Ivana: Today we are very excited to be joined by Jakob Juul Rasmussen, the Managing Director of Pharma IT, and today we will be zooming in on especially biotechs and smaller pharmaceutical companies. Jakob maybe you could take us through what is the traditional way of implementing IT Applications in the pharmaceutical space?
Yeah, thanks for having me. To answer your question, you can say there are a lot of vendors in the industry that provide IT systems for different topics and there are multiple vendors within each domain area. So all the small pharma and biotech companies, and the larger and medium-sized ones as well, of course, they need to scan the market, they need to do a request for information. They need to do a request for proposal for each of these companies, they need to figure out what software to that fits their needs the best. So normally they engage with one of these vendors. They have to pay a fee for the software upfront. Then they have to run an IT implementation project, where they normally hire consultants to support them in the process to ensure both good implementation from a business IT perspective, but also to ensure full validation according to industry requirements.
So, usually, most companies end up spending at least 50 to 200,000€ before they get an IT system implemented. On top of that, they also need to consider what to do when they go into support and maintenance, where they usually have to build up their own IT organization to support this system and to maintain the compliance or validation baseline afterwards.
So it’s a quite cumbersome and effort-massive process to get an IT system implemented.
Ivana: And can you tell us more about these compliance requirements, that we have, that are specific for the life sciences industry?
Looking at it from a high level, the IT applications needs to be validated, and the basis for that is the ISPE GAMP 5 standard, which is basically the V model. Infrastructure needs to be qualified, so ISPE also have some very nice guides on how to do that. And on top of that, you always need to consider data integrity in the business process because there might also be activities going on outside the infrastructure and the IT systems and you always need to make sure that your full business process complies with the data integrity requirements. Which I think can be summarized in the ALCOA++ framework, if you’re familiar with that.
Ivana: Big pharmaceutical companies of course have their own organizations in place to help them with some of these requirements. But what are the challenges for smaller pharmaceutical companies or biotech companies with this kind of framework?
So, I think basically finding their way in the jungle of IT systems, that’s the first problem. Especially because most of the people in small pharma and biotech are scientists and they want to focus on the science in their company instead of cumbersome IT problems. So, finding the right software in the jungle of vendors that are out there is always a problem. That said, there’s usually a majority or three to four vendors, which are the best one in the markets and it doesn’t really matter which one of them you choose because they can all solve the problem. So, if you could narrow it down, you can pretty fast, you can say, find somebody with a solution that fits.
And then, for small pharma and biotechs basically, the processes are the same. But not all systems come preconfigured, so finding you can say a system that is preconfigured to the level or to the extent that is required is of course also needed.
But I think the big problem is finding the right vendor.
The next problem is that you have to pay all this money up front, you have to run a big project in order to get the system implemented, and then you also have to build an internal IT organization afterwards.
I think that’s really the challenges for small companies that really just wanna focus on science and just have the necessary tools to provide the best science to their investors as possible.
Sam: Can you give us a sense as to how many implementations or the percentage or proportion of implementation, still go down this kind of traditional route that you described? Is it the majority, or is this kind of dying approach now?
I think there are trends that things are moving in a different direction. More and more IT systems are coming with a standard configuration setup. Vendors are starting to build you can say pre-validated systems for these standard setups. But authorities still require each and every pharma or biotech company to make their own validation of IT systems, and this is the case for both IT systems that are provided from CROs as part of clinical trials, and for IT systems that are implemented internally.
But I think some vendors are realizing that they need to cut down the cost of implementation in order to make it better for small pharma and biotech, and to obtain the business that lies within that area. But I still think we have some way to go before we are at the place where the requirements from small pharma and biotech are fully fulfilled.
Sam: What about the complexity of the solution being implemented? Does that have any bearing on the approach that needs to be taken or not really?
I think the principles are pretty much the same. For small pharma and biotech, they all need a quality management system with a place to store quality documents and to handle quality processes. Once they get running on their clinical trials, they need a place for The Electronic Trial Master File (eTMF). They can use a CRO in the beginning, but after the study, they will need to archive the eTMF somewhere. During the study, they also need to collect study data from sites and from patients. The capture of clinical data needs to take place, so they also need IT systems for that. And then of course, as they start having clinical results, they need to build their regulatory file so the regulatory documents needs to be handled as well.
So, these are the basic IT systems that needs to be in place for all pharma and biotech. And except for the eCRF, or the clinical data capturing, most of the other systems are setup in the same way and have very similar processes for all companies which could be leveraged more than it is being leveraged today.
Ivana: It sounds like it’s the price of doing business in our industry that you need to have these kinds of systems in place.
Yes, I agree. And I think a lot of people are not using IT systems for this because the cost of implementation is too high and due to that a lot of people stay on paper for a long time.
Ivana: How prevalent is paper still in our industry, as a means of dealing with these complexities?
So, I think that’s an area that is a little bit divided because most companies hire a CRO and they outsource all their clinical activities to CRO. And usually, they also in that process hire the CRO to provide the supporting IT infrastructure for what takes place on the CRO side.
So, as soon as clinical trials are initiated the CRO IT system landscape is utilized in order to provide an electronic platform for supporting the clinical trials activities.
But the sponsors still have oversight responsibility, and they might have several clinical trials coming up in the future, where they’re going to have different CROs with different platforms. So if you’re not careful, you’ll end up in a space where your data is distributed in IT systems with different data models and that might lead to issues.
A good example could be the ability to do signal detection on your safety data if that’s distributed over different CROs and different data formats. So, you really have to be careful on how you do that.
Another challenge is, that the oversight responsibility also implies that there is a lot of documents that need to be handled from the sponsor side. And if you don’t have an IT system available in the company you usually use a hybrid solution of having a paper quality management system, in at least as the official version. But most companies also have a Teams site, SharePoint, Dropbox, or Box solution that they use to actually share this information and in that process, they usually violate the data integrity requirements from authorities in the way they manage documentation. Plus, not all of this documentation is stored in the CRO eTMF so it really becomes a complex landscape when they don’t have their own IT system.
Another downside of that is that they usually have to go with this “one CRO for all activities” outsourcing model, because they don’t have the internal IT landscape to cooperate in a global world and with people from different sides or different parts of the world. So they are limited in their ability to structure their clinical trials and to source the different tasks that needs to be handled in the setup.
Sam: I think there’s some interesting points there. I think, particularly around CROs, and the clinical systems being essentially ran by the CRO in essence, on behalf of the sponsor. And I’ve heard a few different sponsors anecdotally say – look, we’re entrusting our most important asset with CROs, and all of the data is wrapped up and spread thinly, to use your terminology there, in all of these different systems and that’s a real problem. Are you seeing sponsors addressing that particular problem proactively and thinking about this?
I think it’s a result of the IT systems that are being provided to the industry today and the way they are implemented. If we can change the way that IT systems are being offered to small pharma and biotech, I’m sure we will see a trend and I think it’s already starting. Smaller and smaller companies are investing and implementing their own IT systems in order to obtain control of their company assets.
Because in essence, you can say your IP or your drug is usually protected via patterns, so you’re secure in that way. But your documents for whatever clinical trials you’re doing, or whatever discovery or R&D that you’re doing, that’s basically your knowledge. The basics of the company, the company assets. If you put all of that information at the hands of the CRO or external partners who are fully in control of that, you also you lose control of your assets and you might not have the same control of the quality of your assets. All of this could impact, in the end, the price or the value of the company if it’s not controlled in the right way.
So, I do think that a lot of companies are starting to look into, “how can we get better control of our assets and how can we move in the right direction of having IT systems that where we are in control?”
But again you can say the current IT system landscape and the offerings from IT vendors, I think that needs to be changed in order to make you can say the move into everybody taking full control of their assets as it looks right now.
Sam: I have a follow-up to that, could you just unpack that a little bit in terms of those current systems? Like why are they not a good fit for the smaller companies?
One thing is that you have to pay an upfront fee for the software, we have to hire consultants that support you in the implementation and validation of the software, and then you need to set up your own internal IT department for supporting the system afterwards.
And of course, as we in Pharma IT see these setups as issues, we’re also trying to provide solutions for that.
Because we do think that any biotech CEO or Managing Director, they want to spend their money on science. So they don’t wanna spend 100-250€ upfront for an IT system which might fail or be bad for the business if it’s not implemented in the right way.
So, I think they are looking to minimize their risk and if they can avoid having an internal IT department, they would much rather do that and outsource that to more experienced people.
So I think these smaller companies they need a flexible workforce that can go in and solve the tasks that needs to be solved within any company. And as the company grow they can start hiring full-time employees (FTE) when the tasks are big enough. But as long as we’re talking about quarter FTE or half an FTE, they need a partner that can go in and support them in these areas. Both on the support maintenance and implementation side without having these large upfront payment costs.
Ivana: How could that look specifically Jakob, what would be a better solution for these small companies?
I think that the small companies need an IT system which is implemented at zero cost.
I think they need a model where they can buy licenses per user because in normal IT implementations you buy your user packages in bundles of 25 users or 50 users, or maybe it’s record based and then you pay for 1000 records, or 50,000 records. Whatever it is, you might end up having only 55 users but you have to pay for 100.
So, there’s a lot of wasted cost in that setup which doesn’t really support the way a small company is working. It doesn’t matter for large pharma whether they have to pay for 1000 users and they just utilize 975. The percentage of the waste is small in that respect.
But with the existing IT landscape, the percentage of waste for small pharma and biotech is too large.
So, it needs to be per user, it needs to be a monthly fee, it needs to be with zero cost, and they need to be able to outsource you can say support and maintenance — also on Level 1 and 2 because you can say normal IT vendors mostly provide Level 3 support. So, they need to be able to outsource also Level 1 and 2 support and have a partner who can actually go in and support people in the organization when they have problem and solve the problems instead of just trying to close IT tickets as fast as possible.
Sam: Just to kind of play devil’s advocate on that point, then what where’s the win for the vendor for that segment?
I think that’s why it needs to be not an IT vendor. Some of these ties should be solved by an independent third-party. Because if you take the brand IT vendors, as soon as they become a brand then the cost of support also is doubled, or at least they put on sufficient mark-up on the hourly rates.
So, when you’re talking about third-party vendors who might not have the same brand level, they can usually offer better prices.
And if you have more customers with the same setup and you might have a team of IT support persons within the same area, you build up knowledge in that area in a way that you cannot do in a single small company, where you only have this work amounted to a quarter or a half FTE. But you can still use young people and provide them at a cost which would be cheaper than if a company have to hire full person internally and try to train them and keep them up to date on knowledge. They would be more effective, they would be faster, and they are more trained because they do this on a daily basis. Whereas the internal people would only do it maybe once a week.
So, there’s a lot of efficiency gains if you can set the rate level at the right place so that it becomes a win-win situation for everybody.
Sam: I think they’re great points. But how do you for the smaller segment, the biotech segment, how do you kind of keep adoption going post initial implementation? Because to your point, I think those types of individuals that work within those biotechs they’re very focused on the science, right? And to get them to take a step back and embrace the technology, and we all know that there’s bumps in the road when it comes to technology during its implementation and ongoing lifecycle. That can potentially be disruptive. Have you seen good success in that type of segment for ongoing adoption of technology and are there any kind of secrets and tips and tricks to try and drive that type of adoption?
I think you’re touching upon a point which has given many people a headache overtime, right? One thing is that we get IT system implemented, but how do we actually ensure that people use them?
And I think most scientists, if it becomes too complex or too cumbersome to use electronic systems, they’re just gonna find another way to work. Because again, they want to focus on science. But I think the keyword here is of course what would be known as a change management and you need to keep focus overtime.
So, somehow you need to set up communication between the business and the people who are maintaining the IT systems to make sure that you don’t just accept pain points in the business process that are making things difficult for the end-users. But that you collect that input on an ongoing basis and try to adapt and improve the way your IT system is working, in order to ensure that people actually like using the system instead of working, on paper or with their own systems.
But I think also people need to realize what’s the regulatory requirements, because basically it’s the regulatory requirements driving the need for compliant IT solutions.
Sam: Absolutely.
Ivana: And Jakob, looking at this alternative way of implementing or taking systems into use, what would the vendor oversight situation look like for the sponsor company? Because then you have the sponsor, you have a third party, you may have vendors, and who maintains oversight over all their parties?
So, I think it’s always the sponsor who is the oversight responsible. If you have a third party providing the IT system, then of course the third party will ensure the compliance of the IT system.
You can, of course, ask yourself who’s better at providing compliant IT systems? Someone who focuses on that? Or a CRO who actually focus on clinical development?
So maybe, by setting it up like I’m describing it, you can actually gain better oversight and more control of your assets. You can also gain a higher level of computer system validation compliance in the way your computer systems are managed, and then you can have your CRO focus on what they’re good at – clinical development and getting people sourced for the clinical trials and onboard patients and following the clinical trial protocol.
But of course, they would have to do it based on the individual IT company system, which they do for all the larger companies, then they all have their own internal systems and if they used outsourced clinical trial strategies then all the CROs are following the IT systems of the large companies. So I don’t see a problem and they also doing that for the smaller companies, if the systems can be provided at an affordable cost in a better implementation module than is the standard in the market currently.
Ivana: And was there any events or trends that pushed the smaller companies to look for more flexible ways of implementation? Or has it always been an issue in the market?
I think historically people have been working much more on paper. But as the general adaptation of IT in the society is growing … you know everybody uses Word and everybody can set up a Teams since SharePoint site. I think people are just starting to work electronically because it’s faster and easier, and you can share documents and you can edit them at the same time with the tools that are available.
Unfortunately, these tools are not validated tools and they don’t fulfill the industry requirements. So especially for companies who are early phase development, I think a lot of these requirements that the industry is putting forward are not being fulfilled, or they don’t comply with the requirements.
And I’m not sure that authorities are really checking on these early development companies, so they’re kind of turning the blind eye to that part compliance-wise. And they only start to be looking into this when companies get to phase three or are getting closer to the market authorization. Then you start having a more in depth auditing of the internal processes and the compliance of IT systems.
But basically, it’s the same requirements that you can say that are applicable throughout the full life cycle of a clinical trial.
And I think if there were these more of these, easyily implementable, easyily maintainable, easyily configurable solutions available in the market, we would also see smaller companies moving into the trend of taking ownership of their assets earlier in the process.
Sam: I think the feedback that I kind of hear in the marketplace is that there’s a real thirst for almost like a consumer-type experience when they’re dealing with software. They can buy something online, not be tied in for three or four years, cancel at their convenience potentially, and not go through a huge amount of upfront training configuration work to get to their end result. And of course, we know that what we’re doing is different, we’re in a regulated space. But people are people, and they want things to be easy and they want their life to be easier. One thing just to touch upon what you talked about Jakob, in terms of smaller companies, it sounds like they’re almost taking a bit of a risk-based approach to using these non-validated consumer systems. But if they’re not planning to take the assets to phase three then, from their standpoint, what’s the risk? Does there have to be other levers to make them wanna change? Could it affect the potential to pass that asset on to another company in the future if they don’t have the systems in? I’m just trying to put myself in the shoes of perhaps a company that isn’t intending to go all of the way through to phase three and therefore, thinks, why do I need to invest here?
I think part of it is what you’re saying, that they need to show their potential before they start investing too much money in this area. But I also think that the knowledge of computer system validation has been limited for some areas, or the level of people at authorities that have sufficient knowledge about these areas maybe been limited. But I think authorities are also moving in direction of having more focus on this early on the process.
We’ve seen lately that the European Medicines Agency (EMA) has published a notice to sponsors for clinical trials, that the sponsors need to ensure validation of computerized systems and it’s their responsibility.
So, I think more and more focus is coming on this, and you will have to comply with these things more and more in the future, also for early-stage companies. But it is a risk trade-off that the later you can invest in this the better for your business. But on the other hand, you can’t sell your business if you don’t have control of your company assets, and you can’t prove that it fulfills the data requirements of authorities. Then you’ll just create problems for yourself down the line. So if you can set up these processes and systems early in your company and make sure that all your assets are in control, you will be in a much better state than the alternative set up.
Sam: Got that. What about if you say you were working for one of these organisations and emerging biotech company, you have a finite amount of resources, but you feel like you should act somewhere. Are there any quick win-type opportunities that you could focus in on or highlight to us, that perhaps should be top of the list when it comes to considering new systems to adopt from an implementation standpoint?
I think the clinical documentation is the most important part, right? A lot of the quality documents are maybe easier to handle on paper, because the turnover of those documents is lower than the clinical documents.
You generate a lot of documents for even phase one trials. So basically, the Clinical Documents and the Electronic Trial Master File are the most important system for small pharma and biotech.
The next important is the Quality Management System, and then after that an Electronic Document Management System (EDMS) that can control your regulatory documents.
You can say the eCRFs, or the clinical data capturing, maybe that’s fine if you leave that at the CRO, because that’s always trial specific. But the rest of them have the same setup across different trials.
So yeah, in that in that order priority – eTMF, QMS and Regulatory Documents.
Ivana: Jakob, I’m curious if we’re moving some of the IT work out of these smaller companies and they don’t have to, they can wait for longer to hire their own IT resources. What does this do to the way that these applications are anchored within the biotech company?
That’s a really good question, because they are still a overall responsible as a sponsor, and they still need to ensure the validated state of this. So of course, they need to have a partner they trust and who’s specialist within the area. In the same way that they are outsourcing the clinical trials and trusting that the CROs do a good job in that area. They might do QC of the work of the eTMF that the clinical or the CRO is providing, but they as a sponsor you have oversight responsibility.
The same thing would apply for your IT vendor, for the IT systems. You would need to have oversight responsibility and do random checks on validation deliverables and change management and support on those systems.
But I think it does make sense to split it up so that you have another system outside the CRO, where you are in control of the assets and then you use your CRO for the clinical work only. I think you will gain better quality in both areas, and you will gain control of your assets.
Ivana: And Jakob, as far as I understand from a Pharma IT sites, you have created some accelerators for some of these smaller companies. Can you tell us more about those?
Yeah, so all of the challenges that we’ve been talking about today, we tried to find solutions for that. The first challenge is of course electronic signature. And there are a number of vendors who provide you can say electronic signature solutions in the market. But again, they only provide, you can say the lower level of validation for those, so you always have to validate it yourself as a company.
So we made accelerators for a couple of these vendors, one of them being DocuSign where we basically for a very, for a fraction of the price that it would cost you to validate the solution yourself that we have made pre-configured and pre-validated packages for the validation of an IT solution like that. So that you can get electronic signature in your company and use that across different time zones or countries, so that you avoid the paper process and paper signing by hand.
In the same way we try to build a preconfigured QMS both for documents and quality processes. For regulatory documents, which is in, you can say based on the DIA Reference model for both quality documents and the eCTD documents, which we implement for zero cost. And we also offer full support and maintenance on Level 1 and Level 2, and we offer these flexible licenses where you can increase or decrease your number of licenses on a single user basis.
And last but not least, we can put an eTMF platform on top of that, so that you also get your own eTMF set up for clinical trials.
Again, very low implementation fees preconfigured and fully scalable with the size of your clinical trial or the number of users that needs to be implemented. So, we’re trying to you can say, meet some of the needs that we see in the market.
Of course, when you implement IT systems, they still need to be validated and somebody have to spend time doing that. So, if you implement at zero cost, it means that you’re taking a risk or you’re doing an investment in your customer and that needs to be paid back. In this case, we’re offering the IT systems at a bit higher monthly fee that you would pay normally.
But it’s an investment in the customer and of course, that means that we have a very high interest that the customer has success in what they’re doing and that they like using the IT system, because if they terminate the contract too early, we won’t get repaid on that investment.
Ivana: But that’s a very much in tune with this outcome-based pricing model that is becoming so prevalent out there.
Yeah.
Ivana: Can you tell us more about your journey into Pharma IT?
Yes, so I’m a Chemical Engineer by education from ‘98, so that’s quite some years ago. Which means that I have more than 20 years of experience within the pharma and biotech industry. I’ve basically been an IT Project Manager for most of my career. And in 2016, I started up Pharma IT on a vision to challenge and improve the ways of pharma consulting. Initially, it started out as mostly focusing on IT implementation projects within the pharma and biotech industry.
But at some point, I figured out that the pharma and biotech companies have need for more than IT consultants. They also use drug development consultants, etc. So what we’re trying to build now is the one stop pharma consultancy shop, so that any kind of consultancy need a pharma or biotech company might have, they only need to go one place.
Because what we see currently in the market is also that if you’re a regulatory Vice President or Manager of some kind and you need IT help, then you need to go to IT Consultancy Company. If you need help with your regulatory submissions, then you need to go to a Regulatory or a CRO Consultancy Company to get some help. When you need your submissions built, you might have to have a third vendor … and I could go on for different areas of problems where they go to different vendors to get help.
What we want to do is basically provide all these consultancy services within one company to make it easier for the customer, to get whatever problem they have solved.
Ivana: Thank you for that- who are you. So, Jakob we’re approaching the last question, and we always ask our guests the same question on the show. That is, if there was one change you could make in our industry, what would that be?
So what I like is IT and I also like pharma and biotech. And it might be that we’re in Pharma IT trying to solve some of the problems that we’re talking about. But in essence, I don’t really care if it’s us, who are providing these solutions, or if it’s other people who are providing these solutions. If you really think about it, what it comes down to is bringing products to market faster.
So, what I would like is that any pharma, small pharma or biotech has the option to choose a full domain platform that they can leverage to have speedy IT supported business processes within their company that they can start using for zero cost and then at a per user per fee set up.
So, whether it’s our setup or somebody else that provides this setup to the customer, I don’t think that’s important.
What’s important is that that these companies get these solutions offered and they can start leveraging them to bring product to the market faster.
Ivana: That would be an amazing vision to come true.
Sam: Where can our listeners reach out to find you Jakob, if they have questions or wanna learn more about you, or Pharma IT?
So pharmit.dk is our website, so please feel free to visit that at any time and there you will also find the contact details for me and for the rest of the company.
Sam: Amazing, thanks so much and I’m looking forward to reconnecting again soon.
Thank you.