The AI Summit New York 2019 has been promoted as "the only event globally to focus exclusively on the impact of AI in business", and that's not an exaggeration. Attracting >5,000 attendees from all of the world, of whom Prof. Howard Lee is one, the AI summit New York 2019 was featured by three exclusive tracks, i.e., the Deliver Stage for the visionary high-ranked leaders and chief officers, the Implement Stage for the senior strategists, the Develop Stage for the technical leaders. Additionally, there were four summits, each focusing on a specific business field or sector, i.e., finance, retail, healthcare and pharma, and sales and marketing. Lastly, but not the least, AI training academy, mostly introductory though, was provided. Truly, it was enlightening to listen and watch how AI has been implemented to leverage its core technology to maximize the efficiency and productivity of day-to-day business practices in many business areas from strategy planning to decision makings to operations to outcome tracking. 

Of the many talks and show case presentations, Prof. Lee was particularly hooked up with a high-level, inspiring, and thought-provoking presentation by Mr. Jeff McMillan, Chief Analytics and Data Officer at Morgan Stanley. What made his talk unique from many others was that Mr. McMillan helped the audience realize AI is not an objective, but business outcome is. According to him, too many AI has simply failed to deliver what it promised to provide either because it didn't actually do what it said it did, it worked but added no value, it added value but was too complicated to use, it was to expensive to implement, or it lacked the necessary data. Certainly, Mr. McMillan's talk was a wake-up call to many AI-porn geeks. So influenced by Mr. McMillan's talk, Prof. Lee has decided to deliver his own version of Mr. McMillan's presentation after he returns. 

New York City in December was cold and wet as usual, mixed with businessmen, tourists, and passers-by with a motionless face. Prof. Lee has departed for the next destination, Boca Raton, Florida to attend another meeting there. That's is why he had to bring a much bigger suitcase than usual for this trip that suits two different temperature zones.   

On December 5, 2019, CCADD had a 2^nd year-end workshop at the LAKAI Sandpine resort in Gangneung city. The workshop was not only attended by the existing CCADD members, but also by the prospective student Yoona Choi. The aims of the workshop were to overview, evaluate, and celebrate the achievements of year 2019, to set up new goals for 2020, and to build up team spirit among all the current and future lab members. The workshop included 9 presentations, the theme of which covered the milestone and future of CCADD, administration review, talent acquiring strategies, and educational and research activities.

After the workshop, Siun Kim, a 2^nd year Ph.D. student at CCADD, who happens to be a talented dancer taught a couple of basic choreograph. The song used for the dance cover was 'Let's Groove' by Earth, Wind & Fire. Although many were new to dancing, everyone truly enjoyed dancing. At first, many felt so awkward about their moves, but soon after, everyone moved to the music and enjoyed the session. 

You can also find how fun the workshop was! 

Four CCADD members, that is two professors (Prof's. Howard Lee and Kyeong-Ryoon Lee) and two post-docs (Dr's. Hyun-A Lee and Yoo-Kyung Song), taught at a 5-day Advanced Course for Pharmaceutical Medicine or ACPM, December 7-8, 2019, in Seoul National University Hospital. Since 2007, ACPM has been presented 18 times including this year, and Prof. Howard Lee has served as the Chair for the course since 2017. ACPM has been designed to practically dig into seminal areas indispensable for any scientific and efficient drug development program, such as manufacturing and GMP, pre- or non-clinical toxicology, preclinical and clinical ADME (absorption, distribution, metabolism, and excretion), early and late clinical drug developments. 

For this year, Prof. Kyeong-Ryoon Lee, Dr's. Song and Lee shared their >30 year-experience in drug development ADME with a particular emphasis on preclinical pharmacokinetic assessments (Prof. Kyeong-Ryoon Lee), drug metabolism and transporters (Dr. Song), and physiologically-based pharmacokinetic modeling (Dr. Lee). Additionally, Prof. Howard Lee lectured how to design, plan, and conduct efficient early clinical drug development studies. All of the lectures were well accepted! 

Dr. Hyun A Lee attended the SimCYP workshop on model-informed drug development, held on November 12th - 15th, 2019, in Shanghai, China. The SimCYP simulator is a platform for modeling and simulation of physiologically-based pharmacokinetics (PBPK) and pharmacodynamics in virtual humans and laboratory animals. It is one of the most sophisticated solutions for assisting in dose selection and informing product labeling. At CCADD, the SimCYP simulator has been used for physiologically-based pharmacokinetic and pharmacodynamic modeling and simulation of test articles under preclinical and clinical development.

Th workshop offered an in-dept insight into specific areas of PBPK modeling such as transporter-related absorption, distribution, metabolism, excretion, and toxicity (ADMET) and complex drug-drug interactions (DDIs). The workshop courses consisted of lectures and hands-on practical sessions tutored by the SimCYP simulator experts. Dr. Hyun A Lee learned good practices in combining data from both in vitro and clinical studies, while gaining experiences in using such data within physiologically-based pharmacodynamic models to evaluate the DDI liability of drug candidates. She also gained insights into mechanistic approaches to predict the impact of drug transport proteins on ADMET. For those who are interested in the SimCYP workshop's materials, please contact her. 

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 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.

This year's American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 was held in San Antonio, Texas, on November 3 - 6, 2019. AAPS PharmSci 360 is a conference that provides a dynamic forum for the exchange of knowledge among pharmaceutical scientists. Around 6,500 attendees gathered from all over the world to attend this year's conference, where ~1,500 abstracts were presented and >100 individual sessions were provided. Tae Kyu Chung and Siun Kim, two students at CCADD, also joined the conference as a poster author and presenter.

Tae Kyu's poster contained the result of a population pharmacokinetic (PK) modeling exercise of GC1118, a fully human IgG1 monoclonal antibody that is currently under clinical development for the treatment of solid tumor, entitled 'A Target-Mediated Drug Disposition Population Pharmacokinetic Modeling of GC1118, a Novel Anti-Epidermal Growth Factor Receptor Antibody, in Patients with Refractory Solid Tumors.'  He proposed a two-compartment target mediated drug disposition model, which adequately characterized the PK characteristics of GC1118. On the other hand, Siun proposed a population pharmacokinetic-pharmacodynamic (PK-PD) model that adequately described the concentration-time-kPCD (1000 * % ¹³Carbon dose excreted per minute) profiles of orally administered YH12852, a 5-hydroxytryptamine receptor 4 agonist currently under clinical development for the treatment of gastrointestinal motility disorders. Based on the final PK-PD model, Siun found that YH12852 improves one's gastrointestinal motility, resulting in an accelerated gastric emptying and early rise in kPCD values. The poster presentation by Tae Kyu and Siun were well received: many poster-goers, including professors, Ph.D. students, pharmacists, pharmacometricians from Pfizer and Merck, came along and questioned the nitty-gritty details about the models summarized in the posters.

By participating in the conference, Tae Kyu and Siun were able to better understand the recent trend in drug development, state-of-art technologies adopted and implemented in new drug development, and regulatory perspectives on clinical pharmacology strategies. Joining the conference was a great opportunity for learning, networking, and developing their professional careers. 

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. 

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.

Jun Sik Moon has started a new research career in the Center for Convergence Approaches in Drug Development (CCADD) at the Graduate School of Convergence Science and Technology, Seoul National University, since October 1, 2019. Jun Sik was a researcher at the Department of Mathematics, Research & Business Development Foundation, Sogang University (2018-2019) shortly before he joined CCADD. As the research interests in CCADD have gradually expanded, including AI and machine learning in drug development, CCADD wants to acquire talents such as Jun Sik, who could bring CCADD mathematical skills. Please join us in warmly welcoming Jun Sik!