Recommendations for Adopting New Approach Methodologies to Reduce Animal Testing in Drug Development

If your team still defaults to animal studies because you’re not confident regulators will accept the alternative, you’re not alone — only 40% of drug developers currently use in silico NAMs, even though FDA’s 2025 Roadmap and the FDA Modernization Act 2.0 have opened the door wider than ever.

The cost of staying on the sidelines is real: animal studies for monoclonal antibodies alone can require up to 144 non-human primates at $50,000 each and take six months to complete. Meanwhile, AI-driven in silico models have already been shown to cut testing costs by up to 30% and timelines by up to 50%.

This eBook, developed with Certara experts and BioPharma Dive, gives you a clear, actionable path forward.

• Why the FDA and EMA are shifting from “animal testing required” to “fit-for-purpose evidence,” and what that means for your regulatory submissions
• The 3 clearest signals that FDA is ready to accept NAMs in lieu of animal safety data — including ISTAND, ICH guidance updates, and qualification pathways
• A 5-step framework to future-proof your therapeutic pipeline