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 attended the 2023 Fall Conference of the Korean Society of Medical Informatics (KoSMI) held at HIP(Healthcare Innovation Park) of Seoul National University Bundang Hospital, South Korea. The conference spanned three days from November 29th to December 1^st, both online and offline. Aligned with the theme "Beyond Data: Actionable Health AI", the conference featured 27 symposiums covering various topics, from artificial intelligence in the healthcare to standardization of medical data and digital health.

The first day was conducted online. Particularly, ”Symposium 6: Development of Predictive Models for Cardiovascular Diseases Using Medical Big Data” was noteworthy, where Prof. Howard Lee served as the session chair and speaker, attracting significant attention from the audience with the presentation on ”Improving the Performance of Machine Learning Models for Predicting Acute Coronary Syndrome in Type 2 Diabetes Patients through Substitution of Propensity Scores for Binary Variables”. Also, throughout the conference, the poster presentation was led by David Seung U Lee.

On the second day, each symposium delved into topics of medical data and artificial intelligence applications to the healthcare domain. Themes included "Strategies for the Activation and Commercialization of AI-Based Drug Development" and "Smart Curation of Medical Data: Approaches for Preparing for the Utilization of Medical AI." This encompassed insights into the industry's latest strategies for drug target exploration. In Symposium 9, Dr. Siun Kim delivered a presentation on ”Addressing the challenges of data scarcity and bias of AI-based drug development”. The discourse extensively covered specific manifestations of data scarcity and proposed strategies for mitigation within drug development.

During the final day, the symposiums provided an opportunity to approach the trends in the utilization and data processing methods of developing LLM. Participants delved into the practical approaches for utilizing Real-World Data (RWD) in regulatory decision-making, replicating Randomized Controlled Trials (RCT), and employing common data models. CCADD members exchanged ideas with fellow researchers studying similar research topics, offering a valuable opportunity to comprehend ongoing research trends. It was an insightful symposium for healthcare information researchers to share and discuss the latest trends in research.

Prof. Howard Lee shared his past experiences and future perspectives on the 14C-based microtracing and macrodosing studies in humans in South Korea as an invited speaker to the 9th East Asia Accelerator Mass Spectrometry Symposium (EAAMS-9), held at KIST, Seoul, South Korea, on November 22-24, 2023. 

Prof. Lee has introduced the concept and utilizes of the 14C-based microtracing and macrodosing study for new drug development since 2024. As of today, Prof. Lee has completed a total of six microtracing/microdosing studies with one being the IND-opening study for the US FDA. In his talk, Prof. Lee shared his experiences in starting a 14C-labelled human study using the microdosing technology in Korea. Additionally, Prof. Lee gave hist perspective as to how this technology can be further utilized to increase the efficiency of clinical drug development.

Prof. Howard Lee gave a talk at an invited symposium in association with the Annual Conference of the Korean Society of Medical Informatics (KoSMI), held both online and offline on November 29, 2023. The title of his presentation was ‘Performance Increase of the Machine Learning Model to Predict Acute Coronary Syndrome in Patients with Type 2 Diabetes Mellitus by Replacing Binary Variables with Propesnsity Score’. This presentation was a culmination of a research project with the same title supported by the Seokcheon Foundation, 2023, where the current and former CCADD graduate students, namely David Seung U Lee, Jung-Hyun Won, and YeSol Hong collectively contributed by proposing a new novel way to address the falseness of binary feature in the electronic medical records. Prof. Lee's speech was well received by the audience evidenced by 6 follow-up questions! The more detailed methodological aspect of Prof. Lee' talk was presented in an accepted poster led by David Seung U Lee.  

CCADD was honored to participate in the joint symposium organized by Seoul National University (SNU) and Kyushu University (KYU) on September 14th. This marks the fourth year of the annual symposium, which was established to foster research collaboration between SNU and KYU.

This year's symposium focused on the theme of “Navigating the Artificial Intelligence (AI) Frontier: A Collaboration.” The discussions were categorized under three sub-themes:

AI for a Sustainable Future: Advancements and Challenges

AI and Human-Centric Innovation: Shaping the Future Together

AI Ethics and Responsible Innovation: Shaping a Trustworthy Future

Under the second sub-theme, David Seung U Lee represented CCADD and presented on “Predicting the efficacy of investigational drugs using real-world data.” This sparked subsequent discussions exploring avenues for further collaboration among the participants.

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 discussed the issues of new drug development policies and strategies laid out by the Yoon government at the 6th Policy Symposium of the Professional Graduate Schools at Seoul National University, held on September 28, 2022 at the Graduate School of International Studies. Prof. Lee started his presentation by telling why it is important to talk about new drug development policies right at this moment. According to Prof. Lee, the likelihood that South Korea can become a leading country in drug development is the highest in history, but it has to be strengthened and guided by the government to make it a true reality. Prof. Lee pointed out the policies and strategies as proposed were too much focused on biologics, infectious disease, and digital health, urgently requiring some levels of balance. Prof. Lee further emphasized the importance of having a nationwide control tower to reduce redundant investments and to facilitate faster actions currently involving too many government agencies and ministries. Prof. Lee concluded his presentation by saying, "Even though all the recommendations are implemented, Korea cannot become a leading country in new drug development unless the society as a whole is ready to pay a price for innovations."

Prof. Lee's presentation can be watched by clicking the following YouTube link: 

Prof. Howard Lee discussed how the COVID-19 pandemic could change the current paradigm of drug and vaccine developments at a symposium, organized by the Graduate Schools, Seoul National University, October 7, 2020. The symposium featured 5 speakers, each from a graduate school at SNU, and the title of the symposium was "Corona Pandemic: Where Is South Korea Heading?" Each speaker presented his/her view on the impact that the COVID-19 pandemic has brought upon various aspects South Korea has been and will be facing since its beginning. 

Prof. Lee pointed out the unprecedented amount and speed of vaccine/drug developments since the pandemic, which could prompt and hasten the disruption of the old ways to develop drugs and vaccines, such as more virtual and remote clinical trials, open innovations based on massive private-public partnership, and acceptance of new innovative technologies. Prof. Lee's presentation can be watched here. Or, there is a YouTube streaming too as seen below.

The 2019 Observational Health Data Sciences and Informatics (OHDSI) Korea International Symposium was held on December 12-14 at Konjiam Resort, Korea. The symposium gathered nearly 400 participants from nine different countries, clearly showing a growing interest in the OHDSI community. The main session on the second day was followed by full-day tutorial workshops on the first day. The main session began with a warm welcome by Prof. Rong Min Baek, the Chairman of the Department of Plastic and Reconstructive Surgery at Seoul National University College of Medicine, followed by an overview of the Korean OHDSI journey by Prof. Rae Woong Park, the Director and Professor at the Department of Biomedical Informatics at Ajou University School of Medicine. Other topics in the main session included an introduction to the European Health Data & Evidence Network (EHDEN) project, the OHDSI Initiative, and the FeederNet platform. The key message from all these presentations was on generating reproducible and reliable evidence from the existing clinical data standardized by the OHDSI common data model (CDM).  

Among three parallel sessions, 'Clinical trials in OHDSI' session was newly introduced this year. This parallel session purely focused on clinical trials, which consisted of the following three invited talks: 'Introduction to clinical trials', 'Smart User-friendly CDM-based Clinical trial dEsign Support System, SUCCESS', and 'OHDSI use case: clinical trial feasibility'. Charles Joochul Lee, a general manager of Selvas AI Inc., and Ms. Yoomin Jeon were invited to give a talk on the SUCCESS project, a CDM-based simulation system to assist clinical trial feasibility and designing clinical trials. Mr. Lee introduced the principles behind why and how SUCCESS was developed. Mr. Lee then gave a demonstration of SUCCESS system. To provide a better understanding of how a CDM-based simulation system can be implemented, Yoomin spoke about a CDM-based virtual clinical trial project (from the 2nd Korea Clinical Datathon) as a case study. Using the Ajou University Hospital CDM real-world data, her team has successfully shown that patients with type 2 diabetes mellitus, who are treated with metformin, sulfonylurea, and/or dipeptidylpeptidase-4 inhibitors (DPP4i), can benefit from add-on sodium-glucose cotransporter 2 inhibitors (SGLT2i) treatment in terms of both additional efficacy and comparable safety. Based on the analysis using this CDM data, adding an SGLT2i has shown an additional efficacy and comparable safety profiles to those identified with SGLT2i in actual clinical trials. Yoomin concluded her talk by stating that exploring the efficacy and safety of the proposed treatment using simulation experiments can help design an optimized clinical trial, which may increase the chance of success in the clinical trials. The talks by Mr. Lee and Yoomin were well received, and an active and interesting Q & A session was followed.

When Prof. Lee decided to attend the AMIA 2019, the annual symposium sponsored by the American Medical Informatics Association, which was held on November 16-20, in Washington DC, USA, he had two objectives in mind. First, Prof. Lee wanted to get an overview of the impending issues and emerging research topics in the field. Second, he wanted to get some insights how those issues and research topics could meld with those at CCADD such that it may adjust, refine, expand, or even cross the border of what it used to day to day in the form of research and project. 

Did Prof. Lee successfully achieve his objectives? Pretty much. Carefully, but rather passively watching and observing what’s happening now in the medical informatics field, which is rather unusual for him, who used to be quite vocal and involving, Prof. Lee realized again that technology may come and go, but the domain doesn’t. It was a pleasant reaffirmation of his longstanding belief. The speakers and audience always emphasized why, rather than how, they did this or that although they were not shy at all of delving into technical complexities when necessary. This AMIA’s ‘put-patients-first’ philosophy was also highlighted by Dr. Tetteh‘s opening keynote speech, who stressed ‘human care’. Wasn’t this the least likely talk that one could expect to hear at an informatics conference? Oh, by the way, Dr. Tetteh is the Chief Medical Information Officer for the US Navy. The audience wholeheartedly responded to Dr. Tetteh’s speech by standing ovation.     

This was very much enlightening to Prof. Lee, given that KOSMI 2019 he had joined just a couple weeks before in Korea was too much packed with technical dudes, who boasted how skillful and advanced they were while failing to or faintly paying due attention to patients, medicine, and the domain. For example, the electronic medical records (EMR) is a great way and tool. But, do we have any evidence that EMR has improved patient outcomes? Has EMR enabled physicians for analyzing patient data more efficiently, assisting them to make better decisions? Not quite so.  

But, don’t get Prof. Lee wrong! Technology is important. “The more we care about the domain, the more we should be fully cognizant of and conversant in the technology”, Prof. Lee spoke up. “What matters, however, is not to lose our perspectives and reasons why we are doing this in the maze of technological overloads”, he added. This understanding led Prof. Lee to his next question. “Have we arrived at a point that encourages CCADD to rethink about its direction?” “Is the timing right?” 

Not sure yet, frankly speaking. However, one thing is clear. CCADD should not postpone asking themselves those questions!   

The fifth annual Observational Health Data Sciences and Informatics (OHDSI) Symposium was held on September 15-17, 2019. OHDSI is a multi-stakeholder community on a journey to develop reliable real-world evidence through methodological research and open-source analytics development to bring out the value of observational health data. This year, more than 400 attendees gathered in North Bethesda, Maryland for the symposium. Around 70 participants flew in from Korea, including Prof. Howard Lee and Yoomin Jeon. The symposium had 1 day packed with dynamic and engaging keynote lectures, panel discussions, and a collaborator showcase featuring 7 lightning talks, 10 interactive demonstrations of OHDSI's open-source software, and nearly 80 poster presentations. The other 2 days of the symposium offered more practical hands-on tutorial workshops covering 6 different topics related to real-world data. The tutorial sessions covered the following topics: 1) OMOP Common Data Model & Standardized Vocabularies, 2) Cohort Definition/Phenotyping, 3) Patient-Level Prediction (PLP), 4) Population-Level Estimation (PLE), 5) Data Quality, 6) Extraction, Transformation, and Load process (ETL). Through these hands-on tutorial sessions, Prof. Lee and Yoomin were able to better understand how to leverage the ATLAS, a type of OHDSI's open-source software for designing and executing analytical use cases for clinical characterization, PLP, and PLE within one institution or across the entire OHDSI network. All the tutorial materials can be found here!

As a part of the OHDSI's knowledge-sharing mission, the Book of OHDSI was officially released and distributed for free at the symposium. The book is 470 pages long, consists of twenty chapters in 5 different sections: the OHDSI Community, Uniform Data Representation, Data Analytics, Evidence Quality, and OHDSI Studies. Many OHDSI community members voluntarily chipped-in to summarize all the knowledge developed over its existence into one place, which will assist both newcomers and data science veterans in doing research related to common data model. The book is available on Amazon or online for free.