Please Wait...

Jeffrey Heilbraun

Translation skills

Main profile

Jeffrey S. Heilbraun
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. Throughout his career, 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

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.

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.

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

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.

Great #SCOPE2019 panel discussion today with industry veterans sharing ways sponsors and vendors can work together… https://t.co/U8j40R6y6R
Bioclinica (3 hours ago)
RT @teaminspire: Patients Are Eager for Trials But Aren’t Getting the Word, Survey Finds https://t.co/BfLxhmpzZg via @CenterWatch #clinical…
Bioclinica (9 hours ago)
RT @DrugInfoAssn: Didn’t make it to #DIAEurope2019 in Vienna? Read highlights from @EFPIA here: https://t.co/I1XYJkTBha
Bioclinica (9 hours ago)
RT @CDISC: Introducing the CDISC Library https://t.co/KsGqdqIZBO. Join the CDISC Data Science team for two informational webinars to accomm…
Bioclinica (9 hours ago)
RT @PhillyCooke: Reminder that @RAPSorg Philly chapter networking mixer is March 7 at @DePuySynthes in West Chester. Register now: https://…
Bioclinica (10 hours ago)
RT @FDAWomen: #BlackHistoryMonth is also #HeartMonth. With 48% of African American women having a form of cardiovascular disease, it is tim…
Bioclinica (10 hours ago)

Latest Blogs:

Site Payments Solutions
Nonalcoholic steatohepatitis (NASH) development programs
Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
Blood pressure monitor
Prescription box