Prof. Kyeong-Ryoon Lee lectured at the 2021 Annual Meeting of the Korean Society for Clinical Pharmacology and Therapeutics, held in Jeju-do, Korea, November 11-13, 2021. The title of his talk was Development of Phyisologically-Based Pharmacokinetic Model for Orally-Administered Fexuprazan in Humans. In the lecture, Prof. Lee introduced the audience step-by-step to the drug development project he led in collaboration with Daewoong Pharmaceutical Co., Ltd., Seoul, Korea, where a PBPK model developed using pre-clinical animal data accurately predicted the PK profiles of fexuprazan, a potassium-competitive acid blocker, in humans. Prof. Lee's presentation was based on a research paper he recently published, and was well-received.

The 2020 Population Approach Group Korea (PAGK) Annual Meeting was held on November 27 with presenters attending at the WesternLife Hotel, Iksan, Jeolla-do while other participants joining the meeting on-line. The PAGK is a research group affiliated with Korean Society for Clinical Pharmacology and Therapeutics, of which members (currently >180) join from various sectors such as academia (clinical pharmacology, clinical medicine, and pharmacy), hospitals, pharmaceutical companies, CROs, and government agencies.

The plenary speech was delivered by Prof. Yangjin Kim, Professor at the Department of Mathematics at Konkuck University, titled “Mathematical modelling of tumor growth and signaling network, and development of anti-cancer drugs and therapeutic strategies”. The topics in the Young Researchers’ Sessions included physiologically-based pharmacokinetic (PBPK) model for clozapine in Korean patients with schizophrenia, misuse of the Michaelis-Menten for prediction of in vivo clearance for drugs, and microphysiological systems for predicting human pharmacokinetics.

Two PhD students of CCADD, Siun Kim and Tae Kyu Chung, presented their population pharmacokinetic and pharmacokinetic-pharmacodynamic modeling studies in the trainee session. Prof. Howard Lee also attended the PAGK annual meeting on-site to support and encourage Siun and Tae Kyu to expand their networks. The whole presentations of the two students can be watched at the Youtube channel of CCADD.

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 spoke about the utility of artificial intelligence (AI) in clinical drug development at the KDDW or Korean Digestive Disease Week 2020, organized by the Korean Society of Gastrointestinal Endoscopy, on November 20, 2020, held at the Swiss Grand Hotel Convention Center. The conference was aired online and the program is shown below:

The title of Prof. Lee's presentation was 'Artificial Intelligence in Drug Development: Clinical Pharmacology Perspective', and he talked about the potentials and pitfalls of AI in clinical drug development. In his talk, Prof. Lee emphasized the fact that most of the AI technologies that have been ever adopted in drug development are primarily in the area of drug discovery, whereas the preclinical and clinical developments have not witnessed active adoption of AI technologies although this trend can change all of a sudden. Particularly, Prof. Lee set aside the one-thirds of his presentation as to how CCADD could have developed a series of machine learning models to reduce the dimensionality of eligibility criteria to assess clinical trial feasibility using several feature selection algorithms. Below is the photo of those who have contributed to the work Prof. Lee introduced in his talk at the conference. 

Prof. Howard Lee gave an invited presentation at the annual conference 2020, sponsored by the Korean Society for Clinical Pharmacology and Therapeutics. In his presentation, Prof. Lee summarized the various activities to develop therapeutics, mostly drug repositioning, and vaccines against the COVID-19 pandemic worldwide. Prof. Lee's talk was timely in that Pfizer recently announced the extraordinary efficacy seen in their phase III clinical trial with an mRNA vaccine that they had co-developed with BioNTech, a German biotech firm. Prof. Lee also discussed how the private-public partnership to develop vaccines to prevent COVID-19 could change the horizon of new drug development post-pandemic. 

The Korean Academy of Health Policy and Management (KAHPM) invited Prof. Lee as chair to a session at the Annual Fall Conference, November 6, 2020. The title of the session Prof. Lee moderated was 'Individualized Reimbursement Model for Innovative Breakthrough Medicines: Introduction to Policies in Advanced Countries', where Prof. Hye-Young Kang, Department of Pharmacy, College of Pharmacy, Yonsei University, gave an overview presentation. There were three panelists in the session, each representing the pharmaceutical industry, government, and press, respectively. Due to the Covid-19 pandemic, the conference was presented online.  

In her talk, Prof. Kang pointed out that the current reimbursement scheme in Korea, particularly for innovative medicines, has been approached primarily from the cost containment aspect, emphasizing the balance between patients access to innovative drugs and cost. "This is the right time to talk more about drawing a social consensus as to what kinds of extra funding mechanisms other than the nationwide health insurance are available to supplement the limited accessibility to innovative drugs in Korea", Prof. Kang added. 

The full session can be watched here.

Prof. Howard Lee discussed how the COVID-19 pandemic could change the current paradigm of drug and vaccine developments at a symposium, organized by the Graduate Schools, Seoul National University, October 7, 2020. The symposium featured 5 speakers, each from a graduate school at SNU, and the title of the symposium was "Corona Pandemic: Where Is South Korea Heading?" Each speaker presented his/her view on the impact that the COVID-19 pandemic has brought upon various aspects South Korea has been and will be facing since its beginning. 

Prof. Lee pointed out the unprecedented amount and speed of vaccine/drug developments since the pandemic, which could prompt and hasten the disruption of the old ways to develop drugs and vaccines, such as more virtual and remote clinical trials, open innovations based on massive private-public partnership, and acceptance of new innovative technologies. Prof. Lee's presentation can be watched here. Or, there is a YouTube streaming too as seen below.

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 spoke at a webnar co-sponsored by MEDCITY in the UK and the Korea Pharmaceutical and Biopharma Manufacturers Association in Korea (KPBMA). MEDCITY represents the life sciences cluster of London and the Greater South East of England. KPBMA is the largest pharmaceutical industry organization in Korea, which has members of 174 domestic pharmaceutical firms and 21 multinational corporations. 

The title of the webinar was 'New Approaches to Immuno-Oncology', and Prof. Lee introduced the current status of advanced therapeutics development in Korea. In his talk, Prof. Lee gave an overview of the global trend in immune-oncology (IO) drug development. He also discussed a snapshot of IO drug development in South Korea, where he also summarized three of examples, i.e., Hyleukin-7 (Genexin), Pexa-Vec (Shillagen), and ABL501 (ablbio). Prof. Lee concluded his presentation by giving a future prospect for IO drug development in Korea, both the bright and gloomy sides. 

The other speakers included: Prof. Farzin Fazaneh (King's College, UK), Prof. Francesca Ciccarell (Cancer Genomics, King's College, London, UK), and Dr. Jong-Seong Ahn (GC Cell, Seoul, Korea). Siun Kim has contributed to the preparation of the slide deck that Prof. Lee used. 

Prof. Howard Lee gave a talk at a pre-meeting workshop for the American College of Clinical Pharmacology Annual Meeting 2020 on September 16, 2020 (US EST). The title of Prof. Lee's presentation was 'Early Phase Clinical Trials in Korea'. In this talk, Prof. Lee explained how and why Korea has become one of the most attractive countries for clinical drug development, particularly during the past two decades. 

Prof. Lee also introduced the audience to some of his previous works in innovative clinical trial methodologies such as the microtracing technology, which he has spearheaded to make a useful clinical drug development tool in Korea. In association with this, Prof. Lee discussed two of his papers, one in Clinical Pharmacology and Therapeutics, the other Clinical and Translational Science, two reputable journals in clinical pharmacology.