For decades, animal models have been the backbone of drug discovery. But that foundation is shifting. In 2025, both the FDA and NIH announced clear roadmaps to reduce reliance on animal testing and accelerate the adoption of new approach methodologies (NAMs) such as 3D cell cultures, organoids, and organ-on-chip technologies.
“Human-relevant models are no longer optional,” says Ali McCorkindale, PhD, Principal Scientist at Inventia Life Science. “The regulatory and funding environment is signaling a decisive pivot—and the question is whether pharma is ready.”
Earlier this year, the FDA introduced its 2025 roadmap, beginning with monoclonal antibody (mAb) development, outlining how animal testing can be reduced and, in some cases, replaced with validated NAMs. Meanwhile, the NIH ended animal-only funding calls and launched the Office for Research Integrity and Validation of Alternatives (ORIVA) to support the validation and scaling of human-based systems.
“The direction is crystal clear,” Ali notes. “Models that better recapitulate human biology are becoming essential for both regulatory alignment and scientific credibility.”
Platforms like RASTRUM™ have made it faster and easier than ever to generate 3D models. But according to Ali, the critical step is ensuring that the underlying biology is robust, reproducible, and relevant.
“The complexity comes from the inputs: diverse cell sources, patient-derived materials, co-cultures, and the right matrix conditions,” she explains. “It’s an iterative process. You refine until you have a model that is not only viable but also biologically relevant and reproducible.”
Most assays in drug discovery—imaging, staining, or omics, for example—were originally designed for monolayer 2D cultures. When these workflows are applied in 3D, often the assumptions that once held true begin to break down. Reagents penetrate tissues differently, imaging must account for increased model depth, and drug dosing becomes more complex as compounds diffuse and accumulate in 3D tissues in ways that may shift pharmacological readouts and require careful re-benchmarking from 2D.
“Careful adaptation and validation are what unlock the full value of 3D workflows,” Ali explains. “You can’t simply lift a 2D workflow into 3D—but with the right adjustments, they deliver richer, more predictive insights.”
For many pharma teams, the missing piece isn’t just the technology—it’s having access to the right expertise. Designing complex 3D models, optimizing workflows, and interpreting data in a biologically meaningful way requires specialized experience.
“That’s exactly why we established our Discovery Services offering,” says Ali. “We give teams direct access to experts who can assist in all of the necessary aspects of model development and workflow integration to meet their unique needs.”
Designing complex 3D models, adapting assays, and interpreting data in a biologically meaningful way requires this specialized experience.
“That’s where partnerships matter,” Ali explains. “We work with teams to design and optimize bespoke models, adapt assays to 3D, and generate high-quality data. Once validated, we help transfer those workflows back into pharma pipelines. It accelerates adoption while reducing risk.”
With regulators and funders moving quickly, the shift away from animal testing is accelerating. Advanced in vitro models are becoming essential not just for regulatory alignment, but for scientific credibility.
“The fastest path forward is collaboration,” Ali concludes. “By leveraging expert partners to deliver robust biology, reproducible data, and smooth integration into discovery pipelines, pharma can bridge the translational gap and ensure today’s discoveries become tomorrow’s therapies.”
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