Non-Animal Navigator

The Non-Animal Navigator™ offers expert strategy and AI-enabled biosimulation to help reduce, refine, or replace animal studies in drug development. This approach is particularly relevant following the FDA's decision to phase out animal testing for monoclonal antibodies and other drugs, marking a significant shift in preclinical development.

As drug developers navigate this evolving landscape, the Non-Animal Navigator™ assists in selecting and optimizing new approach methodologies (NAMs) such as AI- and in vitro-based toxicity models and predictive biosimulation. These methodologies are crucial for accelerating timelines, reducing costs, and generating more predictive evidence.

Certara's solution begins with a gap analysis to tailor a bespoke software and services package for each asset, ensuring regulatory alignment and cost management. With over 25 years of experience, Certara's consultants bring extensive expertise from both the pharmaceutical industry and regulatory agencies like the FDA and EMA.

Key Features

• Tailored NAM strategies to accelerate drug development and achieve regulatory alignment.
• Integration of clinical trial and real-world data to optimize study designs.
• AI-enabled modeling techniques such as Quantitative Systems Pharmacology (QSP) and Physiologically Based Pharmacokinetic (PBPK) modeling.

These models simulate pharmacokinetics, pharmacodynamics, drug-drug interactions, toxicity, and anti-drug antibody responses across species, supporting species translation and reducing reliance on animal testing.

For companies with monoclonal antibodies in development, the Non-Animal Navigator™ provides a roadmap to design non-clinical safety programs leveraging NAMs. This approach can lower costs, shorten timelines, and reduce animal use, especially in studies involving non-human primates.

Certara's experts, such as Fran Brown, Geoff Fatzinger, and Hannah Jones, bring decades of experience in drug development, regulatory strategy, and modeling services, ensuring that clients receive comprehensive support in transitioning to non-animal methodologies.