Validation of NAMs, Dutch government fund towards non-animal research, ANR call on AI, In silico toxicology training course and more
News on non-animal methods
OCT. 28 - NOV.01, 2024NEWS, REPORTS & POSITION STATEMENTS
1. Accelerating the adoption of NAMs in food safety through collaboration
The European Food Safety Authority (EFSA) has made some progress in recognizing the potential of NAMs, incorporating them into certain updated guidance documents. Nevertheless, traditional toxicological methods still dominate many evaluations, even when non-animal approaches could provide equally, if not more, relevant information. As a result, the food and drink industry often finds itself constrained by outdated testing requirements, which can slow down the development of innovative products and delay market entry.
One of the main barriers to the widespread adoption of NAMs in food safety is the lack of regulatory flexibility. While the scientific community has made significant advancements in the development and validation of NAMs, companies remain uncertain about whether these methods will be accepted by regulators. This uncertainty often discourages the use of NAMs, as applicants may feel compelled to rely on traditional animal testing to ensure their safety dossiers meet regulatory requirements.The transition to NAMs in food safety assessments is not just a regulatory aspiration, it is a necessary evolution to meet the demands of modern food production and consumer expectations. The European food and drink industry is ready to embrace this change, but greater collaboration with EFSA is needed to ensure that the regulatory framework keeps pace with scientific progress.
2. Validation of alternatives to animal testing
For regularly use : Conceptual, ethical, and philosophical foundations
How do we know if new methods for testing chemical safety are reliable and relevant ? This process, called validation, is crucial for protecting public health and reducing animal testing. A new reflection paper by Prof Hartung explores the ethical and philosophical ideas behind validation, asking important questions about fairness, animal welfare, and scientific progress. It is argued that current validation methods need updating to keep pace with new technologies and changing social values. By examining different philosophical viewpoints, ways to make validation more flexible, transparent, and ethically sound are suggested. This matters because better validation can lead to safer products, less animal suffering, and more effective environmental protection. The goal is to spark a conversation about how we can improve the way we evaluate new safety testing methods, balancing scientific rigor with ethical considerations and public trust.
Leveraging biomarkers and translational medicine for preclinical safety
A second reflection paper by Prof Hartung et al. examines how biomarkers and translational science principles can improve safety testing without using animals. Biomarkers are quantifiable indicators of biological processes. Some of these can predict disease progression or drug effects. Translational science aims to apply laboratory findings towards clinical benefits. The article explores how combining these approaches can create better, more human-relevant and validated alternatives to animal testing. It discusses challenges that the field faces, including standardization of methods and getting regulatory acceptance. It also highlights opportunities, like integration with emerging technologies and increased global collaboration. The ultimate goal is to improve human health by streamlining NAM validation processes.
E‑validation – Unleashing AI for validation
Validating new methods to replace traditional animal testing for chemicals can be slow and costly, often taking up to ten years. A third opinion piece Prof Hartung et al. introduces e‑validation, an artificial intelligence (AI)- powered approach designed to speed up and improve this process. E‑validation includes a smart system for choosing test chemicals, virtual simulations to predict study outcomes, and AI tools to understand the biological effects of chemicals. It also provides training in these new methods. E‑validation could accelerate medical research, improve chemical safety, reduce the need for animal testing, and help create safer products faster. While promising, this new approach will need real-world testing to prove its benefits and address potential challenges.
3. Dutch government engaged in incrementally redirecting funding to animal-free research
Great progress in the Netherlands with regard to phasing in non-animal new approach methods : the Parliament has just adopted a motion, submitted by the Party for the Animals — Animal Politics Foundation Socialistische Partij ChristenUnie Dion Graus, demanding the government looks into incrementally redirecting government funding from animal research to animal-free research.
Read more (NL)
4. Animal-free safety assessment of chemicals : An innovation system perspective
A new perspective paper, which is the result of a collaborative effort between toxicologists and scholars in innovation and transition studies, presents a heuristic framework based on innovation system literature for understanding and appraising mission achievement to animal-free chemical safety assessment using New Approach Methodologies (NAMs).
While scientific and technical challenges in this area are relatively well known, the recent establishment of missions and roadmaps to accelerate the acceptance and effective use of NAMs for chemical safety assessment raises new questions about how we can grasp the systemic nature of all changes needed in this transition. This includes recognising broader societal, institutional, and regulatory shifts necessary for NAM acceptance and uptake. The paper discusses how the innovation system approach offers insights into key processes and associated activities that include as well as transcend the technical and scientific realm, and can help to accelerate acceptance and uptake of NAMs. The framework can be used to perform structural and functional analyses of the innovation system and as such provides handholds to track progress and organise collective efforts of actors to make sure we are moving in the right direction.
TOOLS, PLATFORMS, CALLS
5. In silico toxicology training course
Tox Navigation just released the full 2024 version of “NAMs – Use and Application of QSAR and Read-across” course.
The tutor-assisted eLearning course has been extended from 16 hours to over 25 hours of lectures with new quizzes and home assignments. The content includes the latest developments in this field including how to utilize QSAR under the QAF (QSAR Assessment Framework) guidance. Software demonstrations have been updated with the latest models and software releases. Subtitles throughout the course are now available in English, Spanish, French, German, and Italian.
The course is recognised by EUROTOX for Continued Professional Development for ERT accredited toxicologists. With the increasing use and importance of computational methods, this course is a “must” for all toxicologists and regulatory scientists.
6. ANR launches call for specific themes in Artificial Intelligence
Since its 2012 revolution, artificial intelligence (AI) has been introduced at the core of digital solutions and continues to evolve rapidly. These recent developments are notable, both at the core of AI and in its interactions with other research fields. In this sense, this call aims to support the new challenges of artificial intelligence for scientific discovery. It therefore encourages multidisciplinary and collaborative research aimed at promoting the use of AI in scientific practice and in conducting research.
Project submission deadline : March 3, 2025 at 17:00 CET.
7. Computational ADME Tox AnaLYsis for Safer Therapeutics (CATALYST) innovative solutions opening
The Advanced Research Projects Agency for Health (ARPA‑H) is posting a DRAFT Innovative Solutions Opening (ARPA-H-SOL-24 – 114) for the Computational ADME Tox AnaLYsis for Safer Therapeutics (CATALYST) Program in order to help potential proposers prepare for Proposer’s Day and plan for solution summary submission.
Original Response Date : Nov 25, 2024 05:00 pm EST.
INDUSTRY, BIOTECH & PARTNERSHIPS
8. Okomera gets €1.5 million grant to develop microfluidics & AI powered CRISPR editing platform for target validation
Okomera announces Bpi France funding to develop and standardize novel CRISPR screening assay to accelerate drug discovery in oncology with leading cancer research center of Marseille, CRCM. Okomera is developing a desktop platform for automated organoid screening using droplet-microfluidics and AI to accelerate drug discovery. Their patented tech developed after 10 years of research at Pasteur Institute and Ecole Polytechnique, provides Multiplexing, Co-culture and High-throughput screening of drug candidates on miniaturized Patient Derived Organoids (PDOs).
“By integrating CRISPR technology with Okomera’s advanced organoid screening platform, we are setting the stage for more precise and effective therapeutic strategies. This project represents a significant step forward in translating scientific discoveries into tangible clinical applications, ultimately bringing us closer to improving outcomes for cancer patients.”, said Dr. Geraldine Guasch, Research Director Inserm at CRCM and Scientific Director of the 3D-HUB‑O organoid platform.
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. Will it soon be possible to grow your own skin to erase scars ?
A team of researchers from Boston, Newcastle and Cambridge has mapped human skin cells using a laboratory-created organoid. The results, published in the journal Nature, are promising for the future of regenerative medicine, but also for many other application fields.
Developing prenatal human skin atlas, this study characterized the dynamic composition of human prenatal skin during the early stages and highlighted the crucial skin immune and non-immune crosstalk that contributes to skin morphogenesis. By doing a systematic prenatal skin – skin organoids (SkO) comparison, the work provides a blueprint to guide more faithful in vitro SkO generation, which can facilitate future studies of interactions with the microbiota, the pathogenesis of congenital skin disorders, and hair and skin engineering for therapeutic applications, including hair regeneration and skin transplant.
Read more (FR)
Read the publication in Nature
10. Human assembloids reveal the consequences of CACNA1G gene variants in the thalamocortical pathway
Abnormalities in thalamocortical crosstalk can lead to neuropsychiatric disorders. Variants in CACNA1G gene are associated with absence seizures, intellectual disability, and schizophrenia, but the cellular and circuit consequences of these genetic variants in humans remain unknown.
A new research team developed a human assembloid model of the thalamocortical pathway to dissect the contribution of genetic variants in T‑type calcium channels. They discovered that the M1531V CACNA1G variant associated with seizures led to changes in T‑type currents in thalamic neurons, as well as correlated hyperactivity of thalamic and cortical neurons in assembloids. By contrast, CACNA1G loss, which has been associated with risk of schizophrenia, resulted in abnormal thalamocortical connectivity that was related to both increased spontaneous thalamic activity and aberrant axonal projections. These results illustrate the utility of multi-cellular systems for interrogating human genetic disease risk variants at both cellular and circuit level.
