FDA Public Workshop: Cardiovascular Toxicity Assessment in Oncology Trials

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

Co-Chairs: Dr. Laleh Amiri-Kordestani and Dr. Ana Barac

This Food and Drug Administration (FDA) public workshop will provide a forum for discussion of cardiovascular toxicity assessment within oncology clinical trials.  Cardiotoxicity is a well-established complication of oncology therapies. In the past decade, an explosion of novel cancer therapies, often targeted and more specific than conventional therapies, has revolutionized oncology therapy and dramatically changed cancer prognosis. However, some of these therapies have introduced an assortment of cardiovascular complications. At times, these devastating outcomes have only become apparent after drug approval and have limited the use of potent therapies. There is a growing need for better nonclinical testing platforms, imaging and serum biomarkers and trial designs; to screen, monitor and prevent these toxicities. The goals of this public workshop are to:

• Discuss in vitro and in vivo nonclinical models to assess cardiovascular toxicity. 
• Discuss best practices for identifying cardiovascular safety signals within oncology clinical trials. 
• Discuss the role of imaging and biomarkers to predict and monitor cardiovascular toxicities.
• Discuss what cardiovascular risk factors need to be captured at baseline and throughout the study.
• Discuss how to improve the cardiovascular Adverse Events reporting within oncology clinical trials beyond CTCAE. 
• Review the evidence available regarding implementation of cardiovascular prevention strategies.
• Discuss how to design and implement cardiovascular safety registries.

Date: September 22, 2016

Time: 8:00 a.m. to 4:30 p.m.

Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503 A (Great Room), Silver Spring, MD 20993

Webcast Information:

• Part 1
• Part 2
• Part 3

Meeting Information

• Cardiovascular Toxicity Workshop Agenda
• Cardiovascular Toxicity Assessment In Oncology Trials Workshop List of Speakers and Panelist

Presentations

• Introduction – Laleh Amiri-Kordestani, MD
• Current Landscape of LV dysfunction Monitoring: What are the Challenges and Opportunities? - Ana Barac, MD
• Cardiac MR Techniques to Detect Cardiac and Vascular Injury after Treatment for Cancer- W. Gregory Hundley, MD

Presentations

• Hypertension- how to monitor and what is the optimal therapy? - Benjamin D. Humphreys, MD
• Biomarkers be Used to Assess Risk for Vascular Cardiotoxicity? - Kevin J. Croce, MD

Presentations

• Regulatory Recommendations for Nonclinical Studies of Anticancer Pharmaceuticals - Todd Palmby, PhD
• Overview: What Nonclinical Studies are Available to Interrogate Potential Cardiovascular Risk of an Oncology Product? - Hugo M. Vargas, PhD

Presentations

• Strategies to Improve Cardiovascular Phenotyping in Cancer Clinical Trials - Lori Minasian, MD
• Pediatric Survivors: Monitoring and Prevention of Cardiovascular Toxicities - Pediatric Survivors: Monitoring and Prevention of Cardiovascular Toxicities- Steven E. Lipshultz, MD
• Cardiovascular Phenotyping in Cooperative Clinical Trials – What and How to Measure? - Bonnie Ky, MD
• Designing and Implementing Cardio-oncology Safety Registries - Daniel J. Lenihan, MD
• Regulatory Perspective: Opportunities for Postmarketing CV Safety Outcomes Collection Suparna B. Wedam, MD