Two CCADD members, Dr. Soohyun Kim (PhD in statistics) and Siun Kim (BS in biology) gave presentations at the 2018 Korean Statistical Society Fall Conference , held on November 2-3 at Ewha Womans University, Seoul, South Korea. Dr. Kim gave an oral presentation of an update of her research on optimal experimental design. Additionally, Siun presented a poster discussing the appropriateness of an equivalence margin used in a clinical trial with CT-P13, an infliximab biosimilar, developed by Celltrion. Dr. Kim’s presentation was well received from her peer statisticians, who have been actively working in the field of experimental statistics in Korea. Interestingly, statisticians at Celltrion dropped by Siun’s poster and asked several questions. On the first day of the conference, Dr. Kim joined a tutorial session on deep learning from a statistician’s point of view.

Prof. Howard Lee and Hyun A Lee attended the 9^th American Conference on Pharmacometrics (ACoP9), held October 7^th to 10^th, 2018, at the Loews Coronado Bay Resort near San Diego, CA, USA. ACoP is the annual scientific meeting of the International Society of Pharmacometrics (ISoP), an organization comprised individuals from around the globe from various backgrounds in pharmaceutics, engineering, statistics, and mathematics, who are passionate about advancing and promoting the field of pharmacometrics. The theme of ACoP9, "Modeling without Bounds",  means "internationalization/collaboration" and "fusion/integration" of pharmacometrics groups, methods, and tools among the fields of pharmacometrics and systems pharmacology, with more than 1,000 members from over 30 countries. Consistent with this theme, inspiring and innovative talks by the Keynote (Mr. Walter Woltosz, Simulations Plus) and the State of Art ( Prof. Andrew Lo, Massachusetts Institute of Technology) speakers were presented. The titles of their speeches were "Rocket motors, Stephen Hawking, and drug development" and "p-Values vs. Patient values: An Analytic Perspective", respectively. In addition, the pre-conference program on "Digital Health Technology, Machine Learning and Artificial Intelligence: The Future of Clinical Trials and Informative Therapeutic Decisions?" highlighted the latest innovations and clinical applications of digital health technologies. The conference program included >100 invited lectures/presentations and over 300 posters, tutorials, pre- and post-meeting workshops, and abundant networking opportunities with attendees from around the world. 

Hyun A Lee presented a poster at the meeting that detailed the development of a physiologically based pharmacokinetic (PBPK) model of YH4808, a novel potassium-competitive acid blocker to treat gastric acid related disease. In this study, the mechanistic cause of the decreased exposure YH4808 after multiple oral administration particularly at higher doses could be identified using the PBPK model.

In addition, you may want to contact Hyun A for her poster. 

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.   

Three CCADD members (Dr. Jeong An Gim, Yoomin Jeon, and Tae Kyu Chung) attended the Pharma AI & IoT 2018 conference, held in London, UK, from July 11 through 12, 2018. Many invited from pharmaceutical companies, software firms, and universities spoke at the conference. The conference provided a comprehensive outlook on the key issues about artificial intelligence (AI), which has been actively adopted at the pharma and healthcare industry. AI-augmented human decision-making was the central theme of the conference. Dr. Margaret McDonald from Pfizer told the audience machine learning or AI would increase efficiencies in regulatory decision-making. She added, "Unsupervised AI may integrate enormous amounts of data and those real world data support regulatory decision-making about drug safety." Likewise, many attendants emphasized the importance of AI in their field of specialization. During the conference, attendants discussed and shared best practices in furthering AI technology development specific to the pharma and healthcare industry through inspiring presentations and network opportunities.

After the conference, the CCADD attendants visited several landmarks in London such as the Greenwich Observatory, Tate Modern museum, and London Eye. Amazing weather and the scenic view of London was a big plus. Visiting London was a great refreshing and learning opportunity.

Prof. Howard Lee has attended the 40th EMBC (Engineering in Medicine and Biology Conference), Honolulu, Hawaii, USA, on July 17-22. The theme of the meeting was “Learning from the Past, Looking to the Future”, inspired by the 40th anniversary of the world’s largest international biomedical engineering meeting.

In the Conference, Prof. Lee co-chaired a minisymposia with Prof. Kyung-Soo Park, Yonsei University, entitled 'Pharmacometrics Approaches & Novel Drug Delivery Systems in Pharmaceutical Engineering'. Prof. Lee also spoke about the ACTRiS project at the minisymposia, particularly with a strong emphasis on the importance of precision feasibility for clinical trials. The one-page abstract for Prof. Lee's presentation that he co-authored with one of his students, Yoomin Jeon, can be downloaded below. 

Many of CCADD members have attended the Spring Conference of The Korean Society of Medical Informatics (KOSMI), held at Samsung Medical Comprehensive Cancer Center on June 14-15, 2018. Reflecting the recent drastic increase in the demand and importance of data science in health sciences, the theme of the conference was 'Evolving Data for Better Health'. More than 600 researchers, practitioners, and vendors in health informatics gathered together to share their knowledge, experience, results of research, and expertise through a series of keynote speeches, symposia, oral/poster presentations, and exhibitions.

Four abstracts by CCADD were accepted for poster presentation. Yoomin Jeon proposed a new approach to transform clinical trials eligibility criteria (EC, free-text) into structured data using the OMOP-CDM(Feasibility of Using the OMOP Common Data Model to Assess Clinical Trial Feasibility). She found that >75% of the EC could be mapped by the proposed approach, and the most important data group was condition.

Serin Lee, a student intern, gave her poster presentation entitled 'Dimensionality Reduction Model for Common Eligibility Criteria to effectively use Electronic Medical Record: A Pilot Study.' She proposed a dimensionality reduction model for common eligibility features (CEFs) based on ontology and semantic features of EC to reasonably compose the concept sets.

Dr. Soohyun Kim proposed a new type of command data model for clinical trials (Clinical Trial Common Data Model, CT-CDM) to support decision-making processes in clinical trials, entitled 'CDISC-based Common Data Model for Developing an Integrated Decision-Support System in Clinical Trials'. This command data model fully complies with the standards of Clinical Data Interchange Standards Consortium(CDISC) as a global, platform-independent data standard guaranteeing system interoperability. 

Lastly, but not the least, Dr. Jeong-An Gim shared his research findings: Application of Machine Learning Technology to Classify Healthy Subjects into Different Pharmacokinetic Exposure Groups to Tacrolimus. Using the decision-tree approach employed in R, Dr. Gim aimed to identify SNPs that are associated with the exposure to tacrolimus. The rs776746 in the CYP3A5 gene was the most influential mutation.

More detailed research findings can be downloaded below.

Much to everyone's delighted surprise, Serin Lee won an external solid-state drive of 1TB at the raffle draw! Since Serin will graduate in August, the prize was certainly a nice present. 

Hyun A Lee and Dr. Kyeong-Ryoon Lee were invited to speak at a seminar on February 6, 2018, held in a laboratory at the College of Pharmacy, Kyungpook National University (PI: Prof. Kwang-Hee Shin). Hyun A and Dr. Lee shared their real world drug development experience in physiologically-based pharmacokinetic (PBPK) modeling and simulation using the Simcyp Simulator (Certara USA, Inc.). They both had considerable hands-on experience in PBPK modeling and simulation since they worked as researchers at Daewoong Pharmaceuticals, Korea.  

PBPK modeling and simulation can play a significant role in drug development decision-making. Particularly, Cetara's Simcyp Simulator, used by most of the top 50 global pharmaceutical companies along with other key regulatory agencies such as FDA, EMA, and Japan's PMDA, is the most sophisticated solution and has become the standard in the pharmaceutical industry. The Simcyp Simulator can assists determination of a maximum recommended safe starting dose (MRSD) in the first-in-human clinical study, design of optimal clinical trials, evaluation of  new drug formulations, and prediction of drug-drug interactions (DDIs) and pharmacokinetic outcomes in clinical populations. 

For more details about Hyun A and Dr. Lee's presentations, please contact them by clicking one of the following links: Hyun A Lee or Dr. Kyeong-Ryoon Lee. 

Dr. Yuchae Jung introduced the concept of P-MATCH or Precision Machine Learning AssisTed Clinical Trial Eligibility Assessment using Hospital Records at the 5^th Joint Conference on Medical Device between Seoul National University Colleges of Medicine and Engineering and Seoul National University Hospital on November 3, 2017. The title of her talk was 'Application of Artificial Intelligence Technology for Efficient Clinical Trials'. Dr. Jung underlined why artificial intelligence, mainly deep machine learning, can and should be adopted to bring more efficiency to clinical trials, particularly for precise patient enrollment, which allows for patients who are likely to respond to a treatment under testing to have a bigger chance of enrollment. This will also make clinical trials more productive and error-free, Dr. Jung added, because all of the eligibility assessment procedures are algorithm-based using the electronic medical record (EMR). 

Dr. Jung's talk was well received, and there were a couple of questions as to what could make P-MATCH different from other approaches such as the IBM Watson for Oncology. Dr. Jung replied that the biggest difference is P-MATCH's natural language processing capability of more than one language (i.e., Korean and English), which often are used in EMR in a haphazard and inconsistent manner. 

For anyone who wants to learn more about Dr. Jung's presentation, please contact her.