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.

"In South Korea, not all orphan drugs are reimbursed by the National Health Insurance Service primarily because they are different from drugs to treat rare diseases from the legal perspective", talked Prof. Lee at the 7th K-Life Bio Forum, held on September 26, 2023 at the National Assembly, co-sponsored by the Korean Pharmaceutical Association and Congressman Min-Suk Kim, the Democratic Party of Korea. Prof. Lee continued saying "This is why so many orphan drugs cannot be accessed by those who need them desperately although the orphan drugs have been approved the the Ministry of Food and Drug Safety, the regulatory authority in South Kore." Furthermore, Prof. Lee pointed out the drawbacks of reimbursement decision made by the HIRA solely dependent upon the evaluation of cost-effectiveness based on incremental cost-effectiveness ratio or ICER. "We need other funding mechanisms than the national health insurance for patients with rare diseases to get access faster to the orphan drugs they cannot live a quality life without", Prof. Lee stressed. Several news paper articles reported what Prof. Lee presented at the Forum, one of which can be found here. 

Prof. Howard Lee was invited to a forum organized by the Korea Ministry of Food and Drug Safety (MFDS) to celebrate its 10th anniversary of upgrade from a Ministry of Health and Welfare institution to a Prime Ministerial Office institution 10 years ago. Prof. Lee chaired the panel discussion at the forum. More detailed information about the forum can be found at this.

Prof. Howard Lee has been recently awarded Mid-Career Research Grant from the National Research Foundation (NRF) of South Korea. The total funding amounted to approximately 300 million Korean won spread across three years of research (from year 2023 to 2025). Prof. Howard Lee and his team at CCADD will focus on improving the generalization performance of natural language processing models in extracting drug safety information from multi-institutional clinical notes. More specifically, the team will analyze the semi-structured clinical notes written in diverse clinical settings and investigate the feasibility of using them, along with multi-task generative models, as a way to improve model generalizability. Furthermore, the study will explore the applicability of state-of-the-art generative language models and their ability to augment text data to accomplishing the study objective.

On February 24^th, CCADD celebrated the graduation of two of its members, Siun Kim and David Seung U Lee. Siun, an applied bioengineering major, started his joint Masters and PhD program in 2018 and studied under Prof. Howard Lee’s guidance. He received his PhD in Medicine for his thesis on applying natural language processing technology to drug safety monitoring. David, a molecular medicine and biopharmaceutical sciences (MMBS) major, joined CCADD in 2021 and has since studied under Prof. Howard Lee. He received his MSc in Medicine for his study on clinical characteristics associated with dulaglutide treatment adherence.

Siun, for all his contribution to CCADD, embarked on a new career as a postdoctoral researcher at Seoul National University Hospital Biomedical Research Institute. There, he will focus on developing AI models for the prediction of hypoglycemia during dialysis and the analysis of nursing notes of kidney surgery recipients. David will continue to study under Prof. Howard as a PhD student starting 2023.

We congratulate on their accomplishment and convey our best wishes at their new start.

In the 8th Global Bio Conference sponsored by the Korea Ministry of Food and Drug Safety on September 6, 2022, Prof. Howard Lee emphasized the unique nature of biologics in comparison with conventional small-molecule drugs, particularly in terms of their clinical safety and accessibility. "The safety of biologics should be ascertained even after they are approved for marketing since they are way different from the traditional chemistry-based drugs", Prof. Lee argued. Prof. Lee further pointed out the uniqueness of biologics by saying "We have to be well prepared not only for the utility, but for the potential safety issues in every single biologic, which is anticipated to be more frequently used in a clinical setting." Prof. Lee also addressed the reimbursement for biologics because they are typically more expensive although their efficacy can be dramatic.

More details about Prof. Lee's presentation at the GBC can be found at the following online articles: 1 and 2. 

Prof. Howard Lee emphasized the role of regulatory science in the development and fast introduction of advanced medical products including therapeutics, devices, diagnostics, and vaccines to patients in need. He was invited to the fourth series of the Regulatory Science Innovation Forum on May 3, 2022, where Prof. Lee proposed several strategies to facilitate the principles of regulatory science to be implemented in every decision the Ministry of Food and Drug Safety (MFDS) makes. Prof. Lee also stressed MFDS to self-evolve to become a visionary leadership organization through regulatory science, starting from regulatory agency to scientific agency to public health agency. Several newspaper reported what Prof. Lee presented at the forum: 1, 2, and 3. 

A full video clip of Prof. Lee's presentation can be watched by clicking the following YouTube link. 

Yoomin Jeon and Siun Kim were awarded the Best Oral Presentation Award at the 2021 KSCPT Conference.The Best Oral Presentation Award aims to recognize outstanding scientific papers delivered through oral presentations at the conference. The awards were given to oral presentations of the paper titled "A Randomized, Double-blind, Placebo- and Active-controlled, Escalating Single-dose Study to Evaluate Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasians" and "An Annotated Corpus and Natural Language Processing Model for Drug Safety Information Extraction from Free-texts Reporting Adverse Events" for Yoomin and Siun, respectively. 

Yoomin presented the results of a phase 1 clinical trial evaluating the pharmacokinetics and pharmacodynamics of eflapegrastim following subcutaneous administration to healthy subjects. Eflapegrastim (Rolontis®) is a novel, long-acting Granulocyte-Colony Stimulating Factor (G-CSF) being studied as a treatment for neutropenia that utilizes Hanmi's Labscovery, a proprietary platform technology. 

Siun presented an annotated corpus for extracted Korean adverse events using free-texts from the KAERS (Korean Adverse Event Reporting System) database. To this end, Siun Kim developed deep learning models that automatically extract medication and adverse event information, cooperating with MILAB in Seoul National University.

CCADD is breaking the ground for biomedical natural language processing or NLP!

On January 22^nd, 2021, CCADD was nominated by the Ministry of Food and Drug Safety to develop an NLP model that extracts core clinical information from unstructured data in the Korea Adverse Event Reporting System (KAERS). The total research fund amounts to two hundred million Korean won or a hundred and eighty thousand U.S. dollars. The project will be performed in collaboration with the Machine Intelligence lab in the Department of Electrical and Computer Engineering, Seoul National University (Prof. Gyo-Min Jung). 

For starters, CCADD will build a manually annotated dataset, which is indispensable to train and refine any machine learning algorithm including NLP. Next, CCADD plans to build the KAERS-BERT model, an NLP model specifically tuned to handle adverse drug events. The KAERS-BERT model will be pre-trained on KAERS text data, which then will be deployed to extract medical information from free texts, such as hand-written records of adverse events. Once complete, the KAERS-BERT model is expected to address many of the language ambiguities caused by the mixed use of English and Korean in medical domains already peppered with technical and medical jargons. The KAERS-BERT model will significantly improve the performance and the outcome of NLP tasks when extracting information from clinical notes written in English and Korean. 

Prof. Howard Lee, the PI of the grant, congratulated the team, saying "The grant awarding is timely and important since it will help CCADD enter a new area of biomedical NLP." At the conclusion of this project, CCADD will once again have secured its place as the leading lab in the field of convergence science between medicine, drug development, and machine learning including NLP. "This certainly provides CCADD with a momentum to transform into a frontrunner in the field", Prof. Lee added.