I recently sat down with Dr. Boaz Mendzelevski, BioClinica's Vice President of Cardiology, to talk about an upcoming unique drug discovery course taking place in China this week. Dr. Mendzelevski will travel to Beijing to participate and lecture on cardiac safety as part of the course curriculum. Let's hear what he had to say about it.
What is the Chinese Course in Drug Development and Regulatory Science (CCDRS)?
The Chinese Course in Drug Development and Regulatory Science (CCDRS) is a novel, custom-designed, advanced university course that aims to provide an understanding of the biopharmaceutical R&D process and covers the key aspects of lifecycle management for new therapeutic products. It is hosted by The Peking University Clinical Research Institute (PUCRI), and is a joint effort in collaboration with the European Course in Pharmaceutical Medicine (ECPM, University of Basel, Switzerland) and the American Course in Drug Development and Regulatory Science (ACDRS, University of California at San Francisco).
CCDRS attracts a variety of students from diverse sectors, including Chinese professionals working in the pharmaceutical, biotechnology, and device industries, regulatory authorities and University scientists. The students participating in the course represent a range of backgrounds and expertise including Regulatory Affairs, Medical Sciences, Pharmacology, Data management, Statistics, Informatics, Drug Safety, and Project Management.
CCDRS faculty comprise top pharmaceutical executives, academic scientists and officials from international regulatory agencies including the C-FDA, PMDA, MHRA, EMA and FDA.
Have you previously attended the CCDRS?
This is my second year lecturing at CCDRS. I had the privilege of introducing cardiac safety into the course curriculum last year and will be lecturing on this topic again this year.
What is the focus of your presentation at CCDRS?
My lecture will focus on the evolving Cardiovascular (CV) safety field, covering 3 distinct areas of cardiotoxicity associated with drug development:
- Drug-induced repolarization-related cardiotoxicity (QT interval elongation)
- Drug-induced tissue-related cardiotoxicity (cardiac tissue damage and decreased Left Ventricular function)
- Drug-induced vascular-related cardiotoxicity (hypertension, arterial/venous thrombotic events and coronary artery disease associated with VEGF inhibitors, anti-angiogenic drugs and other agents)
My lecture is entitled: "Drug induced cardiotoxicity: An overview of key cardiovascular safety issues in drug development and regulatory responses." You can learn more about this topic from a recent publication which addresses aspects of cardiovascular safety in drug development.
Why it is important to be aware of the CCDRS?
This course is a rare (and great) opportunity to educate the next generation of pharmaceutical, academic and regulatory leaders in China. The importance of this course stems from its unique position as the only internationally led drug development course in China.
CCDRS is taught by eminent faculty and supported by the highest level of industry and regulatory experts, all of whom are leaders in their field and respective organizations. The course provides not only scientific and practical knowledge surrounding drug development but also critical guidance for students (and faculty members) who may be less informed of certain topics in the curriculum, such as cardiovascular safety, etc.
Are there regulatory changes on the horizon in China regarding cardiac safety and drug development?
The Chinese FDA (C-FDA) has recently embarked on an initiative to update its regulatory structure and framework to foster innovative drug development. Their goal is to modernize the existing regulatory system while maintaining high standards for drug development and drug safety. Aligned with this effort, the C-FDA has selected a range of guidance documents from the International Conference on Harmonisation (ICH) to be developed and implemented into C-FDA regulatory guidance. As an example, the ICH-E14 cardiac safety guidance will soon be introduced as C-FDA guidance.
