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.

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.

On December 27th, 2023, CCADD held the year-end workshop at Front1, a startup hub at the heart of Seoul, where PMACH is based. This year, Prof. Howard Lee and the members of CCADD were joined by PMATCH and Dr. Siun Kim. The workshop went on in a dynamic atmosphere, welcoming both Prof. Howard’s part-time student and the interns for the upcoming internship program.

After a brief ice-breaking time, the main session started with a recap of the accomplishments of 2023, reflecting on the overall trajectory. Prof. Howard commended CCADD’s continuous growth in both research and publications. As preparation for 2024, the following session outlined a roadmap, encompassing detailed research ideas and plans for conference to attend in 2024.

The spotlight then turned to CCADD interns. Three passionate interns—Tang Chao, Seorin Choi, and Yunha Noh—who will join the 2024 winter internship program introduced themselves through "Who am I" presentations. Following this, Yujin expressed her aspirations for the path ahead as a new CCADD graduate research student. The workshop proceeded with a lecture on the challenges faced by postdoctoral researchers and strategies for maintaining a healthy mindset among graduate students.

Dr. Siun Kim took a special session to share insights into his post-doctoral journey following graduation. Delivering a lecture on the trending topic of "LLMs in medicine and drug development", he provided valuable perspectives and briefly introduced his ongoing research projects. He candidly shared reflections on the first-year post doc., emphasizing the professional commitment required in the field of research.

Finally, PMATCH summarized their achievements in 2023 and anticipated the upcoming year's developments. With the successful launch of the 'BATTERY' app and a triumphant debut at CES^® 2023, PMATCH envisions a promising future with new team members. Yoomin Jeon, the Chief Technology Officer of PMATCH, expressed her commitment to meeting user’s needs as a must-have app.

The workshop concluded with a keynote address by Prof. Howard. Introducing new trends in 2024, he emphasized the significance of adjusting our research focus and domain knowledge to take another leap forward. Prof. Howard’s central message highlighted 2024 as a pivotal year for CCADD's rebound and PMATCH's inaugural year of growth. 

Yoona Choi and Jung-Hyun Won attended the 65th Annual Meeting & Exposition of the American Society of Hematology (ASH), which took place from December 9 to 12, 2023, in San Diego, USA. Annually, the ASH conference brings together healthcare professionals, researchers, clinicians, and academics from around the globe to explore advancements in hematology. This prestigious event not only focuses on the study, diagnosis, treatment, and prevention of blood disorders but also features a variety of social events and opportunities for collaboration and the sharing of insights among experts in the field. Official photos from ASH are available here.

At the 'Outcomes Research—Lymphoid Malignancies: Poster II' session, Yoona Choi, serving as the first author and representing the entire research team, presented a study titled 'Evaluating the Effectiveness and Safety of Prephase Steroid Treatment before Remission Induction Chemotherapy in Pediatric Acute Lymphoblastic Leukemia: A Common Data Model-Based Real-World Data Approach.' This study investigated steroid pretreatment in pediatric acute lymphoblastic leukemia (ALL) patients undergoing remission induction chemotherapy (RIC), with the aim of reducing complications such as tumor lysis syndrome (TLS). Analyzing data from Seoul National University Hospital and Catholic University Seoul St. Mary’s Hospital, the study compared patients who received steroid pretreatment at least seven days before RIC with those who did not. The findings indicated a significant reduction in TLS incidence in the pretreated group. While overall survival rates were higher in this group, the difference was not statistically significant. These results provide important real-world evidence for the effectiveness of steroid pretreatment in reducing TLS risk in pediatric ALL patients.

This study was part of a larger project, funded by a grant from the Ministry of Health and Welfare, aiming to develop a disease registry database for pediatric ALL using real-world data in the clinical data warehouse (CDW) of Seoul National University Hospital and Catholic University Seoul St. Mary’s Hospital, thereby generating real-world evidence for pediatric ALL. 

CCADD attended the 2023 Fall Conference of the Korean Society of Medical Informatics (KoSMI) held at HIP(Healthcare Innovation Park) of Seoul National University Bundang Hospital, South Korea. The conference spanned three days from November 29th to December 1^st, both online and offline. Aligned with the theme "Beyond Data: Actionable Health AI", the conference featured 27 symposiums covering various topics, from artificial intelligence in the healthcare to standardization of medical data and digital health.

The first day was conducted online. Particularly, ”Symposium 6: Development of Predictive Models for Cardiovascular Diseases Using Medical Big Data” was noteworthy, where Prof. Howard Lee served as the session chair and speaker, attracting significant attention from the audience with the presentation on ”Improving the Performance of Machine Learning Models for Predicting Acute Coronary Syndrome in Type 2 Diabetes Patients through Substitution of Propensity Scores for Binary Variables”. Also, throughout the conference, the poster presentation was led by David Seung U Lee.

On the second day, each symposium delved into topics of medical data and artificial intelligence applications to the healthcare domain. Themes included "Strategies for the Activation and Commercialization of AI-Based Drug Development" and "Smart Curation of Medical Data: Approaches for Preparing for the Utilization of Medical AI." This encompassed insights into the industry's latest strategies for drug target exploration. In Symposium 9, Dr. Siun Kim delivered a presentation on ”Addressing the challenges of data scarcity and bias of AI-based drug development”. The discourse extensively covered specific manifestations of data scarcity and proposed strategies for mitigation within drug development.

During the final day, the symposiums provided an opportunity to approach the trends in the utilization and data processing methods of developing LLM. Participants delved into the practical approaches for utilizing Real-World Data (RWD) in regulatory decision-making, replicating Randomized Controlled Trials (RCT), and employing common data models. CCADD members exchanged ideas with fellow researchers studying similar research topics, offering a valuable opportunity to comprehend ongoing research trends. It was an insightful symposium for healthcare information researchers to share and discuss the latest trends in research.

Yesol Hong won the Excellent Research Award at the 30th Annual Conference of the Korean Society for Clinical Pharmacology & Therapeutics (KSCPT), December 1-3, 2022, held at Bexco, Busan, South Korea. The title of YeSol's presentation was "One-year follow-up of patients with COVID-19: Analysis of new-onset disease after COVID-19 diagnosis using Real-World Data". She discussed the results of an analysis of the occurrence of disease in patients with COVID-19 over a year using two different real-world data sets. One of her analysis results was a nation-wide study, which was significant in that it included the largest number of study subjects among the studies analyzing the post-COVID-19-condition in Korea. Jung Hyun Won equally contributed to this study with Professor Howard Lee serving as the principal investigator.

Additionally, Siun Kim, Yoona Choi, David Seung U Lee also presented their research through poster exhibition at the conference. 

Full presentations can be watched at the following YouTube links: 

YeSol had the honor to deliver oral presentation and won the Excellent Research Award at 2022 fall conference hosted by the Korean Society of Medical Informatics(KOSMI). YeSol has presented her work entitled "Effectiveness and safety of sodium-glucose cotransporter-2 inhibitors(SGLT2i) added to mono, dual or triple treatment in patients with type 2 diabetes mellitus(T2DM)". She discussed the additive efficacy in glycemic control and the tolerability of SGLT2i in T2DM patients when combined with other antihyperglycemic agents, such as metformin, sulfonylureas, and dipeptidyl peptidase-4 inhibitors using real-world data. Yoona Choi, TaeKyu Chung, and Yoomin Jeon also contributed to this study as co-researchers, with Professor Howard Lee serving as the principle investigator.

The conference was a three-day event (from Nov 23rd, 2022 to Nov 25th, 2022) and was held at The International Convention Center, Jeonbuk National University, Jeonju, Jeonbuk, South Korea. This conference, the host(KOSMI) organized the event around the theme, "The Power and Value of Healthcare Data Linkage". The conference was full of enlightening speeches that reflected the progress made in the field of medical informatics. With a total of 1,039 participants, this conference was held on the largest scale ever among KOSMI conferences.