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Cardiovascular Safety in Biopharmaceutical Product Development – From QT Prolongation and Beyond

October 16, 2017 - 11:00am (EDT)

Duration: 60 minutes

Featured Speakers:

The cardiac safety ECG environment continues to mature and expand based on scientific advancements and understanding of pathways and systems associated with generating cardiac risk. The most recent ICH-E14 Q&A, and the ensuing cardiac safety conferences and industry meetings, have highlighted the advancements and direction for evaluating the cardiac safety during the drug development process. In addition to the role of ECG data in cardiac safety assessment, there are also considerations related to the "off-target" blood pressure safety signals, which are a consideration from a safety and regulatory perspective.

Objective

The objective and learning goals for the webinar will include:

  • Provide attendees with the background and perspective on the use of QT prolongation as a cardiac safety endpoint within drug development, and take it forward to the more recent discussions beyond the Through QT (TQT)
  • Learning about additional ECG intervals under discussion related to cardiac safety assessment
  • An overview of the discussion around the use of long term ECG capture versus the 10 second ECG signal/waveform in clinical trials
  • Provide a case study approach looking at therapeutic indications/class of compounds that require specific considerations
  • Present background associated with the focus on BP as a cardiovascular safety endpoint in recent years, specific to the off-target blood pressure signal, using a case study review approach for the discussion

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Jean T. Barbey, MD, Cardiovascular Safety Expert

Dr. Barbey has more than 20 years of experience as a practicing physician, teacher, and clinical researcher in academia and the contract research organization (CRO) industry. He is a fellow of the American College of Cardiology (FACC) and board-certified in internal medicine, clinical pharmacology, cardiovascular disease, and cardiac electrophysiology. He previously served as the medical director at Medifacts International, (now Bioclinica) a global cardiac core laboratory.

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