The Serious Adverse Event Consortium (SAEC) is a non-profit global partnership between leading pharmaceutical companies, drug regulatory authorities and academic institutions aimed at identifying genetic markers that may help to predict which patients are at risk from adverse or serious drug reactions (ADRs). It will provide a global knowledge base about these genetic variations and will be a major step forward in the drive to develop and deliver safer medicines.
ADRs are important causes of illness, limit the usefulness of many otherwise effective drugs, and are under strong genetic influence. Identifying the genetic variants that may influence a patient’s susceptibility to ADRs will greatly improve our understanding of the risk and molecular basis of adverse drug reactions.
Dr. Mariam Molokhia, Clinical Lecturer at the London School of Hygiene & Tropical Medicine, will be one of the main UK investigators of the collaborative project, and will be working jointly with SAEC to address clinical and scientific issues and identify DNA-variants useful in predicting the risk of drug-related serious adverse events, including liver toxicity and other series ADRs.
Dr. Molokhia co-ordinates the EUDRAGENE project, a European collaboration to establish a case-control DNA collection for studying the genetic basis of adverse drug reactions. She comments: ‘Research in this area is hampered by a lack of resources. As most such ADRs are rare, a case-control design is the only feasible approach, and a multi-centre international collaboration is necessary as no single country will generate enough cases of any given ADR within a reasonable time. I am delighted that the London School of Hygiene & Tropical Medicine is going to be playing a key role in a project that will greatly improve our understanding of genetic variation in relation to drug safety’.
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