Cardiac safety testing is an important part of the approval of new chemical entities (NCEs). For more than 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, the expert speaker will discuss:
- The basics of long-term cardiac monitoring
- What the technology entails
- How and when to deploy the technology
- What data are collected
- How the data are analysed
Register for this webinar today to gain insights into the transformative impact of long-term cardiovascular monitoring technologies on clinical trials.
Speakers
Dr. Polina Voloshko, MD, Senior Medical Director and Head of Medical & Scientific Affairs, Cardiovascular & Cardiac Safety Solutions, ICON
Dr. Polina 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 a Cardiology Research Fellow at UCSF and was Chief of Cardiology at Riga City Hospital in Riga, Latvia, an affiliate of the Latvian Medical University.
She is board-certified in cardiology and internal medicine and Dr. Voloshko received her MD, Magna cum Laude, at the First St. Petersburg Medical School.
Message Presenter
Timothy Callahan, PhD, Medical & Scientific Director, Cardiac Safety Solutions, ICON
Dr. Timothy 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 served as the moderator for FDA QT-IRT – ECG Core Lab meetings. Dr Callaghan is a frequent speaker at pharmaceutical industry functions.
Message PresenterWho Should Attend?
This webinar will benefit pharmaceutical and biotech professionals in the following areas:
- Medical monitors
- Clinical operations
- Drug safety professionals
- Project Managers
What You Will Learn
Attendees will learn about:
- The definition of long-term cardiovascular data
- The need for long-term cardiovascular data
- How long-term cardiovascular data can support a cardiac safety portfolio
- What new technologies are available for the collection of long-term cardiovascular data
Xtalks Partner
ICON
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.
With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.
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