Navigating an Uncertain Regulatory Landscape

Pharmaceutical Executive: Due to recent political turbulence, many companies feel like they are facing uncertain regulatory environments. How can they strategize for that?
James Foster: We're, relatively speaking, a small firm, so we're able to stay nimble. As a result of that, we can move with the punches, so to speak. But I think a lot of from an executive perspective, and the way that we have to look at things is you have to strategize around particular events potentially occurring.

This tariff event, if we want to talk about that specifically, is something that we've strategized over the past few years. As a result of that, we have various means and methods in order to work around that particular eventuality. Again, to use the tariff example, we've discussed the possibility of setting up specific operations in the US, or moving more of our supply chain to the US as a result of what's occurring at this point in time and what might occur in the future. That's just one of a number of different scenarios that we've planned out as a result of around the world, geopolitically or otherwise.

I think any good executive would have Action Plan A, B and C and would act accordingly based off of those. If you don't have that, given how unstable things potentially can be, it's going to be difficult. As a relatively small firm, we have a nimbleness within that environment. That gives us a slight advantage because our supply chains aren't set in stone in particular regions or jurisdictions. That allows us to roll with the punches alongside what's happening geopolitically.

PE: How has the recent technological boom impacted launch strategies?
Foster: I think it's assisting. You could be talking about a vast range of different things, but if you want to just pick AI, it's really assisting. It's something that we've integrated in a lot of our systems.

Chat GPT just recently brought out a new feature called deep research. These tools are really fantastic for businesses like ours. In the case of deep research, which we're integrating at this point in time, we would take days, weeks, or even months, producing research reports for what it is we're doing in our back end. As a result of AI, we're getting huge assistance on just the nuts and bolts of what we try to do from a research perspective. We can generate incredibly detailed research reports, which are very accurate, in a matter of minutes. For us, that is absolutely huge, and it's true across the whole of our industry.

PE: How can companies planning for a global launch choose which market to focus on first?
Foster: I preface my answer by saying that every business is different. You have industrial inertia depending on what it is you're doing. In the example of diagnostics, which is our business, it might be the fact that you have a lab in a particular jurisdiction, and therefore it just makes business sense to start in that jurisdiction.

On the other hand, depending on what it is you're really doing, you'd have to look at your total addressable market and look at the big picture. That's what we've been doing for our particular business. A great deal of it goes into the US, so a lot of what we've been doing and attempting to do is work through the various workflows in order to enter the US.