Online registration has been closed, but we still accept your registration by email at japan@diaglobal.org or register at the venue. Please call at +03-6214-0574 for the details.

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The regulatory and scientific discussion surrounding the cardiac safety assessments of new drugs in development continues. Cardiac safety gained clinical and regulatory prominence following major drug-induced cardiovascular (CV) adverse events leading to high profile drug withdrawals and none-approvals. However, since the introduction of the ICH-E14 cardiac safety guidance in 2005 no additional drug withdrawals were reported, suggesting an absolute success of the E14 regulatory strategy. On the other hand, concerns regarding the cost of the E14 approach and the potential loss of otherwise useful drugs, prompted a renewed search for a more efficient paradigm.

Against this backdrop the US FDA introduced in July 2013 an alternative cardiac safety paradigm, known as the ‘Comprehensive in vitro Proarrhythmia Assay’, or CiPA. CiPA is comprised of a number of non-clinical and early-clinical tests, designed to characterise the ion channel interactions and cellular proarrhythmia propensity of investigational drugs and confirm these observations in humans using routine early clinical studies. The CiPA paradigm is still under development and the 6th DIA Cardiac Safety Workshop in Japan will provide insights and the latest information on the CiPA testing strategies and the science behind it.

While drug-induced QT prolongation and proarrhythmia continues to play a central role in drug development, other forms of drug induced cardiotoxicity are increasingly gaining public and regulatory attention. Drug induced contractility dysfunction potentially leading to heart failure, and drug induced hemodynamic changes, possibly resulting in hypertension and increased CV risk, are the two key concerns. These issues are associated with a number of therapeutic areas and drug classes, but are of particular concern with certain anticancer therapeutics. These and other topics will be discussed at the 6th DIA cardiac safety workshop in Japan, by leading clinical, industry and regulatory experts from all ICH regions.