Training opportunities in NAMs, Success using Emulate human Liver chip, Digital twin-enhanced multi-MPS system and more
News on non-animal methods
FEB. 17 - 21, 2025NEWS, REPORTS & POSITION STATEMENTS
1. Creating training opportunities in NAMs for early-career researchers
As research and testing methods rapidly advance, there is a pressing need to train the next generation of scientists in New Approach Methodologies (NAMs) — human-specific, non-animal methods. Aiming to address this need, the Physicians Committee for Responsible Medicine hosted its third biennial Summer Immersion on Innovative Approaches in Sciences in May 2024, an opportunity designed to educate and inspire young scientists to adopt NAMs in their research.
A new report published in the NAM Journal presents proceedings of the 2024 Summer Immersion and provides recommendations for maintaining momentum for innovative science, such as investing in concentrated training events and institutional training programs and promoting research integrity.
2. Beyond the hype with HUMANOID
It is increasingly evident that the capacity of rodents – and even primates – to unravel the mechanisms of diseases like Alzheimer’s, inflammatory bowel disease and various cancers, or to reliably predict the effects of novel compounds in humans, is inherently limited. There is a broad consensus that, without better approaches, we risk entering another era of “reproducibility crisis” potentially worse than the one before.
Organoid technology contains a unique set of characteristics that challenge traditional methods of reproducible and quantitative data collection. Housed within the Institute for Network Medicine, UC San Diego’s HUMANOID™ Centeris ground zero for an integrated engineering – biology approach called BioDESIGN : biology-driven innovation for drug efficacy, safety and integrated next-gen. BioDESIGN seeks to achieve rigor, standardization and precision, while simplifying models to capture what matters most for any given disease.
3. The capacity of legal and regulatory frameworks to accommodate NAMs
A new study employs insights from the literature on technology transitions to explore the limited take-up of New Approach Methodologies (NAMs) into regulatory science. It argues that their development is not a linear process and the change to NAMs is impacted not only by scientific barriers but more often by wider technical and social barriers to transition.The article focuses on legal and regulatory influences at the multi levels before suggesting that law may stifle rather than accommodate or facilitate beneficial and ethical technological development.
An additional review from PrecisionTox serves to illustrate the inextricable links between these debates and suggests that value can be added from NAMs, which is not fully recognised by EU law as currently drafted, applied, or interpreted. A review of judicial interpretation of legislation through an analysis of toxicological court cases relating to the utility of chemical safety testing methods reveals significant complexities for all actors involved in the decision-making process.
4. The UK as a leader in NAMs for safety science
A new report by Lush Prize shares a comprehensive but concise summary of the progress made in developing non-animal, human-relevant NAMs for ensuring the safety of cosmetics. This report shows how the animal testing bans drove a sea change in innovation of human-relevant methods, and were ‘a unique move that cemented the cosmetics industry’s place as a propeller for innovation in the field of safety testing.’
Safer Medicines Trust empathised that the UK could seize this opportunity to become the global leader in animal-free innovation, to the benefit of human and environmental health, as well as the economy.
INTERVIEWS, NOMINATIONS & AWARDS
5. NC3Rs awarded £300k for NAMs to replace the use of birds in toxicity testing
There is an unmet need to develop and integrate alternative approaches in avian toxicity studies to assess the potential of chemicals in the environment to cause acute and chronic toxicity in bird species. NAMs could replace the use of some birds for internal screening of chemicals in development and for regulatory environmental risk assessments.
Two multi-disciplinary teams in Germany, led by Dr Stephan Schaller from ESQlabs GmbH and Dr Jo Nyffeler from Helmhotz Centre for Environmental Research, are starting work to solve the Wings of Change CRACK IT Challenge and develop NAMs to evaluate the potential risks that chemicals such as pesticides pose to birds.
TOOLS, PLATFORMS, CALLS
6. Free remote training course on in silico models and read-across
PARC is organising a remote training course on the use and interpretation of in silico models and read-across, with a special focus on VEGAHUB and applications related to human, ecotoxicological, and environmental properties. The online course will take place on 3 – 4 March 2025. The scientific coordination is provided by the Istituto Mario Negri (IRFMN), Italy.
The course is designed for risk assessors and researchers (beginner level). It will address the uncertainty and purpose of different applications to distinguish their relevance in various regulatory and scientific contexts. Application deadline is February 24 2025.
INDUSTRY, BIOTECH & PARTNERSHIPS
7. Successful collaboration using Emulate human Liver chip for LNP toxicity study
The National Laboratory Animal Center (NLAC) of the National Applied Research Laboratories (NARLabs), Level Biotechnology Inc., Acer Inc., and the world-leading organ-on-chip company Emulate Inc. have successfully collaborated to utilize cutting-edge human liver organ-on-chip systems to assess the potential liver toxicity risks of lipid nanoparticles (LNP).
The experimental results demonstrate that human organ-on-chip systems are not only highly promising testing platforms but also provide more precise and human-relevant data compared to existing technologies. Emulate Inc. highlighted that this collaboration underscores its technology’s ability to play a pivotal role across global markets, facilitating deeper biological research and drug development.
SCIENTIFIC DISCOVERIES & PROTOCOLS
8. Machine learning helped identifying and targeting TNF signaling in idiopathic multicentric castleman’s disease
A patient with longstanding multicentric Castleman’s disease that had progressed after multiple therapies was entering hospice care. By comparing the analyses of 26 patients with those of 15 healthy individuals, the machine learning approach identifies adalimumab, a monoclonal antibody treatment used in chronic auto-inflammatory diseases such as Crohn’s disease and rheumatoid arthritis. With the patient’s approval, the doctor administered the antibody treatment and it worked, the patient has been in remission for two years.
Applied to other rare diseases, this approach could lead to the discovery of appropriate drugs for many other diseases lacking treatment.
Read the Article in Science et Avenir (FR)
9. Digital twin-enhanced multi-MPS system for studying drug pharmacokinetics in pregnant women
A new study used human MPS integrated gut, liver, and placenta models, interconnected via the corresponding vasculature and prednisone as a model compound to simulate oral drug administration and track its metabolism and transplacental transfer. To translate the generated data from MPS to human physiology, computational modelling techniques were developed.
The results demonstrate that the system maintains cellular integrity and accurately mimics in vivo drug dynamics, with predictions closely matching clinical data from pregnant women. Digital twinning closely aligned with the generated experimental data. Long-term exposure simulations confirmed the value of this integrated system for predicting the non-toxic metabolization of prednisone.
10. Protocol to generate a 3D atherogenesis-on-chip model
The endothelium is the gatekeeper of vessel health, and its dysfunction is pivotal in driving atherogenesis. A new paper presents a protocol to replicate endothelial-macrophage crosstalk during atherogenesis, called the “atherogenesis-on-chip” model, based on the Emulate dual-channel perfusion system.
The authors describe a model for studying endothelial-macrophage interactions during atherogenesis in human aortic endothelial cells and human macrophages using qPCR and secretome analysis, fluorescence microscopy, and flow cytometry. This protocol could be adapted toward more complex plaque microenvironment or other disease settings.
11. Cervical mucus in linked human Cervix and Vagina Chips modulates vaginal dysbiosis
A new study explores the protective role of cervicovaginal mucus in maintaining vaginal health, particularly in relation to bacterial vaginosis (BV), using organ-on-chip technology. By integrating human Cervix and Vagina Chips, researchers demonstrated that cervical mucus significantly reduces inflammation and epithelial damage caused by a dysbiotic microbiome commonly associated with BV.
This research provides new insights into the mechanisms underlying vaginal dysbiosis and opens avenues for developing targeted therapies and diagnostic tools to enhance women’s reproductive health.
