The landscape of preclinical safety assessment is undergoing a transformative shift, one that Evotec has been anticipating and actively working towards for over three decades. The FDA's recent announcement, "Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs” and the related roadmap to reducing animal testing in preclinical safety studies, establishes a framework to progressively reduce, refine or potentially replace animal testing for mAbs and other drugs, building on the FDA Modernization Act 2.0 passed by Congress in 2022. This regulatory evolution represents both a validation of Evotec's long-standing approach and an opportunity to leverage our established expertise in navigating this new paradigm.^1,2

The FDA's roadmap signals a decisive move toward human-relevant testing methodologies that promise greater predictive value while reducing reliance on animal models. Initially focusing on monoclonal antibodies (mAbs) as a promising area for implementation, the initiative recognizes what Evotec has long been exploring: the need to improve predictive accuracy and reduce animal use through innovative and human-centric approaches.

This announcement acknowledges that New Approach Methodologies (NAMs)—which include human-based in vitro systems like organoids, sophisticated in silico modeling, and other innovative platforms,— when validated, may collectively deliver more accurate predictions of safety and pharmacodynamics in humans.

The FDA encourages the involvement of industry, academia, as well as with federal agencies (e.g., NIH, VA) through ICCVAM to accelerate validation and adoption of NAMs.

For over three decades, Evotec has been pioneering the very approaches now being advocated by regulatory authorities. Our long-term commitment to the 3Rs principles (Replacement, Reduction, Refinement) has positioned us at the forefront of developing alternatives to traditional animal testing—not merely as a compliance exercise, but as a fundamental scientific strategy to enhance predictive value and accelerate drug development.

Our early adoption of in silico tools, integrated AI/ML approaches, and NAMs-based risk assessment methodologies has evolved into comprehensive platforms that deliver human-relevant insights throughout the drug discovery and development process.

The FDA's roadmap specifically highlights mAb immunotoxicity assessment as an area where human peripheral blood mononuclear cells (PBMCs) combined with cytokine release studies can provide valuable safety data. This approach exemplifies the type of methodology Evotec has been refining and implementing for years, allowing our partners to benefit from more predictive, human-relevant safety assessments.

Consistent with the FDA's roadmap which advocates the use of a weight-of-evidence approach, our integrated solutions extend beyond isolated assays to encompass:

• Advanced organoid-based NAMs supported by sophisticated AI/ML algorithms
  
• Industry-leading Omics platforms that provide deep molecular insights
  
• AI/ML transcriptomics predictive safety platforms that identify potential issues earlier with higher accuracy
  
• Molecular Patient Database (E.MPD) that grounds our work in human-relevant data

For companies working with Evotec, the FDA's new direction presents several strategic advantages:

1. Reduced Regulatory Risk
   Our longstanding experience with NAMs and in silico approaches means that safety packages developed through our platforms are already aligned with the FDA's evolving expectations, reducing the risk of regulatory delays or requests for additional studies.
2. More Predictive Human Outcomes
   By application of human-relevant systems rather than relying solely on animal models, our approach provides deeper insights into how compounds will behave in human patients—the ultimate goal of any safety assessment.
3. Accelerated Development Timelines
   The hope is that implementation of NAMs may allow for more rapid safety evaluations, identify potential issues earlier in the development process when they can be addressed more efficiently and cost-effectively.

At Evotec, we are uniquely positioned to accelerate the paradigm shift now advocated by FDA and supported by other major Health Authorities (including EMA). Our fully integrated suite of advanced capabilities combines in silico-based tools with translational predictive NAMs in ways that few other organizations can match.

Our Integrated R&D teams are already offering next-generation solutions to our partners while actively driving AI-driven innovation to realize the FDA's vision: reducing animal testing in pharmaceutical R&D and replacing it with more predictive, ethical, and efficient methodologies.

As regulatory frameworks continue to evolve, Evotec remains committed to leading the development and implementation of innovative approaches to safety assessment. Our three decades of experience in this domain combined with animal-based safety assessment expertise provides our partners with not only cutting-edge technologies but also the strategic insight necessary to navigate changing regulatory expectations.

The FDA's announcement doesn't represent a sudden shift in direction for Evotec—rather, it confirms that our long-term strategy has been aligned with the future of drug development.

We invite potential partners to engage with our team to discover how our established expertise in NAMs, in silico modeling, and AI/ML-driven approaches can address their specific drug development challenges in this evolving regulatory landscape.

1. FDA. "Roadmap to Reducing Animal Testing in Preclinical Safety Studies." 2025.

2. U.S. Congress. "FDA Modernization Act 2.0." 2022.