Sager P, Heilbraun J, Turner JR, Gintant G, Geiger MJ, Kowey PR, Mansoor GA, Mendzelevski B, Michelson EL, Stockbridge N, Weber MA, White WB. Assessment of drug-induced increases in blood pressure during drug development: report from the Cardiac Safety Research Consortium. Am Heart J. 2013 Apr;165(4):477-88. doi: 10.1016/j.ahj.2013.01.002.
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).
Authored Publications
Braddock M, Heilbraun J, Mendzelevski B. Cardiovascular safety and hemodynamic considerations in oncology drug development -- webinar highlights October 10th 2012. Expert Opin Drug Saf. 2013 Sep;12(5):783-91. doi: 10.1517/14740338.2013.797407. Epub 2013 May 8. PMID: 23651420
Blogs
I recently gave a webinar focused on the implementation and benefits of using remote cardiovascular monitoring (telemonitoring) for clinical trials. Remote monitoring provides a promising patient management approach that produces increased data reliability, availability and early trend analysis and patient compliance with trial protocols. As a companion to my webinar, here are three considerations for clinical trial sponsors when establishing an approach to identifying a blood pressure response (safety or efficacy endpoint) and selecting a blood pressure monitoring method for their study.
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.
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)
Advances in technology are facilitating the acquisition of comprehensive and accurate BP datasets for clinical studies of cardiac safety and efficacy. Sponsors now have a continuum of choices for BP assessments including remote telemonitoring, which provides a promising patient management approach that produces increased data reliability and patient compliance with trial protocols.
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.