We are at an inflection point in drug development.
A recent article from Scientific American points to what many in our industry recognize: the use of animal testing isn’t just evolving, it is giving way to something fundamentally better.
Animal studies have long been a cornerstone of preclinical development, but they come with well-known limitations. Differences in physiology between species can make it difficult to translate findings into human outcomes. As evidence of this, the industry continues to struggle with high attrition rates in clinical development, often because preclinical models fail to accurately predict human pharmacokinetics and bioavailability.
At the same time, there is growing regulatory and societal pressure to reduce animal use. Governments and agencies are actively exploring pathways to minimize reliance on animal testing, while still ensuring safety and efficacy for consumers.
The challenge is clear. We need better tools that are both predictive and human-relevant.
Moving Beyond the Proxy
The next era of drug development will not be defined by better animal models. It will be defined by eliminating the need for them.
We are already seeing the building blocks take shape: organ-on-chip systems that mimic human physiology, AI-driven models that predict drug behavior, and integrated platforms that connect data across the drug development lifecycle.
There’s another critical piece that also needs our attention: understanding how a drug becomes available in the human body. For subcutaneously-administered modalities, this is a significant challenge. Predicting how such a drug behaves at the site of injection, how it releases, and how it ultimately becomes available systemically remains a major source of uncertainty.
To date, the tools available to answer these questions have been limited.
Pion’s Role in the New Paradigm
At Pion, we believe the transition away from animal testing depends on building better, more predictive alternatives, not just refining existing approaches.
For subcutaneous drug development, there are no standardized, predictive in vitro methods for assessing subcutaneous performance. Any tests that do exist are often too simplistic to capture the complexity of what happens at the injection site. Animal studies are still widely used, but are slow, costly, and not representative of human outcomes. With animal testing, rodent studies can take 10–16 weeks, with lengthier time lines required for non-human primate testing (~6–9 months). The result is a familiar challenge: after months of testing, drug development teams are left making high-stakes decisions with limited confidence.
This is where our SCISSOR platform cuts to the chase. (Pun intended.)
SCISSOR is a biorelevant, in vitro platform designed specifically to simulate subcutaneous injection and drug release. By recreating the physical and mechanical environment of the injection site, it enables drug developers to understand how a drug behaves upon and after administration, capturing critical insights that neither animal models nor simple in vitro tests can provide.
Instead of relying on slow, indirect, or poorly translatable data, reproducible, human-relevant insights are obtained in days, not months. This allows for faster iteration, earlier identification of risk, and more confident candidate selection.
Just as importantly, SCISSOR provides a more predictive lens into human outcomes. In comparative studies, SCISSOR-derived models have demonstrated closer alignment with human bioavailability than traditional animal models, enabling more reliable rank-ordering of candidates and better-informed development decisions.
This is the shift from approximation to prediction.
By bridging the gap between in vitro and in vivo, and moving from approximation to prediction, the SCISSOR platform is transformative. It turns subcutaneous drug development into a faster, moredata-driven process, one that reduces reliance on animal testing.
From the 3Rs to a New Mindset
The biopharmaceutical industry has long embraced the concept of replacing, reducing, and refining animal use (the “3Rs”). But incrementalreductions are not enough. We need to focus on replacement with superior science. When human-relevant models become more predictive than animal systems,the rationale for animal testing begins to disappear, not because of policy, but because of performance.
The transition away from animal models will not happen all at once. But it is underway, and it is accelerating. The drug companies that lead in this new era will be those that invest in human-relevant insight early and integrate data across platforms.
At Pion, we are proud to be part of this movement. Because the future of drug development isn’t about doing what we’ve always done, just slightly better. It’s about rethinking the foundation entirely. And building a systemthat is faster, more predictive, and ultimately, more human.
