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Executive Series Episode #6 - Steve Nuckols
94 Plays8 months ago
Welcome to The Gens & Associates Podcast: Executive Series. This exciting series will feature Steve Gens, G&A Managing Partner, conversing with key senior executives that represent the software and services sectors. These informative one on one conversations will explore how they are guiding their organizations to effectively support key industry initiatives and technology advances.
In this episode, Steve Gens is joined by Steve Nuckols (Chief Customer Officer at ArisGlobal) to discuss recent mergers, the benefits of advanced technology, and what is next for ArisGlobal going forward.
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Transcript
Introduction and Guest Overview
00:00:00
Speaker
Welcome to the Gens & Associates Regulatory Executive Podcast Series. I'm your host, Steve Gens, managing partner of Gens & Associates. Today, I have Steve Knuckles with me from Eris Global. Steve, I've been looking forward to this conversation. ah Certainly really enjoyed the Eris Global Conference that was in London in March. so Certainly learned a lot and especially with the advanced technology, everything that you're doing on the safety side and the regulatory side. So I've been looking forward to this conversation. So before we get started, if you can give our listeners a quick introduction of yourself and Eris Global.
00:00:39
Speaker
Absolutely. First off, Steve, thank you so much for inviting me to this podcast today. Pleasure to be with you all. ah My name is Steve Knuckles. I am the Chief Customer Officer of Aeris Global. What that means at the end of the day is I am responsible for all of our go-to-market functions, inclusive of sales, marketing, customer success,
00:01:05
Speaker
global support and solution consulting. So my main focus is to ensure that not only do our customers globally fully understand Aeris Global's capabilities and its applications that it's bringing to market across drug development, safety, regulatory, and medical affairs, but that customers can also benefit from all of the capabilities that we bring and that they fully get all of the features and functionalities that they expect from the ARIS Global ah platform ah to support their endeavors. And that's ultimately what my role is responsible for.
00:01:45
Speaker
Okay, thanks for that,
Eris Global's Evolution and Investments
00:01:46
Speaker
Steve. And it's also very nice, you know, having those end-to-end responsibilities, because at the end of the day, it's it's all about the customer and value, right? So let's start off. I mean, we've been tracking Aeros Global for for a long time. We started our first regulatory benchmark in 2007, and that was yeah really the beginning of companies investing, you know, in, at least from a regulatory standpoint, you know, the registration, you know, management side, a lot of competition. It was either Eris Global or Liquid back in those days. And then then then the bigger piece of Eris Global just being, you know, leaders in the ah in the safety side.
00:02:26
Speaker
But boy, Air's Global has gone through a lot of transitions. More recently, at least for our regulatory audience, the acquisition of Amplexer, Sporify. You have new AI partnerships and some very significant investments. I certainly learned that. That was one of my key takeaways from the March conference.
00:02:44
Speaker
on advanced technology. So how does this combination benefit your ah customers both in the near term? There's a lot of exciting things going on in the near term, but also in the longer term. Yeah, so great question, Stephen. Thank you for that. Over the past year, we've made substantial investments in both R and&D and innovation, including the acquisition of the two you just referenced and Plexer and Sporify.
00:03:11
Speaker
Amplexer has been a significant player in the regulatory and quality space. This technology that they built is value added to what we were already building within our licensure regulatory platform. Sporify is a very unique company and they offer spore data, a very specific type of valuable data for regulatory compliance.
00:03:33
Speaker
And we think about the value of the data and the offering of how valuable those data sets are to our customers. We think about SporeFi was an investment that we felt extremely confident about and strongly about completing our regulatory platform. We have no plans to stop investing in our product or in our and or an innovation. All the investments are at the direct benefit of our customers and are offered as part of our life-sphere regulatory platform.
00:04:01
Speaker
I want to
LifeSphere and Technological Innovation
00:04:02
Speaker
just speak briefly now about our life sphere regulatory platform. Our next generation life sphere regulatory platform enables advanced technologies, including Gen AI and LLM capabilities powered by our life sphere Nava X. With last year's acquisition of Amplexer, we were able to bring together the two platform systems into one holistic offering, making it a true end-to-end regulatory system.
00:04:29
Speaker
With the acquisition of Sporify, users can match, sync, and integrate reference data to simplify ongoing data management and harmonize data across systems and geographies. It's really added benefit for all of our Lysphere customers. And again, we have very aggressive plans to continue innovating and continue developing our Lysphere regulatory platform.
00:04:56
Speaker
Thanks, Steve, for that overview. And when I think about the history of this space, it's very interesting. Amplexer, as you know, was a collection of many different services and also a life sciences software division. Sporify was a recent innovative solution, in our opinion, to fill this growing need of industry to EMA data exchange, making sure the data is aligned.
00:05:20
Speaker
So when I heard the news about Aeros Global buying the Amplexer software division and also Sporify in a relatively close period of time, I thought, what a great move to add these two valuable capabilities. So the one thing we have a very unique view on the market, because you know in addition to market a share, we track customer satisfaction and innovation views. And we started the innovation views when we started our world-class room survey in 2016. And we pay a lot more attention on this side to the combination of innovation views and customer satisfaction, usually as an indicator of longer-term health and not what market share a provider has in any given year, because it's just a snapshot. But the innovation views and customer satisfaction talk more about the organization and when it's headed.
00:06:14
Speaker
And it's some
Nava X and the Technological Roadmap
00:06:15
Speaker
of the first things when we get all the data in, which for our listeners, our world-class RIM study, we had all the data in in mid April, so we go into the database. And one of the first things I look at is the innovation index, how the provider's doing, you know who's going up, who's the same, you know the ones that that might be struggling there. And certainly in this year's benchmark, there was a significant increase um in both the Innovation Index and customer satisfaction, a very positive move for Aeros Global. And again, a lot of moving ah parts. And I think for our listeners, you were with Aeros Global you know many many years ago, and then left and came back. I think a lot of the excitement for the future. So what do you believe this is attributed to? Because it's a it's a really strong story
00:07:06
Speaker
then not only one of those, but both the innovation and customer you know satisfaction really go up in a positive direction. So what's this attributed to, Steve? Yeah, um first off, i'm I'm so delighted you asked this question because, again, I think customer satisfaction is probably most important metric um when when viewing a software provider in terms of how adopted is it, how how happy are customers and how much do customers believe their voice is being heard.
00:07:36
Speaker
And I think it translates to our notable increase in innovation is largely driven by our LifeSphere Nava X, which is our next generation cognitive computing engine. What Nava X does is it enables us to deploy the latest technologies, such as Gen AI and large language models, driving the innovation behind our products and enhancing our capabilities. And we're not just doing Nava X across our regulatory domain. It's also paramount to our safety domain as well.
00:08:06
Speaker
We have significantly strengthened our governance and compliance frameworks. This proactive approach ensures our solutions remain robust, reliable, and most importantly, trustworthy for our customers. By staying ahead of regulatory requirements, we provide our customers with peace of mind and confidence in our offering. Customer satisfaction is of the utmost importance to us, as I mentioned earlier. And I believe innovation is part of the is is part of driving that satisfaction.
00:08:35
Speaker
And I fundamentally fundamentally believe the two are inextricably linked. Aerosglobal's ability to drive innovation with Lyster Nava X, plus our unwavering commitment to investing in our customer excellence team, is what makes a good recipe for increased customer satisfaction. In fact, over the past 12 to 18 months, we've put an increased emphasis on how we deliver, how we support, and how we work with our customers, irrespective of the size, whether you're a large top 50 pharma,
00:09:05
Speaker
medium or a small size firm, you will receive innovation and support consistently from Aeris Global. Our approach marries customer excellence with technological innovation, ensuring a seamless and effective response to meet customer needs. And we believe this has positively impacted our customer set scores.
00:09:25
Speaker
Yeah, excellent. And again, it it was it was a really great site because out of I think it's 19 or 20 providers that we have on our kind of a tracking list and you know the regulatory space and you know the other big thing too is how regulatory connects with the other deep domain you have with safety or the QMS or kind of on the commercial ah side on that.
00:09:48
Speaker
So ah shifting gears, because again, I came from the the March conference in London where where you guys did a deep dive on the short term and long term roadmap of the advanced technology, Nava X, and was really you know impressed with it. And you know maybe before before I get into the question, it's, and I think we you know had talked about this briefly as we are you know preparing for this recording that,
00:10:16
Speaker
in the safety area, how advanced technology is being applied to like the goal of, you know, kind of touchless safe, you know, cases. So realistically, maybe a few years back, it's like, well, 30% of the ah cases and just think about a large multinational, the number of safety cases they get, out you know, a year, or maybe it's 50 to 60%. But it's a journey, right?
00:10:40
Speaker
It just doesn't happen overnight. So I recall you and I started talking about, well, you have the touchless you know safety case studies. you know Is there there a possibility with what ERS Global is doing that the touchless reg ops? Now, there's still a lot of work to be done in reg ops, but kind of that journey. So I think that gets into kind of the last area to touch on, because certainly we see AERS Global as a key innovator. A lot of your competition out there, they talk about advanced technology, but you guys are doing it. So what would you say to kind of your current and maybe more importantly, prospective customers? you know what's what What are they going to be seeing in the coming
Automation in Safety and Regulatory Operations
00:11:25
Speaker
years? And it's more about the value to the organization. How will you know their organizations value?
00:11:31
Speaker
or benefit from the advanced technology that you bring to market? Yeah, again, a ah fantastic question. And and I think i think it's it goes back to our focus on automation, which you just touched on briefly in touchless case processing. We're applying that same methodology to our regulatory platform. And what I mean by that is, customers expect to see continued application of advanced technologies, such as Gen AI and large language models.
00:12:01
Speaker
These innovations will improve decision making process, cost savings, better compliance, real-time insights, improved communication and collaboration, as well as predictive analytics. We're committed to evaluating and deploying the latest technologies, even beyond GenAI, to continually benefit our users. Specifically, I want to talk now about the safety space, but more importantly, the regulatory space.
00:12:27
Speaker
In the safety space, we will we will be introducing narrative generation and dynamic data extraction for case intake processing. Customer feedback during private previews has been very, very positive, and it's getting ready to be adopted by four of the top 20 largest pharma. In the regulatory space this fall, we will introduce health authority interactions and regulatory intelligence that leverage Gen AI and LLMs.
00:12:55
Speaker
And I want to touch briefly on both of these if I can. So for health interactions, as you know, companies need to capture and process high volume of interactions with various health authorities in different formats and in different languages. Intake requires manual effort and coordination for local and other regulatory stakeholders. Correspondence needs to be stored as records within a central regulatory information management system or a RIM system.
00:13:22
Speaker
which is not always directly accessible to all stakeholders. Correspondence records in RIMS trigger notifications and downstream actions. Any responses need to be timely and consistent. So I'll provide an example. yeah Let's pretend for a second the FDA yeah issues a letter. The FDA discipline review letter is related to an NDA application for registration of a new product.
00:13:49
Speaker
The letter needs to be captured as a RIM correspondence record associated to the registration. It triggers follow up actions and specific deadlines. The letter is automatically classified as HA a correspondence. Data points are automatically extracted and matched against RIM data. Additional data points can be extracted with text selection.
00:14:11
Speaker
Upon users' review and confirmation, the system automatically creates a RIM correspondence record in the context of a relevant registration. By doing this, we feel with roughly 90 plus percent accuracy, there's going to be three times less handovers, 50 plus percent faster processing time, and between 18 to 16 of the fields extracted. Thus, applying the same methodology of automation to our regulatory offering. And that's just one of the many things we're gonna be bringing um to our regulatory offerings. The last one I wanna talk about is regulatory intelligence. And another example, companies must comply to regulations and requirements on their target markets. Regulatory requirements are updated frequently and published on health authority websites or circulated via email.
00:15:07
Speaker
They are addressing various regulatory topics and only like and can only be provided in local languages. They often have tight deadlines for adoption. Analyzing and assessing the impact requires a significant amount of effort and specific expertise. As an example, the China ECTD implementation guide. What that does is it defines guidelines on ECTD submissions for drug registration in China.
00:15:35
Speaker
It contains important information on how to compile, publish, and submit ECTD sequences to an NPA. The guideline is provided in Chinese language. What we're doing as an example, again, leveraging our Gen AI and LLM for a regulatory offering, Nava X, is the user asks a question covered in the guideline, which has been previously uploaded to the regulatory intelligence knowledge base.
00:16:02
Speaker
The system will then provide relevant response in English. It includes direct reference to the specific guideline page containing the source information. A user can then provide feedback on accuracy and relevance of the response. What we expect by this, again, 90 plus percent accuracy, two times the amount of less handovers between tasks and systems, 50 plus percent faster processing time,
00:16:31
Speaker
and between 6 to 10 fields extracted. Again, building upon our thesis of touchless or automating the regulatory experience. Those are just two
Comprehensive Solutions and Customer Satisfaction
00:16:42
Speaker
examples of what we're going to be bringing to market, leveraging Nava X across the regulatory space. Lastly, we're also thrilled to be the only provider to offer true end-to-end platform solutions, ah not just across regulatory, but safety, quality, and meta-fares.
00:17:01
Speaker
More and more customers are understanding and expecting the value of interoperable systems, and LifeSphere offers just that. And last but not least, I got to put a plug for our delivery organization. Our consulting services continues to grow and offer robust benefits and experience and subject matter expertise for all of our cluster customers globally. And I believe it's the ingredients of all of these, Steve,
00:17:29
Speaker
that have really been the catalyst for driving innovation, customer satisfaction, and customers adopting the life sphere brand. Yeah, thanks for that, Steve. And and just some comments um on this. You know, first, obviously, the the two areas, the health authority interactions and Reg and Tel.
00:17:48
Speaker
ah Two hot areas over, you know, at least the health authority interactions. That was the number one use case that, you know, we need to apply automation and in 2020 and again in 2022 and twenty two and ah again here in 2024. But nobody has really solved it yet. There's a lot of discussions.
00:18:09
Speaker
and proof of concepts. And some of the competition has some base capabilities, but there's still way too much you know manual entry. So people would be forever appreciative if you guys can really, really nail that one.
00:18:24
Speaker
and And especially, you know, with the reg. Intel, it's such an unmet need on the medicinal side, the biopharmaceutical side. ah We've had several poll surveys, deep diving in reg. Intel and envision a future that it's embedded in the workflow. So, OK, I have a submission in Thailand and knows the requirements. It puts the proper workflow of submission structure kind of, you know, in place. And it seems like you guys are well on the way. But the thing that really peaked out, you know, kind of our interest is what you're doing on the safety side and then porting over on the regulatory, because just that example of the narrative generation.
00:19:05
Speaker
ah we've We've had some recent client work, Q4 of last year, Q1 and 2. So instead of
Steve Knuckles' Return to Eris Global
00:19:12
Speaker
you know thinking about automation in regulatory or in a different domain, it's about cross functionality. So both those projects, whereas, okay, with the connectivity of safety reporting and regulatory or different you know aspects of the regulatory safety connection, you know what are ah prime candidates and the big one is the one your guys are already on with the narrative generation and as Greg and I did a structure content authoring and the whole beginning conversation of the generative side and this is probably it's probably two years ago Steve um we had a 2022 pulse survey I think it was
00:19:52
Speaker
30 to 40 companies, maybe. And this structure content authoring, which is the paradigm of reuse, which has been around 15 years, and there's some interest, proof of concepts, and it goes down, but not too much in production. And it was always about the label and focused on the protocol and more clinical things. But this is when the the conversation and some of the early experimentation like, you know, generative AI ai for the, you know, CSR, in your case,
00:20:22
Speaker
Uh, a lot of the narrative generation where, you know, we believe that is the future, you know, that is the future paradigm. And, you know, the providers that are better and that can interrogate the content to pull the data from it. Now they're going to win this, you know, next wave of innovation. So.
00:20:40
Speaker
And again, that's some of the reasons we were really impressed, you know, myself and part of my team. You know, we're in the March conference with where you're going and showing practical results, as opposed to just speaking of that. So before we end up, I actually have one other question for you. And I was kind of curious, because I know and we used to when I was at Booz Allen, sometimes you leave.
00:21:01
Speaker
and then you come back, and we would call them the comeback kits, right? So you were in Aeros Global earlier on. You recently have come back. So so what if you could share with the listeners, what what was the thing that got you most excited or things coming back to Aeros Global? Because it's a statement about its future, right? Why have you come back in such a critical position? So maybe what comes up for you that, Steve? And then we'll ah kind of close out here. No, phenomenal. So probably the perfect question to end on. um Because you're right. i I am what they call a boomerang. I am back to Aeris Global. And I'm back really ah really for two reasons. ah Number one, I fundamentally believe um in the roadmap and the innovation and the level of investment the organization is making and that our investors and are making in Aeris Global um to drive ah what I'll call a transformation.
00:21:57
Speaker
across ah the landscape of regulatory quality and safety. And what I mean by that is um worse' we're spending a ton of money internally and we're also spending a ton of effort um to get Nava X and our Gen AI and LLM strategy and real world practicality adopted because we fundamentally believe ah in the proof that we've already demonstrated relative to this notion of touchless case processing, tough touchless regulatory submissions, um case intake and processing, regulatory intelligence, content generation and transformation, and submission automation.
00:22:41
Speaker
ah We fundamentally believe that our customers are clamoring for someone such as Aeris Global to innovate and someone such as Aeris Global to drive this adoption. And who better ah than Aeris Global with its 37-year history in safety and in regulatory to drive this transformation? So the impetus for me returning was, first and foremost, the level of investment and innovation the company is making. Lastly,
00:23:11
Speaker
I am extremely passionate about our customers and the success of our customers. And Aeris Global historically always hasn't done the best job in that category. And I think you touched on it recently with the recent customer satisfaction index. That that trend is changing because we are putting a a strong focus and emphasis on not just selling a product, but making sure we solve for a very complex problem and delighting our customers.
00:23:41
Speaker
And do we get it right 100% of the time? No, but we are certainly striving for excellence and we are striving for customer satisfaction. Hence why I chose to come back as the chief customer officer. I didn't want to have a sales moniker attached to my name. It was really around making sure we delight our customers, making sure that we empower our customers, but most importantly, making sure that our customers' needs are being met.
00:24:10
Speaker
And
Conclusion and Future Outlook
00:24:11
Speaker
again, who better than a company like Eris Global with its history, with its heritage, and with its investor community of Nordic Capital, you know who better to solve that problem than Eris Global? And that's that's why I'm back.
00:24:27
Speaker
Yeah, excellent. You know, thanks for that. And I can say from them, I've i've referenced I think twice now, kind of the at the March conference in London, and we learned learned a lot. But the thing that was different and Greg and Priya and john, and I talked about the energy that was in the room at that conference, you know, a sizable part of your customer base,
00:24:50
Speaker
there was tremendous amount of energy and excitement about the future, kind of where the train's heading. So um with that said, are some of our listeners, um you know, might want to get in touch with you, or AERS Global, should they go to the website, LinkedIn, what would you suggest, Steve? Yeah, so I'd love, and again, being the Chief Customer Officer, I'll be more than happy to provide my direct contact information. This is for any existing customer.
00:25:17
Speaker
any prospect, or if anyone wants to learn more about what we're doing. The best way to get a hold of me is my direct email, which is sknuckles, my last name, n-u-c-k-o-l-s, at arisglobal.com, or my direct cell phone is 704-995-9-1 I'm happy to take any phone call from any customer. I'm happy to answer or address any question. And if I personally don't know the answer, I will certainly go find it for someone.
00:25:50
Speaker
Excellent, excellent, Steve. And for our listeners, I think you know how to get ahold of if there's any questions from this podcast, get ahold of us, go to our website on the contact page, or certainly I am on LinkedIn several times a day. So look me up on LinkedIn. So Steve, thanks again. i You know, and congratulations on yeah I guess it's the boomerang.
00:26:13
Speaker
effect there coming back and you know we just see our view is just see a great path you know for Airis Global and an exciting one going forward so thanks again and maybe you know we'll we'll get an update from you and the Airis Global team you know at some point not next year so thanks again for joining me. Thank you guys so much and I appreciated talking to you today Steve. Be well.