Certara, Inc. a global leader in model-informed drug development, 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.

“The FDA announcement and roadmap pave the way for more model-informed drug development approaches that are predictive, efficient, and ethical,” said William F. Feehery, Chief Executive Officer. “It is part of a growing industry adoption trend to use scientifically robust new approach methodologies (NAMs) like AI-enabled biosimulation to improve strategic decision-making and success rates at every phase of drug development.”

“Navigating this paradigm shift requires deep regulatory insight, cross-functional expertise and modeling and simulation technology,” said Patrick Smith, Senior Vice President of Translational Medicine. “Clients have begun reaching out about how to best lead their organizations through this major regulatory and scientific inflection point.”

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.