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Regulatory Executive Series Special: Remco Munnik (Owner and Founder of Arcana)
42 Plays11 days ago
In this special episode, host Steve Gens sits down with Remco Munnik, founder of Arcana, to explore the story behind the company’s creation and its guiding mission. As Arcana takes its first steps, Remco shares the aspirations and early plans that will shape its journey ahead.
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Transcript
Introduction and Guest's News
00:00:06
Speaker
Hi, this is Steve Gens, Managing Partner of Gens & Associates, and welcome to the Regulatory Executive Podcast. I'm very excited about this one. My friend Remco is here. I know most of you know Remco, but he has some recent very exciting news as far as starting his own company. So we're going to explore that today.
Remco's Career and Experience
00:00:24
Speaker
Remco, for our listeners, I'm sure most know you, but for those that might not, why don't you do an introduction and a little introduction about the company? Yeah.
00:00:35
Speaker
Thanks, Steve. So you don't notice it and at us, but I bring over 25 years of experience in life sciences and consultancy leadership. I've been working 10 years in a big pharmaceutical company. And after those 10 years, decided to relocate to the certain parts of Europe in Spain.
Expertise in Regulatory Management
00:00:51
Speaker
And join consulting company.
00:00:53
Speaker
So there been really involved in the hardship of ECD publishing globally, but really going in deep into regulatory information management. So in Europe, we had their new requirements for companies to submit XEVMPD data, switching from XEVMPD to IDMP.
00:01:14
Speaker
um And there became an expert in that topic, helping many pharmaceutical companies on that journey to digitalization, not only from a compliance point of view, but also really from a strategic point of view.
00:01:26
Speaker
Besides my day job as a consultant, I also strongly believe that there's changes are needed on various fronts. And that's why I'm also having two pro bono activities. So one is that I'm representing an industry trade association.
00:01:40
Speaker
And in that role, I'm working together with the European Medicine Agency. I'm a member of the Rekord Torre Optimization Group because I always think that there should be room for improvements. And in addition, I'm part of the IRIS Forum, where I'm a president of the executive committee, really helping the IRIS Forum topic groups to function, to have the discussion between tool vendors, regulators, and industry to bring things forward.
00:02:03
Speaker
I appreciate because, you know, my team, it's the diversity of the team. Like most of us, like yourself, you know, came from industry, did a John Linden Consulting and either went independent or for me, it was more than being independent.
Challenges and Mission of Arcana
00:02:16
Speaker
It was starting a true company and all that. So that combination and like Greg too, he spent all those years at the FDA before going into consulting, then joining that work here. And I just find that balance, you know, it does bring so much more value to the table.
00:02:32
Speaker
But Arcana, we can start there. Starting a company isn't something people do every day. Some people, when they start, they just want to be independent, you know, just kind of solo practitioners.
00:02:42
Speaker
And others actually start a company. And there's a lot that goes into, as you know now, well, what do I call it? What is my mission? There's a lot of things I can do or my team can do, but what are we going to really, really focus on?
00:02:57
Speaker
So it's there's always a story here. So, you know, how you got started and really what's the significance of the name Arcana? Yeah. Yeah, thanks.
Motivation and Meaning Behind Arcana
00:03:08
Speaker
There's one motto in my life that's the biggest room in the world is the room for improvement.
00:03:12
Speaker
And I believe that it's applicable even for you, Steve, but there's always a smarter, braver way forward, right? And after I ended my last job as a consultant for a big consulting firm, I did various interviews with established companies. And often I was, after those calls, I was disappointed. I was not getting the energy that I really wanted to have from matching my view and desire to improve and question the status quo. I really believe that we need to do something different, something better. And that disconnect with those established companies really thought like, okay, it's time that I spread my wings and fly. I need to put my money where my mouth is. And I wanted to start a company that's really driven by curiosity, creating its own momentum, but also the courage to rethink how things are done.
00:04:06
Speaker
And your second part of the question was about Arcana. So to find a company name that's not yet taken, it's very difficult. And identical with Remco and Associates. So Arcana comes from Latin and the meaning is really secret or hidden.
00:04:21
Speaker
But the deeper knowledge is about the knowledge that we possess and want to implement. So it's really specialized knowledge that we want to apply. And what we want to do with secrets and hidden information is we want to do exactly the opposite.
00:04:35
Speaker
We want to make things that are complex. We want to make it clear. We want to turn the regulatory mystery that some companies have with regards to the steps that the regulators are taking into a forward motion at companies to really implement certain things.
00:04:49
Speaker
And we want to bring structure, speed, and human connection to a system that too often stalls. And I'm also saying here, we, so it's also not me. It's also, it is me, but my company, but I'm also discussing with four former colleagues to really bring our knowledge, which ranges from IDMP, subject matter expertise, process optimization, data governance, rim selection and implementation, really bring that knowledge that we have, that we have supported various companies
Industry's Data-Driven Shift
00:05:17
Speaker
to the market and see what we can do.
00:05:20
Speaker
Yeah, that's definitely impressive, Remco. And it's kind of interesting this summer because I've been around the block slightly longer than you, unfortunately by a decade or two. But um you know with all the years that I was in an industry and you know i I was at Booz Allen before I started my company and started in 2005 and all that, that regulatory is always going through incremental change. There's something always going on, right? But Over the last year, it's like something is different. And we finally kind of framed it this summer and speaking at some of the conferences this fall, and we're just calling it very simple, the confluence of change. Because a lot of the things and like the services you're going to offer ah right in the middle of this confluence. This, you know, we talk about documents to data, but it's all about the data, the better
00:06:08
Speaker
the data, the better the structure with a lot of the automation goals, both on the document level, on a dossier level. You need to have a data strategy, not only in regulatory, that thread has to pull through R&D organization.
00:06:21
Speaker
So there's really a lot going on. And what we started, like for the first time talking about, and I was at a forum yesterday, And so we're in the beginning of a new era. So actually starting a company with a lot of specialized skill and knowledge. And I think as you know, too, it's there's consultants and and small consulting companies. They're very, very knowledgeable, but it's how you work with the client. You know, it's a partnership. It's a collaboration. We don't even like using the word projects here. It's a collaboration with our dear clients and all that.
00:06:52
Speaker
So there's a lot of things you could do So I'm sure our listeners are really eager, like coming out of the gate here. What type of service offerings and and what are you most passionate about? Like with those service offerings, what are you going to focus on and and really what are the best type of clients that you're going to be serving?
00:07:11
Speaker
No, I mean, fully agree with that. There's a new change, a new wind is circulating, right?
Importance of IDMP and Compliance
00:07:17
Speaker
We, our expertise is really coming from IDMP, right? We are IDMP subject matter expertise, but it's almost like for me, IDMP is not the data standard. IDMP is really the language that we speak in order to connect systems, data sets to each other, to start understanding what is a pharmaceutical product, what's a medicinal product. And how can we link this to our colleagues in supply chain, in pharmacovigilance, in laboratories? And yes, we need to have some data cleansing and data standardization within regulatory in order to do all these cool stuff that AI promises us. But I think that's where our IDMP subject matter expertise really comes in.
00:07:53
Speaker
Um, yeah, helping still with the regulatory data strategy, because the European medicine agency has set this dot right about PMS, the product database being the source of information, but not only for authorized products, also for development products. So also from your clinical development, you already need to start thinking about this.
00:08:11
Speaker
Now there are very few pharmaceutical companies that only target Europe. So also for your entire portfolio, you need to start thinking, how do I do this on a global level? And FDA might not yet implement mandatory IDMP, but they're also doing things on structured data, right? So there are ICH developments ongoing in the clinical space, in the CMC part of the DOSHA. So you really need to look to the end-to-end process of your product development.
00:08:37
Speaker
and start thinking, how do I manage this data? And not only managing the data out of compliance, but really managing this data as an asset. And I think that's the difference. If you manage this data as an asset, what kind of value can you do derive out of it? And coming back to your question about what clients should call me, I would really like to work with clients. Like it's not clients, like you said, like it's partners, companies that want to do something different that are ready to rethink how regulatory data is driving the strategy.
00:09:06
Speaker
And yeah, that are very bold words, right? Bold companies, but it's really, yeah, it's time to to rethink. Let's not do the things that we have been doing the last 20, 25 years. It's time for something different, something smarter, something agile. And that's also something that we need to adapt to.
00:09:23
Speaker
Yeah, and I certainly can identify with that because, you know, with my limited experience in the IDMP world, he was always referring to Kelly or yourself on these kind of matters. But and maybe I'm looking at it too simply, but I would see like two different cohorts or kind of class of of clients when it comes to IDMP.
00:09:43
Speaker
When some is, hey, it's compliance. So what's the cheapest way to gain compliance,
Client Approaches to Compliance
00:09:47
Speaker
right? And and you do that. um or those that take a different look is, like you said, it's a new language. It's not about system connectivity. It's about information connectivity because systems can be connected. There's data warehouses, data lakes. There's just different styles and techniques. And that's all part of kind of the the data strategy. And we had one very progressive client and they just got done this spring where they had all the different functions in R&D and d and
00:10:14
Speaker
some of the commercial and they talked about their product information backbone and it was they picked 19 data points that were mission critical and it's all based on idmp right so they actually pull that string around and there's so much other business value and the acceleration of process So having a really, really good cross-functional data strategy in our book is really, really important because you know how the story goes. If it's always, well, you know, it's just for compliance. It's the cheapest path.
00:10:43
Speaker
You end up with a lot of silos. You're building complexity versus kind of what you're suggesting is Let's rethink our information highway. Let's streamline it. Let's make it less complex and multi-use. Like I said, when you were talking to me at the Extito conference back there in Maine, Frankfurt, and thinking about this, I'm like, boy, you're going to be great. but You're just a a natural on this.
00:11:07
Speaker
So that's drifted on a little bit. So you're just starting out. I know you're getting your website up. You know, you've got your company name. That's a torturous process. I gave up here. As you know, it was at the end of the year. My tax accountant said, you've got to incorporate what's the name. And I gave up.
00:11:24
Speaker
And I just said Gens and his Associates, but like with my background here, especially for those that are just listening on kind of a voice only podcast, there's these big mountains. It's actually Swiss mountains because I always enjoy the mountains. So like with my company name, I was trying to think about something with the mountains, but so and I didn't. So congratulations on Arcana, a very thoughtful and very meaningful company name.
00:11:48
Speaker
So you're just starting out. It's really, really exciting starting with your first client projects and all that, but but take a look in your crystal ball. So if you look out maybe in the next year or two or longer term, where would you like to be?
00:12:04
Speaker
In the next two to three years, right? I mean, short term, which all already sounds ridiculous, like two, three years short term, but yeah I really hope that as a result of this podcast, also many bold companies have called me, right? Really established established a partnership where we have helped them to just implement the IDMP compliance, but coming from a compliance, really how that drives the regulatory data strategy.
00:12:31
Speaker
And then from a compliance burden, translate this into a competitive edge. And I think that there are many promises of AI, right? I was alluding to that the previous discussion. But I think a AI really requires good data.
00:12:46
Speaker
also So good data quality, data standardization. yeah say IDMP, data governance around that, who's the owner, who's the responsible person for that, what happens if we update the data. And without those rules of engagement, AI will struggle to make sense out of our pharmaceutical data, right? So I think that's really important.
00:13:07
Speaker
You need to have some homework in place in order before you can do the benefits, unfortunately.
Arcana's Vision and AI Role
00:13:12
Speaker
And my goal is then in two to three years to really be Arcana as a go-to partner for regulatory transformation.
00:13:18
Speaker
not for the Not just for the execution, but really for shifting the mindset and sparking momentum Yeah. And that's certainly very exciting because in the age of not only this forum I was at yesterday, there was a deep discussion from a regulatory context about agentic AI and how that's stepping up. and And at some of the conferences I spoke at this fall, I referenced Amara's Law. So that's the basis of the Gartner Hype Curve. And basically with Amara's Law is that the technology, anytime there's a major technology shift, we grossly overestimate it like, hey, AI,
00:13:53
Speaker
People in regulatory are just going to sit in their chairs and AI is going to do everything for them and which we know, obviously, that's not true. But it's it's overestimated in the short term, maybe two or three years, than really underestimated in the longer term.
00:14:07
Speaker
But some of the services and the foundation that you're talking about, it is the new foundation. to really maximize the value of it's a Genic AI or what's going to be next in front of the the term AI into two to three years. So i've certainly well-equipped and certainly as we talk too, um looking forward to like our firms, hopefully we can collaborate on some projects to bring kind of the best of Arcana and getting some associates together. So it's always fun you know collaborating with you, Remco.
00:14:38
Speaker
So um before we ah finish up, any kind of last words or thoughts for our listeners? You know, you're starting up on ah a new chapter. It's, I'm sure, very exciting, but also, you know, a little nervous, too, when you pull the plug and do something as bold. But I think just doing this bold step that you're doing, that's the type of clients you want to work with, those that that want to take a bold step. So kind of any final thoughts or wishes, Remco, today?
00:15:06
Speaker
Maybe one more thought. So when I was couple of years ago, I would have been terrified to start my own company. And I would probably have been very nervous in this starting phase that you're still searching what is my unique selling point? What am I going to sell, right?
00:15:19
Speaker
And I must say that I am happily surprised how confident I am that it will be a success. And I think that confidence is also not coming from just the fact that I want to have clients and I want to have growth and money. I mean, of course, we need to I need to have money on the...
00:15:35
Speaker
to to pay the diapers for the little one, but it's really also building something. So it's building something that shifts how our life science separates things, acts and works together. And think that's also what drives me. That's really my driver, my motivation. It is, we need to think out of the box. We cannot do the same thing over and over again.
00:15:54
Speaker
And that's why also do these pro bono activities. I think as a network, we need to do better to supply internal information, but also external information to patients, to healthcare professionals, better, quicker, in a more sustainable way. So yeah, that is my last thought.
00:16:09
Speaker
Yeah, and I think that balance of the pro bono and then just having your client base is is really important because, like as you know, our survey is is pro bono. And it's a lot of effort, just like you're the
Importance of Pro Bono Work
00:16:22
Speaker
president of IRIS. And for our listeners, if you're not familiar with IRIS, I think in a moment you can get them like how to get in touch if they're interested in IRIS. But it's really those balance because I have always thought in one of my philosophies,
00:16:34
Speaker
you know, when I started the company is you got to give to get and some of the give is through pro bono work that can actually help the entire community. So you express that with what you do with Iris and some of the other work you do, we express it with this so industry standard survey we have that everybody takes. um You know, and it's a lot of effort, but it's also a joy to do it because you can see the results. It's the communities progressing and that's really important.
00:17:00
Speaker
So it'll be good to get get you back in six months or a year, see where you're going. But in the meanwhile, I know a lot of people allowed know you, Remco. You have an amazing reputation. Like I said, you're going to be really good.
00:17:12
Speaker
I'm looking forward to learning more about your team too, and hopefully we can collaborate. But if people don't know how to get hold of you or like, hey, now with your new company, how should I get out in touch with Remco?
00:17:23
Speaker
How should they get in touch with you?
Contact Information for Arcana
00:17:26
Speaker
There are various ways. So actually today I just registered my domain. My website is coming, but um info at arcanaconsultancy.com should be live right now. So happy to help and otherwise LinkedIn or to you, Steve. I mean, happy to to make the connection and see how we can help.
00:17:44
Speaker
Okay, fantastic. And our listeners, you know how to get a hold of us. If there's any questions, just go to our website, the contact page. And just like Remco, I am a LinkedIn addict. So you can just reach out on LinkedIn. So Remco, again, congratulations. You and your team are going to be great. I know you will make an impact. You already have an industry. So really looking forward to see your progress and also hopefully ah collaborate with you on some interesting projects as we get into the new year.