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.
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).
Featured White Paper from the Cardiac Safety Research Consortium
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
Thanks to scientific advancements and increased understanding of pathways and systems that contribute to cardiac risk, the cardiac safety ECG environment continues to mature and expand. Presently, the assessment of QT/QTc from the electrocardiogram is the primary focal endpoint in cardiac safety.
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
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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.
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