This summer, CCADD welcomes three interns-Kim Chanmin, Choi Yunjin, and Yoo Kyungwan -for the 2024 Summer Internship Program.

Kyungwan Yoo, a student at Kyung Hee University, earned his Bachelor’s degree in genetic engineering. He worked as an undergraduate researcher at the Kyung Hee University Regenerative Medicine Institute, focusing on creating cell-targeting treatments. Currently, he is interested in integrating biological science with artificial intelligence (AI) technology and applying it to drug development. Kyungwan applied for the 2024 CCADD Summer Internship Program to expand his knowledge of drug development in general, be it clinical trials, and/or utilizing medical big data. He also intends to gain practical experiences in applying programming languages to these domains.

Yunjin Choi has graduated from Stony Brook University with a Bachelor’s degree in mathematics. After graduating, Yunjin worked as a statistical analyst at the Biomedical Research Institute, Korea University Guro Hospital. She has mainly conducted retrospective studies on nephrology and neurology. For example, she published a paper entitled "Fasting glucose variability and risk of dementia in Parkinson's disease: a 9-year longitudinal follow-up study of a nationwide cohort", which examined the impact of fasting glucose variability on the risk of developing dementia in Parkinson's disease patients over a nine-year period. The study found that greater variability in fasting glucose levels was associated with a higher risk of dementia, further suggesting that stabilizing glucose levels might be beneficial for cognitive health in these patients. Besides being the first author of the study, she was also responsible for data analysis and interpretation, ensuring the accuracy and reliability of the study results. She also has the opportunity to learn how to draft and revise the manu and enhance its scientific merit. During this time, Yunjin developed an interest in Real-World Data (RWD), such as electronic medical records (EMR). She intends to pursue her interest while at CCADD.

Chanmin Kim is a Biological Engineering major at Kangwon National University. She became interested in developing new drugs while learning drug delivery systems. She also completed GMP training. After receiving the Excellence Award for designing smart healthcare products at Gachon University's DNA (Data, Network, AI) School Camp , she became interested in improving the efficiency of developing new drugs by applying data science and AI. Her goal is to become a researcher in the development of new drugs using AI. Through her 2024 CCADD summer internship program, she will pursue this goal.

We hope that during their summer internship, they will gain confidence in their field of study, learn how to study independently and explore new knowledge, and devote all their passion to gaining a deep understanding of drug development and regulatory science over the course of these two months.

Prof. Howard Lee emphasized the willingness to pay for innovation from the whole societal perspective for South Korea. In a forum organized by Hankyung TV to commemorate the 2023 Korean Biopharmaceutical Award, Prof. Lee discussed what South Korea has to equip itself with to become one of the countries that can not only develop, but market innovative new drugs on a global scale. He listed the following conditions: nationwide control center, training and education, megafunds, advanced drug regulatory science, and willingness to pay for innovation as a society. The following YouTube clip captures the 5th condition.

Prof. Howard Lee was invited to the 2022 Spring Conference of the Korean Society of Food, Drug, and Cosmetics Regulatory Sciences, June 24, 2022, where he proposed the most critical and urgent action items to advance regulatory science in Korea. Prof. Lee emphasized that four areas of uncertainty needed to be clarified first before the level of regulatory science in Korea could be improved. According to Prof. Lee, there are four uncertainties in the regulatory science community in Korea, i.e., the focus, driver(s), human resource development, and making regulatory science academically vigorous and independent. Prof. Lee's talk was featured in an article by KPA News. 

Prof. Lee's full  presentation can be watched at the following YouTube link. 

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. 

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. 

Two undergraduate students (Left: Min Ji Kim, Right: Ara Cho) will spend the next eight weeks (January - February, 2018) at CCADD, working as a team through the winter internship program at the Graduate School of Convergence Science and Technology, Seoul National University. Min Ji will graduate in February 2018 with a bachelor's degree in Bioscience and Biotechnology at Hankuk Univeristy of Foreign Studies. Ara is a fourth-year undergraduate student at the School of Biotechnology and Environmental Engineering, Catholic University of Korea with a major in Life Science.

This intensive research internship program aims to provide student interns with hands-on research experience in drug development and regulatory sciences, helping them further build their academic achievements. Min Ji and Ara will delve deeply into various aspects of new drug development. Please join us to welcome Min Ji and Ara!