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FDA Plans to Formally Kick Off SAE Consortium in a Few Weeks; Seeks Participants

NEW YORK (GenomeWeb News) – The US Food and Drug Administration plans to formally launch its newly formed Serious Adverse Events Consortium in “the next couple of weeks,” an FDA official told GenomeWeb News today.
As GenomeWeb News reported this morning, the FDA is forming a consortium of drugmakers and academic research groups that aims to study how genetic biomarkers contribute to serious adverse events.
Wendy Sanhai, senior scientific advisor in the FDA’s Office of the Commissioner, confirmed today that the agency is in discussions with several pharmaceutical firms and colleagues at the National Institutes of Health with the goal of collaborating to gain a better understanding of the genetic underpinnings of drug response.
Sanhai told GenomeWeb News that understanding SAEs “is a huge unmet public health need” and has been a “huge priority for some time” at the FDA.
“Some people are genetically predisposed to have SAEs to some drugs, so it’s not in the best interests [of the FDA and drugmakers] to simply launch these products,” she said, “but it is in their best interests to put appropriate information on labels.”
The goals of the consortium are ambitious. As one pharma official noted upon hearing of the project, many SAEs are extremely rare, which will require “thousands and thousands of patients to screen in order to validate a particular marker.”
Sanhai acknowledged that the consortium has an arduous task ahead.
“A lot of work has to be done to study genetic data because the population of patients who experience certain SAEs may be small,” she said. The consortium is planning studies that will be “sufficiently powered” statistically to identify patient populations at risk for suffering SAEs, she noted.
Consortium organizers are currently in discussions with several drugmakers, Sanhai said. The agency plans to work with these firms under the auspices of the SAE consortium to design and implement a number of studies and information-gathering projects that will look specifically at certain patient populations with the goal of identifying genetic editors for SAE risk.
All information from these studies will be placed in the public domain, Sanhai said.
The SAE Consortium will be managed by the FDA’s Office of Critical Path Programs. Sanhai said that the agency has not yet determined what the overall cost of the public/private initiative will be.
Sanhai said that FDA is in discussions with colleagues within the NIH, including those at the National Human Genome Research Institute, and noted that the agency hopes to attract broader participation in the effort.
“Any party willing to address this issue is welcome to join the consortium,” she said.
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