Glenn Wright Highlights AI, FDA Insights at 34th Annual PDA Regulatory Conference

PDA President and CEO Glenn Wright highlights the significance of the 34th Annual PDA Joint Regulatory Conference, noting his long-standing connection to the event: “I was actually chair of this conference when it was year number five… I've been involved with PDA for 36 years.” He praises the alliance between industry and regulators, emphasizing that “we really have kind of a nice industry-FDA collaborative conference.”

This year’s agenda captures emerging trends, including artificial intelligence (AI) in manufacturing and compliance. Wright shares his enthusiasm: “I always talk about the tidal wave of AI and data analytics that's gonna be hitting the industry. It really is good for the patient. It really means we have more control of the processes.” Attendees can also expect sessions on quality culture, effective remediation, and the critical roles of CDMOs and CMOs in modern manufacturing.

The conference remains a vital source for regulatory updates. “Some really great updates from FDA, really talking about trends that they're seeing, which is really important for the industry as a whole to understand what's going on out there,” notes Wright. He concludes with optimism, adding “We're just really excited. It's gonna be, I think, a hugely successful conference again for year number 34.”

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Transcript

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Glenn Wright, I'm the president and CEO of PDA.

Well, I'm really excited about this year's conference, our 34th regulatory conference. I can remember, quite some time ago, I was quite new to the industry and I was actually chair of this conference when it was year number five. So that should tell you I've been involved with this conference for quite a long time.

I've been involved with PDA for 36 years. You know, every year this conference surprises me because there's always exciting things that are going on in the industry and it kind of captures that, as well as with the heavy FDA involvement. We really have kind of a nice industry FDA collaborative conference, and this year, the topics are diverse. I mean, we're gonna be talking about AI in manufacturing, which I am really excited about. We're also gonna be talking about AI in auditing. I just got done doing a presentation on that topic. It's really incredible when you think about what AI may do in that whole auditing area in regard to looking at data, looking for anomalies, trying to find challenges that a company may have or an area may have, you know, so that's gonna be kind of exciting to me 'cause we see that AI space just continuing to grow. And then just AI in manufacturing, right, because again, you know, if we're thinking about product quality, once we get AI in manufacturing—and it's really ramping up, right. So I think I always talk about the tidal wave of AI and data analytics that's gonna be hitting the industry. It really is good for the patient. It really means we have more control of the processes. So that's just one small area I'm excited about.

I'm also excited about the talks on quality culture and really how to implement quality culture. I think that's fantastic. And there's a couple talks on remediation. So, you know, once you've had challenges and now you're gonna have to remediate those challenges, how do you go about that? How do you develop your plan? Some exciting things there. Again, it covers so many things, supply chain is on there, supply chain disruption, some discussions around use of contract services, so CDMOs and laboratories, and that's really important for the industry now as we see continued increases in the use of CDMOs and CMOs. They're so important because they have the technology that we need a lot of times, and so as new products get more and more complex, a lot of times those CDMOs and CMOs are just critical for that operation. But how do you manage that and how do you make sure you've got enough control over your contracted operations? So, some discussions on that, which I think are gonna be really exciting. I always like group topics, around the pre-approval inspections and what can you kind of expect in pre-approval inspections and what are the trends? So, we're gonna have some topics on that.

And of course, as we do every year, some really great updates from FDA, really talking about trends that they're seeing, which is really important for the industry as a whole to understand what's going on out there, what are they seeing, because when we think about FDA, you know, we have to remember that they see everything. They're the ones that can really help industry by letting us know what kind of trends are going on, what are they seeing as they go out and do inspections or what they see during submission reviews.

Another great topic this year is gonna be on post-approval changes, which, you know, for me being in regulatory for many, many years, is really exciting because we always kind of forget how important the post-approval change process is, how we need to navigate that carefully. You know, it can take years when you think globally about making a change and getting it approved by all the different countries. So that whole PAC (post-approval change) process, I'm really excited to see that topic on this year's agenda as well.

You know, I think the biggest takeaways from this year's conference, I think they're probably gonna come from the FDA speakers as they talk about some of the things they're seeing, some of the challenges they're seeing. That's always kind of the case. I think in this conference, we hear really great things from industry, kind of some practical approaches on how to do things, how to implement things, and that's really great, but there's always those great nuggets that come out of the agency in regard to things they're seeing and the expectations they have. And, so I think, those two areas… really excited to see what comes out.

I never quite know, you kind of got to be there, you got to go through the presentations to understand everything. So, I think, on the back end of this, I'm sure I'll have some, nuggets that we've gained from the conference, but we're just really excited. It's gonna be, I think, a hugely successful conference again for year number 34. Again, FDA is heavily engaged in this conference, as is industry. And we've got folks all the way from heads of manufacturing to heads of quality talking—all kinds of folks from the agency, so I really think it's gonna be a great conference.