VPH Executive Committee Interview Series: Bernard Staumont on Policy, Regulation and Engagement with Industry

As part of the VPH Executive Committee Interview Series, we continue to highlight the perspectives of our Executive Committee members who are actively shaping the future of in silico medicine.

This edition features Bernard Staumont, Project Manager and Senior Researcher at the University of Liège, who leads VPH activities related to policy, regulation, and industry engagement. With extensive experience across European research projects and active involvement in initiatives connecting regulators, industry, and academia, Bernard offers a valuable perspective on how in silico approaches can move from research to real-world application.

In this interview, he reflects on the importance of building trust, aligning with regulatory frameworks, and fostering collaboration across stakeholders to support the broader adoption of in silico medicine.

• Can you tell us what bridging VPH with industry, policymakers, and regulatory bodies implies in practice, and how these connections help bring in silico technologies closer to real-world healthcare?

It is indeed essential to engage with a broad range of stakeholders if we want in silico technologies to be widely adopted in healthcare. In practice, this means first identifying the key players, including within industry, policymakers, regulators, and standardisation bodies, and then establishing structured and continuous dialogue with them. This engagement can take multiple forms. For example, dedicated task forces, such as those within the Avicenna Alliance, bring together academia, industry, and also now notified bodies and standard organisations. We also maintain regular exchanges with notified bodies and the European Medicines Agency, and contribute to discussions at the policy level, for instance, through presentations at the European Parliament. Ultimately, moving in silico technologies into real-world healthcare requires coordinated action across all these actors. Policymakers can provide funding and shape the legislative framework; regulatory bodies can develop guidance and evaluation frameworks to assess the credibility of models; and academia and industry drive the scientific and technological advances that bring these solutions to market. These connections are therefore not optional – they are fundamental to building trust and enabling adoption by clinicians and patients.

• Getting regulators on board is still one of the biggest challenges for in silico methods. Where do you see the main obstacles today, and what do you think the community can realistically do to make progress?

One key issue is awareness and understanding. The diversity of in silico approaches is not always well known, and there is still a need to clearly demonstrate that robust methodologies exist to assess model credibility and reliability. Another challenge lies in the maturity and consistency of the methods themselves. Continued development—both in academia and industry—is essential to provide strong, use-case-driven evidence that highlights where in silico approaches bring clear regulatory value. Finally, there is a structural aspect: increasing the presence of in silico expertise within regulatory bodies would significantly facilitate progress, helping to bridge the gap between innovation and evaluation. Overall, progress will likely come from a combination of raising awareness, strengthening the scientific evidence base, and fostering closer integration between the in silico community and regulatory institutions.

• Through your work in the Avicenna Alliance, especially within the Notified Bodies and Standardisation Task Force, you’re in direct dialogue with regulators and standardisation bodies. What are the latest activities you have been involved with?

Regarding notified bodies, interactions have intensified significantly. Some have recently joined the Avicenna Alliance, which is an important step forward. We work closely with them to better understand their needs and challenges in assessing in silico evidence, and to identify how the community can support them. In addition, under the leadership of the VPH society, we are planning to establish regular exchange meetings to enable more structured and efficient interactions between academia, industry, and notified bodies.

On the standardisation side, we are actively contributing to the development of documents and standards related to in silico methods. This includes direct engagement with organisations such as ISO and IEC, and participation of task force members in the drafting of new standardisation documents (e.g. on the credibility assessment of in silico models). These efforts are critical to providing the frameworks needed for broader regulatory acceptance.

• Translating research into clinical or industrial practice is rarely straightforward. In your experience, what does meaningful academia–industry collaboration look like, and what difference can it make for the uptake of in silico technologies?

Academia–industry collaboration is a key driver for the uptake of in silico technologies.

In practice, meaningful collaboration is based on a genuine exchange of expertise and needs. As an example, while academia provides a huge number of innovative methods and models, industry brings application-driven perspectives, regulatory constraints, and market needs.

For example, within our standardisation task force, industry partners have provided very concrete insights into which standards need to be adapted or developed to better integrate in silico approaches. Similarly, in discussions involving notified bodies, academia often plays a neutral coordinating role, facilitating dialogue while avoiding potential conflicts of interest.

Such collaborations ensure that developments are both scientifically sound and aligned with real-world requirements, ultimately accelerating the path toward adoption.

• Looking ahead, what role do you think VPH should play in shaping the regulatory and policy landscape that supports innovation without compromising safety or public trust?

The strength of the VPH community lies in its ability to represent a broad and diverse ecosystem while speaking with a coherent voice.

Going forward, VPH should continue to play this federating role – bringing together researchers, consolidating their input, and translating it into clear messages for regulators and policymakers. Acting as a bridge between academia, industry, and regulatory stakeholders, and facilitating structured dialogue (for example with notified bodies), is a crucial part of this mission.

At the same time, VPH also has an important role to play in communicating with the broader public. Building trust in in silico technologies requires not only scientific validation but also clear and transparent communication about their benefits and limitations.

Finally, targeted initiatives will remain essential. These include fostering collaborative projects involving multiple stakeholders (such as EU-funded projects) and supporting the development of guidance documents and standards. Together, these efforts can help shape a regulatory and policy environment that enables innovation while maintaining high standards of safety and public trust.

This interview is part of the ongoing VPH Executive Committee Interview Series, which aims to showcase the people and ideas driving progress in in silico medicine.

By strengthening dialogue between researchers, industry, and policymakers, initiatives like these contribute to building a more connected and impactful community. We look forward to continuing this series and sharing further perspectives that support the responsible and effective integration of in silico approaches in healthcare.