A call for more integrated cardiovascular safety assessment

Cardiovascular safety concerns are a significant cause of attrition in the development of new drugs (Lasser et al., 2002). This attrition has significant public health implications and also contributes to the rising cost of developing new drugs. However, a better understanding of the inter-relationship between nonclinical and clinical predictors/measures of cardiovascular risk as well as a more integrated and predictive development strategy could dramatically augment the development of safe and effective medicines for patients in need. In response to this need, a consortium of industrial, academic, and government scientists designed and executed a three day 'think tank' under the auspices of the non-profit ILSI Health and Environmental Sciences Institute (ILSI HESI) in June 2009 in Washington, D.C. This highly interactive scientific forum provided a unique opportunity for experts with diverse cardiovascular-related expertise to collectively discuss issues, challenges, and opportunities to improve the overall pharmaceutical cardiovascular safety assessment paradigm. This article identifies the major points of consensus and recommendations stemming from this workshop.