Certara, Inc. (Nasdaq: CERT) announced the launch of its Non-Animal Navigator™ solution on Monday, designed to help biopharmaceutical companies reduce their reliance on animal testing in preclinical safety studies. This initiative aligns with the FDA's recently announced Roadmap to Reducing Animal Testing, marking what industry experts describe as a significant shift in drug development approaches.
The new solution combines strategic regulatory guidance with artificial intelligence-enabled biosimulation to support model-informed drug development using New Approach Methodologies (NAMs), including physiologically based pharmacokinetic (PBPK) modeling and quantitative systems pharmacology (QSP).
"We believe the FDA's roadmap is a major regulatory and scientific inflection point," said William F. Feehery, Chief Executive Officer of Certara. "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."
Strategic Components of the Solution
The Non-Animal Navigator offers three key components to pharmaceutical developers:
-
Strategic Regulatory Advice – Guidance on designing preclinical programs that incorporate appropriate NAMs while ensuring regulatory alignment for Investigational New Drug (IND) submissions.
-
Integrated Preclinical Development Plan – A comprehensive weight-of-evidence strategy that combines in vitro, in vivo, real-world evidence, and biosimulation data with expert toxicology input.
-
Optimized AI-Enabled Modeling Toolkit – Access to Certara's Simcyp Simulator platform and ready-to-use monoclonal antibody QSP models to accelerate development timelines.
Impact on Biologics Development
According to Certara, the shift away from animal testing is particularly relevant for the thousands of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) currently in early development across various therapeutic areas. The company notes that biosimulation models often predict human outcomes as well as or better than traditional animal studies for these biologics.
"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," said Patrick Smith, Senior Vice President of Translational Medicine at Certara.
Regulatory Context and Industry Trends
The FDA's Roadmap to Reducing Animal Testing in Preclinical Safety Studies represents a pivotal moment in drug development regulatory policy. Companies that adapt early may gain competitive advantages through faster development timelines, lower costs, and potentially stronger predictive evidence for human outcomes.
Certara's approach builds on its extensive experience working with the FDA, European Medicines Agency (EMA), and other major health authorities. The company has been partnering with biopharmaceutical sponsors and regulatory agencies for over two decades to integrate predictive, mechanistic models into the development and regulatory evaluation of biologics.
Market Response
The Non-Animal Navigator is now available and is being actively adopted by clients seeking to advance ethical and innovative development programs across therapeutic areas. Following the announcement, Certara's stock (CERT) was trading up 4.49 percent on the Nasdaq at $13.49.
The company will host a webinar on April 30 at 11 AM ET to provide more insights on the impact of the FDA Roadmap and how pharmaceutical companies can prepare for this new regulatory era.
Broader Implications
This development reflects a growing industry trend toward using scientifically robust new approach methodologies like AI-enabled biosimulation to improve strategic decision-making and success rates throughout drug development phases.
As regulatory agencies worldwide continue to encourage alternatives to animal testing, solutions like the Non-Animal Navigator may play an increasingly important role in helping pharmaceutical companies navigate the complex balance between scientific rigor, regulatory compliance, and ethical considerations in drug development.
