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The article argues that AI will revolutionize drug discovery long before it can streamline clinical development, creating an abundance of candidate molecules but leaving patient trials as the main constraint. As discovery becomes commoditized and more assets target the same biology, real value will hinge on predictive toxicity, clinical efficacy, and strategic trial design.
The EU's new GMP Annex 22 regulation requires pharmaceutical companies to use fully validated and deterministic AI models in manufacturing. ValidTrace offers a solution by providing pre-validated AI models that meet these compliance standards, ensuring predictable outputs critical for the industry.