Putting human biology at the center, AI lab-pilot transition, First self-contained OoC workstation, Organoids as immune-organ interaction models
News on non-animal methods
SEPTEMBER 08 - 12, 2025NEWS, REPORTS & POSITION STATEMENTS
1. The drug development shift : Putting human biology at the center
The biopharma industry continues to face unacceptable high attrition rates in clinical development. Most failures trace back to : 1. Lack of efficacy – animal disease models often fail to capture the true complexity of human biology and pathology. 2. Safety issues – especially those driven by human-specific mechanisms or idiosyncratic reactions. At the core, both challenges reflect the same problem : poor predictability of traditional preclinical models when it comes to human outcomes. This reality makes one conclusion unavoidable : We need to place human biology at the center of decision-making. Where do we stand today ?
In a recent post on LinkedIn, Eckhard von Keutz, Former SVP and Head of Translational Sciences at Bayer sent a Call to Re-Center on Human Biology, in investing in human-relevant platforms ; in building the evidence base for regulatory acceptance ; and in fostering a culture where human biology is the guiding framework.
2. How AI is changing science : Entering a “co-pilot to lab-pilot” transition
In 2025,we now find ourselves in the era of multimodal, agentic systems that listen, see, speak and act, orchestrating cloud software and physical laboratory hardware with a fluency that would have sounded speculative in early 2023.
In a review, Prof. Thomas Hartung merges the substance of his 2024 white paper for the World Economic Forum Top-10-Technologies Report with the latest advances through mid-2025, charting a course from automated literature synthesis and hypothesis generation to self-driving laboratories, organoid intelligence and climate-scale forecasting, arguing that research is entering a “co-pilot to lab-pilot” transition in which AI no longer merely interprets knowledge but increasingly acts upon it.
3. EPA leans on AI to spur faster chemical reviews
The chemical industry has long complained about delayed review processes impeding innovation, as the Environmental Protection Agency (EPA) struggles to meet its up-to-180-day deadline for new chemical assessments under TSCA (Toxic Substances Control Act). EPA Administrator Lee Zeldin has said speeding up new chemical reviews is a priority.
While experts say the core technology already exists, they caution that the agency still faces significant hurdles in data quality and trust. EPA is eyeing development of an “AI Chemist Assistant” that “will help chemical reviewers search various repositories to identify chemical and chemical analog information used in TSCA submission reviews and risk evaluations, possibly saving hundreds of staff hours per review/evaluation”.
Read more in POLITICO’s E&E News
4. ISTAND becomes a Permanent Qualification Program
The U.S. Food and Drug Administration recognizes that innovating drug development is an important way to bring new treatments to patients and consumers expeditiously. For this reason, the FDA announced that its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program has transitioned to a permanent drug development tool (DDT) Qualification Program. Launched in 2020, ISTAND will continue to support innovative, science-driven approaches that improve drug development and regulatory decision-making, ultimately helping to make therapies available to address patients’ unmet needs.
INTERVIEWS, NOMINATIONS & AWARDS
5. Hans Clevers returns to the Hubrecht Institute
Former Hubrecht director and group leader Hans Clevers has returned to the Hubrecht Institute since September 1st. He will lead the Organoid group – now Clevers group – holding the title of distinguished group leader, as a recognition of his special contributions to the institute, as a former director, and for his impact on the institute and society through his groundbreaking scientific discoveries.
Clevers left the Hubrecht Institute in 2022, to become Head of pharma Research and Early Development at Roche in Basel, Switzerland. At Roche he championed the founding of the Institute for Human Biology (IHB), where he currently serves as interim Director.
6. Nicole Kleinstreuer receives the 2025 Humane Science Innovator Award
Dr. Nicole Kleinstreuer, Acting Deputy Director for Program Coordination, Planning, and Strategic Initiatives for The National Institutes of Health (NIH), was presented with the 2025 Humane Science Innovator Award. The award ceremony was held at the WC13 Rio — World Congress on Alternatives and Animal Use in the Life Sciences in Brazil.
Dr. Kleinstreuer was chosen to receive this year’s award because of her leadership and driving efforts within NIH as well as internationally to promote the development and adoption of non-animal methods. Her background in biomedical engineering, applied mathematics, and bioengineering has helped her to apply computational modeling, artificial intelligence, and high-tech toxicology to regulatory science — without animals.
TOOLS, PLATFORMS, CALLS
7. TOXTRUST : a tool leveraging the dempster-shafer theory for robust integration of NAM results in decision-making
In the search for alternatives to replace in vivo studies, the application of assessment frameworks involving NAMs often leads to the simultaneous availability of multiple pieces of evidence of different quality. If they are not integrated correctly, a collection of NAM results may produce misleading results that complicate the assessment process or lead to wrong conclusions.
To support transparent decision-making in situations in which multiple NAMs are applied to generate results for the same toxicological question, Karolina Kopańska et al. developed TOXTRUST –- an open-source computational tool integrating the mathematical framework of the Dempster-Shafer Theory (DST). In a recent article, the researchers illustrate how TOXTRUST can be applied to any endpoint with binary end-results, with a focus on the generation and interpretation of results expressed through probability bounds.
Read the publication in the NAM Journal
INDUSTRY, BIOTECH & PARTNERSHIPS
8. How AVA Emulation System enables human-relevant data for pharma and biotech
Drug discovery is at a crossroads. With nearly 90% of clinical trial candidates failing to reach FDA approval, the need for more predictive, human-relevant models has never been greater. That’s why Emulate recently launched the AVA™ Emulation System, the first self-contained Organ-on-a-Chip workstation designed to bring scale, reproducibility, and accessibility to this transformative technology.
In a blog post, the company’s CEO, Jim Corbett brings a unique perspective on how AVA will accelerate adoption across pharma, biotech, and academia — and why it represents a turning point for human-relevant drug discovery.
Learn more about AVA Emulation System
SCIENTIFIC DISCOVERIES & PROTOCOLS
9. Tunable ECMs for more effective T cell therapies
In ICTs (immune cell therapies), immune cells taken out of patients and engineered and amplified in vitro, act as “living drugs” that recognize and respond to disease states when infused back into the body. Multiple engineered T cell therapies have been approved for the treatment of hematological cancers. Two of the main objectives of ICT developers — to target cells specifically and safely — are being increasingly better addressed by advances in immune cell and genome engineering. However, a third objective, maintaining immune cells’ therapeutic efficacy first during their in vitro amplification (manufacturing) and after their transfer into patients, remains a formidable challenge.
A team led by David Mooney at the Wyss Institute developed a novel tunable biomaterial system that allows researchers to investigate and leverage the effects of tissue mechanics on the state of therapeutic T cells in vitro. The system is an engineered 3D model of the gel-like extracellular matrix (ECM) produced by cells, which is responsible for tissues’ different “stiffnesses” and “viscoelasticities” and allows both parameters to be independently tuned.
10. Single-cell multi-omics characterize colorectal tumors
Colorectal cancer (CRC) arises in the colorectal tissue driven by genetic disorder or the accumulation of somatic mutations, leading to abnormal epithelial cell growth. In a recent study, Dr. Zhijun Yu and team at Prinses Maxima Centrum employed single-nucleus multi-omics analysis on over 100,000 high-quality nuclei to investigate the molecular landscape of both primary tissue and patient-derived organoids (PDOs).
Their analysis showed that normal PDOs derived from tissue adjacent to tumors replicate the cellular composition and differentiation trajectory of colorectal crypts. The study provides a comprehensive view of the transition from normal to malignant colorectal epithelium and underscores the utility of PDOs as a faithful model for capturing both conserved and patient-specific features of colorectal cancer.
Read the article published in the International Journal of Cancer
11. Organoids as models of immune-organ interaction
Incorporating immune cells into organoids enables exploring previously inaccessible aspects of immune-epithelial interactions in vitro. In a review, Nikolche Gjorevski et al. discussed how incorporating immune cells into organoid systems allows scientists to model functional organ-level immune responses, but also study aspects of inflammatory disease and cancer.
Started by detailing how immune-organoid co-cultures can model mucosal immunity at each stage of a functional inflammatory response, the researchers then described how inflammatory organoid systems have informed understanding of the features driving chronic stress and remodeling in autoimmune diseases, and explored how patient-derived carcinoma organoids can be combined with tumor-relevant immune compartments for oncology research. The review outlined major current challenges and the ultimate aspiration to develop systems where homeostatic dynamics are established, maintained, and perturbed in a fully mature differentiated state and where immune memory can be acquired to pathogenic challenges de novo.
Read the full review in Cell Reports
WORTH (RE)SHARING
Ombion Centre for Animal-free Biomedical Translation Survey (deadline : Oct. 31st)
