EHL BIO CEO Hong-ki Lee Emphasizes Institutional Frameworks and Standardization for the Practical Use of Biodata

For biodata to be used in drug development and clinical trials, standards for its use and a standardized environment are as important as the volume of data itself. At the policy forum titled “Measures to Promote Biodata Utilization Intermediary Platforms,” held on August 28 at the National Assembly Members’ Office Building in Yeouido, Seoul, EHL BIO CEO Hong-ki Lee presented key challenges and directions for improvement from the industry’s perspective.

Lee emphasized that, for biodata to be applied to actual research and development, collection procedures, data formats, personal data protection, and standards for institutional recognition must all be considered together. [Source: Daily Hankook]

Standards for Using Biodata in Drug Development

Biodata is a resource whose potential use is being discussed across a range of research processes, including patient cohort analysis, clinical trial participant recruitment, and long-term follow-up. However, the fact that a company or research institution has secured data does not necessarily mean it can immediately be used for clinical trials or therapeutic development.

Lee stated that clear standards are needed to determine whether clinical trials or therapeutic development processes using biodata can be institutionally recognized. This requires the joint verification of data collection processes, methods of use, the legality of research design, and the reliability of records.

Biodata intermediary platforms are expected to connect data providers with data users. Standards must also be established regarding which data may be used under what conditions, as well as how personal data protection and healthcare-related regulations should be applied.

Use of Long-Term Follow-Up Data in Cell Therapy Research

In cell therapy development, patient conditions may need to be monitored over an extended period even after a clinical trial has concluded. Stem cell therapies, in particular, may require observation of safety and patient status over several years, potentially creating significant time and cost burdens for companies and research institutions.

Lee noted that if data accumulated by healthcare institutions or public databases can be used under appropriate standards, the efficiency of certain long-term follow-up processes could be improved. He stressed that the scope of data use, personal data protection, and the applicability of healthcare-related regulations must be determined first.

EHL BIO conducts clinical trials while researching and developing next-generation cell therapies based on stem cells and immune cells. Lee’s remarks were presented as an industry perspective on leveraging data accumulated throughout the cell therapy research process for research and development.

The Need for Preprocessing and Standardization Support

Hospitals and research institutions use different electronic medical record systems and data collection methods. Genomic, clinical, and imaging data also vary in format and structure, making it difficult in some cases for companies to directly apply raw data they have obtained to research analysis or artificial intelligence training.

To use raw data in research, processes such as data cleansing, structuring, labeling, harmonization of identification systems, and enhancement of metadata are required. Data usability may depend less on the amount held than on how quickly and accurately it can be prepared in a form suited to the purpose of research.

Lee noted that it may be burdensome for small and mid-sized biotech companies and research institutions to independently establish specialized preprocessing personnel and systems. This was the context behind his proposal for a “preprocessing and standardization voucher” model that supports the costs of data cleansing and standardization in connection with biodata intermediary platforms.

Compensation for Data Providers and Personal Data Protection Frameworks

Collecting and organizing patient medical information requires the time and labor of healthcare professionals and researchers. Lee stated that it is necessary to consider a structure in which appropriate compensation is provided not only to companies using the data, but also to healthcare institutions and researchers that generate and provide it.

Returning data usage fees to provider institutions or expanding opportunities for collaborative research were cited as possible alternatives. The point is that sustaining the participation of provider institutions requires consideration of the work and responsibilities involved in the data provision process.

Biodata may include sensitive personal information, such as disease information, test results, imaging data, and genomic information. Even as industrial use expands, personal data protection, healthcare-related regulations, and the scope of data use must be considered together.

Lee emphasized that the competitiveness of the biodata industry depends not on the volume of data stored, but on an environment that enables refined, high-quality data to be rapidly used in corporate research and development. Establishing quality management, standardization, institutional standards, and protection procedures remains an essential task following data collection.

About EHL BIO

EHL BIO is a biotechnology company dedicated to advancing healthy human life through stem cell-based regenerative medicine. By scientifically exploring the self-renewal capabilities of cells, it is developing new approaches to aging and disease. Combining premium healthcare with advanced biotechnology, EHL BIO delivers solutions for healthier, more vibrant lives.