Ulf Claesson provides a fascinating and passionate account of how his firm is aiming to remove ‘guesswork’ and estimations for medical practices whilst highlighting interesting developments in the global clinical research industry.
To begin with, we understand that you are a bit of a spin-out & start-up artist, and have been with Clinerion since the beginning of 2012. What initially drew you to the Clinerion “project”?
“Based on the clinical research studies our clients across the pharma industry have requested help with, there is great potential for our business. We are able to facilitate the process of identifying patients in minutes – not the weeks or months it takes today. This is disruptive.”
From the IT side, the original attraction was the increased availability of large pools of patient information. The use of this data to identify patients that are eligible for certain treatments could prove really valuable for the patients – and ultimately for the future of both private and public healthcare as well.
We currently have access to somewhere in the region of 300 to 400 million data entries. This information has a potential reach of 30 million patients. There is no reason why these figures should not double or even triple in forthcoming years. For disclaimer purposes, it is important to state that we do not touch any identifiable patient data (i.e. data that can be traced back to an individual patient), nor do we remove the data from its sources.
When browsing the industry, we recognized inefficiencies in the current clinical research process and quickly realized that there was room for our business. Our team is full of very talented information professionals, but we were also adamant from the beginning that we would need to offer equally superlative services. In this industry, you need to be able to cater for a cluster of hospitals and manage their data effectively.
Can you identify some of the main skills and knowledge you have had to develop, on a personal level?
Patience! Even if the value proposition is extremely attractive, everything progresses in its own timescale. With my background in information technology, this was something I was not necessarily used to.
We work with existing electronic patient data. We are essentially trying to solve a huge IT problem by leveraging Big Data analytics methodologies. Based on the clinical research studies our clients across the pharma industry have requested help with, there is great potential for our business. We are able to facilitate the process of identifying patients in minutes – not the weeks or months it takes today. This is disruptive. Our solution helps remove any ‘guesswork’ aspects from this process.
The chain of events starts with the pharma company putting together a study protocol with all the criteria necessary to define the profile of the volunteer patients they need to find to test their new medication. Before we came along, the pharma company could not be certain to reliably identify the numbers of patients fitting these protocol criteria. The classic approach was first to look at relevant historical data and then to see if any medical personnel in their network had empirical experience.
Now we are in a position to say exactly how many patients fit specific protocols across multiple sites and we do this in real-time. We create full transparency between the protocol and the patients eligible for the study. Typically, we have seven million or more patients available to run studies on at any given time. We can determine within 90 seconds whether we can find patients to participate in a whole range of clinical studies.
We are therefore in the process of improving medical practices whilst steadily removing human ‘guesswork’.
How can you quantify the value this brings?
A molecule is protected for 20 years and the last day of that cycle is the most valuable. If you can extend the time a drug is protected by one day, studies estimate the benefit to be up to $8 million. Per day. If we can reduce the time it takes to bring a new drug to market by a factor of months, that will be a major achievement.
The value that we bring is not just in accelerating a drug’s return on investment, but also in the time saving that in turn gives medical institutions additional space to focus on other things. For example, to perform more studies. We are shortening the process and that is the driver of value.
As it stands, how developed is the network of hospitals and medical facilities with which Clinerion works? To what extent is this tied to the prevalence of Electronic Medical Records?
We launched our electronic medical records network in 2014. We did this in Turkey, primarily because of our contacts there and, more importantly, because of the sophistication of their healthcare system and practices. They have a reimbursement system which is based on accurate and timely reporting of medical data. This strict practice has led to a high quality of data. For the last 20-plus years, many countries have let their healthcare IT systems grow organically. These practices often lead to a proliferation of legacy systems and a complex IT system landscape.
But some countries have not had this legacy. Turkey is for example looking to grow its clinical research industry; the country is aiming to increase the value of the industry to USD 1 billion by 2020. Consequently, a large portion of the data we currently access is from Turkey and we are currently expanding not just in Switzerland/Germany but in Northern Europe and Latin America.
Our ambition is to have 50 million patients on board by the end of this year [Editor’s note: this interview took place in November 2016.]. Obviously, with 30 million accessible today, this is not going to happen, but it shows you the level of ambition we have at Clinerion. Given a recent agreement with a South American group we expect to reach the 50 million in Q2 of 2017. By the end of 2017, we expect to have key centers in most European markets. The process moves much faster when you can cover large clusters of hospital data.
What is your perception of the lack of uniformity in healthcare data and the variations in the way the data is structured?
This is precisely why we need to apply more technology in the industry. There are different terminologies and codes that need to be mapped, and lab standards that need to be cross-compared in a meaningful way. This is also where we can bring benefits. Our system allows querying of wildly differing data sources at the same time to produce a common and consistent set of results.
You have worked with companies based in many parts of the world, including the Mecca of Technology, San Francisco and the IPs that Clinerion currently holds are German registered patents. So why was Clinerion founded here in Basel, and not in California or around Cambridge?
We decided to have our operations here in Switzerland because we have a strong relationship with the local pharma industry and the universities in Basel and Zurich. So it was logical to be positioned here. In Europe, you have 24 languages and traditions of doing things differently, which immediately means a company starts right off being dynamic and flexible in what it develops and brings to market. This is beneficial when compared to starting up in more of a monoculture like that of the US.
We see that Clinerion has participated in the “Swiss-Made Software” program –What value have such programs brought to Clinerion?
In some countries, being Swiss does still provide our company with a slight competitive edge. When you compare with other “Made in” programs, I expect that people match Switzerland with the qualities of a certain level of precision, discretion, and other positive traits. Clinerion has an international focus and multicultural atmosphere which is also reflected in the “Swiss Made” program, as Switzerland has been at the cross-roads of Europe for millennia.
We understand that back in January 2016 you formally debuted the Patient Recruitment System in North America – how have hospital subscriptions in the US proceeded since then?
We have had a good start in the US with a healthy pipeline; expect more on this in the new year.
We have found that the promise of additional revenue streams is a more interesting aspect for hospitals in the US, compared to in Europe, where government funding is more prevalent. As we offer new revenue sources to hospital chains and clusters, we do gain their attention. At the same time, we also make it much easier for hospitals to perform their internal research and other activities relating to patient data analysis.
We have run about 80 different studies, each filtering for patients with between 10 and 80 selection criteria – which shows just how complex these studies can be. In terms of data and information, it is virtually impossible to reach the results we achieve using traditional methods. Yes, you can use current methods with a couple of parameters but we can analyze information from a vast number of different hospital databases, against a vast number of criteria, in a matter of minutes.
We also live and breathe patient privacy and data security. Our business model is breaking new ground and, whilst moving forward, we do so with caution. We simply want to be certain that we protect and secure access to all data at all times.
Establishing a relationship with Clinerion seems to be a rather strategic decision, above the usual purchasing or business development departments. How do you generate interest?
2016 has been a year of tremendous change. We are seeing a lot of interest. Often, companies approach us when their study has stalled in recruitment, asking for additional patients. Typically, we are able to deal with these types of requests quite quickly, which is very impressive for our clients. One of the strengths we have is that in our team we have individuals who are experienced at every stage of the clinical research process so we are in a position to really understand the potential issues within the requests we receive. We also have people with experience in structuring study protocols and a great understanding of the data itself, and are therefore able to create queries from these protocols in a way that our partners and clients can fully embrace.
Consequently, we generate interest by qualifying ourselves, often by resolving the tricky issues that pharmaceutical companies are having problems with.
What are your short and medium term ambitions?
Our ambition is to remove all the guesswork from the clinical research process. Right now, we can offer real, live data from two continents that do not contain any estimations but real-time facts. But we still need to add to that to offer a global coverage. We need to make data available from Asia, the Americas and beyond the existing Western countries. For example, we are also interested in working in Romania, Iran and other developing markets.
We are building our use cases for market access and real-world evidence studies. This also increases our need to have a broad presence across many different countries around the world.
We also believe we need to employ expert, dedicated people in those regions. All of this will take time, resources and the build-up of technological practices in some of these locations.
The challenge going forward will be in developing our business alongside developing our data resources to meet the patient data requirements of the pharmaceuticals industry. But we have patience. And we have a plan.