Prof. Lee was invited to the 6^th Gaucher Regional Forum -virtual edition, where he talked about the biosimilarity in the orphan world, particularly in the drug development for Gaucher disease. Prof. Lee also moderated the session. A year ago, Prof. Lee joined the 5^th of its kind, held in Kuala Lumpur, Malaysia. 

The Forum entailed a series of dynamic and exciting discussion around the diagnosis, patient management and the safety and well-being of patients with Gaucher Disease. In his speech, Prof. Lee contrasted the differences between small molecule drugs and biologics, and how these differences could translate into something every clinician has to understand when she prescribes a biosimilar to her patients. Prof. Lee went further to explain why intended copies are not true biosimilars although almost all of them have been promoted and marketed as they were. For example, Abcertin by ISU ABXIS is not a true biosimilar to its reference biologic, which is imiglucerase by Genzyme®. Knowing the difference between true biosimilars and intended copies is very important not only for every practicing physician, patient, but for regulators to ensure each patient gets a biologic of high quality, which underwent the regulatory review and scrutiny. 

On October 30, 2020, CCADD and collaborating investigators had a workshop at Pocheon, Kyeonggi-do, to celebrate the consecutive two-year success for the common data model (CDM) expansion project. In this workshop, Prof. Howard Lee, Yoomin Jeon, Sium Kim, and Tae Kyu Chung summarized the project outcomes in the second year.

In a session, Tae Kyu evaluated the mapping rates of clinical terminologies, collected from the eligibility criteria, efficacy, and safety outcomes in sampled clinical trials at clinicaltrials.gov, to CDM standardized vocabularies. On the other hand, Prof. Lee detailed the pros and cons of the CDM analytical tools, such as the Atlas and methods Library, which may be used to conduct clinical trial feasibility, efficacy, and safety analysis in a virtual, simulation setting. After the presentations, the workshop participants actively engaged in an interactive discussion how to leverage the potentials of CDM, while minimizing its limitations, to clinical trials. They further discussed the project management plan for the upcoming year to improve project design, setup, execution, and close-out.

The CDM expansion project has been sponsored since 2019 by Korea Health Industry Development Institute through a three-year grant totaling 77 million Korean Won or $66,000. 

Prof. Howard Lee was invited to a forum as the plenary speaker, organized by Congressman Lee Yongho and co-sponsored by the Future Health Network on September 23, 2020. The forum was entitled "How to Enhance Patient Access to New Drugs", and Prof. Lee overviewed the issues pertaining to the current Positive Listing system (PLS) in Korea to curtail pharmaceutical expenditure nationwide. In 2006, the Korean government changed the pharmaceutical pricing system such that only drugs showing sufficient cost-effectiveness could be reimbursed by the National Health Insurance System. Unlike the initial expectation and intention, however, PLS has not contributed much to reducing the nationwide drug expenditure, while it has significantly inhibited patients from getting access to new innovative medicines. In this context, Prof. Lee emphasized PLS had to be supplemented by new systems to drastically promote patient accessibility to new drugs such as realistic and flexible ICER thresholds, extension of the risk sharing arrangement to other disease and therapeutic areas than orphan and serious diseases where no reliable treatments are existing and available, cutting expenses in generic support and medical services that have not proven their efficacy, safety, or cost-effectiveness, and developing new social funds other than health insurance. 

Prof. Lee's presentation was received with a mix of approvals and objections, the latter of which came mostly from the government side including the Ministry of Health and Welfare, the Heath Insurance Review and Assessment, and the National Health Insurance Service. The whole forum was televised live through YouTube.

Prof. Howard Lee has officially expressed strong disapproval of the reimbursement for 'cheobyak' or the mixture of herbal (or natural products-derived) drugs. In a roundtable provoked by the impending reimbursement decision of cheobyak by the Korea National Health Insurance Service against the objections by medical and scientific societies altogether, Prof. Lee raised intense disagreement with the government policy to support reimbursement of cheobyak. Prof. Lee argued that cheobyak has never been shown to be efficacious and safe through scientific assessments by the regulatory agency such as the Ministry of Food and Drug Safety in Korea, not to mention its uncertain quality as a medicine. He continued, discussing "The cost-effectiveness of any cheobyak has never been validly studied and confirmed, which is the minimal requirement for any drug approved and listed for health insurance reimbursement in Korea." 

A summary of Prof. Lee's presentation at the roundtable can be found in many newspaper articles, one example of which is here. Additionally, his full presentation has been uploaded to YouTube as seen below:        

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.

The 2019 fall conference of The Korean Society of Medical Informatics (KOSMI), organized by Kyungpook National University Hospital (KNUH), was held November 8-9, 2019, at the Global Plaza, Kyunpook National University, Daegu. Prof. Howard Lee, Yoomin Jeon and Junsik Moon participated in the conference.

The conference presented 19 symposia, 6 oral presentation sessions of pre-selected paper submissions, and 3 tutorials in healthcare information, pharmaceutical and big data research which focused on analysis, application and standardization of data based on artificial intelligence (AI) and machine learning. Sharing research ideas and analysis techniques, the attendees had an in-depth discussion on emerging issues and utilization in the fields of medical informatics.

On the second day, Prof. Lee chaired one of the oral presentation sessions entitled "New Drug and Pharmacovigilance", where he stressed full understanding of the research domain by communicating with experts in each research field. On the other hand, Yoomin presented two posters titled 'A Dimensionality Reduction Model to Increase the Efficiency and Accuracy of Clinical Trial Feasibility Assessment Using Electronic Medical Records' and 'A CDM-based Clinical Trial to Evaluate the Efficacy and Safety of SGLT2 Inhibitors as Add-on Treatment in Patients with Type 2 Diabetes Mellitus on Metformin, Sulfonylurea and/or DPP-4 Inhibitors'. Yoomin's poster presentations were well received.

Through the conference, the three members of CCADD were delighted to get introduced to the leading academicians and industry experts in the field of medical informatics. Furthermore, Prof. Lee and two CCADD members had a fun discussion that helped them look deeply into their current activities and direction of future research. Their collected insights out of the conference will be further discussed at the upcoming year-end workshop in early December.

Prof. Howard Lee and Yoomin Jeon participated in the 2nd Korea Clinical Datathon, organized by the Korea National Enterprise for Clinical Trials (KoNECT), September 20-22, 2019. The event was well-attended, which brought over 200 participants, almost doubling the number of those who joined last year. A Datathon is a type of data-focused hackathons, where interdisciplinary teams are challenged to come up with analysis results using their creativity and data science skills within a limited amount of time. The Korea Clinical Datathon aims to bring together clinicians, data scientists, statisticians, students, and those with domain-specific knowledge to brainstorm ideas and to address real-world clinical challenges by applying data analytics technologies. Participants were given access to 3 types of datasets extracted from MIMIC-III (Medical Information Mart for Intensive Care-III), the Seoul National University Hospital VitalDB (vital signs database of surgical patients), and the Ajou University Hospital CDM (Common Data Model).

The first day kicked off with 14 different open-ended clinically relevant questions to address a variety of topics in the medical field. Prof. Lee and Yoomin were on Team 6, comprised of 13 members including four clinicians, three statisticians, one data scientist, and three students. Lead by Prof. Lee, Team 6 came up with the following research question: "Are add-on sodium-glucose cotransporter 2 inhibitors (SGLT2i) efficacious and safe in patients with type 2 diabetes mellitus who are on metformin, sulfonylurea and/or dipeptidylpeptidase-4 inhibitors (DPP4i)?". Using the Ajou University Hospital CDM real-world data, Team 6 has successfully shown that patients with type 2 diabetes mellitus can benefit from add-on SGLT2i treatment in terms of both additional efficacy and comparable safety. Based on the analysis, adding an SGLT2i has shown reductions in HbA1c (approximately 0.76%, very similar to previous publication results) and body weight. In addition, a higher risk of urinary tract and genital infections was found, which are the most common side effects identified with SGLT2i in clinical trials. 

On the last day, the sleep-deprived but exhilarated participants presented their findings for a competition. Even though Team 6 failed to win the competition, it was a unique opportunity to get hands-on experience and to learn about possibilities of how machine learning/statistics/data analytic skills can address current challenges in healthcare.

The In Depth 60 Minutes, an investigative journalism program broadcast by KBS, featured an interview with Prof. Howard Lee on August 16, 2019 with respect the recent Invossa debacle. Invossa is a gene and cell therapy approved to treat patients with osteoarthritis of the knee. Invossa was claimed to contain genetically transformed chondrocytes, which turned out not to be the case. Instead, they were cells originated from the human embryonic kidney, which could cause cancer to develop in those who received Invossa. Invossa has been administered to more than 3,000 patients only in Korea. The Korea Ministry of Food and Drug Safety (MFDS) revoked the marketing approval of Invossa, and promised to initiate a nationwide pharmacovigilance program to investigate the safety impact of Invossa, which though has not been in effect yet. 

In the show, Prof. Lee emphasized why misbranding or mislabelling is a significant health harm, which can be legally penalized. Furthermore, he explained why MFDS was not able to detect what went wrong in the case of approval of Invossa. Prof. Lee added, "Although MFDS has been trying to renovate themselves over the past decade or so, it still lacks the expertise and manpower required to adequately review the safety and efficacy of the drug, particularly advanced therapies such as Invossa." Prof. Lee was featured in a total of four clips. 

The full program can be watched by clicking here.

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.