Korea Pharmaceutical and Bio-Pharma Association Selected as Lead Institution for 'K-AI Preclinical and Clinical Model Development Project'

Aiming to Build an AI-Based Preclinical and Clinical Design Support Platform
371 Billion Won Invested Over Four Years

The Korea Pharmaceutical and Bio-Pharma Manufacturers Association announced on November 5 that it has been selected as the lead institution and primary managing organization for the "K-AI Preclinical and Clinical Model Development Project (R&D)" promoted by the Ministry of Health and Welfare.

This project is a large-scale national research initiative that will receive approximately 37.1 billion won in government funding over four years and three months. Its goal is to establish and develop an "AI-based clinical trial design and support platform" for new drug development, and to link preclinical and clinical stages in order to build a domestic AI-driven, full-cycle new drug development ecosystem.

Exterior view of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association in Seocho-gu, Seoul. Korea Pharmaceutical and Bio-Pharma Manufacturers Association

The research and development will be carried out by a system of four lead institutions: the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (overall lead), Seoul National University Hospital, Samsung Medical Center, and the Korea Research Institute of Bioscience and Biotechnology. Each institution will take the lead in its respective field of research.

Accordingly, the association's AI Drug Research Institute will be responsible for the overall management and operation of the project, data construction and standardization, as well as platform development and validation support. The primary team will also include the Korea National Enterprise for Clinical Trials, iGeneScience Co., Ltd., APACE Co., Ltd., C&R Research Co., Ltd., Korea University Industry-Academic Cooperation Foundation, and LG CNS Co., Ltd.

The primary research led by the association will focus on: development of a preclinical and clinical integrated foundation model based on AI federated learning; orchestration for organic linkage and collaboration among the AI models developed by the second to fourth lead organizations; development of a clinical trial design and support platform; construction and standardization of non-clinical and clinical data to support clinical trial design; and support for virtual clinical trial validation. To this end, a federated learning-based cloud platform will be developed to enable learning from research and non-clinical/clinical data held by each institution without external transfer, and advanced security technologies will be applied to facilitate collaborative research.

The K-AI platform established through this project will be validated so that pharmaceutical companies, hospitals, and CROs (Contract Research Organizations) can utilize it for actual clinical trial design. Furthermore, in the second phase of the project (2028-2029), the goal is to achieve six validated cases, such as IND (Investigational New Drug) approvals, through AI-based support for clinical trial design, thereby verifying its effectiveness.

As the lead institution, the association will regularly operate a consultative body, promote platform development and operation, support integration and validation with other projects, establish and utilize a multimodal data system, submit opinions on AI and alternative animal testing guidelines through consultations with regulatory agencies, and devise sustainable strategies for platform independence.

Pyo Junhee, Director of the AI Drug Research Institute at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, stated, "This K-AI Preclinical and Clinical Model Development Project aims to develop the nation's first AI-based clinical trial design and support platform that connects preclinical and clinical data. It will serve as an innovative turning point that reduces time, cost, and risk in new drug development. Through a collaborative system involving industry, academia, research institutes, and hospitals, we will do our utmost to help Korea become a global leader in AI-driven drug development."