Borje Darpo | Global Medical Director
iCardiac Technologies Inc

Borje Darpo is board-certified in cardiology and internal medicine. He has over 12 years of pharmaceutical industry experience, including senior management positions in small, mid-sized and large pharma, as well as in a global CRO. He has led or has been responsible for projects in all phases of clinical development, including filing and approval of an NDA. Dr.Darpo’s experience in cardiovascular safety assessment of drugs is broad and includes participation in the generation of current regulatory guidance on QT assessment (CPMP and ICH E14), previous co-chair of the ILSI/HESI CV safety subcommittee, member of the scientific oversight committee of CSRC, generation of internal company-specific guidelines on CV safety assessment and numerous reviews of programs both internally and as a consultant. Dr. Darpo has served as the EFPIA deputy topic leader for the ICH E14 Implementation Working Group, which worked with regional implementation of this guidance and support to sponsors through a Q&A process. Dr. Darpo is a member of the Scientific Oversight Committee for the Cardiac Safety Research Consortium (CSRC) with participation from FDA, academia and EU/US industry. Additionally, Dr. Darpo is one of the four external consultants to the FDA/CSRC White Paper Working Group developing industry guidance for QT assessment of drugs that has an effect on the heart rate or on autonomic tone and for which standard QTc analyses have clear limitations.