June 12, 2009

EOP2a Returns – A Critical Milestone in the Regulatory Process

The FDA is gearing up to make pharmacometrics an even more critical component of the FDA review process, according to “Remodeling the FDA,” a June 11, 2009, article in Bio-IT World. “Very soon, FDA will restart its End of Phase 2A (EOP2A) meeting program during which sponsors and FDA collaborate often using modeling and simulation (M&S) – pharmacometrics (PM) in FDA parlance – to analyze current data, refine clinical trial design and to inform industry’s critical go/no-go decisions on projects,” states the Bio-IT World article.


The growing importance of modeling and simulation at decision-making milestones like the EOP2a meeting means that companies will be required to defend the science and the data behind their decisions. Cognigen scientists participated in one of the first EOP2a meetings during the pilot program from 2004 to 2007. FDA scientists said that Cognigen set the bar very high for future meetings.


In the Bio-IT World article, Dr. Joga Gobburu, who heads the FDA pharmacometrics group, commented on an early EOP2a meeting, saying, “There was an issue about the dose selection for a compound under development. The sponsor was heading in one direction about the dose selection. The studied doses failed to achieve the clinical significance. Then they came to the EOP2A meeting and we worked with them on the possibility of an alternative dosing which would enhance the success of the trial. The sponsor embraced that. They tested that dose in the next trial and bingo, it passed. And we approved it.”


Cognigen is a state-of-the-art scientific, technical, and strategic partner for clients in the pharmaceutical and biotechnology industries. To learn more about our services and how we can align your drug development programs with pharmacometric initiatives at the FDA, call us at +1.716.633.3463.

 

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EOP2a Returns – A Critical Milestone in the Regulatory Process

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