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.

A column by Prof. Howard Lee, which provided an overview of the issues in drug development in Korea and proposed new strategies to address them, was published at the Op-Ed section of Hankyung, a daily newspaper focusing in economics and finance. In his column, Prof. Lee explained why Korea has not been quite successful in drug development in comparison with its accomplishments in other areas such as semiconductor, automobile, smart phone, and even the content industry these days including K-Pop and K-drama. "There is no drug that has shown commercial viability although >30 new drugs have been developed and approved in Korea since early 2000", Prof. Lee, summarized. "First, and foremost, the business ecosystem has to be revamped", Prof. Lee emphasized, "in order for Korea to show any global leadership in drug development." 

Prof. Lee's column was based on a recent report written by Yoona Choi (lead author), Jung-Hyun Won, YeSol Hong, and himself, which will be published as a stand-alone book early next year. Prof. Lee's column can be accessed by clicking this. 

DailyPharm, an online journalism company, interviewed Prof. Howard Lee as to how new drug accessibility can be increased by easing the current strict criteria for health insurance reimbursement in Korea. More specifically, Prof. Lee argued the ICER cutoff should be lifted much higher to adequately reflect the economic developments over the past decades. Prof. Lee also discussed time has already come to decide if the nation sticks to an old paradigm of ‘reimbursing everything’ in healthcare, which is absolutely unsustainable financially. Prof. Lee urged the Korean government to show leadership developing a society-wide consensus to build a new fund to support patients with life-threatening diseases, who are likely to die soon unless treated with new, innovative drugs, almost all of which are prohibitively expensive.

The details of Prof. Lee’s interview can be found by clicking this link.

In a news show by YTN, entitled 'The Issue Diagnosis for COVID19', Prof. Howard Lee stressed the importance of vaccination in pregnant women.The US CDC strongly recommended COVID19 vaccination in pregnant and nursing mothers, and Korea has adopted the same policy. However, the current vaccination reservation rate in that population in Korea is only 2% or so, mainly because of the concern about the vaccine side effects. 

Prof. Lee also discussed what kind of opportunities follow-on COVID19 vaccine developers might have. They included new formulation including lyophilized vaccine, new route of administration such as intranasal mist or inhalation vaccines, and new vaccines targeting at variants. Toward the end of the show, Prof. Lee required the Korean government listen to true experts before they make any COVID19 policies and systems. 

The news show was aired on October 16, 2021, and the full program can be watched at the following YouTube page. 

On September 30, 2021, Prof. Howard Lee was invited to a live news show, COVID-19 Pandemic, by Arirang TV, an English-speaking broadcasting company in Korea. Prof. Lee introduced the current status of vaccine developments against COVID-19 in Korea, led and sponsored by local biopharmaceutical companies. According to Prof. Lee, there are 10 vaccine candidates in Korea currently under clinical development, phase 1 through 3. Fifty percent or five of those 10 candidates are still in phase I of clinical testing, with 4 and 1 in phase 2 and 3, respectively. Prof. Lee explained, "The vaccine platforms are as diverse as they can be." 

Toward the end of the show, Prof. Lee also discussed the issues pertaining to the vaccine development program by Korean biopharmaceutical companies as a follower. They include design issues, securing a full amount of comparative vaccines, multinational site management, and commitment of the government to purchase or pre-order the vaccine if successfully developed. More details of the news show can be watched by clicking the YouTube link below: 

Prof. Lee discussed several ways to increase patient accessibility to advanced biotherapeutics at an online forum on July 9, 2021, sponsored by the National Assembly of the Republic of Korea. The forum was primarily motivated by the recent introduction of innovative advanced biotherapeutics such cell/gene therapy, CAR-T, immunooncology treatment, and antibody-drug conjugate. 

Following the main discussant's overview on the issues, Prof. Lee pointed out that the current health insurance reimbursement system in Korea is not suitable for advanced biotherapeutics, most of which are likely to fail the so-called cost-effectiveness test set and required by the Health Insurance Review and Assessment Service or HIRA because of their astronomical costs. For example, a typical round of treatment with KYMRIAH® or tisagenlecleucel by Novartis will cost a patient ~$500,000 although it is a life-saving drug for patients with rare, but highly fatal form of lymphoma (adults) and leukemia (children). 

Prof. Lee's speech and his follow-up discussion can be watched at YouTube as below. 

Prof. Howard Lee was appointed to Chief Clinical Development Officer (CCDO), Rosetta Exosome, South Korea, June 14, 2021. In this capacity, Prof. Lee will lead and oversee the clinical development program of REX101, a genetically engineered bacteria-derived exosome. Exosome or extracellular vesicles are d by organisms, unicellular to complex multicellular, are believed to be the core communication tool between a multitude of cells. Rosetta Exosome, founded in 2016 as a spun-off startup from Prof. Yong Song Gho's laboratory at Postech Lifesciences, has investigated the biomedical applications of exosomes to the development of diagnostics and therapeutics. To this end, Rosetta Exosome has commissioned a research project to CCADD in association with a grant application submitted to the Korea Drug Development Fund or KDDF early June this year. 

Convergence Newsletter, a yearly news article published by Graduate School of Convergence Science and Technology, Seoul National University, highlighted two stories from CCADD.

First, the afterword of Chaeyun (then chemical and biological engineering major at Korea University) and her reflection on the 2021 Winter Internship at CCADD received a spotlight dividend in the 2020 Winter Joint Research Program corner.

Looking back on what she did, she is glad that she jumped at the opportunity. For her, being part of the project, “Predicting drug-drug interaction based on machine learning,” was a storehouse of lessons. She was able to gain hands-on experience in the area she had been passionate about, and she could gain a concrete understanding of machine learning technology and its applications to pharmacology. Also, she fondly recalls how she could pick others’ brains while trying to keep up with the rigorous “Book Reading” schedule, during which the CCADD members, interns included, finished off three textbooks on Natural Language Processing and Python. As her closing remark, she admitted the internship experience was a gratifying step toward living her dream as an aspiring future pharmacologist, and she thanked all the lab members, and especially Prof. Lee, for the opportunity and all the supports they’d shown to her.

Next in the Issue Focus section, which showcased the wonderful accomplishments of the professors at Graduate School of Convergence Science and Technology, Seoul National University, Prof. Lee made the headlines. The highlight covers the news that 세종도서 has named the book Siun Kim (a PhD student at CCADD) and Prof. Lee co-wrote, “바이오 의약품 시대가 온다,” as one of the greatest works in 2020. The book was touted for how it effortlessly explicates the complicated drug-approval process. Also, by being comprehensive in its cover of the knowledge (e.g., basic biology) and the domain-specific one (e.g., monoclonal antibodies, gene therapies, and the difference between generics and biologics), the book gently nudges readers toward thinking like biologists and engages them in the collective effort to raise awareness of biologics. This book also has its merit in being accessible to the readers outside the scientific domain, and it’s inviting readers from diverse swaths of to the question of how we will make the great leap forward to the future of biologics.

Prof. Howard Lee was featured in the 'Medical School Library', a lecture series channel at YouTube by the Young Doctors, an online journalism company with a focus on the medical societies, medical issues and policies, and the biopharmaceutical industry. Prof. Lee introduced the audience to the concept of biopharmaceutical products as to how different they are from the traditional, chemically synthesized, small-molecule drugs. He also discussed advanced biotherapeutics using a couple of tragic failures by two Korean biopharmaceutical companies, i.e., Shillazen and Tissugen to emphasize the informed design of clinical trials and the quality manufacturing for biopharmaceutical products. Prof. Lee finally talked about biosimilars: what they are, how different they are from the reference biologic, and what clinicians should know before [s]he prescribes a biosimilar.

Prof. Lee's lectures can be watched by clicking the following links: 

Prof. Howard Lee was invited to a session at the Spring Conference, 2021, organized and sponsored by The Pharmaceutical Society of Korea, April 22, 2021, held in the K-Hotel, Seoul, Korea. In the session, Prof. Lee introduced the audience to a dimension reduction model that CCADD has developed to make clinical trial feasibility assessments efficient, practical, and realistic. The research project has been supported for three years by the National Research Foundation of Korea, which is expected to end by this year. Based on the positive results of the research, particularly in the area of type II diabetes mellitus, a patent has been filed, and CCADD plans to expand it to other disease areas too. Prof. Lee has emphasized in the session that artificial intelligence technologies can and should be applied to clinical drug development to make it more versatile and agile. His talk was well-received.