ASPIS advances the path towards phasing out animal testing

ASPIS advances the path towards phasing out animal testing

RISK-HUNT3R hosts ASPIS satellite meeting on Next-Generation Risk Assessment

On 24 October 2024, RISK-HUNT3R, on behalf of the ASPIS cluster, hosted the satellite meeting “ASPA, making next-generation risk assessment happen” as a precursor to the European Commission’s 2nd workshop on Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments.”

The event opened with Bob van de Water (Leiden University) and Mirjam Luijten (RIVM) introducing the ASPA workflow, embodying ASPIS mission and vision for a Next-Generation Risk Assessment (NGRA) framework rooted in new approach methodologies (NAMs). Barira Islam (Certara) followed with a case study demonstrating the integration of in silico and in vitro methods with physiologically based kinetic (PBK) modelling to assess risks from chemicals producing active metabolites. Sylvia Escher (ITEM Fraunhofer) highlighted a prioritization and screening approach to differentiate toxic from low-toxic chemicals, while Ulrika Sahlin (Lund University) addressed uncertainty characterization in NAM-based risk assessments.

The meeting sparked valuable discussions and questions, reinforcing the collective commitment to advancing NAM-based methodologies. A special thank you to our presenters and participants for their contributions to “making NGRA happen.”

For those who could not attend the event in person, our experts have prepared two short videos that provide a comprehensive overview of the background and key findings related to the ASPA presentation. These resources are intended to offer additional insights, allowing for a deeper exploration of the ASPA workflow, and are available on our webpage or YouTube channel.

On 25 October, ASPIS cluster members gathered at a pivotal European Commission workshop dedicated to progressing toward a future of chemical safety assessment without the need for animal testing.

This was the second European Commission (EC) workshop on the Roadmap towards phasing out animal testing in chemical safety assessments, held online and in Brussels. This Roadmap initiative is part of the Commission’s response to the European Citizens’ Initiative (ECI), “Save Cruelty-Free Cosmetics – Commit to a Europe without Animal Testing.” The Commission welcomed ECI and is firmly committed to developing this Roadmap, which will set out specific actions and key milestones toward an animal-free regulatory framework.

The workshop provided an essential platform for dialogue among Member States and stakeholders, underscoring recent advancements. Attendees discussed vital elements, including the development, validation, and implementation of non-animal methods, and explored ways to integrate these methods across existing chemical legislation.

Representatives from ASPIS’s three projects – RISK-HUNT3RONTOX, and PrecisionTox – shared updates on their innovative contributions, highlighting how these efforts support the Commission’s Roadmap.

Critical contributors to these discussions included Mathieu Vinken (ONTOX coordinator, Vrije Universiteit Brussel), Martijn Moné (RISK-HUNT3R, Leiden University), Sylvia Escher (RISK-HUNT3R, ITEM Fraunhofer) and Leonie Mueller (PrecisionTox, Altertox Academy).

As explained Mathieu Vinken, ONTOX coordinator and ASPIS cluster chair for 2024-2026:

The meeting showed again the importance of 3I (interdisciplinary, intersectoral and international) collaboration for full implementation of the 3Rs. ASPIS, and therefore ONTOX, sets an excellent example in this respect. By joining forces between the 3 consortia, a major contribution to the replacement of animal testing in the safety evaluation of chemicals is provided.”

In closing, the workshop reinforced the collaborative momentum driving NGRA and NAM-based risk assessments forward, paving the way for further progress towards animal-free safety evaluations.

The European Commission aims to release the final Roadmap by the first quarter of 2026, outlining key milestones and essential steps for transitioning to animal-free chemical legislation.

RISK-HUNT3R at EUROTOX 2024: Shaping the Future of Chemical Safety

RISK-HUNT3R at EUROTOX 2024: Shaping the Future of Chemical Safety

Taking place in Copenhagen from September 8-11, 2024, the 58th Congress of the European Societies of Toxicology (EUROTOX 2024) brought together experts to explore the theme “Toxicology – A Quest for safe Chemicals and Medicines“. Central topics included the safety of environmental chemicals, emerging technologies and human health effects from chemical exposure.

The RISK-HUNT3R project made a significant impact at the conference, contributing with several talks and hosting four key sessions. These highlighted RISK-HUNT3R efforts in integrating New Approach Methodologies (NAMs) into regulatory frameworks, offering innovative solutions for modern toxicology.

At the heart of the discussion was ASPA (ASPIS-initiated Safety Profiling Algorithm), a key tool designed by RISK-HUNT3R experts to guide users through every stage of the chemical risk assessment. ASPA guarantees transparency, traceability and reproducibility of data, ensuring consistent and reliable conclusions in the evaluation of chemical safety.

To demonstrate ASPA effectiveness, a series of case-studies were designed. The latest updates, from new in-vitro techniques to predict oral and inhalation uptake, to improvement of our biokinetic models, were presented during these sessions.

These updates highlighted how RISK-HUNT3R innovative approaches are shaping the future of chemical risk assessment, making it safer, more efficient, and scientifically robust.

ASPIS Open Symposium: Advancing Animal-Free Chemical Safety Assessment

ASPIS Open Symposium: Advancing Animal-Free Chemical Safety Assessment

The 4th ASPIS Open Symposium took place in Copenhagen from September 11-12, 2024, and gathered experts from the three consortia—PrecisionTox, ONTOX, and RISK-HUNT3R—to showcase the exciting progress made over the past year. New research highlighted advancements in non-animal toxicology and safety tools, paving the way for faster safety assessments while reducing reliance on animal testing.

This year marked the last leadership transition in ASPIS chairmanship, with Mathieu Vinken (ONTOX coordinator) taking over from John Colbourne (PrecisionTox coordinator). The next two years will be crucial for establishing a Next Generation Risk Assessment (NGRA) framework built on New Approach Methodologies (NAMs).

Read the full press release here:

The ASPIS cluster, a groundbreaking collaboration of three EU-funded research projects, successfully concluded its annual Open Symposium. The event, held in Copenhagen on September 11-12, showcased significant strides in developing and implementing New Approach Methodologies (NAMs) for chemical safety assessment and fostered collaboration among researchers, regulators, and industry stakeholders.

ASPIS, a joint effort by the three scientific consortia ONTOX (led by Vrije Universiteit Brussels), PrecisionTox (led by the University of Birmingham) and RISK-HUNT3R (led by Leiden University), is at the forefront of revolutionizing chemical safety testing through the development of the ASPIS-initiated alternative Safety Profiling Algorithm (ASPA), a well-guided Next Generation Risk Assessment (NGRA) workflow. The cluster assembles 70 scientific organisations and 300 leading European scientists who harness the power of diverse scientific disciplines, including omics, artificial intelligence (AI), and in vitro/in silico methodologies, to deliver faster, more accurate, and affordable alternatives to traditional animal testing.

During the meeting, the chairmanship of the ASPIS cluster was passed from John Colbourne, coordinator of PrecisionTox, to Mathieu Vinken, the ONTOX coordinator. This transition marks a new phase for ASPIS, with ONTOX leading the cluster’s mission to advance sustainable, animal-free, and reliable chemical risk assessment. A key highlight of the symposium was the presentation of groundbreaking advancements in NAM development. The three consortia shared their latest research, highlighting advancements in non-animal toxicology and predictive safety assessments, and showcasing the potential of these innovative tools to streamline safety assessments and reduce reliance on animal models. Notably, ASPA, presented by Dr. Mirjam Luijten (RIVM in association with RISK-HUNT3R), offers a promising approach for streamlining safety profiling. This aligns with the cluster’s goal to operationalize NGRA by developing a well-guided workflow for chemical safety assessment (ASPA) and providing guidance on data generation and interpretation.

Beyond the technical advancements, the symposium underscored the importance of collaboration and knowledge sharing. The ASPIS working groups dedicated to specific areas such as chemical selection, omics, and exposure assessment, fostered valuable discussions and identified synergies. One of the most significant outcomes of the symposium was the progress made towards integrating NAMs into the NGRA framework. The collaborative efforts of ASPIS and the Partnership for the Assessment of Risks from Chemicals (P-A-R-C) have established a robust foundation for a more sustainable and efficient approach to chemical safety assessment. Future collaborations between ASPIS and P-A-R-C will focus on synergies in communication and other working groups. They aim to develop a central metadata registry platform and combine the results of various working groups, leading to the successful integration of NAMs into the broader chemical safety assessment landscape. By cooperating, the two groups seek to maximize their scientific output and to create sustainable change in the regulatory landscape of the EU.

The symposium demonstrated the growing momentum behind the adoption of NAMs. It highlighted the potential of these innovative approaches to modernize chemical safety assessment. This scientific work can be expected to make an impact in the discussion regarding REACH revision and support the EU Commission roadmap for phasing out animal testing in chemical safety assessments.

By Monicah Kirathi – Altertox Academy

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RISK-HUNT3R General Assembly and Stakeholder Symposium

RISK-HUNT3R General Assembly and Stakeholder Symposium

The RISK-HUNT3R consortium meeting and second Stakeholder Symposium in Egmond aan Zee, Netherlands on 10-13 June 2024 were filled with valuable discussions and key takeaways that have re-energized us for the next two years of our project work!

A big thank you to our team of experts, both on the floor and behind the scenes. We are also grateful to the attending Scientific and Regulatory Advisory Board members for providing their expertise and feedback, ensuring the relevance of the various project case studies.

Confident in the power of collaboration and sharing advancements, we are looking forward to the upcoming 4th ASPIS Open Symposium taking place in Copenhagen on 11-12 September 2024 and focusing on the implementation of New Approach Methodologies for chemical risk assessment.

RISK-HUNT3R at EPAA Designathon

RISK-HUNT3R at EPAA Designathon

The RISK-HUNT3R project presented a case study at the EPAA Designathon – New approach methodologies workshop, which was held on the 20th-22nd of March 2024 at the JRC in ISPRA, Italy.

The workshop discussed case studies which proposed a Next Generation Hazard Assessment framework based on NAMs to classify compounds as high, moderate or low toxic with regard to systemic toxicity in humans. Conceptually, toxicodynamic and kinetic properties contribute to this classification. All case studies were asked to assess one to many of 150 preselected model compounds. Beside RHT3R also Ontox and PrecisionTox, also being part of the ASPIS cluster contributed case studies.

RH3R team attending the 2024 EPAA Designathon Workshop.

RHT3R Case Study 2 team presented an integrated approach, which applied high throughput NAM data from ToxCast inventory, the disease associations from the Chemical Effect Predictor as well as high throughput PBK modeling. RHT3R first developed these three models and determined their predictivity with regard to STOT-RE predictions by using about 66 case study compounds from case study 2. Then they performing approach was applied to nine Designathon compounds to predict there STOT-RE classification.

The workshop used the different case studies as starting point to discuss the main principles of NAM based toxicokinetic and dynamic assessment. Discussion of shared assessment elements and main differences helped to crystallize out that it would be a good idea to assess different endpoints by using different criteria and testing approaches, e.g. for acute toxicity, CMR or STOT-RE. While the assumptions and approaches in high throughput kinetic assessments were already fairly similar, more work is needed to agree on the testing strategy for toxicodynamic properties. Workshops like this a needed to evaluate a variety of ideas to then include new ideas into future developments.

RISK-HUNT3R will continue the work in case study 2 using other relevant and promising high throughput methods e.g. expanding to cell painting and reporter based assays. A subset of the Designathon compounds will be used as external validation set.

All information regarding the EPAA Designathon workshop are available here. Recording of the EPAA DESIGNATHON workshop is available here on the European Commission website and a flash report of the event here.

 

 

 

REGISTER NOW – RISK-HUNT3R 2nd Stakeholder Symposium (11-12 June 2024, Netherlands)

REGISTER NOW – RISK-HUNT3R 2nd Stakeholder Symposium (11-12 June 2024, Netherlands)

The RISK-HUNT3R project is pleased to invite all interested stakeholders to the second edition of its public Stakeholder Symposium, taking place on the 11th and 12th of June 2024 at Hotel Zuiderduin in Egmond aan Zee, Netherlands.

The event will be dedicated to RISK-HUNT3R partners and stakeholders from industry, regulatory organizations, and international initiatives on new approach methods (NAM)-based chemical risk assessment.

The second edition of the RISK-HUNT3R Stakeholder Symposium‘s programme will be focusing on four key topics:

  • Update on ASPA safety assessment workflow, with examples on practical application and its incorporation into the ASPA dashboard;
  • RISK-HUNT3R Case studies on applicability of ASPA for NAM-based NGRA;
  • Focus on Case study on hazard endpoints of RISK-HUNT3R;
  • Scientific achievements in RISK-HUNT3R at year-3 of project deployment through speed talks and posters.

All precisions on event hours and topics are available to all in the RISK-HUNT3R Stakeholder Symposium agenda.

Register before May 15th by completing the online registration form: here.

For further information, please contact the Project Office at riskhunt3r_arttic@eurtd.com.