2025 DIA Global Annual Meeting: Driving Global Regulatory Collaboration and Scientific Integrity
In an interview with ACT senior editor Andy Studna at the 2025 DIA Global Annual Meeting, Carie Pierce, SVP, global head of growth & business development, DIA, shares her perspective on the progress of international regulatory initiatives like Project Orbis and highlights the industry’s renewed focus on scientific integrity amid global challenges.
ACT: Looking back on the first half of the year, what are some achievements or advancements from the industry that have excited you most? Is there anything in particular you’re looking forward to in the second half of 2025?
Pierce: This isn't a new thing this year. I'm probably a little behind in learning about it, but I yesterday, was sitting with a panel of regulators, and they were talking about Project Orbis. I think what excites me is seeing some of this evolution of regulatory agencies starting to share data and use data in a different way and really allow the industry to put one submission forward in that, thinking about convergence and harmonization, but really seeing a much more concerted effort. Every time you talk to any regulatory body, that is one of the first things they bring up is the need for harmonization and you talk about these new therapies that are coming to market that didn't exist several years ago, and companies want to be able to approach a market approval in an efficient way. I think Orbis is something that is setting a stage for that. Maybe we'll start seeing that with cell and gene therapies in the future, but I think those are exciting evolutions, and again, technology is enabling a lot of that, but I think it's also the realization that—back to keeping up with innovation—if you want to keep up with the pace of innovation, the regulators have to be able to keep up with that pace too, and that means they have to work more efficiently, use more sophisticated tools, and be able to learn from each other and share that information.
The other thing that I love this year, it's a challenging year, right? There's so much threatening to divide us, in the world, geopolitical conflicts, all of that kind of stuff. I think when we come here, we get to be anchored in science, and I think that the focus on scientific integrity, really making sure that we're anchoring into real-world evidence that we're just working as an industry to really be moving the needle and basing that on scientific principles, and knowing that that always has to be that guiding barometer for the industry. I'm excited to see so much talk about that. Sometimes it takes a little political earthquake to sometimes bring an industry together, and I think we're doing that very effectively.
