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.

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.

Prof. Howard Lee gave a talk at the 17th JSCPT-KSCPT Joint Symposium, Kobe, Japan, on December 15, 2023. In his presentation entitled 'Real-World Data Analysis as a Clinical Pharmacologist: Experience and Some Thoughts', Prof. Lee. introduce the audience to the RWD research works CCADD has performed for the past 3 or so years, all of which have been published in reputable journals or under review shown below. Prof. Lee stressed, "With RWD landscape fast growing, clinical pharmacologists should leverage the potentials of RWD/RWE in drug development by furthering its scientific innovation!" 

Prof. Lee's speech was well received by the audience followed by a welcome reception by JSCPT colleagues, whom he and other delegates have not seen in person for the past three years because of the COVID-19 pandemic. The night was full of talking, drinking, and singing! Both teams promised to meet again next year in Jeju, Korea, for the Spring Conference of 2024 KSCPT. 

CCADD members attended the Annual Conference of the Korean Society for Clinical Pharmacology and Therapeutics (KSCPT), taking place at Sono Belle, Gyeongju, from November 16th to 17th. In this conference, approximately 300 participants shared their insights and findings in the translational pharmacometrics and new drug development realms. 

Representing CCADD, graduate students Tae Kyu and Yoona have delivered oral presentations on the latest advancements in clinical pharmacology and related scientific disciplines at the Conference.

Tae Kyu's oral presentation, centered around the research entitled "Comparison of Machine Learning and Population Pharmacokinetic Models for Predicting Antiepileptic Drug Concentrations Based on Therapeutic Drug Monitoring Records," acquired substantial attention, particularly from pharmacometricians. During the presentation and subsequent discussions, he shared insights on how the application of machine learning to clinical pharmacology holds the potential to revolutionize drug development, dosage optimization, and personalized medicine. 

Yoona also presented her research topic, entitled "Country Contribution of Investigators to Pivotal Clinical Trials and THeir Primary Publications of New Drugs Approved by the US Food and Drug Administration," emphasizing the need for Korean researchers to take an active leadership role in key clinical trials to secure opportunities to contribute as authors to primary publications. The audience also agreed with her suggestions and provided constructive feedback, e.g., why it is not easy to be the author in the primary publications. After her presentation, she commented that it was a valuable opportunity to gauge the interest of clinical pharmacologists in that subject matter. 

In this conference, Tae Kyu and Yoona were bestowed with the esteemed "Best Presentation Award," marking a significant achievement and recognition for their outstanding presentation skills. Out of around 50 accepted abstracts, only the 7 presentations were deemed worthy of the best presentation title. Tae Kyu and Yoona's work was further celebrated with a cash prize of 100,000 KRW.

After all the programmed sessions were over, attendants eagerly awaited the prize draw. In a moment of drawing for the first gift, Howard emerged as the fortunate recipient. With his jaws on the floor, Howard made his way to claim his prize, a Bluetooth Sony Headphone. The annual conference held by KSCPT was a stage to celebrate the lab's commitment to excellence and an opportunity to showcase our gratitute for the fortune we have experienced.

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: 

Prof. Kyeong-Ryoon Lee lectured at the 2021 Annual Meeting of the Korean Society for Clinical Pharmacology and Therapeutics, held in Jeju-do, Korea, November 11-13, 2021. The title of his talk was Development of Phyisologically-Based Pharmacokinetic Model for Orally-Administered Fexuprazan in Humans. In the lecture, Prof. Lee introduced the audience step-by-step to the drug development project he led in collaboration with Daewoong Pharmaceutical Co., Ltd., Seoul, Korea, where a PBPK model developed using pre-clinical animal data accurately predicted the PK profiles of fexuprazan, a potassium-competitive acid blocker, in humans. Prof. Lee's presentation was based on a research paper he recently published, and was well-received.

The 2020 Population Approach Group Korea (PAGK) Annual Meeting was held on November 27 with presenters attending at the WesternLife Hotel, Iksan, Jeolla-do while other participants joining the meeting on-line. The PAGK is a research group affiliated with Korean Society for Clinical Pharmacology and Therapeutics, of which members (currently >180) join from various sectors such as academia (clinical pharmacology, clinical medicine, and pharmacy), hospitals, pharmaceutical companies, CROs, and government agencies.

The plenary speech was delivered by Prof. Yangjin Kim, Professor at the Department of Mathematics at Konkuck University, titled “Mathematical modelling of tumor growth and signaling network, and development of anti-cancer drugs and therapeutic strategies”. The topics in the Young Researchers’ Sessions included physiologically-based pharmacokinetic (PBPK) model for clozapine in Korean patients with schizophrenia, misuse of the Michaelis-Menten for prediction of in vivo clearance for drugs, and microphysiological systems for predicting human pharmacokinetics.

Two PhD students of CCADD, Siun Kim and Tae Kyu Chung, presented their population pharmacokinetic and pharmacokinetic-pharmacodynamic modeling studies in the trainee session. Prof. Howard Lee also attended the PAGK annual meeting on-site to support and encourage Siun and Tae Kyu to expand their networks. The whole presentations of the two students can be watched at the Youtube channel of CCADD.

Prof. Howard Lee spoke about the utility of artificial intelligence (AI) in clinical drug development at the KDDW or Korean Digestive Disease Week 2020, organized by the Korean Society of Gastrointestinal Endoscopy, on November 20, 2020, held at the Swiss Grand Hotel Convention Center. The conference was aired online and the program is shown below:

The title of Prof. Lee's presentation was 'Artificial Intelligence in Drug Development: Clinical Pharmacology Perspective', and he talked about the potentials and pitfalls of AI in clinical drug development. In his talk, Prof. Lee emphasized the fact that most of the AI technologies that have been ever adopted in drug development are primarily in the area of drug discovery, whereas the preclinical and clinical developments have not witnessed active adoption of AI technologies although this trend can change all of a sudden. Particularly, Prof. Lee set aside the one-thirds of his presentation as to how CCADD could have developed a series of machine learning models to reduce the dimensionality of eligibility criteria to assess clinical trial feasibility using several feature selection algorithms. Below is the photo of those who have contributed to the work Prof. Lee introduced in his talk at the conference. 

Prof. Howard Lee gave an invited presentation at the annual conference 2020, sponsored by the Korean Society for Clinical Pharmacology and Therapeutics. In his presentation, Prof. Lee summarized the various activities to develop therapeutics, mostly drug repositioning, and vaccines against the COVID-19 pandemic worldwide. Prof. Lee's talk was timely in that Pfizer recently announced the extraordinary efficacy seen in their phase III clinical trial with an mRNA vaccine that they had co-developed with BioNTech, a German biotech firm. Prof. Lee also discussed how the private-public partnership to develop vaccines to prevent COVID-19 could change the horizon of new drug development post-pandemic. 

Prof. Howard Lee gave a talk at a pre-meeting workshop for the American College of Clinical Pharmacology Annual Meeting 2020 on September 16, 2020 (US EST). The title of Prof. Lee's presentation was 'Early Phase Clinical Trials in Korea'. In this talk, Prof. Lee explained how and why Korea has become one of the most attractive countries for clinical drug development, particularly during the past two decades. 

Prof. Lee also introduced the audience to some of his previous works in innovative clinical trial methodologies such as the microtracing technology, which he has spearheaded to make a useful clinical drug development tool in Korea. In association with this, Prof. Lee discussed two of his papers, one in Clinical Pharmacology and Therapeutics, the other Clinical and Translational Science, two reputable journals in clinical pharmacology.