Prof. Howard Lee gave a talk at the 17th JSCPT-KSCPT Joint Symposium, Kobe, Japan, on December 15, 2023. In his presentation entitled 'Real-World Data Analysis as a Clinical Pharmacologist: Experience and Some Thoughts', Prof. Lee. introduce the audience to the RWD research works CCADD has performed for the past 3 or so years, all of which have been published in reputable journals or under review shown below. Prof. Lee stressed, "With RWD landscape fast growing, clinical pharmacologists should leverage the potentials of RWD/RWE in drug development by furthering its scientific innovation!" 

Prof. Lee's speech was well received by the audience followed by a welcome reception by JSCPT colleagues, whom he and other delegates have not seen in person for the past three years because of the COVID-19 pandemic. The night was full of talking, drinking, and singing! Both teams promised to meet again next year in Jeju, Korea, for the Spring Conference of 2024 KSCPT. 

Prof. Howard Lee shared his past experiences and future perspectives on the 14C-based microtracing and macrodosing studies in humans in South Korea as an invited speaker to the 9th East Asia Accelerator Mass Spectrometry Symposium (EAAMS-9), held at KIST, Seoul, South Korea, on November 22-24, 2023. 

Prof. Lee has introduced the concept and utilizes of the 14C-based microtracing and macrodosing study for new drug development since 2024. As of today, Prof. Lee has completed a total of six microtracing/microdosing studies with one being the IND-opening study for the US FDA. In his talk, Prof. Lee shared his experiences in starting a 14C-labelled human study using the microdosing technology in Korea. Additionally, Prof. Lee gave hist perspective as to how this technology can be further utilized to increase the efficiency of clinical drug development.

Prof. Howard Lee gave a talk at an invited symposium in association with the Annual Conference of the Korean Society of Medical Informatics (KoSMI), held both online and offline on November 29, 2023. The title of his presentation was ‘Performance Increase of the Machine Learning Model to Predict Acute Coronary Syndrome in Patients with Type 2 Diabetes Mellitus by Replacing Binary Variables with Propesnsity Score’. This presentation was a culmination of a research project with the same title supported by the Seokcheon Foundation, 2023, where the current and former CCADD graduate students, namely David Seung U Lee, Jung-Hyun Won, and YeSol Hong collectively contributed by proposing a new novel way to address the falseness of binary feature in the electronic medical records. Prof. Lee's speech was well received by the audience evidenced by 6 follow-up questions! The more detailed methodological aspect of Prof. Lee' talk was presented in an accepted poster led by David Seung U Lee.  

Prof. Howard Lee emphasized the willingness to pay for innovation from the whole societal perspective for South Korea. In a forum organized by Hankyung TV to commemorate the 2023 Korean Biopharmaceutical Award, Prof. Lee discussed what South Korea has to equip itself with to become one of the countries that can not only develop, but market innovative new drugs on a global scale. He listed the following conditions: nationwide control center, training and education, megafunds, advanced drug regulatory science, and willingness to pay for innovation as a society. The following YouTube clip captures the 5th condition.

"Artificial Intelligence (AI) has a bright future in the area of drug discovery and development", Prof. Howard Lee agreed. But, he went on saying, "The focus has been drug discovery, particularly de novo search of new 'drug-like' molecules, which came up with a mix of some successes and mostly failures." To Prof. Lee, there is a more important area where AI applications have not been tried much, and that is clinical development, more expensive, lengthy, and riskier. These statements were made at a K-Healthcare Business Forum, co-sponsored by Young Doctors, KBR, and KHIDI, on October 13, 2023.

In a speech entitled "AI-based drug development: Hype or Reality?", Prof. Lee explained why the application of AI technologies has been mostly limited to early stage or drug discovery, and how this can be expanded to the later phase of drug development such as preclinical toxicity prediction and more robust and efficient design and conduct of clinical trials. The details of Prof. Lee's talk can be found in this news paper article. 

Prof. Lee stressed the co-vaccination with both COVID19 and Flu since we are entering into a season where flu can become epidemic while the antibody level against COVID19 might not be sufficiently high enough for protecting us from becoming seriously ill once infected. This statement was made in an interview with Arirang TV on October 6, 2023. Prof. Lee continued saying "the pandemic is over, but we are still living with the virus", which leads us to getting some protection against a new sub-variant of COVID19, which is XBB1.5. The two mRNA vaccines by Pfizer or Moderna, respectively, got cleared by the regulatory agencies, Prof. Lee added. A full interview can be watched at the following YouTube link.   

"In South Korea, not all orphan drugs are reimbursed by the National Health Insurance Service primarily because they are different from drugs to treat rare diseases from the legal perspective", talked Prof. Lee at the 7th K-Life Bio Forum, held on September 26, 2023 at the National Assembly, co-sponsored by the Korean Pharmaceutical Association and Congressman Min-Suk Kim, the Democratic Party of Korea. Prof. Lee continued saying "This is why so many orphan drugs cannot be accessed by those who need them desperately although the orphan drugs have been approved the the Ministry of Food and Drug Safety, the regulatory authority in South Kore." Furthermore, Prof. Lee pointed out the drawbacks of reimbursement decision made by the HIRA solely dependent upon the evaluation of cost-effectiveness based on incremental cost-effectiveness ratio or ICER. "We need other funding mechanisms than the national health insurance for patients with rare diseases to get access faster to the orphan drugs they cannot live a quality life without", Prof. Lee stressed. Several news paper articles reported what Prof. Lee presented at the Forum, one of which can be found here. 

Money Today Broadcasting or MTN interviews Prof. Howard Lee, where he explained why it is indispensable to have a government-wide control tower for new drug development. Prof. Lee stressed the importance of a control tower, preferably set up as an independent, standing government-wide institute that has discretional power over its budget and Human Resources management to maximize its efficiency, which can lead to increased output of new drug development activities in South Korea. His interview can be watched at the following YouTube clip. Additionally, this news article summarizes what Prof. Lee talked in his interview. 

Prof. Lee and David Seung U Lee met with Prof. M. Madan Babu, PhD, FRS, FMedSci, from St. Jude Children's Research Hospital, Memphis, TN, USA, July 17, 2023 in the Grand Hyatt Incheon. Prof. Babu is currently the Endowed Chair in Biomedical Data Science and Director of the Center of Excellence for Data Driven Discovery, St. Jude Children's Research Hospital. He will soon serve as a Senior Vice President and Chief Data Scientist at St. Jude Children's Research Hospital. Prof. Babu is an acclaimed researcher and scientist in various fields including GPCR signaling, regulation and pharmacology, gene , gene regulation, computational biology, structural bioinformatics, and drug discovery. He published many research articles in high-impact journals such as Nature, Science, and Cell. He is also Chief Editor for Molecular Systems Biology journal. 

It has turned out that Prof. Babu had followed the work from CCADD and is interested to know more about what is currently happening in those research areas. In this regard, the main purpose of Prof. Babu's visit this time was to establish professional relationships and set up international scientific bridges with St. Jude to enrich biomedical data science collaborations. Prof. Lee and David detailed the big data science and AI in drug development and optimal usage projects by CCADD, in which Prof. Babu showed great interest. Prof. Babu asked Prof. Lee for additional information and s for those research projects, which David will soon follow up. 

Out of a 3-hour lunch meeting with Prof. Babu, many collaboration opportunities and projects were discussed and proposed, one of which was an exchange program between the two institutions. Co-publication was also talked about, and Prof. Babu asked if CCADD could write a perspective paper regarding drug repurposing using AI for the Molecular Systems Biology journal. Prof. Lee and David hope to see more details soon and will keep CCADD informed. 

The Korean Society of Medical Oncology or KSMO is the largest academic congregation in the filed of oncology, consisting not only of medical or clinical oncologists, but of basic and clinical researchers involved in the development of anti-cancer drugs, diagnostics, and vaccines. Prof. Howard Lee was invited to this year's general assembly and symposium for KSMO and discussed the potential and pitfalls of antibody-drug conjugates or ADCs. The first ADC, Mylotarg, was approved in 2000 by the US FDA, followed by its voluntary withdrawal in 2010 due to safety issue, and re-approval in 2017, which just tells how difficult it has been to develop a safe and effective ADC for clinical usage in cancer patients. However, eight ADCs have been approved by the US FDA since 2019 totaling 13, and this indicates how promising the development horizon of ADCs can be. Prof. Lee talked about the pros and cons of ADCs mainly from the perspective of drug development. For example, an ADC consists of three independent components: an antibody (mostly monoclonal antibody or mAb), a cytotoxic payload or warhead, and a linker that combines both antibody and payload. Due to its structural complexity and interactions between elements, which has not been fully elucidated yet, the development of an ADC has faced many technical difficulties. At the same time, however, ADCs also can become a much better platform than other competing ones in the field of oncology because of the uniqueness of its mechanism of action.