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. 

Prof. Howard Lee chaired a forum, organized and sponsored by DailyPharm, an online-only journalism company focusing on the pharmaceutical industry, on April 12, 2021. The title of the forum was 'Reimbursement System for High-Priced Drugs in Korea', which has become an issue as more and more advanced therapeutics such as cell and/or gene therapies are introduced as a breakthrough treatment option. The forum had four panelists, three of whom represented the pharmaceutical industry and one the Korea Ministry of Health and Welfare. 

It was a coincidental and timely event because Prof. Lee and Yoona Choi have been working an a research project with an aim to increase patient access  to new drugs in Korea. This project was sponsored by the Future Health Network, and the second round of the research project is under discussion. The results of the first round of the project has been published in a peer-reviewed Journal as a research article. 

The details of the forum can be read and watched here.