Core Insights - Certara, Inc. has launched the Non-Animal Navigator™ solution to assist biopharmaceutical companies in adapting to the FDA's Roadmap aimed at reducing animal testing in preclinical safety studies, marking a significant shift in drug development practices [1][3] Group 1: Company Overview - Certara is a global leader in model-informed drug development, providing biosimulation software and services to enhance drug discovery and development processes [5] - The company has over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [5] Group 2: Industry Context - The FDA's Roadmap is a pivotal moment for the industry, encouraging the adoption of model-informed drug development approaches that are predictive, efficient, and ethical [3] - Monoclonal antibodies and antibody-drug conjugates (ADCs) are in the preclinical phase across various therapeutic areas, with biosimulation models showing predictive capabilities comparable to traditional animal studies [2] Group 3: Product Features - The Non-Animal Navigator offers strategic regulatory advice to design preclinical programs that align with regulatory requirements and utilize new approach methodologies (NAMs) [5] - It includes an integrated preclinical development plan that combines various evidence types, including in vitro, in vivo, and biosimulation data, supported by expert toxicology input [5] - The solution provides access to advanced AI-enabled modeling tools, such as the Simcyp Simulator, to accelerate development timelines [5]