Paving the Way for Innovation: Regulating Tomorrow’s Cancer Therapies

In therapy development, the introduction of innovative new technologies is tightly regulated to protect public health and safety. This is necessary but can create a dilemma. While innovation is needed to continue driving therapies forward to benefit patients, tight regulation to protect those same patients can make the introduction of innovations challenging. 

Regulatory science is the field of work that addresses this dilemma. Jarno Hoekman, Professor in Science Studies for Sustainability at Utrecht University and an expert within the Oncode Accelerator Regulatory Innovation Workstream, explains: “Put simply, regulatory science research focuses on evaluating the functioning of the medicines regulatory system. This includes finding out if emerging technology fits within existing regulatory frameworks.”

For example, new technologies like lab-grown mini-organs (organoids), organ-on-a-chip models, or AI models have the potential to change how therapies are tested. But to realize that potential, regulators need to know how to evaluate and work with those new methods. Jarno elaborates: “When a new technology is developed, regulators can always issue a new guideline or tweak regulatory instruments to address it. Sometimes that is enough… But sometimes it isn’t. And as technology becomes more novel and cross-cutting, it becomes more likely that regulatory innovation is needed.”

Regulatory Innovation: Designing for the Future

While regulatory science is focused on evaluating the current regulatory system, regulatory innovation is an exercise in zooming out. “Regulatory innovation is also about the big questions,” says Jarno. “It asks: how can regulatory systems be equipped for regulating the technologies of the future, while ensuring quality, safety, and efficacy of new therapies? And, if we entertain the possibility of regulatory change, how can scientists and model developers, including those in the Oncode Accelerator program, anticipate and learn about regulatory change while developing these technologies? In short: regulatory innovation is about designing with the future in mind.” 

“With organoid and organ-on-a-chip models, we’ve seen that in their early stages of development, the regulatory implications of those models were not yet sufficiently considered,” Jarno continues. “The result of that is that scientists are now running into challenges in using these innovative models to develop new therapies. But what if they had thought about how these models would fit into a future regulatory system from the beginning? That could have contributed to a better alignment between technological development and the approaches to regulate them. That would be a regulatory innovation approach.”

Importantly, regulatory innovation relies on collaboration and learning. Hoekman elaborates: “Regulatory science researchers are not in a position to change regulatory frameworks, and for good reasons. Their role can be to evaluate whether in certain cases, change is needed, and to think about ways in which stakeholders can collaborate with regulators to make it happen. And if all of us can get that inclusive, forward-looking and learning-oriented conversation going, this can contribute to developing regulatory pathways that are better fit for the technologies of the future.” 

Oncode Accelerator’s Role: Laying the Groundwork

Within the Oncode Accelerator program, there are three innovation Platforms that develop new models, methods, and tools to improve preclinical research and make the development of new cancer therapies more efficient. To succeed in fast-tracking the development of new cancer therapies using innovative scientific tools, we need to make sure that regulatory frameworks are ready to deal with our innovations. 

“Not every tool, model, or method that is developed within Oncode Accelerator is relevant for regulators – but some are,” explains Marlous Kooijman, Program Manager of the Oncode Accelerator Regulatory Innovation Workstream. “The Regulatory Innovation Workstream aims to identify which technologies need to be developed with regulatory acceptance in mind. We also aim to support promising technologies in being accepted, implemented, and used in therapy development.”

“A large part of our work consists of platform studies, carried out by PhD students embedded in our innovation Platforms,” says Marlous. “These studies assess how the innovation Platform technologies are currently used and why regulators accept them, or not.” By looking at these past and current examples, the Regulatory Innovation Workstream can then identify lessons that help researchers to develop new technologies. 

The Regulatory Innovation Workstream also works directly with scientists to understand the path forward: how their innovations can be accepted by regulators in the future. This ranges from discussions about acceptance of new technologies to broader questions about therapy development and healthcare policy. The goal is to create a learning process. “By understanding what researchers encounter in practice, the Workstream can identify best practices, common challenges, and useful strategies,” explains Marlous. Jarno adds, “The questions that need to be addressed often depend on the stage of development. In early stages, it may be important to explore which regulatory frameworks could apply, which stakeholders need to be involved, and the contexts in which new technologies will be used. In later stages, direct interactions with regulators or other authorities become more relevant.”

Based on these insights, the Regulatory Innovation Workstream is developing trainings and other educational material to help researchers navigate the complicated regulatory landscape. “Our aim is to make researchers more aware of how regulators think, and to help them think ahead about possible routes towards regulatory acceptance of new technologies,” explains Marlous.

As well as supporting Oncode Accelerator-affiliated scientists developing innovative platform technologies, the Regulatory Innovation Workstream also develops tools to support regulatory science research. One example of this is the European Medicines Regulatory Database (EMRD), which will be launched in May 2026. The database provides a one-stop shop for information about medicines approved in Europe, making it easier to study how new medicines were evaluated by regulators, and which types of data were used to do so. “The EMRD will help researchers understand how regulatory decisions are made and how new technologies could be used for future therapy development in a way that regulatory agencies will accept,” explains Marlous. 

Helping Innovations Reach Patients

When asked about their overarching goal for the Regulatory Innovation Workstream, Jarno says, “I hope that in the future, we can provide scientists the tools and approaches they need to improve their awareness and understanding of regulation from early stages of development. That would have a big impact.” 

Marlous adds, “We can also support the scientists in our program towards regulatory acceptance. By helping them prepare for interactions with European Medicines Agency, joining them in discussions with regulators, and engaging with their questions from the beginning, we hope to co-create a system that helps set up scientific projects for success.”

Innovation only makes a difference when it is used in practice. By helping scientists think about regulation from the start, the Regulatory Innovation Workstream of Oncode Accelerator supports developers in moving promising new technologies closer to regulatory acceptance.