Overview:
Cardiac safety testing is an important part of the approval of new chemical entities (NCEs). In the last 20+ years, cardiac safety testing has been focused on QT interval assessment as a surrogate for the potential of an NCE to cause “Torsade de Pointes” - a specific life-threatening ventricular arrhythmia that is potentially associated with QT interval prolongation. However, these analyses have been conducted using limited, short-term data in a resting state.
Newer technologies allow for the collection of long-term data in a more dynamic, real-world setting. Cardiac monitoring has benefited from the advent of multiple-day recordings, allowing for ECG collection in dynamic settings.
Regulatory agencies are becoming more aware of the need to gather long term cardiovascular data, and the new technologies available to facilitate collection. As long-term cardiovascular technology advances it will become increasingly easier to utilise it for the collection of continuous cardiovascular safety data in clinical trials.
In this webinar, we will discuss:
- The basics of long-term cardiac monitoring
- Cardiac monitoring technology
- How and when to deploy the technology
- What data is collected
- How the data is analysed
What you will learn:
1. The definition of long-term cardiovascular data
2. The need for long-term cardiovascular data
3. How long-term cardiovascular data can support a cardiac safety portfolio
4. What new technologies are available for the collection of long-term cardiovascular data
Speakers:
Polina Voloshko
Dr. Voloshko provides scientific and medical leadership, direction, training and expertise to ICON’s Cardiac Safety and Cardiac Imaging clinical trial staff, cardiologists, medical and scientific consultants, and sponsors. She has over 35 years of experience in clinical invasive and non-invasive cardiology. For the last 25 years Dr. Voloshko has focused on ECG, Holter, other electrophysiology modalities, and ECHO research and is a recognised expert among the industry cardiology and regulatory community.
Prior to joining the company she was VP of Cardiovascular Clinical Services at the Ischemia Research and Education Foundation, University of California San Francisco (UCSF). She also served as cardiology research fellow at UCSF and was Chief of Cardiology at Riga City Hospital in Riga, Latvia, an affiliate of the Latvian Medical University.
Board-certified in cardiology and internal medicine, Dr. Voloshko received her MD, Magna cum Laude, at the First St. Petersburg Medical School.
Timothy Callahan
Dr. Callahan brings over 35 years of clinical research expertise to the position including research with the NIH and more than 30 years in the diagnostic testing industry. He has co-authored three patents in QT interval analysis and dynamical systems modeling of ECG data. He has also authored many abstracts and publications as well as serving as the moderator for FDA QT-IRT – ECG Core Lab meetings. Dr Callahan is a frequent speaker at Pharmaceutical Industry functions.