The landscape of drug development is at a historic inflection point and undergoing a transformative shift. Scientific advances in human relevant biology, coupled with a growing ethical consensus and progressive regulatory reform, are creating an opportunity to rethink how we evaluate safety and efficacy.
A new report, compiled over the span of one year through a collaboration between Dr. Reddy’s Laboratories, DBT-InSTEM, Humane World for Animals India, and the Animal Law and Policy Network, aims to map emerging NAMs (defined as non-animal methods) and opportunities for their adoption in India and captures both the urgency and the promise of moving toward approaches that better predict human outcomes. The roadmap articulated in this report provides a credible pathway for achieving that vision, grounded in international best practices yet tailored to national priorities and constraints.
Claude Bernard Lyon 1 University, Sartorius, and the French National Research Agency (ANR) announce the launch of the LIFT (Large-scale Innovative Fabrication of in vitro engineered Tissues) research project, winner of the ANR’s 2025 Industrial Chairs program. This highly ambitious project, recognized as such by the members of the evaluation jury, aims to position France at the forefront of in vitro human tissue biofabrication worldwide, paving the way for major advances in regenerative medicine, pharmaceutical research, and alternatives to animal testing.
LIFT is committed to a responsible approach, incorporating training, ethical reflection, and scientific communication initiatives to support developments in medicine and society toward safer, more effective, and more humane practices.
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The Institute of Neurosciences of the University of Barcelona (UBneuro) continues to consolidate its position at the forefront of European neuroscience research through the strategic project “VISI-ON-BRAIN: Cutting-edge Human In Vitro and In Silico Biomedical Tools on Brain Disorders”, led by Josep M. Canals, Professor at the Faculty of Medicine and Health Sciences and UBneuro researcher, and coordinated by Creatio, production and validation center of advanced therapies at UB.
VISI-ON-BRAIN is a training and research programme involving 15 PhD researchers focused on developing next-generation human models to advance the study of complex brain disorders such as Alzheimer’s, Parkinson’s and Huntington’s disease. The project represents a paradigm shift in neuroscience research, moving beyond animal models and advancing more ethical and human-relevant science through experimental (in vitro) and computational (in silico) approaches. The programme is funded with €4.5 million under the Marie Skłodowska-Curie Actions Doctoral Networks (MSCA-DN), within Horizon Europe.
The top 8 systems (cardiovascular, liver, musculoskeletal, genetic, respiratory, renal, gastrointestinal, and CNS) account for 79% and 97% of preclinical and clinical safety failures, respectively. It is conceivable, if appropriately designed, that a NAMs-focused preclinical safety package has the power to evaluate over 85% of preclinical and 95% of clinical organ systems responsible for drug failure. When paired with emerging pharmacokinetics and dose-focused NAMs, this might, one day, enable truly animal-free submissions. However, what is still lacking is more data.
Dozens to hundreds of individual studies will need to be completed with NAMs before there are enough data to conclusively compare their predictive ability to animals. But as NAMs qualification accelerates, regulators will be increasingly equipped to evaluate how much (if at all) NAMs improve human clinical trial outcomes. Should the data pan out, a NAMs-only future might become the reality. With the right scientific, regulatory, and economic incentives, that future could be closer than we realise.
In a recent webinar, Dr. Lena Smirnova, assistant Professor at Johns Hopkins Bloomberg School of Public Health, explained how brain microphysiological systems are transforming in vitro neurotoxicity testing and disease modeling. NewsMedical compiled the key highlights in an interview.
“Challenges include the need for skilled handling, time-intensive differentiation protocols, and iPSC variability. There’s also a pressing need to adapt traditional 2D assay endpoints for use in 3D contexts. Standardization across labs is essential to improve reproducibility and build confidence in these models for regulatory purposes”, says Dr Smirnova.
The growing demand to reduce animal testing has driven the development of alternative methods, including organoids, organs-on-a-chip, and computational approaches such as virtual cells.
The journal scientific reports is calling for papers on original research on engineered platforms that reduce reliance on animal models. The submission deadline is 25 November 2026.
Read more and submit your manuscript
Are you looking to bridge the gap between theoretical knowledge and practical application in in vitro toxicology? You can join in September 20 – 25, 2026 the renowned ESTIV Applied Training Course. This intensive 6‑day program is specifically designed for toxicologists, risk assessors, and students who want to master New Approach Methodologies (NAMs) and their role in regulatory safety assessment.
Seats are strictly limited to ensure a high-quality learning experience. Location: L’Oréal Research & Innovation, Saint-Ouen, France.

On February 18th, Axion BioSystems announced that the FDA’s Center for Drug Evaluation and Research (CDER) has accepted the company’s letter of intent (LOI) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Program for its Human iPSC-Cardiomyocyte Multielectrode Array (MEA) assay for prediction of clinical cardiovascular repolarization risk.
The submission represents the first stem cell-derived, functional cardiac safety assay accepted into the ISTAND program.
CubaseBio, a biotech company founded by pioneers in spatial biology, announced it has secured €5.9 million in blended financing. The funding comprises a €2 million non-dilutive grant from the European Innovation Council (EIC) Transition program and €3.9 million in private capital.
The funding will be used to accelerate the technology development and commercialization of the company’s next-generation spatial transcriptomic technology. Unlike conventional 2D spatial techniques, which are limited to thin tissue sections, CubaseBio’s technology enables true three-dimensional analysis at scale. This technology provides researchers with unprecedented insights into complex 3D tissue structures.
Urine is a dynamic and highly variable biofluid. Urine-urothelium interactions are a critical yet underexplored factor in bladder homoeostasis and urinary tract infections (UTIs).
A team from the Institute of Human Biology report on a human ‘mini-bladder’ model — an engineered bladder-on-chip that brings together three key features: a mature, stratified urothelium, urine perfusion that exposes a stratified urothelium to urine of defined composition, and incorporates micturition. This engineered tissue allows the study of infection resilience and antibiotic tolerance/recurrence in a model much closer to the native bladder environment. Findings expand the conceptual role for cell wall-deficient uropathogenic Escherichia coli in UTIs, and demonstrate the power of the mini-bladder platform to capture urine-urothelial microenvironment dynamics that actively shape UTI pathogenesis and antibiotic tolerance.
Read the publication on Nature Communications
The blood-brain barrier (BBB) is essential for healthy central nervous system (CNS) function but also poses a hurdle in the treatment of increasingly common neurological disorders. BBB dysfunction is also a hallmark of many neurological diseases, further emphasizing a need for a better understanding of BBB function in health and disease.
In a new study, the authors present a human self-assembling 3D model of the BBB in a microfluidic cell culture platform that allows culture of 48 models in parallel on one tissue culture plate. Unlike similar models previously reported, this brain microvasculature model allows for unidirectional perfusion without the need for pumps and syringes. Combined with its high-throughput nature, this feature renders the model suitable for studies of BBB function in health and disease, and assessment of potential BBB restorative therapies.
Read the publication on Fluids Barriers CNS
