Merck KGaA

Ah

... for Merck KGaA, uh, German Merck, not the, the US one, um, in, in Devon and Cornwall.

Um, so hence why I went again and s-s- based with my parents in Somerset.

So the commute was quite a, quite a lengthy one, especially during-

[upbeat music] Welcome to another episode of The Effective Statistician, and today I'm so happy to have Gorana Capkun from Merck on the line.

She is the head of the Real World Evidence department at Merck, the German Merck, and we will talk about a very, very interesting topic, which I think all statisticians should have a close eye on because it's very close to data, and that is integrated evidence planning plans.

And so Gorana, welcome to the podcast episode.

Thank you, Alexander, and hello to everyone who's listening to us.

So this is why starting early with right core representatives of all of our internal functions is really key.

And when these endpoints need to be collected, for example.

I just saw an outcome from a German HDA review, and they had a comparative study.

So that was great.

Today though, we've really got a fantastic panel with us.

From Merck Group, we have Andre Silva.

From MilliporeSigma, we have, uh, Sarah Powell-Price, Sally as we're gonna be calling her.

From Vireo Advisors, we have Joanne Shatkin.

Um, I'm just gonna talk to you a little bit today.

We're setting the stage with regulatory.

Um, so just a quick disclaimer from my side, the life science business, um, Merck KGaA Darmstadt, Germany operates as MilliporeSigma in the US and Canada.

So when we think about, um, setting the stage for, uh, novel proteins, how do you pick the best lab? Um, if you are a lab, how do you become the best partner for manufacturers, for people who are interested in working in the novel food space? Um, the reason that we start with regulatory is because regulatory is probably the best, uh, scene setter for whether you're going to, you can succeed or fail, um, at the get-go.

It's different.

So actually being able to form part of different forums and I've seen people from different companies, let's say like, you know, like the big players in the industry, like Amgen, Novo, Merckx and all those people meeting and trying to find a harmony on how they do, for example, validation, right?

Yeah.

But sometimes what gets discussed there, right, when it gets back to their facilities, it's typically up to high-level managers to have that same mindset, right? And that mindset sometimes is just different from company to company.