“When I first entered the world of regulatory affairs, I quickly realized the importance of institutions like the European Medicines Agency (EMA) and the Dutch Medicines Evaluation Board (CBG-MEB) in advancing public health. At Oncode Accelerator, my goal is to shift the perspective: regulatory involvement is not a hurdle, but an opportunity – already in the earliest stages of preclinical research. Too often, regulators are brought in late, after key decisions have already been made – for example about the use of experimental models, dosing, toxicology, and patient stratification. When scientists engage with agencies like EMA and CBG early on, it can make a huge difference. I've seen this firsthand. By developing a regulatory strategy from the start and submitting it to regulators for feedback, researchers can gain valuable insights, address potential challenges early, and make their approach more efficient. Of course, this may take some extra effort up front, but it saves time in the long run – thereby accelerating the process of bringing promising cancer treatments to patients. And that is what Oncode Accelerator is all about.

That very drive to speed things up and the shared passion for making a real impact is what excites me most about being part of Oncode Accelerator. It’s inspiring to work alongside such brilliant scientists and help bridge the gap between innovation and regulation. Our Workstream uses our expertise in regulatory science, a multidisciplinary field that aims to ensure the safety, efficacy, and quality of products within drug development, to prepare the network for the future. We help our community to take the right regulatory steps to deliver a clinical candidate. 

I'm happy to share that we've recently established our Focus Group for Regulatory Innovation, bringing together representatives from each Workstream and Platform. The goal is to ensure that there is a sufficient level of regulatory awareness across Oncode Accelerator, which will also help to accelerate the progress of our Demonstrator Projects. Other than that, we also organize training and workshops to inform the broader Oncode Accelerator network. By fostering collaboration and sharing knowledge, we’re ensuring that every part of our ecosystem benefits from these insights.

I see regulatory affairs as a dynamic field with the potential to shape the future of medicine. Take animal models, for example. For decades, animal testing has been the standard, but we’re now seeing its limitations, especially when it comes to accurately predicting human responses. This is where innovative technologies like organoids come in. Organoids could revolutionize early clinical research by mimicking human biology more accurately, giving us deeper insights from the very start. It’s exciting to see that the EMA is open to this shift, recognizing the promise of organoid-based methods. Their support in integrating these new approaches helps streamline research by preventing unnecessary studies and guiding us toward better decisions early on. While there are still challenges – like proving organoids are both ethical and scientifically robust – the potential is huge. And this goes beyond incorporating new experimental models; it’s about accelerating drug development and delivering more effective treatments to patients faster.

The same potential lies in AI and well-defined patient cohorts. These Platform technologies within Oncode Accelerator have the power to speed up preclinical drug development. But we’re still working to ensure they’re robust and effective in real-world studies. With limited legislation in place, it's crucial that our projects align with regulatory expectations. To make informed strategic decisions, we aim to engage with regulators like the EMA early in the process, fostering a dialogue that allows us to mutually exchange insights on these emerging technologies. This proactive approach helps us shape research strategies that meet regulatory needs, ultimately increasing the likelihood of future market approval and successful First-In-Human trials. Our Demonstrator Projects, for example, benefit from this strategy. To further our mission, our Workstream has partners including Utrecht University, Leiden University, the Princess Máxima Center for pediatric oncology, and the CBG, who collaborate to implement these innovations quickly, safely, and responsibly. We're on the verge of a transformation, and I’m excited to be part of it.

To end on a personal note, the approach at Oncode Accelerator is not just about accelerating drug development, but also about creating a meaningful shift in how we develop new medicines. One important lesson I've learned is that the people working at the EMA share our motivation and eagerness to innovate and improve the drug development pipeline, to ultimately bring the best medicines to patients. This common drive for progress really gives us energy to keep breaking new ground. It is the potential for lasting impact that motivates me every day, knowing that our work has the power to reshape the future of oncology.”