Choi Y, Kim BK, Won JH, Yoo JW, Choi W, Jung S, Kim JY, Choi IY, Chung NG, Lee JW, Choi JY, Kang HJ, Lee H. A Study to Evaluate the Effectiveness and Safety of Prephase Steroid Treatment before Remission Induction Chemotherapy in Patients with Pediatric Acute Lymphoblastic Leukemia Using Common Data Model-Based Real-World Data: A Retrospective Observational Study. Clin Epidemiol. 2024 Apr 22;16:293-304. doi: 10.2147/CLEP.S454263. PMID: 38681782; PMCID: PMC11049150.

The study "Effectiveness and Safety of Sodium-Glucose Cotransporter 2 Inhibitors Added to Dual or Triple Treatment in Patients with Type 2 Diabetes Mellitus," authored by Yesol Hong, Yoomin Jeon, Yoona Choi, Tae Kyu Chung, and Howard Lee, was published in the Diabetes Therapy on December 20, 2023. Conducted at Seoul National University Hospital (SNUH) in South Korea, this research by the CCADD team delved into the use of Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) in Type 2 Diabetes Mellitus (T2DM) treatment. The study, utilizing Real-World Data (RWD) from electronic medical records (EMR) from SNUH's a Common Data Model database, revealed improvements in HbA1c levels and a higher rate of patients achieving targeted HbA1c levels with SGLT2i therapy.

Furthermore, CCADD is dedicated to continuing its use of EMR-based RWD to generate important clinical evidence, particularly in areas where Randomized Controlled Trials (RCTs) may face limitations. This commitment underscores CCADD's role in advancing medical research and improving patient care through innovative data utilization.

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. 

"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. 

The Korean Society of Medical Oncology or KSMO is the largest academic congregation in the filed of oncology, consisting not only of medical or clinical oncologists, but of basic and clinical researchers involved in the development of anti-cancer drugs, diagnostics, and vaccines. Prof. Howard Lee was invited to this year's general assembly and symposium for KSMO and discussed the potential and pitfalls of antibody-drug conjugates or ADCs. The first ADC, Mylotarg, was approved in 2000 by the US FDA, followed by its voluntary withdrawal in 2010 due to safety issue, and re-approval in 2017, which just tells how difficult it has been to develop a safe and effective ADC for clinical usage in cancer patients. However, eight ADCs have been approved by the US FDA since 2019 totaling 13, and this indicates how promising the development horizon of ADCs can be. Prof. Lee talked about the pros and cons of ADCs mainly from the perspective of drug development. For example, an ADC consists of three independent components: an antibody (mostly monoclonal antibody or mAb), a cytotoxic payload or warhead, and a linker that combines both antibody and payload. Due to its structural complexity and interactions between elements, which has not been fully elucidated yet, the development of an ADC has faced many technical difficulties. At the same time, however, ADCs also can become a much better platform than other competing ones in the field of oncology because of the uniqueness of its mechanism of action. 

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.