FDA's Roadmap to Reducing Animal Testing Validates abc biopply’s Fit-for-Purpose and Integrated Services Approach to Safety Assessment
Dear Colleague,
The FDA's recently updated roadmap for New Approach Methodologies (NAMs) sends a clear message: the future of preclinical drug development will increasingly rely on human-relevant technologies, including organoids, organ-on-chip systems, advanced in vitro models, and in silico approaches. The objective is not only to reduce animal testing but also to improve clinical predictability, accelerate development timelines, and enhance decision-making throughout the R&D process.
What is particularly encouraging is that the FDA acknowledges a challenge that has long slowed adoption of innovative preclinical technologies.
For years, the industry has faced a circular dependency:
- Regulators seek robust industrial data before broad acceptance.
- Drug developers seek regulatory certainty before widespread implementation.
This has often delayed the introduction of promising new technologies, despite their scientific potential.
The FDA's current strategy suggests a pragmatic path forward. Rather than attempting to replace all existing models overnight, NAMs should be designed by the required outcomes and deployed where they provide clear and measurable value. Success will come through fit-for-purpose applications.
As an organoid expert since its beginning, I believe this is exactly the right approach.
2D cell cultures and conventional 3D modelling remain indispensable for high-throughput screening, while animal models continue to provide valuable whole-organism insights in areas where systemic interactions are critical. However, the disruptive increase in complexity paired with the loss of statistical quantities leads to a dramatic reduction in predictiveness. In this preclinical complexity gap 90% of the predictiveness in early phases is lost.
To bridge this gap, abc biopply, Europe's first fully integrated Organoid CRO, has developed the validated 3D CoSeedis™ Humanized Multi-Organoid Technology. By generating highly standardized micro-tissues composed of hundreds of communicating organoids, the platform delivers robust, scalable, and translationally relevant data for efficacy, safety, toxicity, resistance, relapse, and biomarker studies. Importantly, we do not see NAMs as a standalone solution. Through our integrated service offering, we therefore combine the strengths of 2D screening, humanized multi-organoid models, and in vivo studies to create fit-for-purpose development strategies tailored to each stage of drug development.
This approach closely aligns with the FDA's vision: building confidence in NAMs through validated use cases, generating decision-grade human-relevant data, and establishing new standards based on scientific evidence and reproducibility.
Ultimately, the goal is not simply to reduce animal testing. It is to integrate the best available technologies to generate more predictive data, reduce development risk, and accelerate better therapies for patients.
We are actively seeking collaborations with pharmaceutical companies, biotech innovators, CROs, academic groups, and regulatory stakeholders who share the vision of advancing predictive, human-relevant drug development.
If you are exploring how standardized multi-organoid systems can strengthen your efficacy, safety, toxicity, resistance, or biomarker programs, let's start a conversation and build the future of preclinical research together.
Arne Faisst
Founder & CEO | Organoid Expert
abc biopply AG
Europe's First Fully Integrated Organoid CRO