Certara: Certara Launches Non- Animal Navigator?? Solution to Help Drug Developers Reduce Reliance on Animal Testing

Certara, Inc. announced the launch of its Non- Animal Navigator?? solution designed to help biopharmaceutical companies lead the transition ignited by the FDA's Roadmap to Reducing Animal Testing in Preclinical Safety Studies. The Roadmap marks a pivotal moment in drug development. Companies that act now can future-proof their portfolios, gaining competitive advantage through faster timelines, lower costs, and stronger predictive evidence. Globally, there are thousands of monoclonal antibodies and antibody-drug conjugates (ADCs) currently in the preclinical phase of development across a broad range of therapeutic areas. Monoclonal antibodies are a key area in efforts to reduce animal testing, as biosimulation models often predict human outcomes as well as or better than, traditional animal studies. For over two decades, Certara has partnered with biopharmaceutical sponsors and regulatory agencies to integrate predictive, mechanistic models into the development and regulatory evaluation of biologics, including monoclonal antibodies. Based on Certara's extensive experience working with FDA, EMA, and other major health authorities, the Non- Animal Navigator is a flexible solution that ensures each client's development program is compliant, agile, and future ready. It offers clients: Strategic Regulatory Advice - Design preclinical programs that future-proof your INDs and include the appropriate use of NAMs while ensuring regulatory alignment. Integrated Preclinical Development Plan - Build an integrated, weight-of- evidence strategy combining in vitro, in vivo, real-world evidence, and biosimulation data with expert toxicology input. Optimized AI Enabled Modeling Toolkit - Accelerate timelines with access to the most widely adopted platform for PBPK modeling, the Simcyp Simulator®?, and ready-to-use mAb Quantitative Systems Pharmacology models. Certara, Inc. announced the launch of its Non- Animal Navigator?? solution designed to help biopharmaceutical companies lead the transition ignited by the FDA's Roadmap to Reducing Animal Testing in Preclinical Safety Studies. The Roadmap marks a pivotal moment in drug development. Companies that act now can future-proof their portfolios, gaining competitive advantage through faster timelines, lower costs, and stronger predictive evidence. Globally, there are thousands of monoclonal antibodies and antibody-drug conjugates (ADCs) currently in the preclinical phase of development across a broad range of therapeutic areas. Monoclonal antibodies are a key area in efforts to reduce animal testing, as biosimulation models often predict human outcomes as well as or better than, traditional animal studies. For over two decades, Certara has partnered with biopharmaceutical sponsors and regulatory agencies to integrate predictive, mechanistic models into the development and regulatory evaluation of biologics, including monoclonal antibodies. Based on Certara's extensive experience working with FDA, EMA, and other major health authorities, the Non- Animal Navigator is a flexible solution that ensures each client's development program is compliant, agile, and future ready. It offers clients: Strategic Regulatory Advice - Design preclinical programs that future-proof your INDs and include the appropriate use of NAMs while ensuring regulatory alignment. Integrated Preclinical Development Plan - Build an integrated, weight-of- evidence strategy combining in vitro, in vivo, real-world evidence, and biosimulation data with expert toxicology input. Optimized AI Enabled Modeling Toolkit - Accelerate timelines with access to the most widely adopted platform for PBPK modeling, the Simcyp Simulator®?, and ready-to-use mAb Quantitative Systems Pharmacology models.