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.

Date:

December 1, 2017

Time:

9:00 AM to 5:00 PM

Location:

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

Webcast Information:

Meeting Materials:

Final Agenda (PDF - 187 KB)
List of Speakers and Panelists (PDF - 1 MB)

Presentations:

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

Immuno-Oncology and Combination Immunotherapies, Marc Theoret, MD (PDF - 225 KB)
Immunology Overview, Andrew Lichtman, MD, PhD (PDF - 4 MB)
Introduction to Cancer Immunotherapies, James Gulley, MD, PhD (PDF - 4 MB)
Combination Cancer Immunotherapies, Jeffrey Sosman, MD (PDF - 3.5 MB)

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

Clinical Toxicities with Immunotherapies, Michael Atkins, MD (PDF - 462 KB)
Eligibility Criteria for Immune-oncology Trials, Douglas Johnson, MD, MSCI (PDF - 491 KB)
Autoimmunity associated with Checkpoint Inhibitors: Rheumatologist’s Perspective, Paul Utz, MD (PDF - 6 MB)

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

Myocarditis: The Clinician’s Dilemma, JoAnn Lindenfeld, MD, FHSA (PDF - 75 KB)
Cardiovascular Toxicities Associated with Checkpoint-Inhibitors, Javid Moslehi, MD (PDF - 180 KB)
Diabetes associated with Immune Checkpoint Inhibitors-Endocrinologist’s Perspective, Kevan Herold, MD (PDF - 66 KB)
Cancer Immunotherapy-associated Myositis and Myasthenia Gravis, Andrew Mammen, MD, PhD (PDF - 1 MB)

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

General Pathophysiology of Myocarditis, Kirk Knowlton, MD (PDF - 3 MB)
Clinical Myocarditis: Diagnosis and Management, Mariell Jessup, MD, FAHA, FESC, FACC (PDF - 1.5 MB)
Immune-Checkpoint Inhibitor Related Myocarditis: Pathophysiology, Javid Moslehi, MD and Andrew Lichtman, MD, PhD (PDF - 1 MB)

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

How to Screen for Cardiotoxicity, Susan Gilchrist, MD (PDF - 4 MB)
Imaging Modalities to Diagnose Cardiovascular Toxicities, Bonnie Ky, MD, MSCE (PDF - 1 MB)
Adjudicating Cardiovascular Events in Immuno-Oncology Trials, Marc Bonaca, MD, MPH (PDF - 150 KB)
Modernizing Eligibility Criteria for Oncology Clinical Trials, Julia Beaver, MD (PDF - 140- KB)

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

Leveraging Big Data in Drug Development: Toxicity Assessment & Signal Detection, Sean Khozin, MD, MPH (PDF - 1.7 MB)
ASCO’s CancerLinQ: Using real-world evidence for discovery, Robert Miller, MD, FACP, FASCO (PDF - 620 KB)
Patient-Generated Data, Sally Okun, RN, MMHS (PDF - 444 KB)
Post-Marketing Drug Safety Surveillance: Cardiovascular Toxicities, Connie Cheng, PharmD, BCOP and Pritpal Singh, PharmD, BCOP (PDF 600 KB)

Contact:

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