Category: Press release

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Launch international Organ-on-Chip Standardization Roadmap at EUROoCS 2024 – First Step Towards ISO Standard?

logo with text 'EUROoCS Conference 2024' projected on a globe

On the first day of the conference of the European Organ-on-Chip Society (EUROoCS) from July 3-5 2024 in Milan, the international Organ-on-Chip Standardization Roadmap has officially been launched. Andries van der Meer (UTwente and hDMT, The Netherlands), chair of the Focus Group Organ-on-Chip (FG OoC) and also chair of EUROoCS presented the roadmap for the more than 600 participants worldwide in the Aula Magna of Politecnico di Milano.

After 2 years of hard work by 120 European experts, 10 focus group meetings, 90 working group (WG) meetings, and 3 revisions, the final version of the roadmap for Organ-on-Chip standardization is ready. The roadmap can be downloaded here

Organs-on-Chips (OoC) are microfluidic devices, containing small samples of healthy or diseased tissues from one or more organs cultured in controlled smart microenvironments. The cells behave much as they would in the organ in which they are normally found. They can thus simulate body functions. Standardization is important for the further development of this field and NEN is closely involved, in particular by running the secretariat of the Focus Group Organ-on-Chip (FG OoC) and the Dutch expert group Organ-on-Chip.

 

Recommendations

The key recommendations in the roadmap are:

  • Develop standard documents that provide harmonized terminology and definitions for important items and symbols in the OoC domain, especially including the relevant terms described in the roadmap.
  • Work on defining minimum reporting requirements for cells and biomaterials used in OoC systems. Do this in accordance with existing initiatives in this field.
    Develop comprehensive standard documents that address the key technical aspects of OoC systems.
  • Evaluate how OoC is already covered in other laboratory practices and regulatory frameworks and identify where a specific standardization approach is needed.
  • Develop documentation that outlines the specific requirements for experimental design and data management in OoC studies where these gaps are identified. Develop a framework for the qualification of OoC models and their data for specific contexts of use.
  • Develop documentation that outlines the specific requirements for the use of OoC devices in various application domains and facilitate and promote the use of OoC-based methods for specific applications.

Click image to download Roadmap

 

ISO Standard?

Now that the standardization needs in the field of Organ-on-Chip have been identified, the FG OoC advises submitting the work program for adoption to ISO. By choosing standardization at the international ISO level, stakeholders recognize the broad global interest in OoC standardization and the various initiatives already underway. This acknowledges the global value chain for OoC technologies and ensures that standards are developed with input from stakeholders worldwide. This promotes innovation, interoperability, and safety in a rapidly changing field. By leveraging international expertise and perspectives, these standards can promote harmonization, facilitate regulatory compliance, and accelerate the translation of OoC research into impactful applications for healthcare, drug discovery, and more. Simultaneously, it advises establishing the creation of a CENCENELEC Technical Committee to coordinate European interests and to keep an eye on alignment with European regulations.

Organization

The need for standardization in Organ-on-Chip (OoC) was recognized by the Joint Research Centre (JRC) of the European Commission, the European Committee for Standardization, and the European Committee for Electrotechnical Standardization (CEN and CENELEC), supported by the European Organ-on-Chip Society (EUROoCS). This resulted in a Putting Science Into Standards (PSIS) workshop ‘Organ-on-Chip: Towards Standardization’ in April 2021. In March 2022, the Focus Group Organ-on-Chip (FG OoC) was established with Andries van der Meer as chairman and NEN (Netherlands Standardization Institute) as secretariat.

Join the Organ-on-Chip Expert Group

The Dutch Expert Group Organ-on-Chip follows the work of the European Focus Group Organ-on-Chip and coordinates the Dutch input. The expert group also connects various Dutch stakeholders and provides a platform for exchange of (international) knowledge and experiences. If you are a stakeholder in this field and would like to be involved in the development of possible standards, please become a member of our expert group. There are no costs associated with this membership.

More Information?

If you would like more information on the subject, or if you are considering becoming a member of the expert group, please contact Suzie Noten (suzie.noten@nen.nl) or Lysette Meuleman (lysette.meuleman@nen.nl).

Source: NEN / CENELEC

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The ISSCR Releases Global Standards to Enhance Rigor and Reproducibility of Stem Cell Research

The International Society for Stem Cell Research (ISSCR) released the ISSCR Standards for Human Stem Cell Use in Research, an international collaboration aimed at enhancing rigor in preclinical research and ultimately strengthening the pipeline of therapies for patients. Christine Mummery and colleagues were among the many dedicated expert scientists who established this document. These new guidelines will also provide invaluable aid to authors, journal editors, and reviewers in the stem cell field when considering publications.

“This nearly two-year initiative is groundbreaking for the global stem cell research community,” said Haifan Lin, ISSCR president. “The international standards will make a big difference in the quality of science that is performed and published worldwide.”

The ISSCR is the preeminent international stem cell research society with a reputation for scientific and ethical rigor and has produced field-shaping documents such as the Guidelines for Stem Cell Research and Clinical Translation. The current initiative, which establishes the minimum characterization and reporting criteria for scientists, students, and technicians in basic research laboratories working with human stem cells, is led by an international taskforce of scientists chaired by Tenneille Ludwig, WiCell Research Institute, USA and Peter Andrews, University of Sheffield, UK. The ISSCR’s standards for basic and preclinical research draws from previous work to improve the reproducibility of research using pluripotent stem cells, such as that from the International Stem Cell Initiative (ISCI) and the International Stem Cell Banking Initiative (ISBCI), and address tissue stem cells and stem cell-derived model systems with the overall goal of improving reproducibility of experiments from lab to lab and from cell line to cell line.

“The ISSCR Standards represent a huge step forward in articulating Best Practice for use of stem cells in research,” said Tenneille Ludwig, co-chair of the taskforce that developed the recommendations. “When adopted, these basic principles will help drive rigor and reproducibility within the laboratory and improve both the quality and rate of science in our field.  It was an honor to work with such an experienced, dedicated, passionate group of true stem cell legends to establish this consensus document. The commitment to collaborative effort ultimately resulted in a strong document that will drive the field forward.”

One of the most impactful outcomes of the initiative is the development of the “Reporting Practices for Publishing Results with Human Pluripotent and Tissue Stem Cells” checklist. The checklist is intended to help scientists, reviewers, and editors prepare and assess manuscripts for inclusion of critical details relevant to work with pluripotent stem cells (PSCs) and tissue stem cells (TSCs) with the goal of increasing the rigor and reproducibility of research through reporting.

“Stem Cell Reports views these new guidelines as an invaluable aid to authors, journal editors, and reviewers in the stem cell field,” said Martin Pera, Editor-in-Chief of Stem Cell Reports. “At our journal, we will be introducing the checklist for authors that accompanies the guidelines on a trial basis soon and soliciting their feedback along with that of reviewers and our Editorial Team. My colleagues and I feel this is a major step forward in ensuring rigor and reproducibility in all areas of stem cell research.”

Learn more about the evolution of the recommendations made in the ISSCR Standards by reviewing the society’s open access Standards webinars on ISSCR.digital and attending the ISSCR 2023 Annual Meeting in Boston, USA 14-17 June 2023. Visit ISSCR.org/standards-document for the full text and to download the PDF of the ISSCR Standards for Human Stem Cell Use in Research and the “Reporting Practices for Publishing Results with Human Pluripotent and Tissue Stem Cells” checklist.

The ISSCR Standards initiative is supported through contributions by Burroughs Wellcome Fund (BWF), Doris Duke Charitable Foundation (DDCF), and the Simons Foundation Autism Research Initiative (SFARI). Learn more about their support.

About the International Society for Stem Cell Research (www.isscr.org)
With more than 4,600 members from 80 countries worldwide, the International Society for Stem Cell Research is the preeminent global, cross-disciplinary, science-based organization dedicated to stem cell research and its translation to the clinic. The ISSCR mission is to promote excellence in stem cell science and applications to human health. Additional information about stem cell science is available at A Closer Look at Stem Cells, an initiative of the society to inform the public about stem cell research and its potential to improve human health.

 About Burroughs Wellcome Fund

The Burroughs Wellcome Fund (BWF) serves and strengthens society by nurturing a diverse group of leaders in biomedical sciences to improve human health through education and powering discovery in frontiers of greatest need. BWF was founded in 1955 as the corporate foundation of the pharmaceutical firm Burroughs Wellcome Co. In 1993, a generous gift from the Wellcome Trust in the United Kingdom, enabled BWF to become fully independent from the company, which was acquired by Glaxo in 1995. 

 About Doris Duke Charitable Foundation

The mission of the Doris Duke Charitable Foundation is to improve the quality of people’s lives through grants supporting the performing arts, environmental conservation, child well-being and medical research, and through preservation of the cultural and environmental legacy of Doris Duke’s properties. The foundation’s Medical Research Program supports clinical research that advances the translation of biomedical discoveries into new preventions, diagnoses and treatments for human diseases. To learn more about the program, visit www.ddcf.org.

Source: ISSCR
Download the new standards here

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13.5 million euros for hDMT INFRA StemCells

National infrastructure to implement new organ and disease models using human stem cells

Researchers from University Medical Centers in Leiden, Utrecht and Rotterdam in the Netherlands jointly affiliated with the “Institute for human organ and Disease Model Technologies (hDMT),” intend to develop new organ and disease models using human stem cells. This is expected to provide much better insight into the response of the human body to therapy in the future.

Led by principal investigator Christine Mummery of Leiden University Medical Center (LUMC) and Janny van den Eijnden-van Raaij (managing director hDMT), this hDMT partnership has been awarded a grant of almost 13.5 million euros from the National Roadmap Large-Scale Scientific Infrastructure of the Netherlands Organization for Scientific Research (NWO). This funding will be used to establish a national state-of-the-art infrastructure, hDMT INFRA StemCells, that will provide support in setting up and conducting studies on stem cells to all researchers across the Netherlands and beyond.

Combining human stem cells in one disease model

There are currently two main types of human stem cells, adult stem cells (ASCs) and “human induced pluripotent stem cells” (hiPSCs). Both types have strengths and shortcomings. According to hDMT INFRA StemCell researchers, some shortcomings can be overcome by combining these stem cell types. “This makes it possible to develop new and better organ and disease models that can accurately mimic the pathology and physiology of the human body,” said Christine Mummery. “Thanks to these models, we expect better understanding of how healthy- and diseased-tissues function and how effective new drugs might be as therapies.”

Accessible stem cell infrastructure

Thanks to the NWO contribution and the collaboration between the UMCs and hDMT, this will be the first large-scale facility combining hiPSCs and ASCs in single disease models without immune barriers.  According to Janny van den Eijnden-van Raaij, such a national infrastructure should accelerate the ability of researchers to implement this technology. “The uniqueness of hDMT INFRA StemCells, which is coordinated by hDMT, is that it makes the necessary expertise and (stem cell) facilities of the participating organizations widely available to users from both universities and industry.” Joost Gribnau (Erasmus MC): “One of the main goals of hDMT INFRA StemCells is to further increase the reliability of stem cell models through standardization using robotics and automation. In addition, (hands-on) training for different target groups will be provided.”

Personalized disease treatments

With the knowledge gained from the organ and disease models, scientists can test and develop new drugs or gene therapies in the future. The models will also contribute to major developments in the field of (personalized) disease treatments. More knowledge on how disease affects specific tissues in the human body is essential. Instead of treating symptoms, the actual causes of diseases can be addressed much more specifically. “This new infrastructure makes it possible to search for drugs that act on the underlying causes of diseases much more efficiently but also makes it possible to test whether drugs do or do not work for patients even before they are treated,” said Jeffrey Beekman (UMC Utrecht).

More information about the other grant awards on the NWO website.

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300 million euros for a new international stem cell consortium

A grant from the Novo Nordisk Foundation of up to 300 million euro now enables the establishment of a major international research center focused on stem cell medicine. The center will be a collaboration between the University of Copenhagen, Denmark, Murdoch Children’s Research Institute, Australia, and Leiden University Medical Center, The Netherlands. The partnership between these three world-leading research institutions will pave the way for future stem cell-based treatments.

Read more here:

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EMA implements new measures to minimise animal testing during medicines development

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles — replace, reduce and refine; commonly referred to as 3Rs — through EMA’s Innovation Task Force (ITF). This action will facilitate the development and implementation of New Approach Methodologies (NAMs) that are in line with the European Union legislation on the protection of animals used for scientific purposes.

More information see the EMA website.

Source: https://www.ema.europa.eu/en/news/ema-implements-new-measures-minimise-animal-testing-during-medicines-development

 

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EUROoCS for and by members

EUROoCS is a growing society with currently 500 members from 32 different countries. Time to redefine the strategy and look ahead to the coming years. Together with the strategy consultancy Change21 a strategic plan was developed using the outcome of the results of a survey among the EUROoCS members, interviews with the backoffice and online field research. Based on this plan an action plan is now being developed, including the next steps towards: 

– a clear and future-proof Mission and Vision
– (multi)-annual plan with clear goals and evaluation
– stronger member engagement
– more events and activities
– clear communication strategy (website, social media, newsletter)
– visibility and balanced representation of national networks
– fundraising strategy
– supportive back office

The EUROoCS Board will seek advice from the IAB and RAB for working out this action plan further. Different committees, such as an event committee, dissemination/outreach committee, training committee and fundraising committee, will be set up and chaired by EUROoCS Board members, with strong involvement of the EUROoCS members.

 

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Prestigious Lefoulon-Delalande prize for Christine Mummery

Congratulations to professor Christine Mummery from Leiden University Medical Center in the Netherlands who is co-recipient of the 2021 Scientific Grand Prize from the Lefoulon-Delalande Foundation of the Institut de France. The second laureate is professor Gordon Keller from the McEwen Stem Cell Institute and Princess Margaret Cancer Centre in Canada. Continue reading “Prestigious Lefoulon-Delalande prize for Christine Mummery”

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Dutch Organ-on-Chip project receives huge grant to make the leap from lab to fab

NWO, the Dutch Research Council, has awarded a Perspective grant of 4.8 million euros for a Dutch multidisciplinary consortium, led by Eindhoven University of Technology professor Jaap den Toonder to develop much-needed universal standard for the pharmaceutical industry.

A visual representation of one tissue chip of skin and hair and two engineering chips, which are precisely clicked onto the ‘docking’ plate and to each other. Picture: hDMT

Scientists are pushing ahead building ‘organ-on-chips’, small chips with human cells, which are useful, for example, for studying cancerous metastases in the bloodstream or the development of scar tissue, or for testing the effect of drugs or food outside a human body. To make the step to industry, a collective of dozens of research groups, companies and knowledge institutions, brought together by the Dutch organ-on-chip consortium hDMT, are building a universal standard, supported by a NWO Perspective grant of nearly five million euros. The ultimate goal in the future: to link multiple organ chips together to simulate a whole body.

The Dutch organ-on-chip consortium hDMT brought the following partners together for this NWO Perspective program: Amsterdam UMC/VUmc, Delft University of Technology, Eindhoven University of Technology, UMC Utrecht, Leiden University, Maastricht University, Twente University, Wageningen University & Research, 300MICRONS, Applikon, BioLamina, Convergence, Demcon, dsRAT Stichting Proefdiervrij, Galapagos, Genmab, Hy2Care, IBA Lifesciences, ibidi, Life Science Methods, LipoCoat, Micronit Microtechnologies, OnePlanet Research Center/imec, Poietis, PolyVation, provio, Qurin Diagnostics, ReumaNederland, RIVM, Spektrax, TissUse, TNO, Unilever Safety & Environmental Assurance Centre, Ushio INC.

For more information see here. 

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EUROoC Virtual lab tour in 11 laboratories

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.

You are guided through the processes of building and setting-up an Organ-on-Chip experiment for in vitro modeling and drug screening.
For the video and more information about the network please visit the EUROoC website: https://www.eurooc.eu/research/#projects.

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Stem Cell Reports “home” journal for EUROoCS

 

The International Society for Stem Cell Research (ISSCR) and the European Organ-on-Chip Society (EUROoCS) are pleased to announce an agreement that will have Stem Cell Reports, the ISSCR’s online, open-access, peer-reviewed journal, serve as the “home” journal for EUROoCS member publications that focus on the use and application of stem cells. This alliance will help bridge the bioengineering and stem cell communities to enhance the development of technologies, the sharing and application of discovery and ultimately lead to a better understanding of human health and the treatment of disease.

“Stem Cell Reports is excited to partner with EUROoCS to provide a first-class venue for outstanding studies that use stem cells or their derivatives in Organ-on-Chip and microphysiological systems. This is an exciting emerging area of interdisciplinary research that is building the next generation of powerful stem cell modeling tools for the study of human development, physiology and disease.” Martin Pera, Editor-in-Chief, Stem Cell Reports”

“EUROoCS is delighted to have Stem Cell Reports as “home” for papers from its members using Organ-on-Chip and Microphysiological systems to create more predictive models of human tissue based on stem cells. These bioengineered models capture organ physiology beyond the state-of-the art by mimicking complex multi-cell type structures in a microphysiological environment that includes vascular-like perfusion and tissue biomechanics. Partnering with the ISSCR’s premier stem cell journal Stem Cell Reports will provide new perspectives for both EUROoCs and ISSCR members as well as a broader readership to advance understanding of human health and disease.” the EUROoCS Board