Crafting a Translational Medicine Strategy for a Pediatric Antiviral Drug

Alios Biopharma was working on developing ALS-8176 as a treatment for respiratory syncytial virus (RSV) infection. There was no precedent for regulatory acceptance of an accelerated development pathway for an anti-RSV small molecule drug for infants. Read this case study to learn how Certara Strategic Consulting, in collaboration with scientists at Alios Biopharma, helped design and shepherd a translational medicine strategy to support switching from adults to infants at the end of Phase 2a using preclinical models, disease and pharmacokinetic/pharmacodynamic modeling and simulation, and clinical PK, viral kinetic (VK) and safety data from healthy adults and adaptive-design human challenge models (HCM).

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