amiri-Kordestani, MD and Javid Moslehi, MD

The FDA is announcing a public workshop entitled, “Assessment of Cardiovascular Toxicities in Immuno-oncology Trials”. This workshop will provide a forum for discussion of cardiovascular toxicities in immuno-oncology clinical trials. The focus of the workshop is to identify best practices to assess cardiovascular and metabolic toxicities in patients receiving cancer immunotherapies.


December 1, 2017


9:00 AM to 5:00 PM


FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 - Great Room A
Silver Spring, MD 20993

Webcast Information:

Meeting Materials:

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Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance.

Session 1: Immuno-Oncology and Combination Immunotherapies
Moderator: Marc Theoret, MD; FDA/OCE

Session 2: General Toxicities of Cancer Immunotherapies      
Moderators: Apostolia (Lia) Tsimberidou, MD, PhD; MD Anderson Cancer Center and Javid Moslehi, MD; Vanderbilt School of Medicine Cardio-Oncology Program

Session 3: Cardiometabolic Toxicities in Immuno-Oncology Trials  
Moderator:  Jeffrey Sosman, MD; Northwestern Univ. Robert H. Lurie Comprehensive Cancer Center

Session 4: Myocarditis Overview
Moderator: Ana Barac, MD, PhD; MedStar Health Research Institute

Session 5: Screening/Monitoring for Cardiovascular Toxicities associated with Cancer Immunotherapies
Moderator: Daniel Lenihan, MD; Washington University

Session 6: From Big data to Smart Data for Identification of Cardiovascular Toxicities
Moderators: Sean Khozin, MD; FDA/OCE and Elad Sharon, MD, MPH; NCI, Investigational Drugs


Joan Ferlo Todd, RN
E-mail: Joan.Todd@fda.hhs.gov
Regulatory Health Project Manager
Office of Hematology and Oncology Products
Center for Drug Evaluation and Research
Food and Drug Administration

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