15th October 2010Richmond Pharmacology will be attending the 4th DIA European Cardiac Safety Conference taking place later this month in Nice from 25th to 26th October 2010. Cardiovascular safety of new drugs has been at the centre of public attention and concern for more than a decade. Since the release of the ICH-E14 guidance in May 2005 the industry, regulatory and academic debate evolved from a focus on a single dedicated and thorough QT (TQT) study to the broader aspects of developing robust and continuous non-clinical and clinical models to establish scientific and practical methods for cardiovascular risk assessment.
While the TQT study is still the centre-piece of clinical QT assessment, there are several initiatives on-going, which look into the predictive value of alternative approaches, such as combining non-clinical data with intense QT assessment in early clinical studies. In addition, with the benefits of more data and better knowledge, drug-induced effects on other ECG parameters, such as the PR and QRS intervals, and on hemodynamic parameters, such as blood pressure, have gained attention as potential risk markers for adverse cardiovascular effects.These and other topics will be discussed at the conference, alongside presentations of new technologies, methodologies and novel biomarkers for early detection and risk management of drug related cardiovascular toxicity.Key TopicsThe future of thorough QT assessment - Where do we go from here Cardiovascular safety of oncology and biological pharmaceutical productsCardiovascular safety beyond the QT interval - Drug effect on other ECG indicesDrug effect on hemodynamic parameters
Blood pressure and related indicesUnderstanding cardiovascular risk as a cause of compound attritionRPL will be exhibiting at the conference so come down and see us at booth number 4 and speak to the experts about your TQT study needs.We'll see you in Nice!