NAMs Resource Hub

The FDA’s roadmap to reduce, refine, and replace animal testing signals a transformative shift in drug development. New Approach Methodologies (NAMs) are now central to delivering safe and effective medicines ethically, while improving the predictive value of preclinical testing.

NAMs are no longer a future promise but are the standard the industry is moving toward. Evotec makes NAMs work for you by uniting advanced in vitro models, high-throughput automation and in silico prediction to deliver insights that regulators trust and innovators depend on. With over 30 years of leadership in drug discovery and development services, Evotec leverages Cyprotex and its global network of scientific excellence to help partners reduce animal testing, accelerate development timelines, and bring safer, more effective medicines to patients worldwide.

NAMs or New Approach Methodologies represent a modern paradigm in drug discovery and safety assessment. The US FDA, OECD, and other regulatory bodies recognize NAMs as innovative tools designed to reduce or replace traditional animal testing, while delivering insights that are more predictive of human biology. NAMs encompass a range of technologies designed to model human biology more faithfully:

• In vitro systems that probe the complexities of hepatotoxicity, nephrotoxicity, and cardiotoxicity with high mechanistic detail.
• In silico models and AI-driven simulations that forecast pharmacokinetics, off-target activity, and toxicity before the first patient is exposed.
• High-throughput, high-content platforms that merge automation with multiplexed analysis.
• Advanced physiological models, such as 3D cultures and organ-on-chip platforms, that replicate the dynamic environment of human tissues.

Together, these methodologies provide what traditional animal testing often cannot: insights that are not only faster and scalable, but intrinsically human-relevant.

The case for NAMs has never been stronger. Regulatory bodies such as the FDA and OECD are actively guiding industry toward non-animal, human-centric methods. The FDA’s Modernization Act 2.0 underscores this momentum, signaling confidence in alternatives that improve predictivity and safety. The emergence of NAMs reflects both a scientific awakening and a regulatory shift. The life sciences community is reimagining how we evaluate medicines and chemicals. At the same time, the industry faces mounting pressure to reduce late-stage clinical failures, to cut timelines and costs and to respond to growing societal expectations for animal-free testing. NAMs answer all these needs.

Yet implementing NAMs is not trivial. They require not only technical expertise but also rigorous validation, regulatory alignment, and seamless integration into existing pipelines. This is where Evotec leads.

Implementing NAMs requires technical expertise, rigorous validation, regulatory alignment, and seamless integration into existing pipelines. This is where Evotec leads. Our approach supports:

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 our well-established 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
   Implementation of NAMs may allow for more rapid safety evaluations and identify potential issues earlier in the development process when they can be addressed more efficiently and cost-effectively.