Submission Deadline: May 31, 2018 (Japan time)
Although the implementation of the ICH E14/S7B guidelines is considered a success, proarrhythmia risk assessment continues to be one of the most important and challenging issues in drug development. The proarrhythmia risk assessment regulatory paradigm entered a new era in 2015 with the release of the ICH-E14 Q&A R3 document, which allows the use of Concentration Response Modeling of QTc data in lieu of the E14 ‘by-time point’ analysis as the primary basis for regulatory decisions. Concomitantly, development of new non-clinical CV risk assessment strategies, such as the use of induced pluripotent stem cells (iPS) derived cardiomyocyte and in silico cardiac models have been making advances both in Japan and abroad.
In addition to the well documented proarrhythmia risk, other CV risks including those associated with drug-induced changes in blood pressure, cardiac function and cardiomyocyte (structure), have been recognized as important issues requiring attention and appropriate assessment during drug development.
Furthermore, the increasing importance of the emerging field of cardio-oncology, reflects the success of new cancer therapies in improving life expectancy of cancer patients on one hand, and the recognized CV risks of innovative anticancer drugs including molecular targeted therapies on the other hand. A wide range of cardiotoxicities associated with existing and new anticancer therapies were reported, including cardiomyocyte injury and heart failure, vascular injury and hypertension or thrombosis, accelerated coronary artery disease and proarrhythmia, amongst others.
The 7th Cardiac Safety Workshop in Japan will deal with the above and other topics. The program committee is inviting authors to submit abstracts for review, for oral presentation at the main event.
TOPICS FOR ABSTRACT SUBMISSION
Non-Clinical Safety Pharmacology and Electrophysiology
Novel surrogate biomarkers for pro-arrhythmia
Integrated cardiac safety assessment throughout the drug development
QT dynamics under normal conditions and conditions favouring arrhythmia
Assessment of drug effects on multiple ionic currents for cardiac safety screening
Utility of human induced pluripotent stem cell derived cardiomyocytes to predict pro-arrhythmia risk
Possible roles of in silico predictive modeling in assessing pro-arrhythmia risk
Non-clinical assessment of cardiac contractility or cardiac conduction
Clinical QT assessment - Study Design, Analysis and Outcome
Ethnic differences in QT pharmacodynamics
Concentration-Response modelling in TQT and intensive Phase 1 ECG studies
Statistical hypothesis and interpretations of TQT study
Correlation between QT assessment in early trials and TQT studies
Study design and statistical considerations for intensive Phase 1 ECG studies.
Clinical Cardiac Safety Assessments
Assessment of cardiotoxicity in oncology drug development
Design and interpretation of Cardiovascular Outcome studies
Assessment of other ECG biomarkers including HR, PR and QRS intervals and autonomic effects
Study design and experience in monitoring blood pressure as a safety end point
Peri-Approval and Post Marketing Cardiac Safety Strategies
Novel post-marketing risk management strategies
Cardiac Adverse Event classification and reporting
Capturing clinical CV safety outcome data using post market surveillance data
Big data analysis
Drug development and clinical research managers and associates
Pharmaceutical physicians and medical directors
Safety pharmacology and non-clinical scientists
Drug safety and drug surveillance personnel
Clinical pharmacology scientists
Regulatory affairs managers
Outsourcing and marketing managers
Decision makers in drug safety, including toxicology, pharmacology and compliance
INSTRUCTIONS FOR SUBMISSION
Abstract must be typed in English.
Abbreviations should be avoided.
Submission of an abstract is understood to imply that the article is original and is not being considered for publication elsewhere.
If you are accepted as a presenter, your registration to the workshop would be complimentary.
Please view also CFA Flyer.
Please also visit this workshop website.
If you have any questions, please contact JapanAnnual@DIAglobal.org