On March 10, the Yongeon Lab of CCADD completed its renovation, marking a new phase in the research infrastructure. Equipped with high-performance computers and upgraded research facilities, the Yongeon Lab now offers a more efficient and productive environment for ongoing projects. The renovation was made possible through the generous support of Prof. Howard Lee and the collaborative efforts of team members. The enhanced space is expected to significantly boost research capacity.

Alongside the renovation, CCADD has launched the full-scale operation of its dual-site research system, connecting the Yongeon Lab with the Gwanggyo Lab. The two labs are tightly integrated, ensuring smooth collaboration and optimal resource sharing. With this dual-site model, CCADD aims to build a more flexible and interconnected research ecosystem—reinforcing its position as a leading hub for their research.

Suhyun An is currently an undergraduate researcher at CCADD after completing the 2024 winter internship program. She is majoring in  Stem Cell and Regenerative Biotechnology at Konkuk University . Her recent interests lie in research utilizing large language models and deep neural networks, with a particular focus on AI-based drug discovery. More specifically, she focuses on the applications of drug-drug interactions and PK/PD modeling. Her research goal is to leverage these technologies to predict drug toxicity using clinical notes, as well as explore machine learning models for drug repurposing.

Yura Choi is currently an undergraduate researcher at CCADD after successfully completing the 2024 Winter Internship Program. She is majoring in Chemistry at Kyung Hee University. During her internship, she participated in developing a deep learning-based Drug-Drug Interaction (DDI) prediction model, utilizing protein information to enhance model performance. Through this project, she gained hands-on experience in data processing, programming, and predictive modeling. She continues to explore various approaches to DDI prediction modeling and has a growing interest in ADMET prediction and PK/PD modeling. She aims to apply AI-powered data analysis to contribute to novel drug development strategies and innovations. 

Seoyoon Jang is currently an undergraduate researcher at CCADD after diligently completing the 2024 winter internship program. Seoyoon Jang is majoring in Systems Biotechnology at Chung-Ang University. Her research interests include generating real-world evidence (RWE) based on real-world data (RWD) using electronic medical records (EMR) and regulatory science. During her internship, she became proficient in R and gained hands-on experience with both representation and generative LLM models.

Nayoung Ku is currently an undergraduate researcher at CCADD, following the successful completion of her internship program. She is pursuing studies in life science and AI convergence at Handong Global University, with a previous Bachelor's degree in psychology. Nayoung specializes in developing prediction modeling and optimization algorithms with diverse datasets.

Her research includes work at the Biodata Laboratory developing cancer diagnostic machine learning models, and she received the Daewoong Pharmaceutical CEO Award at the JUMP AI 2024 Drug Discovery Competition for her team's work on IRAK4 inhibitor prediction.

Seeun Park is currently an undergraduate researcher at CCADD. She became an undergraduate student researcher after successfully completing the 2024 Winter Internship program. She is a Bioengineering major at Yonsei University. She was able to gain knowledge and hands-on experience on artificial intelligence for clinical drug development by the project “Improving the Generalizability of Natural Language Process Models to Extract Drug Safety Information from Clinical Notes”. With passion in healthcare and safety, she focuses on exploring clinical pharmacology and regulatory science more specifically Real-World Data (RWD) and policy analysis in Korea. It is her goal to work on expertise for the improvement of disease prevention and control.

On January 16, CCADD was selected as the lead research institution for the 2025 Contract Research and Development Project by the Ministry of Food and Drug Safety (MFDS). The project aims to develop a large-scale Korean-English corpus and translation model specialized in the pharmaceutical field. The total research funding amounts to KRW 1 billion (approximately USD 692,900). For this project, CCADD will collaborate with the Structure & Knowledge Injection into Machine Learning lab (SKIML) at the Graduate School of Data Science, Seoul National University (PI: Prof. Jaeyoon Lee) and the Korea Regulatory Science Center (PI: Dr. Sungkoo Son).

As part of this research, the team will develop a high-quality, domain-specific Korean-English corpus, ensuring consistent translation quality. The corpus will be rigorously validated and evaluated by experts to maintain translation accuracy and reliability. Furthermore, the team will develop a -level Korean-English neural machine translation (NMT) model and a large language model (LLM) in the pharmaceutical and medical fields based on this corpus.

CCADD and its research team officially launched the project with an initiation meeting on February 13 with MFDS. During the meeting, key stakeholders established research objectives and outlined a strategic roadmap for the next two years.

The team members, David Seung U Lee, Yujin Kim, and Prof. Howard Lee anticipate this research will establish Korea’s first high-quality pharmaceutical corpus and develop an advanced translation model processing pharmaceutical information accurately. With expertise in regulatory science, drug development, and AI, CCADD aims to successfully complete the project and contribute to advancements in pharmaceutical and medical fields.

A research article, entitled “Country Contribution to Investigators of Pivotal Clinical Trials and their Primary Publications of New Drugs Approved by the US Food and Drug Administration, 2012–2021”, authored by Yoona Choi, Jung-Hyun Won, Heeju Kim, YeSol Hong, Yujin Kim, and Howard Lee, has been published in Clinical Pharmacology & Therapeutics (CPT) on February 5, 2025. Clinical Pharmacology & Therapeutics (CPT) is one of the most prestigious journals in the field of clinical pharmacology (impact factor of 6.3 in 2023), reflecting its significant influence in translational medicine and regulatory science.

This study investigated the geographical distribution of investigators and authors in pivotal clinical trials (PCTs) for new drugs approved by the U.S. Food and Drug Administration (FDA) from 2012 to 2021 and its association with the racial and ethnic diversity of study participants. While PCTs are often conducted across multiple countries to ensure broad participant enrollment and generalizability of clinical trial findings, the diversity of trial participants remains inadequate, with a predominant representation of White. To address this, the study analyzed 429 new drugs, 734 PCTs, and 718 primary publications (PPubs), extracting data from FDA labels, review s, PPubs, and clinicaltrials.gov. The findings revealed that North America and Western Europe (NAWE) accounted for the largest proportion of PCT investigators (62.9%), PPub authors (81.7%), and lead authors (90.9%). Among 521 PPubs reporting racial and ethnic distribution of participants, the median Diversity Index (DI) was 0.33, with only 16.3% of PPubs exceeding a DI of 0.5.

This study shows that evidence generation for new drug approval has remained concentrated in NAWE, with an even stronger presence in PPub authorship. This study emphasizes that to improve the racial/ethnic diversity of PCT participants, investigators from non-NAWE countries should be encouraged to take on more leadership roles, thereby increasing their likelihood of serving as authors in PPub.

This winter, CCADD welcomes six interns - Minsol Kim, Suhyun An, Seo-Yoon Jang, Seeun Park, Yura Choi and Nayoung Ku - for the 2025 Winter Internship Program.

Minsol Kim is majoring in veterinary medicine at Seoul National University. She is interested in exploring the application of domain knowledge in the process of AI model development by utilizing her knowledge of pharmacology, toxicology, and physiology. Her goal is to build a solid foundation in AI and gain hands-on experience analyzing clinical data and investigating the drug development process. Through the 2025 CCADD winter internship program, she aims to explore potential career paths in the field of drug discovery.

Suhyun An is a student majoring in Stem Cell and Regenerative Biotechnology at Konkuk University. She previously worked as an undergraduate researcher in the Immunopharmacology Laboratory at Seoul National University College of Medicine, where she studied drug toxicity. Her current research interests include Drug-Drug Interactions (DDIs) and drug repurposing using artificial intelligence (AI). Her previous training primarily involved wet lab research. The CCADD internship will allow her to gain experience in data science applied to drug development, which will serve as a critical foundation for achieving her future research goals.

Seo-Yoon Jang is majoring in Systems Biotechnology at Chung-Ang University. She has a keen interest in AI and data science, which led her to complete the 2024 Boostcourse <DATA SCIENCE PROJECTS> coaching study program. Subsequently, she developed an interest in drug delivery and interned at the Lab of Drug Delivery and Cell Therapy at Sungkyunkwan University School of Medicine. Her growing passion for integrating AI into drug development led her to a winter internship at the CCADD. Through this internship, she aims to gain proficiency in data analysis tools and deepen her domain knowledge, with the goal of becoming a researcher specializing in AI-driven drug development.

Seeun Park is a senior at Yonsei University, double majoring in Biotechnology and Public Administration. She is willing to explore clinical pharmacology and regulatory science during this winter internship program. With passion in healthcare and safety, she focuses on gaining more experience and knowledge on artificial intelligence for clinical drug development and more specifically epigenetic study and policy analysis in Korea. It is her goal to work on expertise for the improvement of disease prevention and control.

Yura Choi is an undergraduate student in the Department of Chemistry at Kyung Hee University. She is passionate about AI-driven drug development, applying data science to pharmaceutical research. Through the LAIDD program, she has gained valuable insights into how AI can be applied to drug development. She aims to contribute to drug development and explore innovative therapeutic modalities by leveraging AI-driven data analysis. Currently, she is participating in the CCADD winter internship to strengthen her AI and data science expertise and deepen her understanding of research in drug development.

Nayoung Ku is an undergraduate in life science and AI convergence at Handong Global University. She previously earned a Bachelor’s degree in psychology at the National Institute of Lifelong Education by Examination for Self-Education. Nowadays, Nayoung mainly develops prediction modelling and optimization algorithms with various datasets. She had been a research assistant at Biodata Laboratory, Handong Global University, focusing on cancer diagnostic machine learning models using tumour-educated platelet (TEP) RNA-seq data for a year. Recently, she did a capstone project on NLP for an ovarian cancer diagnostic model using TEP RNA-seq pre-processed data, which showed her creativity in analytic approach. She received the Daewoong Pharmaceutical CEO Award at the JUMP AI 2024 Drug Discovery Competition, sponsored by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. In the competition, Nayoung and her team developed an advanced multi- perceptron to predict IC50 values for IRAK4 inhibitors by applying novel and strategic approaches to accelerate drug discovery processes. With her enthusiasm for enhancing the efficiency of drug discovery, she participates in this internship to experience real-world clinical data and its analysis, like electronic medical records. With a heart of admiration, she is yearning to learn the extraordinary methodology of CCADD.

We hope that during their winter internship, they will build confidence in their area of expertise, develop independent learning skills to explore new knowledge, and dedicate their enthusiasm to gaining a comprehensive understanding of drug development and regulatory science throughout these two months.