- Certara (CERT, Financial) launches Non-Animal Navigator™ to reduce reliance on animal testing in drug development.
- The solution aligns with FDA's new roadmap to reduce animal testing, particularly in monoclonal antibodies and antibody-drug conjugates.
- It offers strategic regulatory advice, integrated development plans, and AI-enabled modeling tools to accelerate drug development while ensuring compliance.
Certara Inc. (CERT), a leading company in model-informed drug development, has introduced its Non-Animal Navigator™ solution, aimed at aiding biopharmaceutical companies in reducing animal testing during the drug development process. This innovative solution is launched in alignment with the FDA’s new roadmap, which emphasizes reducing animal testing in preclinical safety studies.
Non-Animal Navigator™ specifically targets monoclonal antibodies and antibody-drug conjugates (ADCs), where biosimulation models can predict human outcomes as effectively as traditional animal studies. By focusing on these areas, Certara aims to meet the growing industry demand for alternative testing methods that are not only ethical but also enhance predictive accuracy and efficiency in drug development.
The solution is composed of three key elements: strategic regulatory advice to future-proof Investigational New Drug (IND) submissions, an integrated preclinical development plan that amalgamates various data sources, and an optimized AI-enabled modeling toolkit featuring the Simcyp Simulator® and mAb Quantitative Systems Pharmacology models. These components are designed to accelerate development timelines, reduce costs, and strengthen the predictive evidence while maintaining regulatory compliance.
The launch of Non-Animal Navigator™ signifies a strategic expansion in Certara's service portfolio, leveraging its existing Simcyp Simulator platform. This positions Certara as a key player in the biopharmaceutical industry, capitalizing on regulatory changes that encourage a shift towards non-animal testing methods. The company's approach not only aligns with the FDA’s roadmap but also potentially provides Certara with a competitive edge by enhancing development speed and cost efficiency.
For further information about Certara’s Non-Animal Navigator™ and how it supports preclinical development, visit their website and join their webinar on April 30th. Certara continues to build its reputation as a strategic partner in navigating the evolving landscape of drug development and regulatory compliance.
