 Boaz Mendzelevski, MD Medifacts International Vice President of Cardiology & Chief Medical Officer Visit Website |
Dr. Mendzelevski received his degree in Medicine and Board Certification in Internal Medicine from the Ben-Gurion University Medical School and Hospital in Beer-Sheva, Israel. He then trained in cardiology and received a board certification in Cardiology from the Shaare-Zedek Medical Centre and Hebrew University in Jerusalem, Israel. Dr. Mendzelevski completed further postgraduate training in Interventional Cardiology and Clinical Electrophysiology at the Royal Brompton National Heart and Lung Hospital in London.
Dr. Mendzelevski has authored approximately 220 cardiology expert reports, most of which supported NDA regulatory submissions. He has represented pharma clients before the US FDA and the European regulatory authorities on several occasions and has participated in multiple pharmaceutical advisory boards and Data Safety Monitoring Boards (DSMBs). Dr. Mendzelevski was the only CRO expert to be invited by the FDA and ICH to serve on the ICH-E14 expert advisory panel.
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Cardiac Safety Q&A
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Are there any ways to ameliorate the cardiac risks of a drug in development, if such risks are detected early enough? Is it possible to “rescue” a drug that exhibits those risks in the early clinical stages? Or should the developer just move on?Answered January 27th, 2010 by Expert:Affirmative. There are several examples of drugs including antipsychotics and antiarrhythmic that had to be withdrawn from the market due to cardiotoxicity, in order to be reassessed and possibly redesigned. Some of these effects and adverse drug reactions (ADR), including unnecessary loss of lives, could have been prevented if dose-limiting toxicities had been appropriately assessed during development program. We have been party to a few drug-development programs where we were able to guide the development team on the DLT or the maximum tolerated doses based on serious cardiovascular ADRs, while maintaining a good balance between safety and efficacy.
1 commentOne response to to “Are there any ways to ameliorate the cardiac risks of a drug in development, if such risks are detected early enough? Is it possible to “rescue” a drug that exhibits those risks in the early clinical stages? Or should the developer just move on?”
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Please take the time to evaluate SPECKLE TRACKING which quantifies regional strain in echocardiography and is a TRANSLATABLE tool without side effects and can be performed at a low cost compared to other imaging modalities.
We are finding VERY early readouts in small animal studies using this technique that are far more valuable than standard ejection fraction measures in cardiac imaging.
This is being used in SCREENING for a wide variety of compounds in drug development and is proving to be invaluable in go/no-go decisions in drug development programs.
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