In case you missed it, the 16th of December 2025 was a significant day in the US Senate, passing the FDA Modernization Act unanimously, validating a shift away from conventional animal testing which has relied notoriously on mice, rats, rabbits, beagles, and primates to name a few, finally towards human-relevant, non-animal models.
https://centerforahumaneeconomy.org/senate-passes-fda-modernization-act-3-0-by-unanimous-consent/
The case has long been clear why. The scientific community has always recognized that animals do not provide adequate models of human health and disease.
At least 90% of drugs which appear to be safe and effective in animals do not go further on to receive FDA approval in humans due to ongoing safety or efficacy issues [1]. Animal-based data have traditionally been particularly poor predictors of drug success for diseases such as cancer, Alzheimer’s and inflammatory diseases [1, 2]. A nice example of medications which are generally recognized safe in humans, e.g. aspirin,
may have never have actually passed animal trials [1]. Conversely, there are clear examples of drugs which may have appeared safe in animal models which have actually been lethal in human trials. In 1999, Vioxx, marketed by Merck & Co., was approved as a popular prescription non-steroidal anti-inflammatory drug (NSAID) for arthritis and acute pain relief. In animal studies it was not only very safe, but also demonstrated protective properties. A so called ‘miracle drug’ earning Merck billions of dollars. After approval, and by 2004, it was determined Vioxx significantly increased the risk of heart attack and strokes, leading to an estimated 140,000 cases of serious cardiovascular damage [3]. There had been some 80 million patients treated with Vioxx by the time of its withdrawal which remains today as one of the largest cases in pharmaceutical history, and consequently 27,000 lawsuits and settlements ensued.
These examples highlight that there are basic physiological differences between humans and other animal species, and that there are potentially catastrophic consequences of getting it wrong.
Queue March 18th 2026 when the US FDA released their draft guidance on alternatives to animal testing in drug development.
The intent by the FDA – setting out a roadmap to reduce animal testing in pre-clinical safety studies with validated new approach methodologies – NAM’s – leveraging organoids, organ-on-a-chip (OOAC) and microphysiological systems (MPS), in silica and computational modelling (AI I’m sure will have a significant role here), and in vitro-cell based assays. And it goes further in the draft guidance setting out validation expectations around these models, their context of use, human biological relevance, how to technically characterize them and their fit-for-purpose use.
Why? In order to streamline drug R&D, to become more ethical, more efficient, ensure patients benefit from safer therapies, and get those therapies to patients faster – all without the need for animals testing and ushering a new era in drug discovery R&D finally into the 21st century.
So you may be asking yourself, so what? How does Qkine fit into all this?
NAM’s will only be as robust as the biological inputs which will define it. Qkine helps reduce hidden variability from animal-derived, poorly defined or inconsistent growth factors, supporting more reproducible, human-relevant model development.
- Defined culture systems
Using animal-origin-free recombinant growth factors supports the move away from undefined animal-derived materials, which is critically important for NAMs positioned as human-relevant alternatives. - Improved reproducibility
Organoids and stem-cell models are highly sensitive to growth factor potency, purity and lot variability. Qkine’s emphasis on high-purity, bioactive, animal-free proteins aligns directly with FDA’s “technical characterization” and reproducibility expectations. - Reduced reliance on conditioned media
For organoid customers, replacing conditioned media with recombinant R-spondin 1 or noggin components can make protocols easier to standardize, scale and transfer between labs. - Better suitability for translational workflows
Customers moving from discovery into translational, pharma-partnered or regulatory-facing work can benefit from animal-free reagents, with industry low endotoxin levels, documented bioactivity and clear lot information. - Support for model validation packages
FDA’s 2026 draft guidance is clear that sponsors need to justify how a NAM is reliable, biologically relevant and fit for purpose. Qkine can help customers evidence the reagent-control part of that package, even though Qkine products themselves do not make a NAM “FDA validated”.
FDA Modernization Act 3.0 and FDA’s broader NAMs roadmap has created a strong signal: as drug developers, you are being strongly encouraged to generate more human-relevant, scientifically validated non-clinical data. You may be developing organoids, iPSC-derived models, organ-on-chip systems, 3D cultures, high-throughput toxicity screens or disease models. Your system can benefit from Qkine products as they will help reduce variability, replace undefined or animal-derived components, and support more robust model validation packages in order to make your models 1) more consistent and 2) easier to defend scientifically to regulators such as the FDA.
You may also have seen our recent press release signing with Pluristyx.
https://qkine.com/2026/05/01/pluristyx-qkine-announce-reciprocal-distribution-agreement/
And there is a clear fit. Together with Pluristyx the synergy our portfolios create we will address the needs of regenerative medicine, organoid manufacturing and NAMs researchers and product developers to benefit from optimized protocols which leverage the standardized complementarity of Qkine’s proteins to Pluristyx’s iPSC for differentiating cells and tissues. And there is more to come.
Qkine is here to help you develop and define your reproducible, human-relevant disease model.
References
[1] Roadmap to Reducing Animal Testing in Preclinical Safety Studies
[2] In-Depth Briefing on Herbie’s Law and the Animals in Medical Research (Prohibition) Bill
[3] Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx? BMJ. 2007 Jan 20;334(7585):120-3. doi: 10.1136/bmj.39024.487720.68