Regulators and pharma to join forces on drug safety monitoring
pharmafile | September 28, 2007 | News story | Sales and Marketing |Â Â reg, safetyÂ
Regulators, the pharma industry and academic institutions are to come together in a new global alliance to research drug side-effects.
The Serious Adverse Event Consortium could represent a new era of joined-up thinking in terms of understanding drug safety, pooling for the first time the data and expertise of the industry, leading research hospitals and regulators.
The consortium specifically aims to identify genetic markers that may help to predict which patients are at risk from adverse or serious drug reactions (ADRs), and provide a global knowledge base to help develop safer medicines.
Formation of the group (SAEC) was announced by Janet Woodcock, deputy commissioner and chief medical officer of the FDA, along with Arthur Holden, chairman of the SAEC.
Dan Burns, senior vice president for pharmacogenetics is one of the industry representatives who will take part in the work.
"Improved technology makes it more possible for us to identify and even predict how patients may react to a particular medicine," said Burns.
"By working together, we can accelerate and expand work already under way to understand how we can use genes to identify which patients will benefit most from which medicines."
The London School of Hygiene & Tropical Medicine is to be one of the academic bodies contributing to the consortium.
Dr Mariam Molokhia, clinical lecturer at the school, will be one of the main UK investigators in the collaborative project, and will be studying and identifying DNA variants useful in predicting the risk of drug-related, serious adverse events, including liver toxicity and other serious 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 said: "Research in this area is hampered by a lack of resources. As 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."
The launch of the new consortium coincides with a raft of other measures to strengthen post-marketing safety monitoring, particularly in the wake of the Vioxx withdrawal in 2004.
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