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Service Provider Executive Series #16 - Accumulus’ Dominique Lagrave on the Future of Global Regulatory Collaboration
18 Plays1 day ago
In today’s episode, host Steve Gens is joined by Dominique Lagrave (Chief Regulatory Officer, Accumulus Technologies) to look at the future of regulatory collaboration — from one‑to‑many submissions to one‑click connectivity between sponsors and agencies. Join us for this insightful discussion on Regulatory Operations and the exciting future for Accumulus Technologies!
To learn more about Accumulus, reach out at connect@accumulustech.com — or visit their website here: https://accumulustechnologies.com
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Transcript
Introduction and Background
00:00:06
Speaker
Welcome to the Gens and Associates Regulatory Executive Podcast Series, where we explore innovation in the regulatory space. This is Steve Gens, Managing Partner, and today I'm happy to be speaking with somebody that many of you know very well, Dom from Accumulus Technologies.
Dom's Journey and Accumulus Technologies Overview
00:00:24
Speaker
So, Dom, we've known each other for many, many years. And when you went to Accumulus, I believe it was four years ago, it's like, wow, that's really, really interesting. We have a very seasoned industry veteran joining, so this must be a serious proposition. So it's four years later, so really glad that you're joining us. And to give an update to our listeners. So before we get started, don't you just introduce yourself and the company, Accumulus Technologies. For those, I think it's you know probably just a small amount that might not know you or Accumulus
Accumulus Synergies Formation and Mission
00:00:56
Speaker
Technologies. So take it away, Dom.
00:00:58
Speaker
First of all, Steve, thank you for having me today. yeah It's a great pleasure to be here and also, again, connecting after all those years, as you mentioned. So by way of introductions, I've been working in this industry for over 30 years now, close to 30 years, um really looking from the beginning of how document management system was created. I remember implementing the very first company, EDMS 98, for ah people who go so give it my age a little bit in the day areas.
00:01:24
Speaker
always been passionate about technology and regulatory affairs. I'm a pharmacist by training and I've been working with supporting patients globally since I started to work in this industry. I've been working in various pharmaceutical companies. I had the pleasure of working into some vendors in the past, CDC Solutions, again, for people who still remember CDC Solutions, yeah became liquid afterwards, really supporting move from paper to digital.
00:01:49
Speaker
At the time we were starting to get ECTD in the very first place. And then I had after that working in different places, um you know, from France where I'm originally from, but also moving to the U.S. over 20 years ago and working at companies such as Novo Nordisk and more recently at Amgen when I was leading global rights operations.
00:02:08
Speaker
And Amgen also had the pleasure of implementing VivaRim for the whole company as the business leader. So two and a half years of work to implement multiple modules. Which then led me to, you know, when I was working in Amgen, Amgen was one of the first companies to sign up for our community synergy as a sponsor.
00:02:26
Speaker
And for me, with natural progression start working as a community as well, um first of all, resources that was provided for our communities to get started. So Accumulus is a very interesting story. I think it's very unique because about five plus years ago, you had the head of R&D for multiple pharmaceutical companies together with the head of civil regulatory agencies getting together and looking about how can we do better for the future, supporting our patients, be more efficient in our processes, and essentially how technology can help us to get there.
00:02:58
Speaker
And the realization that technology was advancing pretty fast But then the processes and the way we're processing submissions today was not. We're still into an ECTD world and we're still pushing digital paper pretty much.
00:03:11
Speaker
So how can we accelerate that part? And so the concept of creating company dedicated to work to that extent was actually supported by those organizations.
00:03:23
Speaker
So Accumulus was created as a non-for-profit Accumulus Synergies and at the beginning was truly a virtual organization. So no dedicated headcounts.
Platform Collaboration and Impact
00:03:31
Speaker
It was essentially the funding from 12 pharmaceutical companies plus those companies providing people like me to help support the creation of these organizations.
00:03:42
Speaker
So each companies have provided people in different capacity to support different aspects of the company. And in the company was formally created slightly over four years ago now, close to four years.
00:03:54
Speaker
I wasn't playing number three. So we're at the beginning of the company and say, well, we're here dedicated to really change the ecosystem. And the first aspect of our work was, of course, establishing the organization, but looking around how technology can help support greater collaboration. and first aspect is looking at currently available technology. And as you know, Steve, did the technology available four years ago was very siloed. Document management system was created with the intents to be only used by one company and not to be used across multiple in the ecosystem.
00:04:25
Speaker
And so we decided actually to build a new platform, a SaaS platform from the ground up. Because nothing was currently available that we can leverage in order to go at the scale wanted it to go. And so we're starting to build the platforms and continue to engage with our regional sponsors and then engage with a greater ecosystem. And today we have made huge tries and be able to have actually over 70 regulatory agencies using the platform.
00:04:50
Speaker
And then a large numbers of projects, or sometimes called pilot by agencies, running into into the platform. We, I think the company went into production in January, 2024, which is often referenced as the rush pilot Reliance.
00:05:06
Speaker
Again, Reliance has been existing for many, many years, but it was a unique opportunity to had technology to the audience processes and principles and how technology can help scale up reliance principles and providing what is essential transparency. So same information to everyone that help build trust amongst regulatory agencies.
00:05:28
Speaker
And so this is how essentially the first pilot was run and um Now, again, we fast forward, we have a lot of different projects currently running in the platform, lot more regulatory agencies involved and very excited to be part of this journey, having worked in different parts of the ecosystem and now be able to get and interact a lot with regulatory agencies and NGOs around the globe.
Regulatory Process Innovations
00:05:50
Speaker
Thanks, Tom, for that out good introduction. And certainly when I heard about Accumulus four years ago, and I'm just being transparent here, and I was a little skeptical because but there's been a few generations of attempts like the CBIX initiative and things like this. And it's like, yeah, is it going to be a CBIX?
00:06:08
Speaker
However, there's really, like to your point, originally it really good sponsorship from 12 major multinationals. And as you guys started getting into kind of when I know you've had to educate me when I say pilot, it's like, well, these are real projects, right?
00:06:24
Speaker
We know what, when that started coming about, it's like, wow, this thing has legs. And we always talk about the digital bridge between sponsors and health authorities and This is true end-to-end thinking because people would say, the complexity and regulatory. I said, well, I have a simple solution. you know, I'll never see it in my lifetime. If we just had one worldwide health organization and kind of regional offices that we wouldn't have these 150 health agencies and all the complexities.
00:06:52
Speaker
Because if you think about it, like from a math standpoint, it's the ah permutations that like in labeling and different areas that Well, you say that's just a submission, you just a label change because you bought somebody, but people just don't realize all the complexity, time, cost. That's very, very distracting from the mission about getting to patients and all that.
00:07:12
Speaker
So it's really been interesting. And I know when you and I talked earlier in the year, it's like, this is really real. I need to get educated. And thanks again for presenting at our private webinar with our members that everybody realizes.
00:07:25
Speaker
It's not only innovation, this could be a serious game changer because the more I thought about it, getting back to, a well, we just need one worldwide health organization. It's like, actually, we don't. If we had one kind of standard where we all collaborate, we can have these different organizational reflections. yeah And certainly on the medicinal side with the ECTD and some of the standards work with the ICH over the last 25 years is kind of foundational to really allow some of the stuff that you're doing. i was just at a med tech forum when they ah talked talked a little bit about Cumios at the med tech forum on Monday.
00:07:58
Speaker
So you gave a great introduction as far as how Chemless got started to present day. So I think where we would really want to jump in for our listeners is really sharing some of the experiences.
Platform Expansion and Global Impact
00:08:10
Speaker
Because like, where is the innovation? and like with any big kind of change or innovations, there's perceptions of what we believe the benefits are. And then some of them happen them and some of them don't.
00:08:23
Speaker
But there's also surprises along the way. Some of the things that you didn't imagine, but there's great benefits. So because the thing when you were sharing and really updating me, the the first thing that came to mind is like, wow, as this matures, it can or it should fundamentally alter a regulatory strategy as opposed to the 30 year paradigm of wave one, wave two, wave three. Right.
00:08:46
Speaker
So why don't you just take us through the many different kinds of projects, experiences, where you're seeing the benefits, projected future benefits, any surprises. Why don't we start there? Okay. No, that's good, Steve.
00:08:58
Speaker
And yes, you know, we, I agree with you that for me, this is a game changer because you can have really the sense of this concept of a global dossier. And I think when you talk with regulators around the globe,
00:09:11
Speaker
Everybody is for a global dossier. The sense of, hey, it's one science. It shouldn't be 30 different dossiers getting shipped around the globe where you have agencies duplicating the efforts with the same content pretty much.
00:09:23
Speaker
and And these were little wake up calls from COVID, right? Where COVID agency pulled together their resources to go faster. But now getting back to to to the use of the platform, as I mentioned, the first pilot that was running into the platform, and again, when I mentioned pilot, this is actually a real submission with all content and real outcomes. So it's production data, of course.
00:09:43
Speaker
Started with Roche, where initial phase was to share half-borded questions. part of reliance and the principles of knowledge sharing is that you share your authority questions in real time based upon a common dossier.
00:09:55
Speaker
And then each agency can see each other's questions along the way. Well, we started the journey, and again, very grateful for the partnership with Raj, We honestly didn't know if the fact that having access to the same information and other agency questions will generate more questions because, oh, I see an interesting question from this agency. I'm going to ask the same or I'm interested in that as well. Or would you reduce the numbers of questions overall? all So you have avoid duplication because you've seen already a question asked by agency.
00:10:22
Speaker
And therefore you feel comfortable with the answer provided and you don't ask the same questions. So what we see in the central pilot actually is a reduction of questions along the way and a very significant reductions of duplication, as well as many actually agencies truly applying the principles of reliance in this case, didn't ask any questions.
00:10:41
Speaker
Just look at what it was in the platforms, had access to an assessment report, the same dossier that in this case, Ima had reviewed and approved. And the timing was around, again, general timing generally given the whole project is around six six to nine months.
00:10:56
Speaker
And what is key in this approach is the regulatory predictability. Today, if you do major manufacturing changes, let's say type two variations, for example, equivalents in Europe,
00:11:08
Speaker
You have pretty standard timelines in countries that have a higher level of maturity. That per future in three, four months, you're going to get decisions, hopefully, and approval. In other parts of the world, this can take two to three years.
00:11:21
Speaker
So from a supply chain, this is a major burden to have to predict on how you might be able to shift to a new manufacturing process. And this predictability help enable greater planning and be able to free up resources in different manufacturing, so much more manufacturing agility um along the way.
00:11:40
Speaker
And so what we're seeing now in the platform is I think we have dozens of projects, pilots running into the platform at the moment. We still see a bulk of those to be in the CMC area because it's well-established processes.
00:11:53
Speaker
And as I mentioned, we already have 70 agencies that have been part of one or more project into the platform. So those are becoming more and more standards in approaching agencies and be able to share not only need the questions, but now we're sharing the full dossier in the platform so agencies can see the same dossier in these digital forms.
00:12:13
Speaker
We leverage the CTD as a backbone so that it's a common ground that any agencies, even if they're still on a paper review processes, have a digital copy of it. And then they had access to an assessment reports, approval letters, hopefully question responses in real time.
00:12:28
Speaker
to facilitate these processes. And we see the results to be very consistent. Different companies run different pilots, different set of countries, different health authority as a reference health authority as well. But the consistency around roughly 80% of the countries do follow these roughly six months principles.
00:12:45
Speaker
So you know that you invite the 30, 40 countries, you're going to get roughly 80% of dues that's going to approve within the six months and roughly about 100% within nine months. To-dos enables companies to reflect on the reg strategy and says, well, I have these major manufacturing changes.
00:13:02
Speaker
that will enable better supply chain, which is core to what countries want, right? We've seen during COVID and after major supply chain issues. So health authorities are very supportive of those principles because it provides insurance that they won't get any drug shortage or other areas within their countries. So agencies are very eager to participate because they truly see the benefits for the patients, and the support within their own countries.
00:13:28
Speaker
Yeah. And I would imagine, sorry, Dom, the the thing with your supply chain, because anybody in supply chain, they would want predictability. So I would imagine this is increases, you know, the predictability, the visibility, like you said, is is everything. Because again, under the covers of this, it's such complexity every day.
00:13:47
Speaker
It is. Yeah, it is. and and And, you know, generally have multiple, you know, changes happening in the same time and everything. So it's simplified processes, but also you have, again, a single dossier for everyone. Yeah. Which is again a benefit, but also a challenge for the industry. Industry is not used to have a single dossier for all countries.
00:14:03
Speaker
And therefore they're providing more information to specific countries that in the past had the more redacted version of it. Yep. So it's a change in paradigm around same information to everyone. And again, as I mentioned before, even though they have access to more information, this is not joining more questions, which is one of the key hesitations at the moment, at the beginning, and says, if you provide more, we get more questions.
00:14:27
Speaker
What also has been interesting to to watch is now we're starting to move, and we still, of course, do a lot of CMC post-application changes, But we've seen new clinical indications running in the platform. We see joint assessments in clinical trials, joint scientific advice that was done in a partnership, for example, weipp with CPI with 21 countries.
00:14:48
Speaker
So these are showing the art the possible. Once you have the established framework in the platform to exchange informations and invite at will regulatory agencies, you can think of different regulatory processes.
00:14:59
Speaker
Again, possible changes remains core, but we're starting to see companies who wants to innovate and ensure and in bringing like five agencies together on a new initial applications really says, Hey, you can all benefit from each other from a joint review perspective.
00:15:16
Speaker
And we're seeing this machinery working and then snowballing all of it around, have another idea. And then reach out to the agencies, say, would you be interested in exploring this or this?
00:15:27
Speaker
So think the future is bright in terms of collaboration. I'm very happy to see that happening. It's it's taking shape as more and more countries join and more and more countries do accept multiple projects after the initial one.
00:15:42
Speaker
And also more and more companies are looking to to do, again, more and more projects in this right-to-re collaboration. You asked me about two listeners, or a few listeners. I think for me, the first one is the engagements of right-to-reagencies.
00:15:57
Speaker
At the beginning, it's it's a new system, it's a new process, it's it like new everything. So we didn't know how well it would be received by agencies. and And actually it's been very well received. And we have agencies presenting, I was at DIA Japan recently, and had agencies presenting around the experience around occupators, providing feedback on how we can improve the platform.
00:16:18
Speaker
And a surprise tidbit that was given was one agency is that they're using actually the platform for education purposes. And it was something we didn't start at the beginning and say, we can see everybody's else's questions. We can see their assessment reports.
00:16:30
Speaker
And therefore, our new trainees at the agency, we show them the platform and we show how an agency is doing their reviews. We show them the questions and it helps support our educations. And to WHO's perspective, it helps support regulatory strengthening, which is essential to get a level on which a country can become fully independent with their review processes.
00:16:51
Speaker
And many agencies share with us that They're using the platform as a way to grow their maturity levels and move toward the more digital environments without the requirements of heavy investment that sometimes low and medium income countries cannot afford, but enable them to leapfrog a little bit to a more digital world and having access to the same information that for them I think is invaluable that they know they have the same dossier than email because they can see it.
00:17:19
Speaker
And that point was very telling when we talk with them around the passion that we have from agencies in actually asking for more content to be brought to them because they're eager to have access to this information.
00:17:31
Speaker
Yeah. And before you get to the second point, I mean, this is really fascinating. What's coming up for me and with people in the health ministries that as they're collaborating with others, there is an educational process, like you're saying, you know, they have broader context. Well, this country is looking at it this way. I'm looking at it this way.
00:17:50
Speaker
but We all look at things differently, right? It brings a lot more diversity to the thinking and then strengthens the overall package. And certainly there's been so much discussion with other providers in the whole Africa space, you know, and I know you're very active
Building Trust and Transparency
00:18:04
Speaker
there. And I think that's that's a great example of a leapfrog instead of the classic, everybody has to have their own individual systems and that they're just fast forward and can be an equal with companies that are really mature through a platform like you have.
00:18:20
Speaker
So it must be really rewarding too, Dom, just to be part of that experience. so Exactly. you know know till You know, i had the pleasure of talking with these virus regulators at the very senior levels around around the globe and probably a lot as well.
00:18:32
Speaker
Just came back from Argentina. I'm heading to Kenya in a couple of weeks, really engaging locally with the authorities and organizations such as WHO, the Gates Foundation, against CP for pandemic preparedness.
00:18:46
Speaker
ensuring that we have a framework to support collaboration at scale. And I think, again, what we've been able to have, you know, discussions directly with with regulators is these little tidbits of information. this is One mentioned, they say, you know, we don't want to ask a stupid question because we've been watched.
00:19:03
Speaker
Yeah. We see the other ones in there. And ifrefore if we don't feel the question is pardoned, we're not going to ask it. And also they told us what's interesting, all the Tibbits, is creates healthy competition between regulatory agencies.
00:19:16
Speaker
Because they go in there and you can see in real time all the approval being granted. And one mentioned to us and say, we don't want, we don't want to be the last one. So we we're looking at others, we're looking at the neighbors. And then, um, so it's interesting. And again, he was not, story of course the intent, but he's a benefit that we're saying and says, because everything is visible, creating very interesting connection between those agencies, more regional clusters, and they watch each other. And some at the beginning, you know, didn't participate in the platform for whatever reasons.
00:19:50
Speaker
But I see the neighbors on the side that says, oh, they're all participating. So we should be as well. We don't want be left behind. And it's very interesting to watch that dynamic evolutions of engagements happening.
00:20:02
Speaker
Yeah, and it's what comes up for me on those comments. It must, you know, from a regulator, and I'm just guessing, Dom, it must bring a higher level of confidence knowing that you have a lot of different colleagues. They just happen to be in different agencies also looking at it. So maybe that's another aspect of the benefit. Well, you know, when the confidence goes up, the more likelihood to say, okay, we're going improve and we're still shorting the cycle time because there's increased confidence. I'm just guessing. I don't know.
00:20:28
Speaker
Yeah, no, exactly. getting through the tea leaves with kind of shared experiences. No, no, exactly. I think even Imgen was public with it recently in in their project. They have seen agencies that have reached out to them and says, hey, we've seen all the processes and we decided not to ask any questions and grant to direct approval.
00:20:45
Speaker
Wow. It's building trust, right? a lot of things we're missing in our industry is trust. Absolutely. There are various reasons, but in this case, it's very transparent. You see everything. There's nothing that you say, I need to ask a question about this because I don't know this aspect.
00:20:59
Speaker
And you see all the other agencies have done in theory the same work that that you're doing as well and says, Hey, I'm confident because I have WLA countries or level of maturity four countries already approving this.
00:21:11
Speaker
And I know the regulatory system is very mature. I will dedicate my resources somewhere else where it matters most. And I will, in this case, approve these changes without without any questions because I trust the regulatory system of my peers and I don't need to add them an extra level of review.
Future Innovations and Collaborations
00:21:27
Speaker
And I'm going to use my staff to other areas. Everybody's challenged with resources and also the increased complexity of some of the drugs we're having, right? It's difficult if you have cell therapies or gene therapies.
00:21:39
Speaker
to have expertise everywhere. so this case, work sharing is very important. And you trust an expert that will be part of another country because you may not have the expertise locally. And that's fine.
00:21:50
Speaker
Yeah, and maybe just yeah for our listeners, I mean, you and I have been around the block a long time. Maybe I've had a few more laps than you, Dom, so but we won't get into that. But think about when the ECTD came out and from an organizational construct that really kind of fueled the regional hubs. You know, you have a regional hub in Japan, maybe a couple in Europe.
00:22:10
Speaker
here in North America, but anytime there are standards, just like in clinical with CDISC, only good things come out of it. But the terminology was simultaneous submissions. And it's like, wow, we submitted to 20 countries this week and ah look at us go, but that's still the one-to-one relationship versus one-to-many that you guys have started. and Who knows in two or three years, hopefully it'll be one to most a type of thing because it's kind of a whole new, this is just not an incremental innovation. it's It's just a complete rethink. Because a lot of times like with process, you know, the word optimization, but you're not rethinking the whole frame of the process, which you guys did. So so hands off to that.
00:22:52
Speaker
So I thought with our listeners, this train, um it's a bullet train, right? You know, it's not a slow steam engine. It's a bullet train that you're on. So what are you most excited about in the next year or maybe two or three years out where a Cumulus is going with the health authorities and sponsors? I mean, what does your crystal ball tell us?
00:23:11
Speaker
It's a great question. I think, you know, when i'm no we're we're on the tail end of 2025. So um in 2026, what I'm looking for really is we have actually quite a large numbers of of new companies joining at communities at the moment. And it's very exciting because they're also very happy to see they're all in different shape and size.
00:23:29
Speaker
yep Some are more regional based, some are small biotech companies, some are you know rare disease and et cetera. So we're seeing big pharma, little biotechs and actually very, very small ones. We have one company is doing part currently in Africa.
00:23:43
Speaker
There's probably a virtual company with 10 people. This level of adoption is very interesting because you see different companies who see different value depending on what they are within their level of maturity. Some of them are very interested, for example, to take their product already approved in, let's take example, of maybe Europe and push it to rest the world and want to see this. Can I push the same dossier to other agencies?
00:24:06
Speaker
um Well, yes, yes, you can. um So we're seeing this coming up more and more or about companies thinking of the box. We now passed most of the company first, quote unquote, first pilot.
00:24:18
Speaker
I'd say normal processes. You do your first pilot project, again, production, and then you'll be able to define your return investments, your benefits along the way. And now we're seeing companies accelerating.
00:24:29
Speaker
I think last week we had three projects starting one week. So we're having more and more projects starting in parallel, different again different agencies, some agencies covered, and we continue to push that forward with some very exciting new projects starting next year. As you mentioned, something in Africa that I think is going to help shape the future of clinical trials on the African continent.
00:24:51
Speaker
But also understanding that we want to connect to the source of the information. So we announced recently a partnership with Viva for us to build Boolean end-to-end. The information is stored by most companies Viva or the Word Document Management System.
00:25:06
Speaker
And we want to ensure that there is a frictionless connectivity between the system that you can interact directly with agencies on the Acumetis platform and then the system of references that this company are using to manage their registrations, information along the way.
00:25:22
Speaker
And so the notion of what we call one-click submission, I think is one the most eager to see in 2026. That's kind of my my little dream as a reg ops person is I go and plan my submissions, in this case, in Viva.
00:25:37
Speaker
I select my countries and then go with one click and I push my full dossier, my information, the Acumulus platform, when I can invite 20, 30, 40, 50 countries to review the same dossiers. So that will become a reality in 2026, which is very exciting.
00:25:50
Speaker
And we're going to continue to build with the support of our ecosystems. Again, we're getting requirements and feedback from agencies around things they would like to see in the platform to enhance productivity, to enhance their work and access to the information, as well as the industry.
00:26:06
Speaker
And then we continue a journey to build and and enhance you know features and listening to the ecosystems and our customers provide, again, more efficient efficientci processes, higher your value, and then continue to build other capabilities that would expand the type of project that people will be able to run within the platform.
00:26:24
Speaker
Fast forward a few years, I think it's difficult to tell what few years are going to be down the road, to be honest. I mean, we've seen the pace of AI and we took off for the last year or less than a year. would be good advice to tell you, well, I have my crystal ball and i can tell you in five years we're going to be. What I hope for, again, is that we're going to be more connected.
00:26:43
Speaker
Stronger collaborations. I love the concept of one world, one health, one dossier, right? I love these to evolve and having more work sharing and collaborations. Having, you know, of course, this done directly to initial applications.
00:26:57
Speaker
I think there is, would say, generational opportunity and and potentially I think an obligation for us to work differently. We, as we know, we had, you know, ECTD took, you know,
00:27:10
Speaker
15 years to go from initial specs to be used widely. It's not fully used widely today, to be honest. I don't have the time in front of me or potentially the patience to work another 20, 30 years for the next revolutions. So I love that we can play a role in accelerating the pace of the change within the ecosystem, partnering with trade associations, with industry, with regulators, and NGOs, and explore the art to the possible.
00:27:35
Speaker
So that's really what I'm looking for is coming to push this vision of one global dossier in the cloud, which I think everybody can agree upon at general terms. The how, that's the difficult part.
00:27:47
Speaker
And I don't think technology is the issue. The how would be how do we harmonize requirements? How do we solve for course border data, informations, all these things that currently are impediment to greater use of collaboration.
00:28:03
Speaker
I have hoped that technology can help support what we're doing, that AI will help support faster review processes, faster in clinical trials. I think there's a lot of things that AI can help with.
00:28:14
Speaker
But again, I think the core of it is the willingness to people to come together and make a difference. And I think we're getting there and I'm very optimistic about the future. Yeah, and it seems like you've gotten a lot of success. So actually a few comments and then one last question for you ah before we wrap it up.
00:28:32
Speaker
Now, as you were talking about some of the newer companies, the smaller, like smaller biotech, so where my mind wandered is it's very, very different. Larger companies, they want to reduce complexity first and foremost. But, you know, on those smaller companies, especially coming out of the clinical stage,
00:28:50
Speaker
is how do I scale most appropriately? I'm conserving cash. We're investing to the ah the growth curve. And like, how do I get from one or two initial markets to the fifth market, to 10th, the 20th market, and actually expanding that out is very timely and very costly in the historic construct. But Kind of imagining instead of wave one, two or three, you think about cohorts with markets, like different arrangements, like regardless of size or geographic location or a maturity of the health authority that you could have different cohorts. And maybe from a regulatory perspective, you know, that scaling just became simpler and not as, you know, kind of costly.
00:29:31
Speaker
with better predictability and confidence and like who wouldn't want that, right? So that that was kind of my impression would be a small kind of story. and And who knows in your crystal ball, because again, I've just came fresh from the MedTech forum that I participated in, did a little presentation.
00:29:46
Speaker
And we call ah what you do cloud-based regulatory spaces, right? So the CBRSs. But accumulus did come up. And although there isn't that strict ECTD standard on the medtech, you know, they're trying to modernize and why not take a big leap as opposed to kind of like the small steps here on the medicinal side that we've taken over the last 20 years, like Why they couldn't they fast forward and instead of 20 years, it's five to seven years to really get that breadth? Because we see it in our survey from our first survey in 2007. So the one we have open right now, the percentage of companies that have combinational products, both the MedTech
00:30:26
Speaker
and the biopharmaceutical side, that's increasing substantially.
Engagement and Integration with Accumulus
00:30:30
Speaker
So just a couple of comments there, Don. One last question, and I think it's well known with the ah the announcement this summer with Viva, but you do work with other software providers on some of these projects, like I think Lorenz and others. Certainly the software provider space in the medtech is different, you know, some different players. But maybe for our listeners, could you speak to, besides the partnership with Viva,
00:30:53
Speaker
Are there other partnerships or it's really kind of independent? You can really work with a variety of of different software providers. Now, it is a great question. Yes. And again, we we went through the nonsense with Viva this summer. But the way we were anchoring and building the platform is that we can we have open APIs for people working more in technology side. And therefore, we can connect pretty much with any system of references. and And I think you know we're going to see the evolution. You do have you have multiple system of references, even though... yeah Viva is predominant now.
00:31:23
Speaker
You have other RIM systems, obviously, publishing systems like the RIMs, as you mentioned, um but also you have data sources. All this information is available and i think for us, having built a very modern platform, again, it was built recently, so we have the latest technology architecture and build inside the platforms, we're able to connect pretty easily with any system or references. So for us, again, an opportunity to be frictionless from the source of this information. Ideally,
00:31:50
Speaker
We may even think in the future, not even to move information, right? Presenting to an agency without moving it. But sometimes doesn't make sense to move 50 gigabyte of information to to one place to another. Maybe not. ah So all this is top of mind for us, how we architecture the platforms. And then again, a first engagement is use Viva for obvious various reasons, you know as well.
00:32:10
Speaker
We're very happy to engage with other um you know technology vendors today to build a connector and share open APIs with them and and ensure that, a again, you have the system, an end-to-end process. right Continuity of the information, the traceability, the integrity is top of mind. and And therefore, again, very happy to work with the whole ecosystem. Google syncs to the next next phase, next generation.
00:32:36
Speaker
Thanks, Tom. Very interesting discussion. and I'm sure we just are hitting the tip of the iceberg. A lot of learning, a lot of innovation, a lot of possibility. So for our listeners, um many of them know you, but those that don't, and especially with a lot of the smaller companies coming on board, how can they get a hold of you? What's the best way?
00:32:56
Speaker
So thank you very much, Steve. And I think we want to engage with the great ecosystem, we want to listen to what companies have in mind. and And as I mentioned before, agencies are waiting and happy to have facilitated those conversations.
00:33:08
Speaker
So the best way to reach out to me, a through directly to me, you can go to my email address, which is dominic.lograv.acomutistech.com. But also we have an inquiry forms directly available on our website. Again, acomutistech.com.
00:33:22
Speaker
Feel free to reach out to us. We're wonderful team that will be eager to discuss with you on your need, your potential project. And I think I will reiterate every pilot's cons and because it helps move the discussions one step further.
00:33:38
Speaker
And there's no, you don't have to do a 50 country pilots, three, four countries, five countries helps. Everything helps to move the discussions further. And again, I want to encourage companies to reach out to us, happy to work with you around what fits best your needs and eager to engage and make a difference.
00:33:57
Speaker
All right. Well, thanks, Dom. And for our listeners, you know how to get ahold of us in case you have any questions. Just go to our website, gensonassociates.com. There's the contact page or I'm very active on LinkedIn, as everybody knows.
00:34:11
Speaker
Just reach out on LinkedIn. So Dom, thanks again. Always a great discussion when we connect. And i think you have a lot going on in 2026. So maybe next fall.
00:34:22
Speaker
We can see where you're at, you know, what was achieved. And the fascinating thing with this discussion, it's just all these, since it's the early days of innovation in this, there's a lot of offshoots, a lot of learning offshoots, both on the sponsor side and also on the health authority side. So it'll be good maybe have you back in a year and and keep the learning going on this because it's definitely a brave new world. And Probably long overdue, but in our industry, we tend to move pretty slow, but now this is certainly an initiative that's really picking up the pace. So thanks again so much, Tom.
00:34:57
Speaker
Thank you for having Steve, and will be a pleasure to reconnect so next year and share what 2026 brought to us. Thank you again. Fantastic. Thanks.