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! 

Join us in congratulating Hyun A Lee for her successful graduation with a PhD degree in medical science in August 2019! Dr. Hyun A Lee came to CCADD in 2017, 2 years after she started pursuing a PhD degree under Prof. Howard Lee's supervision in association with the Graduate School of Convergence Science and Technology, Seoul National University. Dr. Lee is the first PhD student who has ever graduated from CCADD. The title of her thesis was "Mechanistic Physiologically based Pharmacokinetic/Pharmacodynamic Models to Evaluate the Mutual Relationship between an Acid Pump Antagonist and Intragastric pH in Humans (Using YH4808, a novel K⁺-competitive acid blocker, as an example)".

Dr. Lee will stay with CCADD at least an additional year as a BK21 Plus postdoctoral researcher. She will be performing research in the areas of physiologically-based pharmacokinetic modeling, pharmacokinetic/pharmacodynamics (PK/PD) modeling and simulation, and artificial intelligence-based PK/PD modeling and simulation in clinical drug development. 

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.  

We cannot believe how quickly time has passed. CCADD students have finished the 15-week 'Clinical Pharmacokinetics and Pharmacodynamics in Drug Development' course with no leftovers or dropouts. The students have learned in details how the core principles and concepts of pharmacokinetics and pharmacodynamics could be applied to speed up clinical drug development and to increase its efficiency, particularly for anti-cancer drugs. In the class, students have not only thoroughly reviewed two textbooks ('Pharmacokinetics in Drug Development, Volume 3 and 4') from chapter to chapter, but also studied other literature, which could go up to tens of published papers. Tae, one of the students who took the course, said, "It was eye-opening to see how what we studied in clinical pharmacokinetics and pharmacodynamics has been used to real world drug development." He added, "The class was also full of fun. It was an opportunity for the CCADD students to know each other better."

This course was taught in English. That means all the student presentations were given in English!

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.   

Two scientists from Samsung SDS, Mr. Jaeho Yang, Principal Engineer (Sr. Expert), IoT Lab, and Dr. Sunghoon Joo, PhD, Senior Engineer, Advance Research Lab, visited CCADD on August 24, 2018 to have a joint seminar. In this joint seminar, Prof. Howard Lee gave an overview of the research projects CCADD has performed in the area of applying the artificial intelligence (AI) technology to clinical drug development, entitled with 'AI-enriched Clinical Trials'. Prof. Lee emphasized how AI could streamline various research activities pertaining to clinical trials, one of which is patient enrollment. For example, it is important to know who did what and how before planning any clinical trial, which is the main theme of the grant that the Korea Clinical Trials Global Initiative or KCGI has recently awarded CCADD, named 'AI-based Clinical Trial Resource Integration System or ACTRiS',

Following Prof. Lee's presentation, Mr. Yang introduced CCADD to the core concepts of several AI technologies and their potentials in drug discovery. Recurrent Neural Network (RNN) and autoencoding (AE) were a few examples Mr. Yang put emphasis on during his presentation. After that, Dr. Joo expanded further on several research projects Samsung SDS has conducted to design new molecules for drug discover in silico using advanced AI technologies such as molecular graphs and AE. Collectively, Mr. Yang and Dr. Joo showed how AI could fasten the discovery of new drug candidates that are likely to maintain excellent bio-physico-chemical properties, which may save time, resources, and costs in the whole drug development program. 

CCADD and Samsung SDS agreed to continue looking for a cadre of collaboration and joint research opportunities that may benefit both organizations.   

The best model for humans is human. Drug development has long been suffering from the lack of translatability and predictability of the preclinical animal experiments to humans. Dr. Richard Klausner, former Director of the US National Cancer Institute, commented in 1998, “the history of cancer research has been a history of curing cancer in the mouse. … and it simply didn’t work in humans.” Twenty years fast forward, drug development scientists are still struggling with the same issue.

Microtracing/microdosing is an innovative technology that can revolutionize the current paradigm of clinical drug development. Typically, a very small amount of the drug, i.e., ‘microdose’, which is less than 100 micrograms (or 30 nmoles for proteins), is administered to humans. Since this is much smaller than 1/100 of the pharmacologically active dose, microtracing/microdosing technology can be employed at a very early stage of clinical drug development even when there is limited animal toxicology data. Furthermore, in order to trace minute doses, an accelerator mass spectrometer (AMS) is required and the compound should be labeled, typically with ¹⁴C. The microtracing/microdosing study allows clinical drug development scientists for generating the intravenous pharmacokinetics, mass balance, metabolite profiling, and absolute bioavailability data much easier, faster, and at a lower cost.  

Dr. Howard Lee has spearheaded the employment of microtracing/microdosing technology for drug development in Korea since 2012, supported by three government grants. Dr. Lee has successfully d a new research ecosystem for the microtracing/microdosing study, which helped him perform the first microtracing/microdosing study under a full investigational new drug (IND) application in 2014. The result of this study was published at the most reputable journal in the field. Dr. Lee has conducted two additional microtracing/microdosing studies, and has recently won a two-year grant of $1 mil, in which microtracing/microdosing technology will be applied to a new drug development study with biologics.

The Convergence Story, a periodical news letter published by the Graduate School of Convergence and Science Technology (GCST) at Seoul National University, interviewed Dr. Yuchae Jung on Sep 21 2017 about her past research experience and accomplishments, new research interests, and future plans. In the interview, Dr. Jung emphasized the application of artificial intelligence technology to streamline clinical drug development, particularly for efficient patient enrollment using machine learning algorithms based on the electronic medical record (EMR). More details about Dr. Jung's interview can be found at News letter.