EMA’s workplan on data and AI, Advancing EFSA’s regulatory science, Diversity in a Dish, Organoid library to help understand human lung cancer and more
News on non-animal methods
MAY 12 - 16, 2025NEWS, REPORTS & POSITION STATEMENTS
1. EMA’s workplan : ‘Data and AI in medicines regulation to 2028’
EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan “Data and AI in medicines regulation to 2028”. It sets out how the European medicines regulatory network plans to leverage large volumes of regulatory and health data as well as new tools, including AI, to encourage research, innovation, and to support regulatory decision making for better medicines that reach patients faster.
The workplan lays out a roadmap for managing, analysing, and sharing data across the network, while adhering to high security and ethical standards. It also provides a framework for coordination to address new legislative initiatives in the European Union (EU), notably the pharmaceutical legislation, the European Health Data Space (EHDS), the Interoperable Europe Act and the AI Act.
2. Advancing EFSA’s regulatory science : Updated research and innovation needs
A new editorial provides an update on research & innovation (R&I) needs that can support EFSA’s regulatory science in the coming years. The paper presents research needs for EFSA’s work in a number of domains : omics technologies ; gut microbiome ; new approach methodologies (NAMs); allergenicity risk assessment ; aggregate exposure assessment and environmental risk assessment (ERA).
Although non-exhaustive and calling for transdisciplinary research so as to cover interdependencies between human, animal, plant and environmental health, this editorial will be valuable to stakeholders, research agenda setters and funders, both public and private, in formulating calls for research and project funding related to food safety.
3. Opinion : Could drug agencies disclose the list of qualified NAM ?
The European Medicines Agency (EMA) has been steadily advancing its commitment to the 3Rs and animal welfare through a robust and forward-looking work plan.
However, in a recent Linkedin post, Thierry Decelle, from DCL Solutions, highlights a missing and valuable / useful aspect : the disclosure by the drug agencies of the list of NAMs already qualified to support drug development. “It would be even better if the EMA, as well the FDA with the new roadmap, establishes and discloses metrics and defines key performance indicators. A baseline is required to figure out the progress. (…) As we know the overall number of animals used is not the right indicator of 3Rs.” writes Thierry Decelle.
4. Diversity in a Dish : Leveraging organoids to reflect genetic ancestry and sex differences in health and disease
Current research highlights significant disparities in disease susceptibility and therapeutic responses across different ancestral groups and sexes, with underrepresentation of diverse populations in genomic studies impeding progress. Most Genome-Wide Association Studies (GWAS) remain predominantly European. Additionally, sex-related differences in drug metabolism, immune response, and disease prevalence necessitate sex-stratified analyses.
A recent underscores the potential of advanced in vitro models, particularly human pluripotent stem cells (hPSCs) and adult stem cell-derived organoids, to bridge these gaps by providing platforms that reflect human genetic diversity and facilitate high-throughput screening.
INTERVIEWS, NOMINATIONS & AWARDS
5. How MPS can address shortcomings of animal models for mAb development
In a new article of its blog series, CN-Bio explores the FDA’s announcement to phase out the animal testing requirement for monoclonal antibodies (mAbs), and other drugs, in favor of human-relevant NAMs. In part one of the blog, they unpicked the reasons behind the FDA’s decision to focus on mAbs first.
CN-Bio continues the commentary by taking a deeper dive into the PhysioMimix® OOC range of microphysiological systems (MPS), also known as organ-on-a-chip (OOC), exploring how microphysiological systems address the shortcomings of animal models for mAb development and the role that CN Bio is taking to support this awaited switch to a NAMs-based approach.
6. Roper Toxicology Consulting : Winner of the Biotechnology & Lifesciences Awards 2025
Roper Toxicology Consulting Limited, committed to helping clients develop cutting-edge and reliable NAMs, has received a Biotechnology & Lifesciences Award 2025 from Global Health & Pharma (GHP) recognized in the categories of Leading Toxicology Consultancy – UK and Leadership Collaboration Excellence. This award highlights Clive Roper’s commitment to scientific integrity and regulatory excellence supporting the development of safer, more effective therapies.
Read announcement from Clive Roper
SCIENTIFIC DISCOVERIES & PROTOCOLS
7. 3D bioprinting of collagen-based high-resolution internally perfusable scaffolds
Organ-on-a-chip (OoC) and microfluidic systems have improved the translational relevance of in vitro systems ; however, current manufacturing approaches impart limitations on materials selection, non-native mechanical properties, geometric complexity, and cell-driven remodeling into functional tissues.
In a new article, authors three-dimensionally (3D) bioprinted extracellular matrix (ECM) and cells into collagen-based high-resolution internally perfusable scaffolds that integrate with a vascular and perfusion OoC reactor to form a complete tissue engineering platform. They improve the fidelity of freeform reversible embedding of suspended hydrogels bioprinting to produce a range of designs fabricated in a one-step process. Together, these scaffolds and reactors form a platform technology toward engineering full organ-scale function for disease modeling and cell replacement therapy.
Read the publication in Science Advances
8. Patient-derived SCLC organoid library unveils subtype-specific dependency
Small cell lung cancer (SCLC) is a devastating disease with limited therapeutic advancements. Although SCLC has recently been classified into four molecular subtypes, subtype-specific therapies are still lacking. In a new article, researchers established 40 patient-derived SCLC organoid lines with predominant genes (TP53 and RB1) mutations and rare targetable genetic lesions.
Transcriptome profiling divided the SCLC organoids into neuroendocrine (NE) and non-NE-type, with the latter characterized by YAP1 or POU2F3 expression, whereas non-NE-type SCLC organoids relied on insulin-like growth factor (IGF)-1-driven YAP1 and AP1 activation. This SCLC organoid library represents a valuable resource for developing biology-based therapies and has the potential to reshape the drug discovery landscape.
Read the publication in Nature Cancer
9. In vitro to in vivo extrapolation modeling to facilitate the integration of transcriptomics data into genotoxicity assessment
In vitro transcriptomics holds promise for high-throughput, human-relevant data but is not yet integrated into regulatory decision-making due to the lack of standardized approaches. For genotoxicity assessment, transcriptomic biomarkers such as GENOMARK and TGx-DDI facilitate qualitative and quantitative analysis of complex in vitro transcriptomic datasets. However, advancing their use in quantitative testing requires standardized methods for deriving transcriptomic Points of Departure (tPoDs) and linking them to in vivo responses.
In a new article, researchers investigated different approaches to calculate tPoDs and applied in vitro to in vivo extrapolation to obtain administered equivalent doses (AEDs). They found that the generic AEDs were more conservative than genotoxicity-specific biomarker AEDs. For six of the nine genotoxicants, transcriptomic AEDs were lower than the in vivo PoDs ; refined kinetic models may improve predictions. Overall, in vitro transcriptomic data in HepaRG cells provide protective estimates of in vivo genotoxic concentrations, consistent with other in vitro genotoxicity testing systems.
Read the publication in Toxicology
