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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
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.
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
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.
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
Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.
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