2009 London Genetics / International SAEC Transaction

Setting:

The International Serious Adverse Events Consortium is working to improve drug development and safety via identification of genetic markers associated with drug-related side-effects. It was launched in August 2007 as an industrial biomedical consortium, focused on identifying and validating DNA variants useful in predicting the risk of drug induced, rare serious adverse events. The Consortium was developed with the FDA and launched with the scientific, technical and financial support of eight initial founding members Abbott, GSK, J&J, Novartis, Pfizer, Roche, Sanofi-Aventis, and Wyeth. The DARE study, a collaboration St George's University of London and the Drug Safety Research Unit (Southampton), was a five-year study of genetic factors underlying drug-induced cardiac arrhythmia. St George's University of London is a founding partner of London Genetics.

Objectives:

The International SAEC wanted to undertake a genome-wide study to identify those at risk of drug-induced torsade de pointes, a potentially lethal ventricular arrhythmia. Preventative strategies could then be developed.

Process:

Following an initial meeting with the SAEC, London Genetics located and brought the relevant parties together, and developed the collaboration agreement.

Results:

In April 2009 a collaboration between the International SAEC, St George's University of London, the DRSU and DARE was announced. St George's University of London is providing the International SAEC with clinical samples and data, and as a of the collaboration, more samples are being added to the DARE database.