Korea to build multiomics-based ‘drug response map’ for precision medicine

The MFDS is accelerating the development of a Korean drug response prediction platform based on multiomics data from 7,500 chronic disease patients. As concerns grow over rising side effects and healthcare costs, the push to explain why individuals respond differently to the same medication has become more urgent.

Park Sang-ae, director of the Toxicology Research Division at the National Institute of Food and Drug Safety Evaluation, presented a plan to create a “Korean Drug Response Map” at a news briefing on Tuesday. (KBR photo)

On Tuesday, Park Sang-ae, director of the Toxicology Research Division at the National Institute of Food and Drug Safety Evaluation, disclosed interim results from the three-year “Development of Drug Response Prediction Technology Based on Metabolomics and Medical Big Data” research during a briefing for reporters.

“Multilayer omics signals capable of explaining individual differences in drug side effects and efficacy are emerging from a prospective cohort of 7,500 individuals,” Park said. “Data refinement and analysis are currently in their final stages.”

The cohort, primarily diabetes patients, provides standardized clinical and medication histories, physical measurements, and blood and urine samples for genomic, proteomic, and metabolomic analysis.

Park emphasized data precision, explaining that five hospitals used identical data formats and all omics analyses followed the same SOPs at one institution, minimizing variability. "We secured data as dense as a corn cob—complete and not patchy," she said.

Confirming unique Korean genomic characteristics

The genomic data collected by the MFDS includes approximately 700,000 variants per individual, proteomic data quantifying the expression of over 5,000 proteins, and metabolomic data describing concentrations of more than 1,000 metabolites. Metabolites rapidly reflect shifts in environmental factors—such as disease state, diet, and medication—making them key indicators of drug responsiveness.

“Simultaneously analyzing genomes, proteomes, and metabolomes yields billions of combinations, challenging conventional statistical methods,” Park explained. “We are also developing AI-driven algorithms jointly with Seoul National University's Graduate School of Data Science.”

Park specifically noted that unique genomic characteristics of Koreans are also being identified. “Compared to the U.K. Biobank, we are identifying genomic signals unique to Koreans. This means that Korean drug response analysis cannot be replaced by overseas data,” Park said.

Common metabolite and proteome patterns in patients with side effects are being found, and some are in patent review. Park clarified, "We're in the correlation phase; proving causality requires more research."

Identifying complex drug interactions in the era of polypharmacy

Park noted the cohort, despite focusing on diabetes, includes patients with various metabolic and cardiovascular diseases, enabling research on complex chronic drug responses.

Reflecting the current healthcare environment, where polypharmacy prevails due to an aging population, an infrastructure is being established to enable AI to assess metabolic changes or side effects that specific drug combinations may cause.

"We are building a model where AI analyzes drug interactions to find correlations," Park said. "Longitudinal blood samples allow us to track response over time, enhancing prediction accuracy."

37.5 billion won to be invested from 2026 to 2030 into building ‘Korean Drug Safety Platform’

Building on the achievements of the three-year project ending this year, the MFDS will launch a new “AI-based Drug Reactivity Prediction and Evaluation Platform” project, totaling 37.5 billion won ($25.5 million) over five years from 2026 to 2030.

This will expand the cohort from 7,500 to over 40,000 and extend omics data collection to include epigenomics and transcriptomics.

Park noted, "National omics data, as seen with the U.S. NIH and U.K. Biobank, is a strategic asset. A Korean-specific data platform will aid in new drug development, repurposing, label improvement, and high-risk group screening."

Personalized toxicity assessment research group launched in cooperation with SNU

On Wednesday, MFDS launched the "Personalized Toxicity Assessment Research Group (PTI)" at Seoul National University Hospital, with over 60 experts from industry, academia, research, government, and hospitals participating.

At the same venue, an MOU will be signed with Seoul National University's Graduate School of Data Science to establish an AI-based platform for predicting drug reactivity. The agreement covers joint development of AI analysis technology, creation of a shared data and platform system, and management of data quality and specialized personnel training.

PTI will discuss sharing research, planning the next five-year project, expanding omics, resolving data linkage issues, and defining industrial applications.

Data from the first 7,500 individuals will be deposited in the National BioData Station (K-BDS). PTI will graduallydiscuss how researchers and companies can use it.

Park said, "This data must serve as a shared resource for industry, academia, medical, and regulators—not just the MFDS. Success depends on data quality, standardization, and integration."

She added, "AI-based drug reactivity prediction is just beginning. As integrated omics data grows, we'll be able to predict individual drug responses and side effects in advance."

Park said, "This will be a national project that strengthens public safety, reduces healthcare costs, and boosts Korea's pharmaceutical and bio industries."