Henrik Nakskov — An AI Can't Ask Questions of the Future: Data Trust in Clinical Research

Adam Walker:I'm Adam Walker, a biometrics consultant and this is the Pharma Prescribed podcast, where: leaders, innovators, and hidden voices in healthcare open up. No sound bites, no spin, just raw insight, one prescription at a time. In an industry driven by: data, protocols and pressure, we rarely pause to ask the human questions:

What drives us? What breaks us? And what truths live behind the titles we wear?

Adam Walker:Henrik Nakskov is a Danish life sciences specialist who spent more than 20 years in clinical drug development. He's worked hands-on with clinical data management and has built and led: data management, biometrics, clinical informatics and information management functions.

He spent a decade at Novo Nordisk, held senior roles at NNIT and led biometrics at Symphogen. That experience now runs through three companies:

Sims Consult is his life sciences consultancy.

Novyra Life Sciences is the IT company where he's CEO and Clinical Information Management Lead.

Safe Implant Technology is the research company where he is CEO and leads: science, chemistry and development.

Henrik cares more about collecting data than most. He wants to know where it comes from, how it moves and whether it can be trusted when the decisions on the other end affect patients.

Henrik, it's a pleasure to welcome you to Pharma Prescribed today.

For those of our audience who are not familiar with you, who are you and what is the mission you're on?

Henrik Nakskov:Thank you very much. Thank you for the introduction. That was a very nice summary. Very good then. So yeah, who am I?

As a background, I am a medical chemist. Worked with medicine and chemistry for, yeah, since the year 2000 actually began. Did my Bachelor in Cadmium Mobility in Kidney and Toxicology.

My Master was in Enzymatic Degradation of Polyaromatic Hydrocarbons in Lung Tissue and Associated Carcinogenic Effect. A very long title, also very exciting. That actually just spurred me into my interest in immunology. Because what we did at that point was actually how does our body's immune system actually function? How does it work? Inorganic, organic chemistry. What are the balances that we are having in our body? That has led me through my full career. As you said, I was 10 years in Novo Nordisk in haematology. I never had anything to do with diabetes. I was pure haematology, coagulation factors. So I ended up as PDM (Project Data Manager) for all the haematology studies. That was: liver, cardiovascular, ICH (intracerebral haemorrhage) and very exciting trauma studies. We tried to help patients that had either a bleeding disorder or had a stroke, in this case haemorrhage, or was actually messed up in a car accident or in a war or what have you. Very exciting studies. Quite fascinating.

What also fascinated me at that point was- you can actually use data for a lot of things, not only to test a hypothesis, but actually dive into data and see what is the data telling us around the circumstances under which it's actually captured. It is one thing that you capture a lab value, but do we have data that can tell us a story around the conditions under which it's captured and hence the trustworthiness of the data? I assembled at that point a team together with my boss at that point, it was Liselotte Hyveled. Fabulous scientist and really experienced and visionary. She could foresee the future before it happened. That was a fascinating time. So we assembled a team and said: "Okay, how do we utilise all of that data that is floating in?" So the first study we had, we collected 414 data points in six weeks. The last study, we collected 1,102 data points in three hours! Trauma study under conditions which was absurd. War, car accidents and what have you. And all of these patients, they have a tendency of not lying still. So it was quite stressful to collect data at that point. But what we did was actually we went in there say: "Okay, can we control that data?" So in order to do that, I actually took an HD in Supply Chain Management and I used these theories of supply chain management, which has been around for many decades, more or less developed during the Second World War in the US. I know a lot of people talk about Toyota being the inventor of that, but that's not the case. It was invented to increase production from '40 to '45. But anyway, we took all these theories:

How is data coming in?

How is it moving?

Who is the owner?

How is it actually progressing?

Who needs it afterwards?

How is it floating in?

Then we align all of this mapping up. You can say data governance, what we call it today. We lined it up and say: "If we can predict when it comes in and we can predict what the next steps are, then we can also assume that we can predict who needs that data at what point, then we can control the total supply chain management around the data." At the same time, we can also control the data quality. So what we actually did was we merged those theories together and then we could more or less foresee that this data point needs to come in at this time and it goes to this person at this time. The interesting part about the data is you can't see it. You can read it, right? But you can't see the data like a proton in CERN. You can't see it, but you can see how it influences the surroundings. That's how you know it's there. It's the same thing with the data. You can see if a person has got the right data because he or she is reacting upon it and you can see the next step is rolling in the supply chain. So that is actually what we monitor.

Henrik Nakskov:So we got all of these elements to work together and it was quite successful actually, because I think that we went from last patient out to database release, it was normally around eight to 12 weeks, which is normal. We went down to one week and then in a particular couple of studies, we went down to two days because we could actually control it all the way through and we had already assembled and evaluated all the data quality on an ongoing basis.

So it's like:That's the Toyota way of management, just in time. So we knew exactly what we needed at that point, so we took it further than the supply chain management developed during the Second World War, but we actually adapted Toyota's way of management and logistics into the way of working, it's quite astonishing. It also saved us a lot of money, because in these big trials we've had 100 sites in trauma trials. Some were producing quite well and performing quite well and some were less. So instead of hammering down on everybody and saying: "You need to learn this" and all 100, then we identified which one had a problem and we developed what we call recruitment managers and educational managers. For example, questionnaires in ICH, intracerebral haemorrhage, where you are measuring the Quality of Life for patients with a stroke. They can be difficult for some people if you're not trained in them, and we could see that in the data. So instead of training everybody, we just sent people out to the two or three that actually needed training and very skilled, diplomatic recruitment managers to try to diplomatically tell people that maybe we should do a little bit of training here and it worked! We could actually see the DCFs going down, zoom, immediately after the training. They have learned it and we didn't have to spend $100 for each DCF each time that we did a clarification form each time we sent it out. That cost, at that point: $100. We saved quite a lot of money on that. Yeah.

So the story about data is very dear to my heart because it can actually change what the patient's perspective of actually recovering and coming back from a disease. Not only can we prove that the medicine works or where it doesn't work, but we can also see how the functions out on sites are actually working.

We had an interesting story and I know that the FDA was actually using that afterwards to teach people: What is Data Intelligence actually all about?

So in ICH we mapped when the patients actually had the stroke because we're very close to the elderly homes and often it is elderly patients who get strokes, intracerebral haemorrhage. So we could pinpoint when they got the stroke. Then we actually mapped in, okay, when are they admitted to the hospital? Then we mapped on top of that when did they have their CT scan? Then on top of that, when were they actually given medication, namely Factor VII, which we use to stop the bleeding. By doing that we can actually see that there were great differences between the different sites. So some had an immediate response on getting the patients in. Obviously, that was the elderly care homes which were next to a hospital or associated with a hospital. It also happens in some countries. You actually have an elderly care home and a hospital next to it, that helped the patient quite a bit. Then the transportation time was quite low. Then the scanning itself was also quite coordinated in some of the hospitals. Then the immediate administration was also quite coordinated. So we could foresee that if you came in within three hours from stroke and get medication, then you actually walked out of the hospital. Plus four hours, then you had a greater probability of actually be somehow disabled!

Adam Walker:It's an amazing point that you've made there and it's something that I've had personal experience of with my father, who himself had several strokes. It was something that we were very aware of at the time: the importance of not just identifying the fact that he'd had either a TIA or a stroke. It was exactly as you say: getting on those medications as quickly as possible- the anticoagulants to just get the blood flowing, but removing the clots as quickly as you possibly can. Your background is so fascinating in the respect of: what you've done, how you came to where you are today. That example, I think is just one of probably many that we might touch upon today in the fact that- there is so much impact, isn't there, in the work that you've done and the work that you continue to do? I'm just wondering how that then translated itself forward into the three companies that you're now involved in and you've taken that learning forward and those examples into your own setting? Because, again, analogous to your experience, having worked for Novo, I know exactly the role that you were performing because I worked alongside many Project Data Managers like yourself. There is a culture around learning and action and doing that you've clearly taken forward into your own organisations. I'd love to hear more about that...

Henrik Nakskov:Oh, yes, absolutely. Yes, it is actually, yeah, it is quite interesting. Funny anecdote by the way a stroke is not just a stroke. There is a bleeding or a clot and here comes the interesting part: when you do a CT scan on a bleeding, then it's bright white, you'll see that immediately! When you do a CT scan on a clot, then it becomes dark, but it only becomes darker when you're actually having a deterioration of your brain tissue. So you can immediately identify a bleeding, but you have to wait until there is actually consequence of a clot! That is a remarkable difference because if you're treating a bleeding with anticoagulant, then you're making the bleeding worse. So it's an interesting part also identifying those on CT scans immediately.

Yeah. I'll move on to that a little bit later, but there is a small anecdote here. I'm not gonna tell you which country it was. We could see that the patient were actually coming in very fast and we could see that the patient was not having a CT scan. It took a while, even hours. So why are the patients lying there? Then we found out at that particular hospital, the CT scanner was administered by two secretaries. You have to book a time. So the acute patient was not immediately assigned to a CT scanner. We found that out. We contacted the hospital and they acknowledged the fact that, oh, there is a mismatch in the processes here. Our QMS system didn't catch that. That's why it is actually educating some of their analysts on that subject. Small anecdote. Yeah. Where did we take it further?

Henrik Nakskov:Well- it actually triggered my interest of data analysis. So I went from Novo Nordisk, then I went into NNIT and I built up the clinical offerings in NNIT from a point of view:

What is a clinical setting?

How do you do clinical studies?

What is a hospital setting?

You have to learn that and then try to combine that with all of the great people in NNIT. This is a company very dear to my heart. I love that company for many reasons. One of the reasons is that if you make a mistake in NNIT, you immediately are backed up by 10 or 15 consultants who are trying to help you out. So that is a spirit that they have in that company and I absolutely love that. You are not left alone. You are backed up all the time. They have three you can say values:

One of them is 'open and honest', which I actually took for my own companies. I literally stole it. That's how open and honest I am and I think it's great and it works.

It's also they are 'conscience-driven' and 'value-adding' and that also works. I didn't take those. I think one was enough.

So I worked with them for some years and did a lot of stuff there: implemented CDISC in very big organisations, tried to structure the way that data is flowing. Also implemented clinical informatics- as a function that they were offering. So we went in and said: "Okay, how do we establish a dashboard? How do we help you to map out all of your data and all your data point and say, the crossroads that is meeting and how do we ensure that you have a QMS system which allows you to continue to do that after we've left?" This is just as important that you go in and you help the patient, I call the clients sometimes patient. You go in there and you help them and then you assist them in maintaining that momentum. That obviously is part of a QMS system. So yeah, it was quite good. One of the things that also struck me about NNIT is that they are extremely well-educated consultants. They are high degree out there all the way on the best of the best and of course, they are running ISO standards and guidelines, and their QMS system is absolutely fabulous. They were born out of Novo Nordisk. So in 2000, they actually went out of Novo Nordisk as their own separate company and it was quite interesting. It was the first time I saw a pharma company actually utilising their own IT department as making money for them and also quite fascinating.

Yeah, so we went on from there and tried to implement that and had a lot of good experience, as I said, CDISC, clinical informatics. Also helping smaller companies to assemble and grow into the larger one. It was difficult because NNIT was big and big companies are costly. They cost a lot of money. But I'll bring that on a little bit later...

But then after a while, I said: "Okay, now I would actually like to do some research again." So I went out of NNIT and then I went back to oncology, which was what Symphogen was doing. They were researchers in oncology: colorectal cancer, with monoclonal antibodies, the immune defence system, immunology and IgG. Then I'm back to the immunology combined with data and then also did the same thing there- tried to establish the foundation for all the data and different sources and tried to establish some really good stuff there. We did. It actually showed that it worked. Unfortunately, then the company moved to the US and I had children in Denmark so I said: "Okay, maybe it's the time to stay at home and do something else."

Henrik Nakskov:So I went you can say, into my own company, created my own company in 2015, Sims Consult. But took all of the experience with me and tried to help smaller companies, medium-sized companies. We also did some very large companies. That was also good because sometimes you have to be small to come in and be the icebreaker in a very large company.

We have one client that is fairly large. It's a really big German pharma company. They are quite happy with what we're doing for them. But normally we settle into small or medium enterprises and some startups. But we had that for some years. Then we structured that and said: "Okay, how do we make an offering that is genuine? How do we make sure that these small companies and medium companies, they are living up to the compliance that they need to be in compliance with? How do we make sure that we can help them on that journey to become big?" So everybody wants to grow. How do we make sure that we can help them through that journey? So then we got certified and Morten and myself, my partner there, we got a Lead Auditor Certification in ISO 9001 and of course also in ISO 27001 examined there. So we took all the standards and then we applied them to all the regulations, then we started to make you could say, standard offerings that we can deliver to the small clients- so they wouldn't have to go through the very big analysis that is often associated with a cost that they can't afford. So that's actually what we tried to do. We tried to keep the cost down but make sure that they were in compliance all the way and it worked! We did have and we still have, some smaller clients that were start-ups and now they've grown out of there. Now they're up into small and medium enterprises. Then, we say: "Okay, it works quite well." We did a lot and we're still doing a lot of audits each year in: GMP, GCP, GVP, pharmacovigilance. We do quite a lot in pharmacovigilance, because it actually speaks into the data and data volumes and the data analysis and also because it's a high-risk area. Many people underestimate the associated responsibilities of pharmacovigilance. Even when you're small, how can you oversee the full GVP, especially with the new legislation in Europe and all the GVP modules? There are plus 20 of them now and you have to live up to that. The good part is that they are resting and relying upon ISO 9001 and ICH standards, obviously. So we've managed to put together a framework for them as well, so they can adapt it. Then we help them create their own quality management systems. We say: "This is what you need, this is what you need." You should only be getting what you need to begin with. I see so many companies break their neck. They have good ideas. They want to start: two, three and four trials up at the same time and they're running out of money just before they get clinical proof of concept. Just before they go in there and say: "Now we need additional investors." The investors say: "Okay, can you show us some data?"

"We just had it, but nearly." Then the investors nowadays say: "It's not good enough, it's not good enough that you have a good idea." What they're doing now, they're diving into the data, we see that continuously. We're doing a lot of due diligence and also helping investors dive into data and they want to look at data, in details.

Do you have a question, Adam?

Adam Walker:Yeah. So as you were describing and talking around that, loads of ideas were coming through my mind. The expertise you've gained over this career of yours has really driven and directed you to support other companies and through best practice that you learned with Novo and other companies has driven your ideas. I'm wondering how does that play out in team settings? How do you translate that into these different arms of companies that you are now responsible for? Because-... There's only so many hours in the day. You're clearly very hands-on and you understand the detail and the minutiae. How good are you at delegating to other people and how do you bring those kind of people into the organisations that you're responsible for?

Henrik Nakskov:I'm, actually, I would say, in all modesty, I'm actually quite good at it because otherwise they wouldn't exist. So I'm not an oracle here, I'm surrounded by people who are really bright and intelligent. I normally say that I'm blessed with having some of the most intelligent people around me and they are. Then I'm also blessed with having people that understand organisational psychology and help me out in that manner. So my wonderful girlfriend, she's an expert in profiling and psychology and she helps me out with setting the teams. We're using Jung's Type Indicator quite a lot. We are using Enneagram. We're using a lot of other profiles. So that means that I can set teams very fast and it also means that I seldom fail because she has done a lot of the pre-work for me. So a lot of the failure is associated with people not working together. So if you have eliminated that, I know my math, I know my statistics, I know my data management, I know my medical and immunology stuff and you can read about that in textbooks and you can have the best expert in the world helping you and luckily enough, we do and I'll come to that a little bit later when we discuss SIT. But, what is really important is that you set the right teams. So you have to get the right profiles to work together. You can have a totally opposite profile. My personal profile is INTP. That is one. That's a little bit introvert, but I can also do the extrovert stuff. But I do like to dive into things. But I'm like a big picture. I'm a thinker and I can live with the flow. That's my profile. Try to set that up against somebody else who is a J. They need predictability all the time and if somebody like me comes in, say: "Yeah, take it easy. Let's see how it works out," then they go like: "What? What did he just say? I want predictability immediately. I want to know where it is." You have to know. You have to meet the people where they are. Yeah. Kierkegaard, who was one of our philosophers in existence, Danish philosopher, he founded existentialism. He said: "If you want to help people, you have to meet them where they are. If you do not, then you cannot meet people and if you do not do your homework, then you cannot meet the people and help them where they are."

So by doing your homework from a psychological perspective and person profiling perspective, you are actually stepping across the river many times because you're not falling in. You are creating bridges that would avoid that you fall in and have to come up again. If you've lost the trust once, then you might, it might be regained if you've done it three times in a row, then it becomes harder, right? So don't go there immediately if you can avoid that. That has always helped me both in NNIT but also in Sims Consult because that's what we're going in with.

As I said, we work a lot with different companies, but the big company that I just told you about, we redesigned a whole preclinical way of working with data. I had a team there of four people and the good part was that they had tried themselves for quite some time, but it didn't really move because they were internally. It's hard to break things up from inside. You have to get somebody from the outside to bring it up because the psychology is forgive him, he doesn't know what he's doing. He hasn't been here for 20 years. So that's quite good. So you'd ask for forgiveness, right? We went in there and we broke it up and then we assembled it again and it worked. Lucky enough for us that it did. So that was good. You can say: funny anecdote on that one is that if they've tried themselves and they didn't succeed, then if we came in and we didn't succeed, they were not worse off than they already were. But if we succeed, then we are the heroes, right?

Adam Walker:It's a really interesting point you've made there because on the one hand, with the assistance of your other half, she's giving you insights into people and personalities and then you're working with, you've said, small or medium sized companies. There is a company culture and there is a people culture, isn't there? Of course, the other thing that I really inherently understand from my time in Denmark and working with Danes and alongside them and integrating into that culture is the Danish culture as well, which is very distinct. I just also wanna give you credit. Whilst you identify yourself as an introvert, I think you're extremely humble around that, around the approach that you've taken to success. But I'd love to just understand a little bit more around that people and company culture because- it's one thing figuring out the person that's sat in front of you. It's quite another when there is layer upon layer within those organisations where you're trying to drive change and change management is something that comes up a lot in these conversations.

Yeah.

I'd love to know a little bit more about that.

Henrik Nakskov:Yeah, so we work quite a lot with that as well.

We did that in France. We had some clients in France that we work quite a lot with. They can be quite difficult actually. Not that French people are difficult, it is just a different culture that you have to adapt to. They're quite different from German culture. Then again, I relied heavily upon my better half and I say: "Okay, what is the sequential consequence of me doing something and what would the next step be higher up in the hierarchy, but also parallel?" There are waves like waves in the water, right? So dump a stone there. What is the sequential consequence of that? Then we dived and say: "Okay, this is this personality and this organisation." So I learned quite a lot from that. But it's also an iterative process because you have to dump the stone and then you have to see how they react and then you have to think about the reaction. If it goes like you expected, then it's good. If it didn't, then you have to decipher what went wrong. It's not wrong, but what went as not expected and what should have been done differently? So you have to address that. Often it is associated, now we're coming back to the information, it is associated with a comfort zone of knowing what is going on. So if people are feeling insecure, they will often address that with having a lot of information, the right information. Not a lot, not drown them. For Heaven's sake, never do that. But having the right information, this is what you need. Do you feel that you're in comfort zone now? I have a client right now, we're doing quite a substantial amount of data transfer for them and they are insecure on how to do that and I said: "We've done it quite a lot." But then I'm feeding them continuously- daily updates on where we are and that has helped out. They say: "Okay, that's fine. Now we can see that you are in the right direction." That helped, actually. So it's about foreseeing what the people's needs are and nobody is the same. We are all individuals and everybody needs special treatment, especially when you're a small to medium enterprise. Because you don't have those cast-in-stone roles that you might have in Novo Nordisk or in Pfizer or in Merck or what have you. There are, you can say, cast-in-stone rules, what I normally call your framework within your QMS. You are not necessarily, you have different hats that you're juggling in small and medium enterprises and you're insecure in where is the overlap and have you done something between two responsibilities? If you share responsibility, then something falls between there. How do we make sure that is actually not happening? So that is what we're using there. So it's the combination between the psychology and the data flow. So you can see these stepping stones that I've had along the way. How do we make sure that we control the data? How do we control the people? Not control in a matter of controlling people and people's mindset, but delivering what they actually need and helping them out, but also from a respectful perspective on knowing their psychology, knowing what they need without being you say- better-minded or a little bit arrogant or something. For God's sake, never be arrogant. Everybody has needs. So that is what we're trying to avoid. That actually led up to, yeah, the next one. When we've worked with that and we worked with that from 2015 and then Corona occurred in 2020 and some of my previous acquaintances also in research came to me and said: "Henrik, there's a lot of new regulations here and honestly, first of all, we are scientists and we are medical doctors and we don't understand them. Secondarily, we don't have the money to buy all of these systems that would help us collect all of that data and surveillance and pharmacovigilance and monitoring and GMP, GCP. We are small." So they said: "We can't afford it. Can you do something?" Then Morten and myself and Jenny, we sat down and said: "Okay, what can we do?" So what we tried to do is actually we tried to create a system for small and medium enterprises and startups that was intuitively easy. They should be capable of using it immediately without having pre-analysis and six months pre-analysis and all of that and investigating the organisation. So what we did was we used 18 months to actually validate SharePoint and to bring it onto a GxP level. You can see here, I took all the knowledge that I had from NNIT, working there for four years on GxP IT systems and applying that to SharePoint and of course, with a lot of help from Microsoft as well. They were quite interested in listening to what we have to say about that and asking into that. Microsoft is actually interested in moving into the clinic. They just didn't succeed yet because it's a whole different ballgame. You have Oracle and Veeva and what have you in the big ones there. So it's another ballgame there. But anyway, we actually managed to validate the SharePoint. We created a system and I'd always say to the client: "What you're getting here is not an Audi or a Porsche. You're getting a Volkswagen Up. That's what you're getting and that's what you're paying for. You're getting exactly what you need. Once you get more money and you get more wealthy, you get more sponsors, then we can always give you better tyres or a roof, or we can expand the car a little bit and we can work with you on expanding to what you need. But don't waste your money on having something you don't need." It's often that they come to us, say: "Oh, we would really like to have this workflow."

I say:"Do you really need that?" It's not that I don't want to do it for you and we make money there, but we're not in it for the money. So do you really need that? Maybe those 5,000 euros or whatever that would cost could be spent somewhere else in your own research. Maybe it could be spent on your QA. Maybe you would like to improve your QMS system because your foundation for your whole research is actually residing within your QMS system. So we have our own QMS system for the eSystem that we built. At that point, that was actually called Sims eSystem. So we built a whole framework of that. So we say: "Okay, now we've got a SharePoint." We built it in, we protect it, we have the full framework, so it's GxP level. We validate it, obviously. We do the normal validation report and validate it via GAMP 5 and we have also the ability to do a lot of workflows. The interesting part in this eSystem is actually not only the surface, because it's very straightforward. Everybody knows SharePoint, but it's actually what happens in the background. That's actually what happens on the Azure servers. It's actually what happens on the indexing. So if you can't find your document, for example, we all know that we are drowning in information. So if you can't find your document, we have an engine running in the back indexing all of that, not only from a work perspective, from an information perspective on the naming convention or the naming, but also inside the document. So if you know a word inside the document, it will search for you and it will find it for you and then you can find your way back. For example, approve submission. Yeah? So you search on that and then you'll get all the relevant documents in that. So it's focused on doing that and of course, with indexing. You can export it and you can do all kinds of stuff. We're focused on doing that, so it actually helps the small and medium enterprises on a daily basis because they're drowning, as everybody else. Then we help them out. We have all the audit logs. We run all the audit logs continuously and we have a, of course, a backup, two-hourly backup. All of that they don't need to think about. We do that for them. We maintain it. We say, this is a truck, yeah? So you rent it from us. We maintain it. We do the oil change. We do the tyres. We do the maintenance. We operate it when you need it. What you put into the truck and transport around, that is your business. But if you need us from a consultancy perspective, then we bring in Sims Consult, and there we do all consulting. With the exception of, I think I told you that, we don't do submission because there you really have to be an expert through many years and we stay out of that and we don't do medical writing. But that is also okay, because that is later in the phases of your development. We normally say: When you have grown enough, then it's time to say goodbye. Then it's time to say, now you have gone through kindergarten and your high school. Now you're moving into something different. Maybe you're going into phase three. Then you shouldn't have us anymore. Then you are moving on to something different. Maybe you're even having additional funding. Then it's goodbye.

Yeah.

Adam Walker:Yeah, I think that's a... Wonderful example you've given there and a really interesting perspective because whilst you're describing that, all I keep thinking, this word that just keeps coming back to me, is 'trust'. You're working and you're building trust all the time with these clients. You're giving them confidence that they have the tools that they need. As you've so eloquently explained, you then want to hand it back to them in a better place than they've started, certainly with far more perspective and validation and guidelines adhered to. That's an incredible model to work to because most companies these days, they're all driven by the dollar value and they're driven by: What can we continue to do? Of course, the pivot, I think, around the consulting services is really fascinating because what that clearly brings in is: Yeah, we could do this, but there are other ways of doing it and actually just handing it back to them, I think builds far more longevity in those relationships, doesn't it?

I'd love to hear a little bit more about that if you could explain?

Henrik Nakskov:Absolutely. We can actually prove that what we're doing, we're saying we're doing, because we have normally said, a little bit of maybe bragging, but we never lost a client. But now we've lost one and that is because that client has actually grown from being very small to being in a whole different ball game. They are now the talk of the town within their area and of course, it's confidential, but they are now leaving us and moving into something different, a larger system. But they are also heavily bombarded with funders and they get additional funding, so they're expanding quite rapidly. We also have another client who is intending to go to the stock market in the US in two or three years. So we are helping them establishing the transition for the IT strategy. So right now, we are maintaining those, so they're always in GxP and we are maintaining the data standards and the building up. So we always run by standards. So we run the CDISC and TMF standards and we run the ICH common technical documents that we have there and of course, we run it by all the standards. We make sure they stay within those boundaries. I normally say to them and that's quite motivating for them: "If you have control over your data and you can put a bow tie on that, then you can put a zero behind the value of your company." So it actually doubles your value of your company because what the investors are looking at nowadays is not only the idea. They want to see that the data's valid. They want to see that it's genuine. They want to see that it's trustworthy. So we also, in the trust process, we also help them do internal audits. We help them build up their audit functions, teach them how to do audits, or we do it for them. Quite a lot of our clients they buy actually assets outside, so we do the due diligence on their data and run through the data and then if we say thumbs up, they buy it and if we say thumbs down, they don't buy it. It's also quite a trust that we have there because it actually shows that they trust us. It's a lot of money, without saying how much money it is, but I can assure you it's a lot of money buying another company's data, clinical data and put it in a system for them to work with, but they do so that's great, and we're well proud of that. That is actually all the stepping stones that we've had and then we try to teach them a lot about what is ISO, why do you think in ISO and you said this about that is the ISO way of thinking. You identify and then you learn, then you correct and then you move on from there. That's the sort of learning adapting methodology and then you have a continuous improvement.

So when I do audits, I always go by the flow of ISO. So I have many years of experience and I can always find something if I want to. As I said: I also do a little bit of training and education on health authorities- how to do data management and statistical audits because they don't have a lot in these areas that can do that. I did that one day while the EMA was in London. Now they've moved. Sorry about that. I lost all my good contacts. But that's okay. I still have a lot of sparring there.

Henrik Nakskov:But it is important to have that mindset built in and that's why I say when I do audits, let's relax here. I'm not here to slaughter you. I'm actually here to find opportunities for improvement. If I can see that you meant well unless you're totally critical and you totally ignored safety, then it's, of course it's critical. But otherwise, let's work with that. Normally when I do an audit, I say: "I would like to see this proof and the reason I would like to see it is this and this is the consequences if you're not living up to the standards."

So people then always:"Okay." So they learn from that. So they're not saying: "Here you got an observation and it's a major one." "Okay. What should I do about that?"

"You go figure it out." That's not the way we work. So we would like to say: "Okay. The reason why I ask these three steps is this is what I would like to see. The reason is that, and these are the consequences if you're not in compliance."

Then they normally say:"We're not in compliance. How do we get there?" An inspector can't help.

We auditors, we can and I normally can lead them in the right direction and say: "This is what I would expect you to see..."

Adam Walker:Yeah.

Yeah. As an auditor myself, when you're talking through the principles, it's building on that: 'Show Me, Tell Me' principle, isn't it? Also, having been on the receiving end of plenty of audits, as I'm sure you have, you know what you like and you know how you don't like to be treated and we don't like to be told off like we're being naughty school kids in the playground. We want to be guided and shown and elevated in our thinking as to how we can do it better next time, 'Even Better Ifs' kind of approach. I think it's a really rich perspective that you've offered there.

Adam Walker:What then comes to mind as we're talking this through is really: The New World.

When I talk about The New World, I know you have some very strong opinions and some principles around how Artificial Intelligence (AI) and overlaying everything that you've learned and implemented in all these organisations- your own and others, to that New World setting. I think it would be absolutely remiss of us not to have this conversation around: What your perspective is, how you're using it today for yourself, how you're advising companies around that? Because in many conferences I've been to, there have been auditors: from the EMA, from the MHRA, from the FDA and they have a perspective. I just really would love to hear more about what you think best practice will look like for AI in clinical research and drug development in all the aspects that we've talked about?

Henrik Nakskov:Yeah.

So we use, of course, as everybody else, we use AI, but we don't use it blindfolded.

So what is our foundation is all the way back and then back to Novo and clinical informatics, we are following data points from creation to archiving. So what I normally do is I go in and I pick maybe 10 data points or 20 or 100, depends upon how large the order is and then I follow them through the different processes which are guided by your QMS system. Your QMS system, I hold up against the regulations and the statutory regulations and the legislation and say: "Okay, what should you live up to? Is your QMS supporting that? Are you actually acting according to your QMS and can prove that via all the data points?" Which is the evidence, what we call Quality Records. You can say you can always pump a lot of data into an AI machine, that is not a big problem. But what I've seen is that they take off. Suddenly they will zoom in another direction.

Henrik Nakskov:So we always set the scene with a framework. We build a framework and tell the engine: "This is the framework and you're not allowed to go beyond those boundaries." Then we also build checkpoints around that and say: "We test you all the time, so you stay within this framework." Why do we do that? Because I've seen too many times that really good machines. I often use Grok. I like that. It's more scientifically oriented. It's trained more in science and in data and statistics. We often use that and say: "Okay, how do you make sure that you stay within the boundaries?" Lately, I've actually been using Grok and ChatGPT against each other. So I've actually managed to work with those two together. It's actually good, it helps. It's quite interesting to see what comes out when they're starting to communicate. I tell them that's what I'm doing within the framework and it actually works. I say: "Did they actually say that? No, it is that." So it actually works. They are trying to not downplay each other, but either confirm or find holes, the black holes, as I say. That's what I do when we do orders and use AI. I try to find the black holes, because I can see that the data point working through all the processes, all the systems. It goes from birth into another system, into a third system and all of these system, of course, must be validated and that's where I bring the expertise in from NNIT and I can check that the systems are validated. So it's the triangulation, you can say, of: your QMS system, your regulation and your IT system. In the middle, in this triangle, there is your data and that's what I'm following in the audit or the inspection. So that's if I can get this triangulation to work, then I know that they are in compliance. If it doesn't, then I can see, okay, you have a hole in your QMS, or you have a hole in your execution of your data or your IT system is not living up to the compliance level that you should have. What I often see is when data is being exchanged, they are running in CDMS systems, Clinical Data Management System, all validated, all good, beautiful. Then they are exchanged by a secure FTP site. I had a good example. I had an audit and I looked at this secure FTP site and they exchanged SDTM data. Yeah. I said: "Okay." So I went in there. I said: "Okay," to the auditee. I said: "Try to open that file. It's an XPT file. You can open that with SAS." They did. So I tried to change this male to a female. They did. Tried to save. They saved it and go out again, then came back. It's still female, right? So they've actually changed the data and there was no audit log. So they could actually go in there and actually change the data without an audit log because they exchanged it on a secure FTP site. Some are also using Box or something else. But there was no audit log. There was no change control. They actually had, in this particular case, they actually... I think that- was it 15 administrators? So absolutely no control over who was in there at what point. I said: "Okay, we can also compare this," but then you have to go back to the CDMS. But when you move forward, you should maintain your compliance because what really costs a lot of money is when you're going back to do the re-evaluation and that is actually what investors are doing nowadays. They're actually hiring somebody like me to go back to see, are we genuine? Can we trust that data? They don't want to buy data for a lot of money which has changed during the process and it happens. I've seen it many times. It happens. Of course, you got methodology. There you can really use a lot of AI there and say: "Okay, how come this, this person is a male when the uterus has been removed?" There's something wrong there, right? So bad example, but that has happened. It happens. So that is how we work in all of these stepping stone, but always maintaining the framework of AI so it doesn't take off.

I think that the biggest challenge we have nowadays with AI is to maintain the trustworthiness. AI sometimes, AI is like a horse. They want to serve, right? They want to really serve you and they want to make you happy. If you thank them, they say: "Oh." It's like working with a person. You can actually flatter an AI machine. So what really is interesting is you have to know potentially the outcome before you ask the question, but you use AI to framework that. So what I do, I always use all the building blocks. I use the building blocks and build them myself. I do the analysis, for example. So when I do an audit, I do all the analysis. I do the audit, I do the auditing notes, but I of course use an AI machine to structure that. So you have a good solid structure, your spell check is immediate, there are no misspelling and all of that. That's where you really shine. So you focus on the building block. You focus on the knowledge of your background, having that background in clinical, medical and working with that. So that's what takes us into the combination between Sims eSystem and Sims Consult, and eSystem, as you know now, is becoming Novyra because we are moving that to Switzerland due to many reasons. We have a great deal of Swiss clients who actually like to have the company in Switzerland and a lot of other reasons for that. We had some good people coming in that would actually like to work out of Switzerland and that's what we're doing. Yeah. But we still have eSystem in Denmark and we still have Consult, and Consult is supporting both eSystem in Denmark and Novyra.

Adam Walker:Yeah. I think just to follow on from that, what I think I heard was there will always be a human in the loop.

Henrik Nakskov:Yeah.

Adam Walker:And with someone with your expertise and the people that you surround yourself with, I would anticipate those will be some very highly qualified, very capable humans in the loop. Just to flip that on its head, I'm just wondering whether or not some companies may well just say: "Do you know what? We're just gonna stay old school. Because we know old school, we understand it, we've got a framework-... And we don't then have to reinvent the wheel to fit around the unknowns." But I'm just challenging that back to you, because I just wonder how that sits with you when I said that?

Henrik Nakskov:Yeah.

Henrik Nakskov:No, I don't think that is gonna be the case.

First of all, it's too expensive. You can actually benefit quite a lot from AI if you use it correctly. You can also make a devastating tragedy out of your company if you use it incorrectly and that is the lack of knowledge of your data and data facility. You remember I told you to begin with when we took all the theories from supply chain. So we actually created functions like: data logistics, information logistics, information supply chain management and data intelligence. So data logistics, that's only moving data around. Information supply chain management, that was the- how do you move the right data to the right people at the right time? But data intelligence is how do you benefit from foreseeing and predicting the next step for your data and raising a flag for the receiver of data that: "Remember, 14 days from now you will be getting this. Please be prepared." So if you know that something's coming towards you, you are prepared. That is actually what helps companies move forward if they use AI correctly. But you have to take those steps, otherwise it's just one big black box. That is also a prerequisite from health authorities that you can show that you have taken those steps. So, occasionally I am found worthy of giving input to some of the regulations. At least they ask me from time to time, some of the regulators that we have. I happily do that. We had the discussion some while ago and I had the same discussion with Grok actually. I say: "So, how do we know that the reflection of what you're seeing is actually genuine?" Because I said: "If I had the power to remove all of the articles in a particular subject and only retain the articles that I thought was the right ones and not the questionable ones, what would you then respond to me?"

I would obviously respond in the lack of knowledge. I don't know what I don't know. Exactly. You don't know what you don't know. But a human being would say: "There is something wrong here." Because here comes the interesting part...

Henrik Nakskov:An AI machine cannot ask questions of the future! They cannot suddenly invent something and say: "Oh, this is where we want to do the research," unless it is backed up with references. So an AI machine: Grok, ChatGPT, Claude, what have you, it is actually based upon references of what it has learned. It is not a human brain. It is not suddenly developing a good new idea and this is where we're moving on. That's my take on this and I had the same thing with the health authorities here. So what do we do with AI when it becomes a black box? Is that you have to increase the surveillance of your safety because you are increasing the unknown parameters. When you are increasing the unknown parameters, then obviously your statistical probability of you having a risk associated with that safety-wise, for your patient, that increases as well. I'm not saying that necessarily it may come true, but you increase your unknown. So you have to increase your observance if you're using an AI. You literally have to compensate for using an AI. But you can do that fairly easily because then we're back to the framework. You have to make testing of whether or not your AI takes off in a direction you don't want it to be. So we're back to the framework of the AI. You stay within the framework and it actually works and yeah, it has helped us quite a lot.

As you said in the beginning I also have a research company: Safe Implant Technology. That brings me back to the immunology. Some years ago, I was asked to decipher why a particular gel not a gel, but a particular methodology or a compound could actually close down the immune defence system around a medical implant. Because what happens when you are, for example, putting a continuous glucose measurement into the body, then it actually gets encapsulated. So within 10 days, the function, if you have it under the skin subcutaneously, it actually gets encapsulated and the function of measuring, it deteriorates. Then the producers actually increase the signal, but when you're increasing the signal by increased power, then you're also increasing the insecurity of the measurement. So sooner or later you will have the same insecurity as the measurement itself and you can't trust your data. So they asked us if we could figure out how to actually make a local environment around the implant. So what we did was actually we developed GRP5, which is a gel and we are testing that right now on continuous glucose measurements, medical devices. We are in preclinical and we have seen that it works. We can actually put the devices into the preclinical testing and we can also see it in other aspects. There is no fibrosis and it works. We've had trackers subcutaneously. It shows that we can go beyond the 10 days, which is actually the limit for transcutaneously. The ones that you put on your shoulders. They should be replaced after 10 days. That's because the clotting on the measurement is actually covering up the signal, then you have to replace it. So we can actually go beyond that. So now we are moving in to pre-clinical analysis for approximately six months, starting next week actually and doing the clinical research there. Again, I'm lucky enough to have some of the best people in the world, the best medical doctors, some cardiologists. That brings me to another story actually...

We were requested if we could do that, could we then also develop an implantable device that would measure your blood pressure? That was actually Aalborg University Hospital who asked us could we do that. I said: "I think that yes, we can."

So we designed it and then we're starting on that one. We're just seeking funding for that now. Because if we can do that and the reason why they asked was if you take the blood pressure of your patient with a cuff, you know, a normal cuff that you have on your arm, that is a blood pressure in the moment, in that instant. It doesn't say anything about the blood pressure 10 minutes from now. What we really need for patients with a heart disease, what we really need there is actually a continuous blood pressure measurement morning, evening, sleep. Also another point is as one of the doctors said we have difficulties for elderly ladies who are in the elderly care home. They live longer, so normally it's ladies, but a lot of them are skin and bone. So if you come running along with the protocol saying that you should have measurement of your blood pressure three times a day, it hurts a lot, when you put a cuff on and some of them- they're having maybe cognitive difficulties, Alzheimer's, what have you. They don't know who they are, but they remember the cuff because it hurts. So if we could measure them continuously, then it would help us out. So that's what we're working on now in SIT. As I said, I have been blessed with some of the best medical doctors in the world that are supporting that, both in Denmark and also in other places. We've had support from a medical device company. It's public, I would say but it's something, two from the US, and they're quite big.

They've said:"If you can succeed with that, we will open the doors for you."

I said:"Thank you. We'll do our best. We'll do our best." So that's good. So of course we will need funding first and stuff like that.

Henrik Nakskov:But my dream scenario is I would like to develop a medical science implantable medical device which continuously could measure the consequence of medication. Why is that? Because when you give medications to patients nowadays as you, from your background, we are having cohorts of patients, male and female and children and pregnant and what have you, but it's not good enough. It's not fine-tuned enough. We all react differently on cardiovascular medication or cancer medication what have you. Immunology medication and stuff like that. The new immune defence system, the treatments that we're using for cancer nowadays. We all are acting differently and it's all about adjustment. So I don't see, actually, to be very blunt and honest, I don't see when I'm scanning the market a lot of new medicine coming on the market, but I do see a potential for optimising the existing medication in combination on the market. But all people react differently. So if we could monitor the vital signs continuously- in the patient when they are given the medication. It's not only now, it's hours from now the medication takes into effect.

So we can actually adjust the medication. So what we did in 2007, I think it was, in all the West, we started to use combination treatments. That actually worked because you can see in the statistics, at least in: Denmark and Germany and Sweden and what have you, the average mortality it actually decreased. People stopped dying at around 73, 76 and then they suddenly continued to live on and died around 83, 84 and that is due to medication. That is due to hospitalisation, a good healthcare system. Also maybe due to people stop smoking too much and drinking too much and what have you and awareness. But it is also very much a large part of the way that we are treating people. But I see that if we can get a medical device to monitor that, then we can actually go to the existing pharmaceutical companies and say: "We can help you optimise your administration of your medication that you have to the individual person." So instead of saying: "Okay, it works within this boundary," then you would have of your existing medication- individualised treatment. That is interesting and that's where I wanna go. That is my dream scenario. You asked me where I was on the road, that is where I wanna go. That is my road, yeah.

Adam Walker:I'm really reassured by that, Henrik, because there are so many interesting aspects to you, not least of all, for anyone that's watching this, they can see behind you. I don't believe that to be a fake backdrop. It looks like a wet chemistry lab or something like that...

Henrik Nakskov:Oh, yeah. I'm in the lab actually now.

Adam Walker:Yeah.

Henrik Nakskov:Yeah.

Adam Walker:So that in itself speaks volumes to the work that you're doing. But I think also it's-

Henrik Nakskov:This is fascinating. You see I'm actually doing a gel now. It's running here.

Adam Walker:Go on.

Henrik Nakskov:I hope you will see it. So this is my new gel and it is in preparation. Takes two or three hours to create. Once I put it on a medical device, it stays there when it's dried and you can't scratch it off. When I put it into a body or a water or what have you, then it dissolves immediately and releases all of the elements that we have in the gel. So that I'm working on, so I'm actually done with that. When we're done, then I'm done with that one and it needs to go into vacuum to get all the air out and... It's a long story.

Adam Walker:Story... I love that. I love that. I hope we're not breaking any confidentiality by-

No-

By us, by you showing us anything that-

Not at all.

Henrik Nakskov:Not at all-

Adam Walker:that's on screen today.

At this point in the conversation, Henrik, I like to conclude with a quick-fire round.

I'm wondering, what is the one piece of advice you would give to your younger self?

Henrik Nakskov:Oh, do what you did. Follow your lead.

I've stumbled across many obstacles. But what I've always known is that you should surround yourself with good people. If you're surrounding yourself with bad people, then you are polluting your soul. I've been blessed, my biggest... I really admire her, but my biggest idol and that is one of the persons that I've really looked up to all my life, that is Liselotte Hyveled, she was in Novo Nordisk. She's still in Novo Nordisk. She's on the board now. She is an outspoken person in: understanding people, having brilliant leadership, having the feeling of leading people, but also having the potential of bringing people forward to shine without her shining, but she's actually pushing the people forward and bringing the right people in there. It has been a blessing to work with her. I have worked with a lot of good people and I am working with a lot of good people. I'm not in any way saying that to downgrade the people that I'm working with now because they're also really skilled. Some of them are extrovert and all over the place. Some of them are more introvert and then we dive into the engine room together and then we figure out what the problem here is. That is also a lot of fun. But meeting a person like that and through 10 years developing myself and her and all of the funny things that we have developed, we even wrote some articles about in books if people are interested. They can go in and look it up. That's the best thing I've ever done. Be true to myself.

The next part is I've always done that- educate myself. I got a lot of educations and I do that continuously, also now.

Adam Walker:It's clear. It's absolutely clear in everything that you say and everything that you talk about.

What are the top three qualities you value most when building a team?

Henrik Nakskov:It is first of all that I reach out to my better half and say: "Which people should be in this team given the nature of the task?"

I more or less have learned it from an intuition and I can feel people, what they are. I don't have the skills that Shinetta has, but I can feel people.

But it's also, of course other people, can they work in this environment? So you have to bring it up to this environment. There are some people who are not suited for working in highly changeable, aggressive, positively aggressive environments and some people love it. It's a rodeo ride for them and they love it. So you have to find the right person to that. That is not something about your type. That is also something about your personality. So- Your type is how to shine the most. What is your preferred way of working? But you also have a personality that comes into effect and you have to actually have that.

The third one is:are you willing to continuously learn and develop and take people with you? One of the things that is dear to me is- now we've made, for example we have designed the implantable medical device of vital signs, the first one actually blood pressure. What I did to the consortium and we create consortiums. So we have Norway University, we have a company in Norway that do the devices. We have Aalborg University Hospital and we have another company that is actually helping us out. We have ourselves. So, what I did there was I suggested and they bought into that, we share the IP. Because nowadays we do not sit down individually and discover that we create what do I know? Some aluminium or some nylon or what have you that you create yourself and then you patent that and then it's yours. Nowadays, it's a chain. It has always been a chain, but you can actually patent individual... But this one, it's a full chain, so if we don't have the gel, then it gets encapsulated. If we don't have the medical device created in the right way, then it doesn't work. If we don't have the blood pressure measurement and the MEMS, then it doesn't work. If we don't have the machine learning, because all of these parameters that we take out of the medical device, in this case, it's the blood pressure, they're four parameters. But it's rubbish if you look at it from a data point of view. It's just a lot of fuzziness. So you have to use machine learning to decipher that and to coordinate that up against the actual blood pressure. That's the machine learning part. But here is the interesting part: I believe in sharing the IP because everybody's contributing and I can surely assure you that I'm certainly not in any way socialist. Not in any way. I'm quite the opposite. I'm all the way out there to the right. I believe in the liberal market and market economy and development. I believe in competition, strongly believe in competition. But I also believe in the people that contribute should also be part of it. So that's what I said to the teams. They are also, of course, there is a psychological perspective of this. If you know that you're part of it and you have a stake in there, then you also work and we work really hard. Not that the people that I have around me didn't do that to begin with, they take the phone Sunday evening at 8 o'clock.

Adam Walker:I can see that you certainly would bring out the best in me and I think you must bring out the best in everyone that you come across.

What is your favourite thing outside of work, Henrik?

Henrik Nakskov:Here's the problem: I work a lot. One of my friends he's really good. I talk to him and we do a lot of those bar, and he said... I said: "Sometimes I struggle to sometimes find meaning."

He said:"That's because you work too much. You have to find something to do outside work."

I said:"I wouldn't know what that would be."

I used to do a lot of painting, but it takes a lot of time. What I do every day what I do, I work out and I do that every day. I have a schedule. Now we have almost like day one, day two, day three, day four, start all over again. Day one, day two, day three, day four and it works for me. I'm 63. I'm in good shape. My own physician tells me that...

He said:"You got numbers like a 20-year-old."

Thank you. That's a lot of fun. It's a good thing, isn't it? So that's what I try to do every day. I try to work out every day because you can be that much nerdy, but it clicks off my brain when I'm in the gym or when I go out running.

I used to do sailing, but I've given up that because it was too expensive and lately I've been sailing one or two times a year and having a boat for that is highly questionable considering the price associated with actually doing sailing. But that was a lot of fun.

But right now it's just working out, cooking a lot of nice meals- which is the advantage of doing a lot of sports- you can drink a lot of wine and you can eat a lot of good food without gaining weight. So that is nice and I like that actually.

Adam Walker:I've got to compliment you. You look incredible for 63, honestly. You really do. If I look a fraction as good as you when I hit 63, I'd be very happy.

Finally, Henrik, what is your number one golden rule in life and in business?

Henrik Nakskov:My number one goal in life and business?

My number one goal in life are my children.

My children are my first priority. Nothing compares to that. Nothing sideways. It is my first priority. During the weekend, I was lucky enough to become a granddad and that is, of course, it increases the priority obviously. Now I have the privilege of having somebody that I can totally spoil without having the consequences of doing that and that's my daughter's responsibility. I would love that. It's gonna be great. It's gonna be a great life.

My priority in work obviously is, as I said: I would really love to pave the stepping stones for having created a vital signs implantable sensor that could optimise the treatment for patients. Also, bringing that beyond that, if we could have an implantable medical device which could actually monitor patients in a critical setting. Right now we're having a lot of nurses and medical doctors doing surveillance. So I discussed this with one of my medical doctors and said: "There is the pyruvate–lactate balance." You remember that from... Yeah. This is normally a balance, right? So with this is taking off- we know that something's gonna happen to the patients in a couple of hours. So again, it is the predictability. So if we can predict that patient comes into difficulties in those rates within one or two hours, then we know where to go. So we don't have to have that continuous surveillance of 10 or 15 patients. We get the warning signals before things actually go sour or go south. So that would be my goal, my dream. I am sure that it's gonna take 10 years, maybe 15, so maybe it's not gonna be in my time. But at least I can try to create the stepping stones for moving forward with that.

Also in my world, as I said: I love immunology. I find it really fascinating and I would love to learn more. Actually, I would love to learn more in that area, in that field. So I have started to study the immunology cascade together with the haematology cascade. That is quite fascinating. The haematology cascade, you remember that from your studies, right? It's like a prothrombin and thrombin and factor five, factor seven, eight, nine, 10, 13. They're all balancing each other. Otherwise, you would become jelly, right? Disseminated intravascular coagulation. So they are in balance. So it is the same with the immunology. So if they are out of balance, then your immunology will actually attack you and that's what you have when you're having an immunological reaction against yourself. That's actually increasing in the world, that you're having immunological diseases in the world. That is actually a quite steep increase. So a lot of people are trying to figure out why that is the case. That's also an interest for me. So what is the case and why are we seeing this steepness? It actually combines with my research in cancer because inflammation, we showed that in the Master that I did, inflammation is actually carcinogenic. So if you're having an increased inflammation where it goes into overdrive, then it actually becomes carcinogenic. So it actually creates cancer. So again, we are into the immune defence system coming out of balance and if it goes in overdrive, you create cancer. That's back to the balance and that's why I'm trying to figure out the balance. Your whole body is one big immunochemical reaction all the time and that's why you stay alive. If we had that continuously in homeostasis, then we would continue to actually live. We don't have that, luckily enough. I don't believe in immortality. I believe that we are here for a reason and we're also here to actually die. Renewal process, I would call it and yeah, but while we're here, we should have a good time.

Yeah.

Adam Walker:It's so clear in everything that you've said today, Henrik, around your principles and your values and that background in medicinal chemistry that you touched upon, bringing that through to immunology and also framing that as a lifelong learner. You're definitely going to be leaving things better than when you found them. That's absolutely crystal clear to me in all the things that you're doing, in those three arms of the companies that you're now responsible for and have oversight for.

Really I just think it's been a fascinating insight in how to translate what you describe yourself as: an introvert, an expert, a big thinker, into really a work setting where you're helping people where they are. Getting people to where they are and just really identifying around: those principles, the relationships and the systems and the manner in which you can best get outcomes around those things, what we talked around with trust and inserting yourself and your colleagues into organisations.

I've learned so much in this conversation. It's been so fascinating, Henrik and I've made so many notes throughout the entire conversation that have just got me thinking on so many different levels.

I really wanted to thank you for taking the time for explaining things and simplifying the complex, because we have a very broad audience on this podcast, on Pharma Prescribed, and I think anyone who listens to this will just really appreciate the way in which you've done that so absolutely eloquently. It's just been fascinating and I really just wanted to thank you for taking the time today on coming to speak with me on Pharma Prescribed, Henrik.

Henrik Nakskov:Of course. Of course. If it makes a difference, then I'm really happy.

Adam Walker:Thank you so much.

Henrik Nakskov:Likewise, Adam. It's been a pleasure.