In this article, we shine the spotlight on Chantal van Gils, Director of Epidemiology and Real-World Evidence for the NDA Advisory Board.


A story told by real-world information

“Ever since I was 12 years old, I wanted to study medicine and become a paediatrician”. Chantal van Gils, NDA Advisory Board member and Director of Epidemiology and Real-World Evidence, always wanted to become a doctor. However, her perspective shifted when she came to the realization that her true passion lay in practicing medicine on a population-wide scale.

“While others were captivated by the idea of treating patients, I realized at the end of medical school that I was more passionate about epidemiology and biostatistics, that is, health education on a population level rather than on an individual patient level,” Chantal said.

After medical school, Chantal worked as a physician at an ICU unit for a year. “I enjoyed it because it's very technical and involves working with numbers, balances, physiology, and pathophysiology. But I wanted to do something different and broaden my perspective, so I started a master’s program in health economics,” she recalled. Chantal wanted to learn more about the field of health economics, so she started a PhD after her master’s program, which sparked her interest in real-world evidence.

“I realized that with my medical background and PhD, if I wanted to focus on real data collection, another master's degree would be a nice addition. So, I grabbed the opportunity to do a two-year master’s program in epidemiology while studying for my PhD. It was more like learning on the job, so it was not so difficult for me.”

Towards the end of the PhD, Chantal started working at a pharma company. She worked in several roles: as a market access manager, health economist, and a medical advisor. She later moved to a company in Brussels, where she gained her first experience as a consultant. “After working for about four years in market access and health economics and outcomes research, my colleagues stumbled upon my PhD in epidemiology, which led to an invitation to join the global epidemiology team as a director. This opportunity exposed me to a diverse range of real-world studies and their applications in addressing regulator and payer needs, as well as their relevance at the local country level. This invaluable experience deepened my understanding of how these studies serve their ultimate purpose.” Chantal recounted.

From one chapter to the next

Last year, Chantal joined the NDA Advisory Board as Director of Epidemiology and Real-World Evidence. As a member of the NDA Advisory Board, she actively engages in multiple projects, leveraging her expertise and experience to offer strategic advice to sponsors.

“I joined NDA because I wanted to make an impact in drug development. My main driver in whatever I do and positions I've taken has always been to learn; I always want to ensure that my learning curve is not flattening. My main experience was with payers and HTA bodies, not necessarily with FDA and EMA, especially not in a pre-approval setting, so I felt it was time to go on a new journey. I wanted to be challenged and I thought it would be nice to bring my very specific experience to a great environment where we can learn from each other; I can tap into the extremely attractive knowledge base of the experts at NDA who have a rich background in regulator’s needs, and they in turn can learn t about my specific expertise. I desire to bring in more considerations of real-world evidence into the regulatory area because I think this type of evidence should be considered much earlier. When we are late to the game, it's often too late to make big changes to the drug development program, or suboptimal and not addressing the patients’ needs. My goal has always been to connect the medical world with the economic world and my vision for drug development is to put the patient first. When clients think about early clinical development, they have already considered all key stakeholders’ evidence needs, so including regulators, payers, physicians and patients. This means building an ‘integrated’ evidence generation strategy.   So as my amazing NDA colleagues, many of whom are ex-regulators, are providing strategic advice for the agencies, I'm learning from them, but at the same time I'm asking if they have considered the potential added value of real-world evidence, as well as Payer/HTA evidence needs, so I think it's a perfect match and I'm excited to be part of this process.”

Chantal provides advice and scientific leadership pertaining to real world evidence and epidemiology in drug development to NDA clients. “I am a problem solver and I feel so fulfilled knowing that I can help a client solve their problems,” Chantal said. “I am passionate about working with our clients by providing strategies and helping them find solutions to their needs. I also enjoy the fact that the interaction with clients is very collaborative. It means that everyone has a sense of belonging and we want to find a solution together. Working with clients in this way makes it easier for me to see things from a different perspective. It means that our business at NDA is about people — working with people, connecting with people, and providing solutions together.”

Be open for new evidence

Chantal further emphasises the relevance of real-world evidence and HTA to our clients by explaining, “I think real-world evidence is important for a regulatory approval path, especially if the clients work with single-arm trials. If a client is developing a new drug, they can investigate the new drug in a patient population and see what the effect is. If they don't have a randomized study, they don't know how the patient would have behaved if they did not get the drug”.

As the HTA regulation of 2025 approaches, Chantal reflects on the significant challenges facing sponsors in the industry. With the introduction of this new regulation, clients will be required to simultaneously prepare for their MAA application and navigate an additional application for Joint Clinical Assessments. This means that alongside assessing benefit-risk evidence, companies must also provide evidence for relative effectiveness versus relevant comparators. Chantal emphasizes the need for proactive preparation to ensure that organizations have all the necessary data timely available. By recognizing the forthcoming requirements and strategically planning their approach, companies can effectively adapt to the evolving regulatory landscape and meet the demands of the HTA regulation.

Based on her expertise in real-world evidence and HTA, Chantal invites stakeholders to step out of their comfort zones and start connecting the dots between real-world evidence and clinical evidence.

“Real world evidence and HTA is all about clinical evidence. They’re all so connected that it's like a seamless extension of traditional research. If you think about clinical evidence in terms of patient data, whether you think about it from a relative effectiveness perspective, a real-world perspective, or a traditional technical research perspective, it's all the same. It's just a little different twist, a different focus area, or a different viewpoint, addressing different research questions, but it's all patient evidence. I think anyone who feels passionate about drug development and clinical studies can easily understand how real-world evidence and HTA come into the mix. I would like to invite stakeholders to embrace alternative types of evidence, particularly real-world evidence, and consider the perspectives of patients, physicians, and HTA bodies when evaluating such evidence.”

About

Chantal van Gils

Advisory Board Director

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