Certara, Inc. (CERT), Monday announced the launch of Non-Animal Navigator, a new solution designed to help biopharmaceutical companies reduce reliance on animal testing in preclinical safety studies, in alignment with the FDA recently announced Roadmap to Reducing Animal Testing.
Certara said the Non-Animal Navigator combines strategic regulatory guidance with AI-enabled biosimulation to support model-informed drug development using New Approach Methodologies or NAMs, including physiologically based pharmacokinetic or PBPK modeling and quantitative systems pharmacology or QSP.
The offering leverages Certara's long-standing collaborations with FDA, EMA, and other global regulatory authorities, and is intended to help companies future-proof their IND submissions, accelerate timelines, lower development costs, and improve prediction of human outcomes.
"We believe the FDA's roadmap is a major regulatory and scientific inflection point," said William F. Feehery, Chief Executive Officer of Certara.
He further added that, "The Non-Animal Navigator provides clients with a powerful and ethical tool to lead this transition using AI-powered modeling and simulation that's already proven in drug development."
Certara noted that the shift away from animal testing is especially relevant for the thousands of monoclonal antibodies or mAbs and antibody-drug conjugates or ADCs in early development.
The Non-Animal Navigator includes access to Certara's Simcyp Simulator platform and ready-to-use mAb QSP models to support a data-driven, weight-of-evidence approach in regulatory submissions.
"The industry is moving quickly to adopt predictive, human-relevant methods. This solution ensures our clients are well-equipped to navigate the changes and maintain alignment with global regulatory expectations," added Patrick Smith, Senior Vice President of Translational Medicine at Certara.
The Non-Animal Navigator is now available and is being actively adopted by clients looking to advance ethical and innovative development programs across therapeutic areas.
CERT is trading at $13.49 up by 4.49 percent on the Nasdaq.
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