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IRISS Forum Insider: What is the IRISS Forum and what's ahead in 2026
18 Plays1 month ago
Welcome to our new podcast series from the IRISS Forum! Today’s episode is all about getting to know IRISS and our exciting plans for the future.
Board Chair Jake Doran and President Brooke Casselberry share the history and mission of IRISS, reflect on its evolution, and highlight what’s ahead for 2026 — from data‑centric topic groups to expanded membership and refreshed leadership.
If you’d like to learn more about IRISS and our mission, visit us at: https://iriss-forum.org
We hope to see you in our community!
Transcript
Introduction to IRIS Forum and Podcast Series
00:00:00
Speaker
Hi everyone, welcome to the first episode of our new podcast series featuring the IRIS Forum. Today we're going to take some time to give an overview of what the IRIS Forum is for those who may be new here, and also share some exciting updates and plans for the future.
00:00:12
Speaker
Stay tuned for more episodes in the future all about standards and readiness in the regulatory life sciences industry, and be sure to check out our website to learn more about IRIS and our global community. Thanks for joining us today, hope you enjoy.
Role of IRIS in Regulatory Life Sciences
00:00:25
Speaker
Hi Brooke, how are you today? Hi, Jake. I'm doing well. It's good to be working with you again. Yeah, very, very excited about this. It's been some time. Really happy that you've joined the IRIS community here, and I think but we'll take a little bit of time today to go through a little bit about IRIS. We'll share for our listeners what IRIS is all about, how we came to be, some of the exciting things that are going on in 2026. We just got back from Washington, D.C., our annual face-to-face. So I think we've got a lot of great things to talk about today.
00:00:54
Speaker
Yeah, we have a lot of really good things to talk about. And I'm really honored to be back here. Kind of feel like a boomerang a little bit with the IRIS community. It's been around for quite some time. And i'm really I'm really proud to be able to volunteer with this group of leaders. So again, thank you for having me. It was really nice to be able to brainstorm some of the ideas that we had that you guys have been working on for a long time while we were in D.C.
00:01:19
Speaker
I thought maybe where we could start is, you know, there may be listeners who are are new to Iris. So take a little bit of time, a couple of minutes just to describe the best way to capture the essence of Iris. and And I think to me, it comes down to like Iris is a a global multi-stakeholder, first and foremost, nonprofit organization, focus on only understanding and educating the industry around regulatory information and submission standards as they come into existence.
00:01:49
Speaker
Is it also fair to say that IRS typically does not participate in commenting on guidances as well, right? So new guidance comes out, new FDA regulations comes out when it has open commenting period. Now, IRS might come together as the community to review it and discuss it openly, but we typically would not directly submit comments to those guidance.
00:02:13
Speaker
yeah Yeah, with almost a thousand members across IRIS, it's easy to state that everybody's going to have an opinion. Everybody's going have a perspective on these standards. But as an organization, we don't collectively put a position on any of those standards. So we leave that to the sponsor organizations that participate with trade associations. We would never be able to satisfy all thousand members with a single position. So while we discuss those things, IRIS itself does not take a position position on policy.
Transition to Electronic Submissions
00:02:40
Speaker
Very good to call that out.
00:02:42
Speaker
I thought we can get into a little bit about the the history of Iris and why it was created, what problem it was created to solve. And just, I'm not going to dive into the full history of it, but we do have a timeline on the website. So iris-forum.org, anybody can visit to get more information, but maybe we'll just take a couple of minutes now to talk a little bit about how Iris came to be. As I mentioned earlier,
00:03:04
Speaker
I've only been involved in leadership for the last seven years, but IRIS has been around since the early 2000s. And really, it was brought into existence to help the organization help industry deal with the shift from paper submissions to structured electronic formats, really with the introduction of ECTD. And at the time, you know standards were emerging quickly. Implementation across companies was very inconsistent, and it was often unclear. It was very difficult for sponsor organizations to get time with regulatory regulators to understand.
00:03:34
Speaker
What standards were required, what was expected of them. And then ultimately, it came down to the companies to determine like how they can most efficiently operationalize and implement those standards into the into their organization. And Iris was really created to bridge that gap.
00:03:51
Speaker
Yeah, there are definitely some things that have changed since IRIS has started. And there's some things that we would really like to see change a little bit faster. And I think that's also where IRIS has been such a great consortium of individuals to come together to help influence
Global Submission Standards
00:04:05
Speaker
that change. and help to just keep everybody aware of what is going on and what is top of mind. And like the GSO so group within the Irish community has done such a fantastic job over the last couple of years, especially as they got formulated out on staying on the forefront of global submissions and what does globalization look like from a sponsor's perspective. And, you know, especially with the last couple of years have had to hold for us since 2020, you know what I mean? It's had a lot of really good influence. And with ah then I think you're going to talk a little bit more about the topic groups specifically.
00:04:35
Speaker
But yeah, I do recall, you know, all the years ago when I think it was Rick Regal that brought Iris together at the start of ECTD. And to see it still be such a prosperous community after all of this time, I think speaks volumes for all the work that has come together and all of the volunteers that continue to keep it energized, which is really critical because it it wouldn't be what it is without the volunteers, right? And that's that's for sure. And i think it's easy to call out one of the biggest moves has been moving from a document centric to a more data centric. And like you mentioned that it hasn't happened, maybe at the acceleration of the speed that industry or we would have liked, but it continues to move in that direction. so
00:05:18
Speaker
As we move into 2026, like we're not reinventing Iris, but there's certain things that we're going focus on. So I think it's really a okay, what I'll phrase a meaningful phase of evolution.
2026 Focus and Membership Growth
00:05:28
Speaker
And there's three things that we really want to focus on going forward. One's going to be membership, growth and engagement.
00:05:33
Speaker
Second one's going to be continued evolution of topic groups, right? This is something that continues and this is really where data comes into. So I'll touch on this in a little bit. And lastly is leadership, renewal and commitment. So Brooke, I know, you know, you're, you've got some really good ideas on what you're seeing around our members, that membership growth and engagement. So you want to share a little bit about thoughts there?
00:05:54
Speaker
Yeah, absolutely. As we go through, one of the things that I think that sets IRIS apart from other consortium and communities, and there are quite a few out there, but there's a few things. One is significantly cheaper than everything else. So I'll have a little bit more dialogue on that, but it is 100% cheaper.
00:06:10
Speaker
And the other thing is it is the one consortium that is open to all. So it is not just for large pharma who can afford to pay to play or have a lot of resources at hand that can participate in activities like this.
00:06:27
Speaker
It is also small pharma, medium pharma, the size of your organization is all inclusive and also is inclusive for consultants and for software vendors and for university individuals and people who are really figuring out a place to get mentorship and to identify like, how do I learn, you know, what should I be doing next as a brand new regulatory person coming into this industry? Iris provides a great platform for that. but A lot of the members that do participate on a regular basis is they're, they're so happy to share their experiences and their knowledge and provide mentoring and capabilities and activities, you know, and We need to see that growth in our industry. you know, it's really important that we bring up the next individuals that are going to be running these platforms and running these these organizations and products to the market. So I think that's a massive benefit that Iris brings. And again, because it is cost effective. Yes, you can be in university and still afford to be able to be a part of this community, which is massive. you know And I think in some cases, we see a lot of experiences that consultants and software vendors, you know they have and they see, and they also want to see the changes that can have a good impact on our industry.
00:07:34
Speaker
And they bring those stories not in a promotional self-promotion or like a sales fashion. That's not the intention and that wouldn't be... where we would want to go. But absolutely, if you've had an experience and you said, listen, we did this, these are the lessons learned on doing a deployment across the master data management solution, please come and share those experiences. This is a great platform for that so we can be better every time as an industry as we go through this. so i think I think that inclusiveness for all is the key for Iris and what really sets it apart to others.
00:08:06
Speaker
Yeah, great bit to call out there. And we've got some really exciting things going on with the academic institutions where we can share some more on that. We'll have that up on the website as well. And then the other piece is regulators, right? It's one of the one of the few forums out there that has a significant amount of regulator participant participation, excuse me. And then we've also got some incentives for regulators to to join as well, which will also be on the website also. So yeah, thanks for sharing that.
00:08:33
Speaker
The other piece is we we touched on data, right?
Enhancing Member Participation
00:08:36
Speaker
We touched on be data a bunch of times, i think coming out of the DIA-RSIDM event last week, like everything was data and everything was also AI, but that's another story. But what we've done is is we want to make sure that we continue to focus on the evolution of the topic groups, right? So we've had topic groups like acquisitions, mergers, and divestitures, CMC, digitalization, electronic product information, EPI,
00:08:56
Speaker
Global Submission Operations, IDMP has been around for about 10 years. And all of these groups really you know meet on a monthly basis or quarterly basis and produce a lot of meaningful dialogue. But what we've really seen lately, and shout out to our topic group leads and our executive committee for bringing this forward as a recommendation at our annual face-to-face meeting and the board for adopting this, but we really want to focus on bringing things together more from a data standpoint, right? It's all interconnected. So,
00:09:25
Speaker
CFC intersects with IDMP, EPI connects to structured content, digitalization affects every function. And then now we're seeing AI readiness everywhere, right? So if we can take a more data centric approach, I think not necessarily combining some of these topic groups, but having cross-disciplinary sessions I think it'll really increase member participation. We get a lot more visibility out there.
00:09:50
Speaker
i think you only the only other feedback that we get with having separate topic groups is that if I attend the EPI session this week and I intend the IDMP session next week, there's a lot of cross messaging And by having structured sessions where we bring some of those topic groups together, we're going to reduce the fragmentation across those discussions and see less branches going in different direction and really create a more integrated conversation that mirrors our operational reality across regulatory space.
00:10:18
Speaker
No, it's really great because we want to be more efficient, right? We can't be efficient if we're in five different meetings in a week. That's, again, a volunteer type of activity, right? So efficiency is important. And one thing I do want to highlight on the data and yes, data and looking at how that impacts on other areas, supply chain and and all of the things you said, but I was really happy to see that the board of directors and the executive committee had also identified that governance piece. So we're also going to be keeping an eye on the people in process portion of it because it's always ah that's always a pretty major topic for all. like you get it
00:10:51
Speaker
You can go down that path, but then how do you really keep it that way for a long time, all that effort that goes into it? and that's... back to people in process. I want to be clear that the new Iris setup with the topic groups isn't is not intended to be strictly a technology.
00:11:07
Speaker
It is not just technology focused. Right to say that, right, Jake? We're looking at that to be, it has technology components, it has data components, but it has the people and the process components, which is equally as critical. Absolutely. has to be operationalized. And then the last piece you touched on a little bit is really the leadership as well. So we are seeing some leadership transitions. We've got some longstanding contributors that have done such a great job and have been great contributors for us. Stepping aside, we've got an open board seat now that we're actively interviewing to fill.
00:11:35
Speaker
Our institutional knowledge remains very strong. We've got folks like yourself, Brooke, coming into the organization as president of the executive committee. And I think there's a lot of renewed energy and lot of fresh voices and perspectives that are entering the organization. So this to me is just a natural maturation of the Iris Forum. And and to be honest with you, it's a natural
Membership Price Increase and Benefits
00:11:58
Speaker
maturation for any collaborative professional forum out there. So I'm really excited about some of the things that are going forward here in 26. Yeah.
00:12:06
Speaker
Yeah, me too. I am too. And I think one of the other things that we need to talk about a little bit, Brooke, is the price change. Do you want me to talk about it, Jake? Sure, go ahead. You can introduce our new pricing model. Yes. So like I said, you know Jake and I have been doing this for quite some time and Iris has been around for some time. And one of the things that has not ever happened is the price has never changed for Iris. It has a simple $99 year, which I mean, that's practically free in today's time. So we are increasing the price this year. It's a simple, I guess, $26, right? A year. So $125 a year, slight price increase. That goes into effect on April 1st. And it is not an April Fool's joke. It is for real. That's actually, it's going to happen.
00:12:58
Speaker
So I would say if you're not a member now, go sign up now, lock in your $99, but also the benefits that you get from basically the price of a dinner for two, depending on where you like to eat out, I guess.
00:13:10
Speaker
You still will be able to get all of the benefits from Iris and it still is something that is incredibly reasonable for everybody at all stages of their career, I believe. One of the things that we will, you'll see more is what are the benefits of why are we going up in price and what do we get from that as members as ah participating in this community, because it has been pretty low cost. It's not like this is a high revenue generating non-for-profit organization. It's not. So things like keeping the website so that it's up to date and a ease of use of technology. So you you can quickly add meetings to your calendar, you know, and so it's not so hard to like do five links and figure out what the next meeting is like things like like that we'll see benefits from. So it's really going to make it easier for all the members to access the information and what you need access. And like this, the podcast that we're doing here with you know, with John Gins, and we really appreciate the support on, you know getting this put together. So there are benefits that are going to come from that very slight price increase. Yeah.
00:14:07
Speaker
We used to say it's the best $99 a regulatory but professional can spend. Now we'll just say it's the best $125 regulatory Still is. yeah and and And what hasn't gone up in price over the last 20 years. so I think it's just a natural evolution
Industry Conversation and Leadership Transition
00:14:19
Speaker
of where we are. And again, like you stated, our members will continue to get the value from from that investment.
00:14:26
Speaker
All right, cool. So I think we've pretty much shared everything that we wanted to get across today. Just, you know, if you've got a closing message, Brooke, that you want to share to our ourrs community, feel free and then I'll go ahead and wrap it up.
00:14:40
Speaker
Yeah, I absolutely do. i think one thing I just want to take give out to everyone who who participates and is interested in participation, you know, this is, again, built for the community. This isn't, you know, we have the top agreed leads that do a lot to keep it going and make sure that things get scheduled. And sometimes it's a lot of logistic management.
00:14:59
Speaker
but But also we look to the industry and we look to everybody who's participating to bring forth your topics and bring forth your ideas and share with us what you like and what you don't like. You know what i mean? Like we can only get as good as the information that we have. So I just want to do just a little bit of a call to action on, you know, please be open with us. Give us feedback. If there's new topics that you say, hey, listen, this keeps coming up a lot in my life. Can we have a can we have some dialogue on this? Like, let's do that. And if you're interested in volunteering or having more participation in IRS outside of just joining the calls, and we're also always open for that. So please just, you know, keep the door open and let us know.
00:15:35
Speaker
Great. Thanks. Yeah, it's been fun talking to you today. I think when I step back and look at IRS, I think what excites me most is not just what we're planning for 2026. It really, and and we talked about this at the face-to-face, it's really an opportunity to express gratitude, look back, and really be proud of what we've built already. It's a trusted community. It's a neutral space in an industry that often pulls in many directions, right? So we've built this very tight knit community where regulators, industry professionals, solution providers, they all sit at the same table and have practical, honest conversations about the troubles they face, the difficulties they have, the solutions that they want to put in place. And I think based on the length of time that IRIS has been around, it's it's clear that this is an adorable. organization. And now we're maturing, right? So moving towards data groups really reflects how industry operates today. Leadership transitions, bringing new new faces into the organization shows that we're we're healthy and sustainable. And continued membership growth says that this is a foundation that is needed across the industry.
00:16:44
Speaker
so really holless Did you just call it us adorable? I just had to... Adorable. I love that.
Encouraging Member Feedback
00:16:52
Speaker
I love that. I think we are adorable. And I also do think that maybe there's others and you guys can correct me if I'm wrong, but Iris holds vendor showcases.
00:17:00
Speaker
yeah And a vendor showcase is a great way to accelerate. If you're looking at a new direction that you're going in your organization, you know, kind of accelerating that laborious ah RFP process by participating in these vendor showcases. Nobody likes them, right? We've held them in the past.
00:17:15
Speaker
I'm sure we'll hold more in the future just on where things go. So I also would say, if anything else, also keep an eye out for that because don't think anybody else provides that. Yeah, no, it's a great, great call out. And again, just remaining neutral as an organization. So Wrapping up, I mean, I'm incredibly proud of what this group's accomplished. I'm even more excited about we're building next. And if you're listening to this and you care about regulatory data, interoperability, implementation of standards, future of structured submissions, any of all those things, AI readiness, really now is the moment to engage with Iris. And looking forward to welcoming you into the folds of Iris and looking forward to additional podcasts in the future and being able to share more information about what the exciting things that Iris has going on.
00:17:59
Speaker
Yeah, it's
Conclusion and Future Excitement
00:18:00
Speaker
going to be fun. Thank you. Fun talking with you today, Brooke. Wish you well and see you soon. Bye.