ACT: What were your impressions of the sessions at DIA?
Pierce: The sessions that I saw that were the most well attended really had extensive presence from either patients or from regulators, and the town halls continue to be one of the most popular things at the Global Annual Meeting—that’s where various countries have their regulatory panel sitting there and talking about their priorities, their challenges, and what’s keeping them up at night. What do they want to focus on for the next year? When you can go around the world and really sit in—whether it’s Europe or FDA or PMDA, Anvisa—and hear this and you’re a company that’s focused on global drug development, it just gives you a bird’s eye view into what they’re thinking and maybe how to approach those conversations with those regulators and what you might expect to see from them.
I love those meetings because both sides of the coin get to present their challenges. You hear from drug companies what the challenges are in recruitment for clinical trials, for example, but then you hear from the regulators some of their challenges in regulating some of the novel technologies that are coming forward, like AI and cell and gene therapies. When both sides can really hear where the intersections are and where some of the challenges are, I think that’s only going to lead to people working together more effectively in the future.
We also had a number of great innovation theaters this year and a number of sessions talking about AI, and I just don’t think that’s going to slow down anytime soon. Everybody is getting on the bandwagon of AI and trying to figure out where do we use it? How do we use it? How are the regulators going to look at AI? I think the regulators are interested in the topic too, right? They want to know what’s going to be coming their direction, that they’re going to have to regulate, and what do they need to understand to be able to feel comfortable with that technology? I think everything that was tied to AI, I saw just standing room only, lines out the door, and people continue to talk about those sessions.
Last, I’ll say there was a session on global harmonization, and we had the chairman of the FDA, chairwoman of EMA, and a number of other regulatory bodies, all on the stage together. I think that’s something you don’t get to see very often, but that was a standing room only. I know I had a seat in the back, actually sitting on the floor, because it was such a packed session, but to be able to hear the challenges that people are experiencing with the FDA, with EMA, with Anvisa, etc—that they’re very similar across the world, they’re all struggling with the same things, and they have similar points of view on their mind, and they’re also discussing where their views differ, and how they think they can work together to really make a more efficient, streamlined global regulatory process.