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Jeffrey Heilbraun

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Jeffrey Heilbraun
Sr. Director Medical and Scientific Affairs

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. Throughout his career, Jeff has maintained his focus on the science, technology,  trial design and regulatory considerations surrounding  cardiac safety (ECG and blood pressure endpoints) 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), and at the Cardiac Safety Research Consortium (CSRC).  He has supported publications in cardiac safety considerations in Oncology drug development and the regulatory considerations for “off-target” blood pressure response in compound development.

 

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Authored Publications

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 2012Expert Opin Drug Saf. 2013 Sep;12(5):783-91. doi: 10.1517/14740338.2013.797407. Epub 2013 May 8. PMID: 23651420

Blogs

If you are in clinical development and interested in latest developments in cardiac safety blood pressure (BP) requirements, I encourage you to attend a public workshop announced by the U.S. Food and Drug Administration (FDA) entitled "Evaluating the Pressor Effects of Drugs & Ambulatory Blood Pressure Monitoring Studies." This workshop is convened by the Duke-Robert J.

Blood pressure monitor

— Part 2 in a 3-part blog series on cardiac safety regulatory developments

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.

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