"From preclinical to clinical trials, all in one go with AI!" Korea is set to establish the world's first integrated AI platform for preclinical and clinical drug development. On November 5, the Ministry of Health and Welfare announced the final selection of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association as the lead institution for the 'K-AI Drug Development Preclinical and Clinical Model Development Project.' Approximately 37.1 billion KRW in government funding will be invested over the next 4 years and 3 months, aiming to establish a full-cycle AI-based drug development ecosystem. This marks the nation's first large-scale national project to develop an AI-based clinical trial design and support platform by linking preclinical and clinical data. A massive industry-academia-research-hospital collaborative system will be established, involving 4 lead institutions, including Seoul National University Hospital, Samsung Medical Center, and Korea Research Institute of Bioscience and Biotechnology, along with a total of 31 participating organizations. "No data outflow, maximum security!" Data sovereignty protected through federated learning. A key aspect of this project is a 'Federated Learning' cloud environment, which allows data from each institution to be utilized without being transferred externally. This resolves security concerns by enabling AI models to be trained without directly sharing sensitive patient data from hospitals or core research data from pharmaceutical companies. Key tasks include: ▲Establishing an AI federated learning-based integrated preclinical and clinical foundation model ▲Orchestrating AI model linkages between lead institutions ▲Developing a clinical trial design and support platform ▲Advancing clinical strategies based on data standardization ▲Supporting virtual clinical trial validation. The completed K-AI platform is expected to be used by pharmaceutical companies, hospitals, and CROs (Contract Research Organizations) for actual clinical trial design. In the second phase of the project (2028-2029), the goal is to achieve 6 IND (Investigational New Drug) approvals validated through AI-based clinical trial design. "Significantly reducing time, cost, and risk!" K-AI is the key to becoming a global leader in drug development. Pyo Jun-hee, Director of the AI Drug Research Institute at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, stated, "As the nation's first AI-based clinical trial design platform connecting preclinical and clinical data, it will dramatically reduce the time, cost, and risk of drug development. We will do our best to help Korea leap forward as a global leader in AI drug development through industry-academia-research-hospital collaboration." Typically, drug development takes 10-15 years and costs over 1 trillion KRW, but utilizing AI can more than halve the development period and increase success rates. The association will also pursue initiatives such as operating a consultative body, linking with other research projects, consulting with regulatory agencies, proposing guidelines for AI and alternative animal testing methods, and developing strategies for platform self-reliance. If this project succeeds, Korea is expected to emerge as one of the top 3 global nations in AI drug development, standing alongside the United States and China.