Global Collaboration and Technological Acceleration to Evolve Drug Innovation

PharmTech recently spoke with Frits Stulp, Partner Life Sciences, Implement Consulting Group, to get his perspective on trends that shaped pharmaceutical development and manufacturing in 2025 and where things are headed in 2026. In this part 2 of our two-part interview, Stulp highlights that "geopolitics influence" the current pharmaceutical landscape, noting that "ever since COVID, there has been a lot of concern on the supply chain" and an unprecedented "focus on shortage management." He observes that the industry is struggling with the "challenges of patent cliffs" and the reality that "it is difficult to find new blockbusters." As a result, he expects that "M&A activity... will continue" and potentially grow because "considering how difficult it is to find new blockbusters... that level of interest will stay there or even get bigger."

Addressing the "decline of clinical research taking place in Europe," Stulp argues that balancing local and global efforts is vital because "looking across all these different continents is what gives the power to develop the right medicines and to monitor our medicines." He identifies "the application of new technology, like AI" as the primary solution for "addressing patent cliffs and concerns." A key area of interest is the "concept of working together with the regulator in a secure space," specifically through pilots like the PRISM project.

These environments allow for the use of "AI agent-like functions" to "accelerate the regulatory process." Stulp notes that this requires a "cultural change" for scientific authors, shifting from trading comments on documents to a system in which participants "actually work in the same document and we have a common thread that's taking place there." He notes that many current initiatives involve "live products, live variations of those products, and with real regulators." While this evolution may be "scary, maybe even a bit risky for some people," Stulp maintains it is necessary to show "that this can work" because the industry needs to "accelerate."

Watch Part 1 of this interview here!

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

I think it's a very relevant topic at this time, and I'm afraid that even the geopolitics influence this. There has, of course, ever since COVID, been a lot of concern on the supply chain. And I've never seen as much focus on shortage management as we do today both in Europe and other regions.

At the same time, we see, of course, that this industry has been faced with challenges of patent cliffs. It is difficult to find new blockbusters. And I think we even see how geopolitically some regions are advancing faster or differently. There's a lot going on in the US. There's of course a lot going on in China.

And being a European, I actually see the decline of, for example, clinical research taking place in Europe. So there is both from a governmental point of view, but also from local industry or at least local representation of industry, there's a lot of focus on “How do we balance it out?” Because actually looking across all these different continents is what gives the power to develop the right medicines and to monitor our medicines.

And I think that's something we should really be looking at. I do expect that the application of new technology, like AI, like we said is going to be a key way of addressing patent cliffs and concerns. I think there is a lot of M&A activity and I think that will continue because of course, as economies change opportunities may arise, and considering how difficult it is to find new blockbusters, I think that level of interest will stay there or even get bigger.

And then of course the challenge is “How do I integrate that into my existing company? How do I keep the data, how do I streamline my processes?” And that's actually where I think it gets interesting for me again. “How can we make all of that work?”

Like I mentioned, the concept of working together with the regulator in a secure space, and the pilots that are taking place in that field, many of them coming from the PRISM project in the US but also some of the companies undertaking efforts in that already is extremely interesting in my view.

Working together in a highly secure environment also allows you to start using some of the new tools that are out there. And I think a great example is how can you use AI agent-like functions in an environment that's secure for your data, often very sensitive data, so that you can actually accelerate the regulatory process that you're in?

That accelerated regulatory process is something we also have to get used to because you can already see that the way of working is the way that we have been used to for a long time, and now all of a sudden when we don't share documents with comments to each other, but we actually work in the same document and we have a common thread that's taking place there, that does change the ball game a lot and that does make it exciting as well. And I think that's also asking for a cultural change. For some authors in the scientific field, that may be challenging. But I think that is what I'm really looking forward to, and it will require more pilots. And I'm also happy to say that many of the pilots that I've seen in this space, you can barely call them pilots because they are with live products, live variations of those products, and with real regulators.

And the outcomes are, therefore, also real world to be used. And I think that's exciting, sometimes a bit scary, maybe even a bit risky for some people, but that is the way to show that this can work and we do need to accelerate.