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Advancing Regulatory Science and New Approach Methodologies: Key Insights from the 2025 Expert Meeting
On December 9th, the masterclass ๐๐ฟ๐ถ๐ฑ๐ด๐ถ๐ป๐ด ๐๐ป๐ป๐ผ๐๐ฎ๐๐ถ๐ผ๐ป ๐ฎ๐ป๐ฑ ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ถ๐ผ๐ป โ ๐ง๐ต๐ฒ ๐ก๐๐ ๐ ๐๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ on New Approach Methodologies (NAMs) brought together scientists, regulators, industry leaders and innovation networks to discuss how scientific advances can accelerate safer, more effective, and increasingly animal-free drug development.
Hosted at the Brightlands Maastricht Health Campus and co-organized by the Regulatory Science Network Netherlands (RSNN) and Future, Affordable, and Sustainable Therapy development (FAST), the session featured contributions from leading experts in the field of NAMs.
Opening the meeting, Marieke De Bruin (UU, co-chair RSNN) set the stage with an interactive introduction, followed by Yves Slenter (Brightlands), who highlighted Brightlandsโ mission to connect innovation across its four campuses, with Maastricht focusing, amongst other themes, on regenerative medicine.
Marjon Pasmooij (CBG-MEB/UU, co-chair RSNN) introduced regulatory science, which aims to improve the regulatory system and has the goal to innovate. She further introduced the RSNN, highlighting the importance of collaborative initiatives in regulatory science research, such as the RSNN and the emerging European Platform for Regulatory Science Research, in supporting the development of new and improved tools and methods that enable medicine developers and regulators to make well-informed decisions throughout the entire lifecycle of a medicine, from development to patient use.
Marlous Kooijman (FAST) showed that Future, Affordable, and Sustainable Therapy development (FAST) addresses topics such as new technologies and methods for drug development and contribute to the acceleration and sustainability of therapy development.โฏ
Researchers and stakeholders with questions on regulatory science or an interest in further information and collaboration are encouraged to contact FAST and RSNN as accessible points of contact and knowledge exchange.
Regulatory Acceptance: Context of Use Comes First
A central theme was the path toward regulatory acceptance of NAMs. Peter van Meer (CBG-MEB) explained that acceptance hinges on two core elements:
- A clearly defined Context of Use (CoU) โ describing what a methodology predicts, under which conditions, and for which product types.
- Demonstrating Fit-for-Purpose โ showing robustness, accuracy, sensitivity, specificity, and biological plausibility.
While clinical efficacy markers have more flexibility, safety endpoints require alignment with global standards such as ICH guidelines. EMA offers multiple interaction routes: Innovation Task Force meetings, Scientific Advice, qualification procedures, and the Safe Harbour pilot, to help innovators advance NAMs.
Organ-on-Chip and Future Applications
Carlo Alberto (Chiron) presented the growing promise of organ-on-chip systems within preclinical development. Their ability to model mechanisms of action and improve human relevance offers value from the pre-investigational new drug (IND) stage through Phase II. He highlighted the difference between ISO standardization (hardware and method standards) and EMA regulatory standards (application and evidence).
Using osteoarthritis as a case study, a field where 50 years of animal research have not yielded an effective treatment, he underscored the potential of OOC platforms to reduce failure rates and improve translational success.
Want to know more? Contact: carlo@chrn.co
Pharma Perspective: EFPIAโs Roadmap for NAMs
Bert Haenen (EFPIA / Johnson & Johnson) shared industry insights, including EFPIAโs three-basket roadmap for phasing out animal testing. Different types of NAMs were discussed, highlighting their use across drug modalities, particularly in early toxicity testing. He also presented results from a survey among pharmaceutical companies, showing that NAM-based approaches are most often justified when animal models lack translational value (scientific justification) or for implementation of 3R (replacement, reduction, refinement).
Lastly, it was highlighted that NAMs used in early screening typically require only minimal qualification or validation. The extent of formal qualification within pharma remains unclear due to proprietary considerations, with OECD-aligned validation seen as important and further guidance from health authorities still awaited. Significant uncertainty persists around regulatory acceptance, particularly across regions, although a BIO survey indicated that nine companies have achieved regulatory acceptance of NAMs as animal test replacements, with around two-thirds obtaining multiregional approval.
ZonMw and the Dutch NAMs Landscape
Martijn Nolte (ZonMw) provided an overview of Dutch initiatives driving the transition toward animal-free innovation, including:
- Transition Programme for Innovation (TPI)
- More Knowledge with Fewer Animals (MKMD 2024โ2028)
- VitalTissue for accessible human tissue supply
- Ombion, National Growth Fund initiative accelerating animal-free biomedical translation
- hDMT, the national organ-on-chip network
- The NAM Navigator, outlining the steps toward validation, qualification, and regulatory acceptance
Want to know more? Contact: mkmd@zonmw.nl or nolte@zonmw.nl
Dialogue and Future Directions
During the discussion, participants emphasized:
- The need for early regulatory engagement and sufficient funding.
- The importance of validation expertise, where Clinical Research Organisations can play a key role.
- A knowledge gap in academia, highlighting the need for increased regulatory awareness.
- The potential impact of European harmonisation, with the Netherlands taking a leading role
As several speakers noted, while full replacement of animal studies is not yet feasible, momentum is strong, scientifically, politically, and societally, to make NAMs the new standard where possible.