Author: Jenny Ullrich

Even though still online, the EUROoC-ITN met again from 28 to 30 June 2021 for the biannual consortium meeting, consisting of the project progress reports and the workshop on 3R Principles and Regulatory Requirements. Despite the COVID-19 pandemic, all ESRs managed to show substantial progress in their projects.

The workshop on 3R principles and regulatory requirements highlighted the use of animal testing with focus on the application of the 3Rs principles and the validation of alternative methods. During a morning session, speakers from regulatory agencies and experts from the field of 3Rs set the scene. This was complemented by 3 parallel session between Validation Board Members and ESRs in the afternoon. Each ESR received feedback from the experts and the next steps will be supervised by 1-2 experts per ESR. All information will be collated and shared within the project. The aim is to eventually make this information publicly available.

During the whole workshop, ESRs were involved in active discussions with regulatory experts about the purpose and potential validation of their own systems as models for drug testing and disease modelling. They were keen in understanding how to fill the gap between commonly used in-vitro model and humans and what regulatory procedures a new technology or model should go through to be accepted as a relevant testing tool. All ESRs found this very useful to look at their systems from an application perspective and hope there will be a chance to further discuss it with the experts at the end of their projects.

Regarding the secondments at the regulatory agencies, it is planned that all ESRs together, will physically visit each of the three regulatory agencies BfR (Berlin, Germany), BfArM (Bonn, Germany) and RIVM (Bilthoven, NL). This secondment will probably take place in January 2022. Whether the secondments will indeed be physical, depends on developments in the Covid-19 situation.

Our project partners, the German Federal Instiute for Risk Assessment (BFR) and the Dutch National Institute for Public Health and the Environment (RIVM), have published a paper on the “Applicability of organ-on-chip systems in toxicology and pharmacology”. The relative complexity of Organ-on-chip (OoC) over simple in vitro assays provides advantages and disadvantages in the context of compound testing. The broader biological domain of OoC potentially enhances their predictive value, whereas their complexity present issues with throughput, standardization and transferability. Using OoCs for regulatory purposes requires detailed and standardized protocols, providing reproducible results in an interlaboratory setting. The focus of applying OoCs in safety assessment is currently directed to characterization (the biology represented in the test) and qualification (the performance of the test). To this aim, OoCs are evaluated on a limited scale, especially in the pharmaceutical industry, with restricted sets of reference substances. Read more. M. R. Schneider, M. Oelgeschlaeger, T. Burgdorf, P. van Meer, P. Theunissen, A. S. Kienhuis, A. H. Piersma, R. J. Vandebriel. Applicability of organ-on-chip systems in toxicology and pharmacology. Publication: Critical Reviews in Toxicology, 2021. https://doi.org/10.1080/10408444.2021.1953439

Our project partners, the University of Luxembourg (UL) and the Jena University Hospital (JUH), have published a paper on the “Emulating the gut–liver axis: Dissecting the microbiome’s effect on drug metabolism using multiorgan-on-chip models”.

The homeostatic relationship between the gut, its microbiome, and the liver is crucial for the regulation of drug metabolism processes. Modeling the highly variable luminal gut environment and understanding how gut microbes can modulate drug availability or induce liver toxicity remains a challenge. However, microfluidics-based technologies such as organ-on-chips could overcome current challenges in drug toxicity assessment assays because these technologies are able to better recapitulate complex human responses. Read more (LINK).

M. Lucchetti, M. Kaminska, A. Kehinde Oluwasegun,Alexander S. Mosig, P. Wilmes.
Emulating the gut–liver axis: Dissecting the microbiome’s effecton drug metabolism using multiorgan-on-chip models.
Publication: Current Opinion in Endocrine and Metabolic Research, 2021, 18:94–101.
https://doi.org/10.1016/j.coemr.2021.03.003

The 5th edition of the EUROoC project newsletter has been published!

The fifth EUROoC project newsletter is now available for viewing.

It highlights EUROoC project activities over the last 6 months and provides you with news and events around the Organ-on-Chip technology. Furthermore, we inform you on the challenges posed to the project by the current SARS-CoV-2 outbreak.

Stay tuned and subscribe!

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Our 15 PhD students give you a virtual lab tour in 11 laboratories involved in the EUROoC International Training Network, where  they are working on finding alternatives to reduce animal testing. They not only introduce the EUROoC network, but explain the principles of the 3R and provide a broad overview of the organ-on-chip technology and its benefits. You are guided through the processes of building and setting-up an organ-on-chip experiment for in vitro modeling and drug screening. 4 PhD students will highlight their chips and applications.

The video is now available on our website.

The 3rd edition of the EUROoC project newsletter has been published!

The third EUROoC project newsletter is now available for viewing.

It highlights EUROoC project activities over the last 6 months and provides you with news and events around the Organ-on-Chip technology. Furthermore, we inform you on the challenges posed to the project by the current SARS-CoV-2 outbreak. We hope you are all well and save.

Stay tuned and subscribe!

Click here to view the newsletter