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SAE Consortium Kicks Off; Begins Two Projects to ID Genetic Markers Linked to Adverse Events

NEW YORK (GenomeWeb News) - Several large pharmaceutical firms and academic research groups today kicked off a collaborative effort that will use genomics to attack a central challenge of drug development: the fact that adverse drug reactions affecting only a few patients can hold up or prevent the release of a drug that could help many.
As GenomeWeb Daily News reported in May, the Serious Adverse Events Consortium plans to identify genetic markers that may help predict which individuals are at risk for serious drug-related adverse events. Today, consortium members officially launched the initiative and identified two specific studies they plan to conduct: One will address drug-related liver toxicity and the other will study a rare but serious drug-related skin condition called Stevens-Johnson Syndrome.
Member organizations include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, Pfizer, Roche, Sanofi-Aventis, Wyeth, Newcastle University, DILIGEN (a UK program that is developing a test to identify patients at high risk of developing drug-induced liver disease), EUDRAGENE (a European academic consortium conducting research on drug-related liver toxicity), Illumina, and Columbia University.
In addition, the US Food and Drug Administration is providing “scientific and strategic input” regarding the design and conduct of SAEC studies. The consortium said it also plans to consult the European Agency for the Evaluation of Medicinal Products and other national regulatory bodies for guidance.
SAEC chairman Arthur Holden said in a conference call today that the consortium plans to make all of the information it gains from these studies public so it may be developed into tests.
Holden, who also is senior vice president of corporate and market development at Illumina, said the SAEC expects to release the data from its first two studies in around a year in order to “create a knowledgebase to be available to future researchers.”
The SAEC is funding liver toxicity and SJS studies at Columbia University and at the University of North Carolina at Chapel Hill, which will perform analysis and genotyping studies on samples collected largely from Europe.
The consortium’s corporate partners will “provide needed financial contributions and define strategy and organize and manage research,” Holden said.
He added that the SAEC is not disclosing the buy-in cost for corporate partners, but said an article in today’s New York Times that reported a cost of $1 million per member group had misquoted him.
Paul Watkins, director of the Genetic Clinical Research Center at UNC-CH and a leader in the liver toxicity project, told GenomeWeb Daily News in May that the companies were paying $500,000 each to be involved in the consortium.
“It’s a great tragedy when a whole drug program is closed down because one or two people experience an adverse event,” Watkins said today during the conference call. Watkins said this effort is “an exciting and pioneering opportunity to gather DNA banks from around the world,” and then make this information available to pharma and academic researchers.
Watkins said the project’s “immediate goal would be a genetic test that would allow us to identify who might have a problem with a drug,” such as liver toxicity.
The FDA has been struggling for three decades with SAEs, said Janet Woodcock, assistant director of the FDA, adding that good drugs have been stalled or removed from development programs because of the “fear” of these reactions.
“We haven’t been able to do anything about this until recently,” Woodcock said, noting that recent advances in genomics may help finally address this issue. In a year or two, she said, drugs could be labeled with information about genetic-based adverse events and drugmakers could begin tailoring drugs for specific patient populations. 
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