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:
- Part 1: 9:00 AM – 11:15 AM
- Part 2: 11:22 AM – 12:45 PM
- Part 3: 1:32 PM – 3:30 PM
- Part 4: 3:49 PM – 5:20 PM
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