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Dilesh Doshi

Sep 21, 2026

9:14
How do you define real world evidence? in the context of today's FDA, particularly as it relates to rare diseases.
9:23
Yeah, thanks, Wayne.
9:24
I think I'm going to... dissect your questions in three parts, because I think it's important to provide perspective on the definition, as you said, asked for the real-world evidence.
9:35
You said today's FDA, so I want to come back to some of the comments Bethany made a minute ago in rare disease.
9:41
So, you know, if we keep it simple, FDA has definition that they have released around real-world evidence, real-world data, right? And So I think we can always refer to that.
9:52
From my perspective, it's really data that's the how and the where of the data, right? From a drug developer's perspective, our gold standards, our development programs are centered on clinical trial.
10:04
And that's our currency, essentially, right? Real-world evidence is everything else outside that.

9 MINS LATER

18:46
What makes a registry a lasting research resource for you?

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