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.

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. 

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.

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. 

The book 'There's no such thing as K-Quarantine', written by Prof.Howard Lee, Jung-Hyun Won, YeSol Hong and 13 others, was selected in the liberal arts section of the Sejong Cultural Book Program this year. The Sejong Cultural Book Program is organized by the Publication industry Promotion Agency of Korea. This program aims to promote domestic publishing activities and to build a knowledge-based society by selecting outstanding books among those published throughout the year. Books worth 8 million Korean won will be distributed to public libraries nationwide. In 2022, 550 books were selected from a total of 8,698 candidates. The book There's no such thing as K-quarantine was selected as an excellent book in the field of technology science. 

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. 

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.

The In Depth 60 Minutes, an investigative journalism program broadcast by KBS, featured an interview with Prof. Howard Lee on August 16, 2019 with respect the recent Invossa debacle. Invossa is a gene and cell therapy approved to treat patients with osteoarthritis of the knee. Invossa was claimed to contain genetically transformed chondrocytes, which turned out not to be the case. Instead, they were cells originated from the human embryonic kidney, which could cause cancer to develop in those who received Invossa. Invossa has been administered to more than 3,000 patients only in Korea. The Korea Ministry of Food and Drug Safety (MFDS) revoked the marketing approval of Invossa, and promised to initiate a nationwide pharmacovigilance program to investigate the safety impact of Invossa, which though has not been in effect yet. 

In the show, Prof. Lee emphasized why misbranding or mislabelling is a significant health harm, which can be legally penalized. Furthermore, he explained why MFDS was not able to detect what went wrong in the case of approval of Invossa. Prof. Lee added, "Although MFDS has been trying to renovate themselves over the past decade or so, it still lacks the expertise and manpower required to adequately review the safety and efficacy of the drug, particularly advanced therapies such as Invossa." Prof. Lee was featured in a total of four clips. 

The full program can be watched by clicking here.

Prof. Howard Lee proposed health insurance reimbursement for the combination therapy of DPP4 inhibitors and SGLT2 inhibitors, irrespective of their labels as approved by the Korea Ministry Food and Drug Safety (MFDS), at a special session organized by the Korean Diabetes Association (KDA), in association with its Spring Conference 2019, held on May 9-11, 2019, at the HICO, Kyeongju, Korea. Unlike other countries including the USA, EU, and Japan, MFDS in Korea has approved the combination therapy of SGLT2 inhibitors with other oral hypoglycemic agents, particularly with DPP4 inhibitors, only on the basis individual drugs, not on the therapeutic class. This unique regulatory approval has contributed to the delayed reimbursement of various combination therapies involving SGLT2 inhibitors since their approvals. 

The delayed reimbursement has caused a lot of debates not only between the pharmaceutical industry and the Health Insurance Review and Assessment Service or HIRA, but also among clinicians. With this background, the KDA asked Prof. Lee to share his perspectives from the points of drug regulatory science if the reimbursement for the combination therapy of DPP4 inhibitors and SGLT2 inhibitors on the basis of therapeutic class, not on the individual drug, has any scientific and clinical rationale. Prof. Lee, based on an intensive systematic literature review focusing on the pharmacokinetics, drug-drug interactions, clinical efficacy, and safety profiles of the combination treatment with DPP4 inhibitors and SGLT2 inhibitors, discussed that it is highly unlikely any combination of the two classes would interact in a clinically meaningful and significant way. Furthermore, Prof. Lee argued that it is very likely for every combination of a DPP4 inhibitor with an SGLT2 inhibitor to result in an additional, significant, and clinically meaningful decrease in HbA1c or glycated hemoglobin. However, since not every combination has been studied for its safety profiles although it is likely to be similar to those of monotherapy, Prof. Lee proposed to perform a real world data study under the auspice of KDA, sponsored by the pharmaceutical industry, to explore and confirm the safety and efficacy profiles of the combination therapy.      

Reflecting the interest in the reimbursement issue, the conference room was full of clinicians, industry representative, and journalists even though the session was presented early in the morning on Saturday. More detailed information on the session can be found here. 

"The recent recall of valsartan API made by Zhejiang Huahai (China) following detection of a potential carcinogen has revealed the weak and scientifically unsound basis of the generic approval system in Korea", Prof. Lee spoke in a telephone interview with KBS. Prof. Lee detailed about this issue in a newspaper column. The number of recalled valsartan generics in Korea was 115, which was way greater than that in the UK (only 8) and Japan (only 1). The reason behind this difference was that Korea has maintained a relatively low bar for the approval of generics. For example, any company can sell generics if they could obtain them from anyone who has a marketing authorization of the generic. In other words, the company is not necessarily responsible for the quality of the generic, nor they have to show that they could make a qualified generic, which meets all of the regulatory requirements including the proof of bioequivalence. 

As a result, there are numerous generics for a single original product. This, in turn, has introduced an exceptionally high competition among the companies, which has implicitly encouraged unethical business practices such as kick-back and unlawful rebates. The issue also has brought some quality issues to manufacturing of generics in Korea. For example, many companies have switched their API source after approval, mostly to a low-quality Chinese company, of which Zhejiang Huahai may be one. 

Therefore, to preempt the recurrence of this quality API source issue for generics in Korea, the approval system has to be heightened, Prof. Lee summarized.