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Accelerating FDA Approval with MIDD: How A2-Ai Secured a New Dose Without a Phase 3 Trial

Eric StormsNovember 14, 2025
The future of MIDD - How are you preparing? The FDA has officially announced their roadmap to phase out animal testing for monoclonal antibodies. How are you preparing? When your regulatory and operational questions inevitably arise, our experts will be there to answer them every step of the way. Jack Cook SVP, Clinical Pharmacology • 30+ years at Pfizer • 35+ years in pharmaceutical sciences • MIDD leader Linh Nguyen EVP, Clinical Pharmacology • 20+ years in Drug Development • Modeling and Clinical Pharmacology leader • Amgen, Exelixis, Medivation, Pfizer, Arcus, and Treadwell Limitations of Animal Testing: • Safety signals - extremely difficult to translate in animals to men for biologics • Variability in immune architecture can obscure translatability • Interspecies differences cause limitations in predicting human toxicity "more effective, human-relevant methods" AI-based computational models Mimic human cognition to analyze data and measure toxicity within a drug - Reliably predict side-effects and the drugs mollecular composition Humanoids/Organoids Mimic human organs, such as the liver, heart, and immune organs to test drug safety Reveals toxic effects that could easily be undetected in animals Real-world Human Data Using Safety data from countries with similar regulatory standards where the drugs with similar targets have already undergone human studies
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MIDD - FDA Has Officially Announced Their Roadmap to Phase Out Animal Testing for Monoclonal Antibodies

Simonne BruckApril 30, 2025