Improving Preclinical and Clinical Regulatory Submissions Through Enhanced ECG Interval and Arrhythmia Assessment

Improving Preclinical and Clinical Regulatory Submissions Through Enhanced ECG Interval and Arrhythmia Assessment

DATE: THURSDAY, MARCH 1, 2018

TIME: 11:00 AM – 12:00 PM EST (UTC -5)

Experts in preclinical and clinical ECG safety assessment discuss how advances in arrhythmia detection and concentration effects modelling improve study outcomes.

Comprehensive assessment of ECG intervals and arrhythmias is now practical in both preclinical and clinical research studies. A subset of the available information is currently required by the FDA, and researchers are challenged to balance the value of knowing more against potential liabilities of evaluating and submitting incremental data.

During this webinar, sponsored by VivaQuant, experts will review advances in ECG safety assessment including reductions in interval measurement variability, reductions in confidence limits in concentration effect models, and accurate reporting of up to 20 common arrhythmias.

The clinical perspective will be delivered by Dr. Jay W. Mason. He will discuss reductions in interval measurement variability and confidence limits in concentration effect models and review the implications for clinical TQT studies and Phase I (IQ-CSRC) studies supporting TQT waivers, supporting why tighter confidence limits and more accurate measurements matter.

Following, Mike Gralinski, CEO of CorDynamics, will offer a preclinical perspective on the potential of incorporating detailed assessment of arrhythmias for every cardiovascular study, and share his thoughts on how and when this additional information should be leveraged. He will discuss the value of knowledge versus liability of disclosure, the potential value of pre-study arrhythmia screening, and incorporating baseline/control arrhythmia assessment.

Key topics covered during this webinar will include:

  • Opportunities to improve FDA acceptance of phase I (IQ-CSRC) studies in support of TQT waivers.
  • How and when comprehensive arrhythmia assessment should be leveraged in preclinical safety assessment.
  • Why accurate interval measurements and tighter confidence limits matter.

Jay W. Mason, MD

University of Utah

Dr. Mason is an independent consultant in the cardiac safety of pharmaceuticals. He also serves, in a consultative role, as Chief Medical Officer of Spaulding Clinical Research.  He graduated from Princeton University and obtained his MD degree from the University of Pennsylvania. He trained in Medicine and Cardiovascular Diseases at Stanford University Medical Center where he was a member of the Faculty from 1975 to 1983 and served as Director of the Cardiac Arrhythmia Service and Co-director of the Cardiac Catheterization Laboratories. He became Chief of Cardiology at the University of Utah in 1983, where he was PI of two major NIH-funded international clinical trials and an NIH-funded Specialized Center of Research in Sudden Death, and remains a faculty member. He was Chairman of the Department of Medicine at the University of Kentucky from 1999 to 2003.  His clinical, teaching and research emphasis is in cardiac arrhythmias and electrophysiology.

Michael Gralinski, Ph.D.

CEO and Co-Founder
CorDynamics

Michael R. Gralinski, PhD, is the Chief Executive Officer and Co-Founder of CorDynamics, a cardiovascular contract research organization and consulting group in Chicago. He earned his BS in Pharmacology & Toxicology at the University of Wisconsin-Madison and PhD in Pharmacology at the University of Michigan. Along with his partners, Mike started CorDynamics in 2002 and since then the company has grown into a leading provider of nonclinical cardiovascular services for many international biopharmaceutical clients. Mike also has extensive management experience working for multiple pharmaceutical companies including Warner-Lambert/Parke Davis, G.D. Searle, Pharmacia, and Pfizer.

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