Seoyoon Jang is currently an undergraduate researcher at CCADD after diligently completing the 2024 winter internship program. Seoyoon Jang is majoring in Systems Biotechnology at Chung-Ang University. Her research interests include generating real-world evidence (RWE) based on real-world data (RWD) using electronic medical records (EMR) and regulatory science. During her internship, she became proficient in R and gained hands-on experience with both representation and generative LLM models.

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.

On Friday, December 27, 2024, the 2024 CCADD Year-End Workshop was successfully held at the Seoul National University (SNU) Yongon Campus. The event was attended by Prof. Howard Lee, CCADD members, interns, and alumni. Notably, Research Professor Yoona Choi joined the event in person, while Prof. Asa Johansson and Dr. Tae Kyu Chung participated online, adding an international dimension to the program.

The workshop began with a brief icebreaking session, followed by a series of meaningful presentations. The first presenter, Yunjin Choi, shared her growth and learning experiences over the past six months in her presentation titled “The Serendipitous Road: Lessons from the Past 6 Months.” Next, Yujin Kim reflected on her first year as a graduate student, highlighting her research projects, achievements, and key takeaways. In the afternoon session, Junghyun Won provided a retrospective on her 4.5 years as a graduate student, offering valuable insights into the diverse experiences of graduate life.

The main session reviewed CCADD's accomplishments in 2024, celebrating the research group's growth and achievements. Prof. Howard Lee commended the group’s continued success in research and publications. The workshop then shifted its focus to 2025, with a session outlining a roadmap emphasizing emerging AI concepts and innovative research ideas aligned with the latest trends.

Three special lectures added depth and inspiration to the workshop. Dr. Tae Kyu Chung, a postdoctoral researcher at the University of California San Francisco, delivered a lecture titled “Postdoc Diaries: A Glimpse of Life in the US,” offering a vivid account of his life and research abroad, which resonated strongly with the audience. Research Professor Yoona Choi reflected on her year as a research professor at Child Cancer and Rare Disease Project, Seoul National University Hospital. Her presentation detailed the challenges and achievements of her rigorous research journey, offering valuable insights for fellow researchers. Prof. Asa Johansson from Uppsala University delivered a lecture titled “Pharmacoepidemiology in the Era of Precision Health,” introducing the latest developments in precision medicine and pharmacoepidemiology. Her session provided an opportunity for attendees to exchange ideas with an international expert.

The workshop concluded with an inspiring speech by Prof. Howard Lee, who has been serving as the Dean of the Graduate School of Convergence Science and Technology at SNU. Prof. Lee praised CCADD's remarkable achievements throughout 2024 and expressed his strong support for the group’s ambitious goals in 2025. The 2024 CCADD Year-End Workshop provided members and alumni with a valuable opportunity to strengthen their relationships, exchange ideas, and align on a shared vision for the journey ahead.

The semester-long course "Understanding New Health Technology Development" successfully concluded on December 9 with final presentations by students. The event provided an opportunity for participants to demonstrate their comprehensive understanding of the drug development process and gain practical experience with its complexities.

During the presentations, students analyzed and presented the development journey of globally recognized drugs, including Leqembi, Wegovy, and Zolgensma. Each team focused on the New Drug Application (NDA) process, addressing preclinical and clinical phases, regulatory hurdles, and market entry strategies. Their presentations showcased a well-rounded understanding of the scientific, regulatory, and market challenges involved in drug development.

The course was designed to emphasize the importance of interdisciplinary collaboration in creating new health technologies. Students explored critical decision-making principles at each stage of the development process, equipping themselves with practical knowledge essential for careers in the health tech sector. Key topics in the presentations included — The mechanism of action and scientific foundations of the drugs, Preclinical and clinical testing phases, Regulatory approval procedures, and Market strategies and societal impact.

One student shared, "This course gave us the unique opportunity to design and analyze the entire drug development process, offering invaluable insights that extend beyond theoretical knowledge." The "Understanding New Health Technology Development" course concluded successfully, marking a significant milestone in fostering future professionals equipped to advance the health technology field.

Professor Howard and David attended the 84th Scientific Sessions of the American Diabetes Association (ADA). It was held from June 21 to 24 in Orlando, Florida, hosting experts in diabetes research from all over the world. The event brought together leading scientists, healthcare professionals, and stakeholders to discuss critical issues, including advancements in diabetes technology. It also showcased cutting-edge research and innovations in diabetes treatment and management, ranging from obesity and GLP-1 receptor agonists to autoantibody testing and early diabetes detection.

The event also provided a memorable venue for Prof. Howard and David, where they presented their work on “Developing Machine Learning Model for Predicting Acute Coronary Syndrome in Type 2 Diabetes Mellitus Patients through Substitution of Propensity Scores for Binary Variables”. During the poster presentation session, questions were asked and answered, ideas were exchanged, and constructive comments were offered. The event, along with the opportunity to present the work, paved the way for improving the study and provided a valuable experience to learn from world-renowned researchers.

On February 26th, Professor Howard and the CCADD members gathered to honor the graduation of Tae Kyu Chung and the successful completion of the winter internship program by Seorin Choi and Yunha Noh.

Tae Kyu, who studied the realm of biology-neurobiology as an undergrad, joined CCADD in February 2018 as an intern. Under the guidance of Professor Howard Lee thenceforth, he navigated through the rigors of an integrated master's and PhD program. His persistent dedication to PKPD modeling culminated in a doctoral thesis entitled “Comparison of Machine Learning and Population Pharmacokinetic Models for Predicting Antiepileptic Drug Concentrations Based on Therapeutic Drug Monitoring Records”, earning him a Doctor of Medicine degree. On the graduation day, his relentless pursuit was duly awarded.

Simultaneously, a ceremony to mark the completion of Seorin and Yunha's internship was conducted at the main campus of Seoul National University. Throughout their internship, they immersed themselves in a series of educational endeavors, presentations, and assignments. On that day, their efforts, all contained within a comprehensive poster presentation, were met with a deep appreciation. Members of CCADD also attended the ceremony to celebrate the completion of their internships.

As we congratulate their accomplishments, we also look forward with anticipation to their future as independent researchers.