SK bioscience has announced that it will lead the Research Optimisation and Trial Outcome Recommender (ROTOR) project, an AI-powered evidence synthesis and clinical development decision-support platform initiative funded by the Gates Foundation, establishing a global collaboration framework. The project is expected to involve technical collaboration with global health non-profit PATH, and global technology consulting firm Slalom.

ROTOR is designed to build a platform that leverages AI to analyse diverse clinical, immunogenicity, and scientific datasets generated throughout the vaccine development process. The platform will support R&D decision-making and optimise clinical development strategies, facilitating more informed and evidence-based decisions under uncertainty. Over time, the platform is expected to evolve into a scalable AI solution applicable across a broad range of vaccines and disease areas.

The platform will be developed and validated using rotavirus vaccine development experience and datasets from both SK bioscience and PATH. By doing so, the initiative aims to strengthen R&D capabilities among vaccine developers in Low- and Middle-Income Countries (LMICs) and contribute to expanding global vaccine access. Reusable components of the platform are expected to support broader adoption across the vaccine development ecosystem.

In pharmaceutical development, decisions on whether to advance into large-scale phase 3 clinical trials are typically made based on phase 2 trial results. However, in many vaccine fields, including rotavirus, decisions about whether to advance to large-scale phase 3 trials are particularly challenging because validated immune correlates of protection may be limited or absent, and assay results may vary across methodologies. Given that phase 3 clinical trials demand substantial financial resources and long-term investment period, the need to build a more scientific and objective decision-making framework has been consistently raised.

The ROTOR platform is expected to address these challenges by applying AI to analyse extensive clinical and research datasets, integrate diverse sources of scientific evidence, and generate structured decision-support insights for vaccine developers. This approach may improve development efficiency of vaccine development programs.

SK bioscience has built a strong track record of collaboration with global public health organisations, including the World Health Organization (WHO), Coalition for Epidemic Preparedness Innovations (CEPI), International Vaccine Institute (IVI), Pan American Health Organization (PAHO), Gavi, the Vaccine Alliance, and the US Centers for Disease Control and Prevention (CDC), helping expand global health infrastructure and vaccine accessibility.

Most recently, the company signed a licensing agreement with the CDC to develop an injectable rotavirus vaccine. Earlier this year, it also entered into an agreement with Gates Medical Research Institute (Gates MRI) for the development of a novel Respiratory Syncytial Virus (RSV) antibody therapy.

In February, SK bioscience secured a project from a European Union (EU) agency to develop a pandemic influenza (avian influenza) patch vaccine. The company is also advancing a broad infectious disease pipeline that includes Ebola vaccines and cell-culture-based avian influenza vaccines as part of its strategy to become a leading global vaccine company.

Jaeyong Ahn, CEO, SK bioscience, stated, "This project represents a new approach to reducing uncertainty in vaccine development through AI and enabling more scientific and efficient decision-making. Through this consortium, we aim to drive innovation in vaccine R&D while contributing to improved vaccine access worldwide."

SK bioscience continues to advance AI-driven innovation across its R&D operations. The company has established AI-assisted experimental design systems based on accumulated research and manufacturing data to improve efficiency and identify optimal experimental conditions, reducing development timelines and trial-and-error processes. It is also implementing digital twin technologies to transform vaccine R&D and further enhancing AI-based data analytics and decision-making capabilities as part of its broader Digital Transformation (DT) strategy.