Six undergraduate students (Sung Jong Kim, Hwe Won Kim, Jinyeong Yang, Song Yeon Oh, Chae Jeong Lee, and Yura Hwang) joined CCADD for the 2020 Winter Smart Internship, and they will spend the next 8 weeks in exploring the research environment at CCADD while having opportunities to participate in the ongoing research projects.

Sung Jong Kim is a fourth-year undergraduate student at Hankuk University of Foreign Studies, double majoring in Molecular Biotechnology and English-Korean Interpretation and Translation Studies. Studying biology and biotechnologies, Sung Jong has developed a broad interest in pharmacology and computer science. He is looking forward to learning NONMEM, an analysis program for pharmacokinetic pharmacodynamic (PKPD) modeling, during his internship program.

Song Yeon Oh is also a senior student at HanKuk University of Foreign Studies, and has studied Environmental Science. Song Yeon's research interests include applying artificial intelligence (AI) technologies into the pharmaceutical area to make drug development processes more efficient. During the internship program, she wants to learn methods to analyze medical data using computer language, such as Python and R, by participating in the CCADD's current projects.

Chae Jeong Lee is a second-year student at HanKuk University of Foreign Studies, majoring in Biomedical Engineering and Computer and Electronic Systems Engineering. Being familiar with C and Python, Chae Jeong wants to participate in CCADD's current AI projects such as those awarded by National Institute of Food Drug Safety Evaluation (NIFDS) and South Korean Ministry of Trade, Industry, and Energy (MOTIE). Through this winter internship program, she is looking forward to learning R to improve her coding skills.

Hwe Won Kim is a fourth-year undergraduate student at Konkuk University. She studies Converged Material Engineering and Environmental Engineering. Prior to the internship program at CCADD, Hwe Won worked as an intern researcher in the Department of Stem cell and Regenerative Biotechnology laboratory and has become interested in pharmacology and AI technologies. Through the internship program, she is looking forward to learning the basics of clinical pharmacology and AI algorithms applicable to pharmaceutical area.

Jinyeong Yang is a second-year student at College of Agriculture and Life Sciences, Seoul National University. Jinyeong was involved in research project project to develop a liquid bandage for patients with atopy to prevent potential secondary infections. Through her past experience, Jinyeong has become more interested in PK, PD, and development process of a drug. She is looking forward to learning the pharmacology and drug development process, as well as experiencing the research environment in graduate school. 

Yura Hwang is a senior student at Pusan University with a major in Molecular Biology and a minor in Chemistry. Previously, Yura worked in PRG S&T, a pharmaceutical start-up, where she has developed an interest in theoretical and computational methods to describe variability in PK. She is looking forward to learning NONMEM during her internship program.

This 2020 winter internship program will provide participants with opportunities to learn clinical pharmacology, machine learning algorithms, and computer languages for data analysis as shown below. CCADD wholeheartedly welcomes the 6 intern students, and hopes them to enjoy, learn, and experience as much as they want and can during the rest of their internship programs.

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.

On December 4-5, 2019, CCADD and Selvas AI Inc held their first-ever joint workshop on Common Data Model (CDM)-based simulation system project, which were co-awarded by the South Korean Ministry of Trade, Industry, and Energy (MOTIE) (a link to previous news). The project is coined as SUCCESS or 'Smart User-friendly CDM-based Clinical trial dEsign Support System. The main objective of this workshop was to share what Selvas and CCADD have accomplished during the first-year of this on-going project and to plan for the following year. 

On the first day, a hands-on tutorial on ATLAS was led by two invited outside speakers, Mr. Jaehyung Cho and Mr. Chungsoo Kim from Ajou University. ATLAS is a web-based open-source platform developed by the OHDSI community aiming to perform complex patient/population studies on OMOP CDM databases and visualize the results. This hands-on tutorial focused on presenting the fundamental principles and implementations on ATLAS, covering CDM vocabulary tables, standard vocabulary browsing, concept sets, cohort definition/phenotyping, and population-level estimation. The tutorial was well organized and interactive, which helped all the participants better understand the implications and possibilities of ATLAS for SUCCESS.

On the second day, a year-end performance review for SUCCESS was presented by Mr. Charles Joochul Lee, a general manager of Selvas AI Inc., who has led the project in collaboration with Prof. Howard Lee. Additionally, a domain expert in the field of clinical trials, Ms. Jumi Han, a team leader, Daewoong Pharmaceuticals, was invited. Ms. Han gave the team an instantaneous feedback on the aspects of practical implementation of SUCCESS. This session of the workshop was a unique opportunity to identify ways to improve the performance of SUCCESS. 

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!   

Two senior undergraduate students, Yonghan Kwon and Won Jeong Go, joined CCADD for the summer internship program on July 1, 2019, which will end in eight weeks.

Yonghan has studied applied statistics and taken several data mining and machine learning classes at Kyonggi University. Being familiar with R and Python, Yonghan wants to improve his coding/programming skills by participating in several CCADD's ongoing AI projects awarded by the National Institute of Food Drug Safety Evaluation (NIFDS) and South Korean Ministry of Trade, Industry, and Energy (MOTIE).

Won Jeong has studied at Handong University with a major in life science and a minor in computer science. Won Jung's research interests include genomic analysis for the safe use of drugs, and is happy to work with Dr. Jeong-An Gim in the pharmacoepigenomic study of tacrolimus. She hopes to learn essential concepts necessary for the analysis of genomic data using computational techniques.

CCADD welcomes Yonghan and Won Jeong, and hopes them to enjoy the rest of their internship programs.

CCADD has been recently awarded a new research grant from the South Korean Ministry of Trade, Industry, and Energy (MOTIE) to develop a clinical trial simulation system. The kick-off meeting was held on June 3, 2019. The total research funding was 1.4 billion Korean Won, which is equivalent to $1,200,000. The three-year project will be led by Mr. Charles Joochul Lee, a general manager of Selvas AI Inc, and CCADD (PI: Prof. Howard Lee) will develop a CDM-based simulation system, by which clinical trial feasibility is performed. In the process, CCADD will also design a user-friendly interface for the system. 

The title of the proposed research plan is the 'Smart User-friendly CDM-based Clinical trial dEsign Support System, or SUCCESS', an interesting term coined by Prof. Howard Lee, which symbolizes the desire for success in clinical drug development.  

On April 24, 2019, Prof. Howard Lee and 5 CCADD members presented a seminar at the Laboratory of Genome Epidemiology and Health Big Data (G-Epi), Graduate School of Public Health at Seoul National University. It was a return visit in response to G-Epi's one 10 months ago. G-Epi (PI: Joohon Sung) focuses on the data analysis of genetic, demographic, physiological, and environmental factors of complex diseases. G-Epi uses epidemiological, statistical, and bioinformatics approaches to analyze large-scale omics data.

In the seminar, Prof. Howard Lee introduced G-Epi to one of the CCADD's current Artificial Intelligence (AI) research projects, entitled 'A dimensionality reduction model to increase the efficacy and accuracy of clinical trial feasibility assessment using electronic medical records.' Hyun A Lee and Dr. Jeong-An Kim also spoke about their research projects, a PBPK modeling analysis of an acid-reducing agent under clinical development and a pharmacoepigenomic analysis of Tacrolimus, respectively. The seminar was a great opportunity for both labs to share their research experiences, ideas, and future perspectives. G-Epi and CCADD are looking forward to closely working together in various research projects in the future. 

ACTRiS or the AI-based Clinical Trial Resource Information System is one of the CCADD’s recent research projects, which was successfully completed by early 2019. On January 9, KIPO or the Korea Intellecutal Property Office granted a trademark registration for ACTRiS. This is a little, but meaningful success for those who have been actively involved in the design, plan, conduct, and completion of the ACTRiS research project, which include, but are not limited to, CCADD members, Prof. Joon Sik Lee and his UX lab, Prof. Jin Wook Choi and his medical informatics lab, Prof. Jang Hee Hong and his Pharmacogenetics lab, Prof. Hyoun-Joong Kong, Mebixon, and, lastly, but not the least, Selvas AI.

CCADD has also filed the logos for P-MATCH and ACTRiS for registration with KIPO. 

Prof. Howard Lee was invited to speak at an educational seminar and an international symposium, both sponsored by the Pharmaceutical Society of Korea, in association of its spring convention, held in the Millennium Hilton Seoul, Korea, on April 25-26. The PSK is an academic organization representing pharmacy since its foundation in 1946, which has grown into the biggest institution for pharmacists in Korea. In the educational seminar, Prof. Lee talked about how bio-big data can be used for the efficient planning and conduct of clinical drug development. His talk was based on his experience and lessons learned in the two recent research projects that CCADD led and will be actively participating, i.e., ACTRiS and SUCCESS. His presentation has received media attention as summarized in a newspaper article.   

The international symposium was held on the second day of the convention. Prof. Lee introduced the audience to several possible applications of artificial intelligence (AI) to clinical trials, with a special focus on a CCADD research project using feature selection for clinical trial feasibility. This symposium was organized by Prof. Hwi-yeol Yun, Chungnam National University College of Pharmacy, a long-time friend and collaborator of Prof. Lee's.