Asembia's AXS26 Summit: How US Regulatory Updates are Impacting Global Launch Strategies

In January 2026, FDA issued draft guidance that expanded the potential use of real-world evidence (RWE) during the clinical trial process. At the time, FDA commissioner Marty Makary explained that the decision was made to improve the cost and timelines of the drug development process.

This is just the latest move from FDA to expand the use of RWE. Pharmaceutical Executive caught up with Tommy Brammley, SVP of global consulting at Cencora at AXS 2026 in Las Vegas to discuss how regulatory changes for RWE are impacting global launch strategies.

According to him, the move to accept RWE started about a decade ago with a major regulatory action.

Click here for our full coverage of Asembia’s AXS Summit 2026!

Pharmaceutical Executive: How are US regulatory updates impacting global strategies, specifically global launch strategies?
Tommy Bramley: FDA really led the way with the 21st Century Cures Act in 2016 to lay the groundwork for the acceptance of RWE into the approval process. EMA is also on that same path, and has been very receptive to those evidence packages.

Sometimes the data is not viewed as fit for purpose, and it's too messy. That's where we can come in to help make sure the data is collected in the right way, that there's reliable methodologies being used, and we're removing any of those biases that could plague a RWE submission.

It's happening across the globe. There are several guidances that are being put in place, but what you have to keep in mind is what you are trying to improve. How are you going to do that, and what are the best methodologies to capture that information?