This week, I will be hosting a webinar focused on considerations and best practices for Blood Pressure (BP) monitoring as part of the cardiac safety assessment for compounds in development. The evaluation of BP responses to drugs being developed for non-cardiovascular indications is garnering increased public awareness and regulatory focus, evidenced by formal scientific discussions at prominent meetings and recent publications by the Cardiac Safety Research Consortium (CSRC) on this topic.
Jeffrey Heilbraun
Main profile
Director, Strategic Development
Jeffrey Heilbraun attended Tufts University in Boston, Massachusetts where he completed his Bachelor of Science degree in Biology with a focus on physiology. Jeff continued his studies at The American University in Washington D.C., receiving a fellowship and completing his Masters of Science in Health Promotion and Disease Management. He was employed at The American University as an adjunct professor in the Health Promotion program. Jeff joined the Medifacts team in 1993 and has supported activities in Data Management, Operations, and Business Development. Throughout his career at Medifacts, Jeff has maintained his focus on the science and physiology behind cardiac safety within pharmaceutical development, with a special interest in hemodynamics. Jeff has presented posters and session participation at the Drug Information Association (DIA) meeting, American Society of Hypertension (ASH), Canadian Clinical Pharmacology Association and recently at the Cardiac Safety Research Consortium (CSRC).
Blogs
Cardiovascular risks associated with drugs across many therapeutic areas have necessitated cardiac safety evaluation during the drug development process. Over the years, defining cardiac risk has matured from ECG evaluation to detailed regulatory guidance, such as the ICH-E14 (adopted by the FDA, EMA, and PMDA), which details the formal Thorough QT (TQT) study for assessing cardiac safety
Webinars
December 31, 2015 - 12:00pm (EST)
There has been an increased interest and focus from a regulatory perspective on the off-target blood pressure effects of compounds in development. This has led to a number of key considerations from regulatory agencies and drug sponsors related to blood pressure monitoring as a component of cardiac safety profiles and benefit/risk assessment across a range of therapeutic areas and drug classes.