What's the best strategy for working with FDA regulators?

Today FDA staffers published an even-handed evaluation of VEGF Trap Eye (aflibercept). As Bloomberg reports, the drug helps prevent vision loss just as well as a rival treatment on the market. And it has a more attractive dosing regimen to attract patients.

Regeneron and its partner Bayer--which has submitted the treatment for European approval--have done an impressive job building up a data set that will be on full display Friday as their regulatory team makes a long planned presentation to an FDA advisory committee.

There's a lot riding on the new treatment for neovascular age-related macular degeneration. If the AdComm group waves it through, analysts give Regeneron good odds for a final approval at the FDA, which would open the door to direct competition with the blockbuster Lucentis. And there were some early indications today that analysts like Deutsche Bank's Robyn Karnauskas were happy to see no nasty surprises in the staff review.

But Regeneron didn't get here by chance. It had to coordinate a global regulatory strategy in a way that was most likely to deliver an approval as speedily as possible, without jeopardizing the outcome. That's no easy task in the biotech world. And it's a subject every drug developer has to consider carefully from a very early stage of development.

I'll be hosting an executive breakfast session at BIO's international confab later this month to query some of the industry's top regulatory strategists on just how clinical trial plans dovetail with the regulatory agenda. If you're planning to head to Washington, DC for BIO, make plans to come to the breakfast at the Grand Hyatt, where you'll hear from execs at AstraZeneca, Biogen Idec, Sanofi, Human Genome Sciences and Acorda.

I hope to see you there. Register here. - John Carroll (twitter | email) 

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