Galapagos recently launched the FILOSOPHY study, its first ever phase IV, real world evidence study, looking at the effectiveness and safety of filgotinib as it is used with patients in a ‘real world’ setting. The objective is to better understand the patient experience outside of a strictly controlled clinical setting and with a broader diversity of patients. To shed further light on this milestone event for Galapagos, we caught up with Mona Khalid, the Head of the Evidence Generation and Epidemiology team at Galapagos.
I: Interviewer M: Mona
I: Hi Mona, thank you for making the time to join us.
M: Happy to be here.
I: Before we jump into the world of Real World Evidence studies, tell us a bit about your journey, what attracted you to come to Galapagos?
M: One of the reasons I came to Galapagos is because I believe that in a smaller, more agile company, the data and information collected from epidemiological or Real World Evidence studies can be fully leveraged to generate insights that help us to understand how patients are truly benefitting from treatments, as well as providing understanding that will inform the business and influence the development and commercialization decisions that we make.
I: So please tell us about what you do. What would be a fair description of the work of the Evidence Generation and Epidemiology team that you lead?
M: My team brings together epidemiologists, clinicians, data analysts, statisticians and pharmacists who not only demonstrate the ability to interpret different types of data but also have an expert understanding of biology, disease areas and the context in which our industry operates. Together the team are spearheading Real World Evidence studies for the company to make science-led decisions through data.
The work and scope of our team is quite broad. It includes generating data that will provide evidence relating to a particular therapy area or disease, where unmet needs remain, and to understand how medicines can address those unmet needs, amongst different patient types or in different populations. Further on as we launch treatments, it also allows us to generate evidence on the effectiveness and safety of our medicines when used in clinical practice. We work very closely with both the research and development and commercial teams within our company.
I: So, what exactly are Real World Evidence studies?
M: Real World Evidence (RWE) studies may seem to be a buzzword that only started trending relatively recently in the industry, but they have been around in different forms for a number of decades. These studies effectively reflect observations and outcomes of patients when treated in clinical practice, the so-called ‘real world’. However, the power, the volume and the quality of the information we collect has changed significantly thanks to the tools we have now at our disposal, particularly the increase of IT/digital interface in general healthcare management, including wearable technologies and the use of artificial intelligence (AI) to model and importantly, predict, patterns. In short, the case for undertaking Real World Evidence studies within industry has expanded beyond traditional uses such as, monitoring the safety of a medicine, and can now be used to help us to determine what medicines we should we be developing and when, how and with whom to use our medicines.
I: How are Real World Evidence studies organized at Galapagos?
M: At Galapagos, we use RWE studies broadly, to answer questions throughout the development and commercialization lifecycle of a molecule. Often these types of studies are only used after commercialization of a medicine as a phase four activity, however, at Galapagos we believe RWE studies can support our pipeline asset development, as we can look at other molecules in development, or medicines on the market and use these data to serve as analogues to some of the compounds we have in very early development. For example, we can model what would happen if two mechanisms of actions were combined, by using the analogue data in clinical practice and then give this information back to teams who haven’t had the chance to test these molecules in humans, but have very relevant questions. In this way, we can manage theoretical risks from very early on. For later stage compounds, we are able work with cross functional team members to capture outcomes of interest that perhaps were not collected in the development trial programs.
One of the reasons why leveraging this capability is perfect for a biotech – is that we’re agile enough to take the information and the insights from these studies and be able to enact and make quick decisions.
I: Can you tell us more about the FILOSOPHY study? Does it have the potential to improve treatment for patients?
M: This is the first such study at Galapagos and it has, not surprisingly, created a lot of excitement and engagement in the teams. FILOSOPHY is an ambitious study, undertaken in several EU countries. Our aim is to recruit 1500 patients suffering from moderate to severe active RA and follow each patient for a minimum of 2 years. We’re going to look at safety, effectiveness and patient reported outcomes, all to better understand how the medicine works, how patients experience their treatment and to learn as much as possible about their treatment journey. We are going to rely on mobile device technology in the collection of PROs, allowing data collection to begin within the first weeks of treatment. This may also prove to be an effective tool during the pandemic, while in-person clinic visits are harder to achieve.
I: Going forward, what’s your vision for the Evidence Generation and Epidemiology team at Galapagos?
M: For me, the vision is about continuing to build this capability, which allows us to make science-led decisions using data insights that can be generated from the broad scope of this research. Showing a formal commitment to the disease areas we’re in and improving patient outcomes through the addition of these types of studies, while at the same time partnering with the entire healthcare ecosystem to be able to do that. It’s an area where true innovation can happen, and we want to be there to make it happen.
I: Very well said. Thank you so much for taking time, Mona, to introduce us to the world of Real World Evidence studies.
M: You’re welcome.