How AI is Revolutionizing Drug Development and Manufacturing with Real-World Data
Turning Real-World Data into Actionable Drug Development Insights With AI
Summary
Dr. Gustavo Ferrer explains that AI accelerates drug development and pharmaceutical manufacturing by transforming real-world clinical data into actionable insights. Platforms like Moxie-Link, which are FHIR-compliant, integrate care environments directly into research to reduce timelines and costs.
Details
In his presentation at CPHI Europe, Dr. Gustavo Ferrer (CEO of Moxie Health Group) detailed how AI is rapidly reshaping drug development, R&D, and manufacturing processes. AI accelerates the entire lifecycle—from target discovery using predictive modeling to optimizing clinical trial protocols. A key capability highlighted is the ability of platforms like Moxie-Link to convert every routine clinical encounter into actionable, research-grade real-world data. This process utilizes Natural Language Processing (NLP) to extract phenotypes and comorbidities from unstructured clinical notes, enabling advanced pattern recognition for detecting adverse trends or identifying responder subpopulations. This technology significantly improves decentralized clinical trials (DCTs) by supporting remote patient monitoring and ePRO/eTRO, thereby increasing retention and diversity. In manufacturing, AI-based anomaly detection and yield prediction minimize downtime and batch failures. However, wider adoption faces barriers such as regulatory ambiguity regarding AI/ML lifecycle management and data fragmentation across heterogeneous EHRs and siloed registries. The solution requires FHIR-compliant architectures for bidirectional integration and centralized governance to ensure safety and compliance.
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