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. 

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.

Prof. Howard Lee was invited to a forum, sponsored by the National Academy of Medicine of Korea, entitled "Enhancing the role of physicians in the biomedical industry", March 31, 2021. As a panelist, Prof. Lee stressed the integrated nature of basic and applied sciences to develop more medical products such as drugs, medical devices, vaccines, diagnostics, preventive goods, and so on. Prof. Lee also emphasized to rear a rich nurturing environment, in which a diverse 'physician-X', with X being anything, career track can emerge and thrive by quoting a recent paper. 

A full video clip of Prof. Lee's talk can be watched at the following YouTube link: 

In the first quarter of 2021, CCADD got off to a good start with a new project deal with Korea Ginseng Corporation (KGC).

Korea’s leading ginseng brand for over a century, KGC has a distinguished track record of making quality dietary products. CCADD, on the other side of the deal, has been receiving high marks on its clinical science expertise. So, the handshake between the two definitely holds the promise of achieving something big and previously unimagined.

And the promise is becoming real. Staring this March, KGC and CCADD set out on a project to develop a mobile healthcare application called ‘Care Now Q.’ Once complete, the mobile application will be the first in the market that utilizes data from medical checkups, direct-to-consumer genetic tests, and health survey results to recommend individualized health guidance and dietary supplement suggestions. For this ambitious project, CCADD will play an active role as a clinical expert and project manager, providing expertise and orchestrating the entire process. This project will be led by Yoomin Jeon (team leader), Jung-Hyun Won, and David Seung U Lee under the supervision of Prof. Howard Lee.

The stakes are high. This project will not only turn the idea of individualized health management into reality but also open the door for CCADD to a new area of research, moving forward.

March 2021 marks the end of CCADD's advisory to Idience's new molecule research.

Idience Co., LTD., a subsidiary of Ildong Pharmaceutical Co.,Ltd. (a major pharmaceutical company in Korea), is a No-Research-Development-Only (NRDO) company that focuses on developing and commercializing novel oncology drugs. 

Particularly, IDX-1197, a potent poly (ADP-ribose) polymerase (PARP) inhibitors that causes synthetic lethality in cancer cells, has received the spotlight not only from the researchers, but from the investigators. Idience has successfully filed an investigational new drug (IND) for IDX-1197 to the U.S. Food and Drug Administration (FDA) last year. If approved and marketed, IDX-1197 will be used as monotherapy or an add-on to other anti-cancer agents targeting multiple solid tumors.

CCADD played a key role in speeding up the clinical development process of IDX-1197. From January to March 2021, CCADD analyzed preclinical and clinical data on other PARP inhibitors already developed or under development. Besides, CCADD comprehensively reviewed the results of completed, ongoing, or planned studies of IDX-1197, and compared the results with those of other PARP inhibitors such as Olaparib, Rucaparib, Niraparib, and Talazoparib. The analysis laid the foundation for how CCADD could help Idience better navigate the complex drug development process. This consulting project was led by Siun Kim, Yesol Hong, and Jung-Hyun Won under the auspice of Prof. Howard Lee.

On balance, it was a great experience to have worked with Idience on this project, and CCADD gives its best wishes to Idience for a successful global clinical development of IDX-1197 in the near future.

CCADD is breaking the ground for biomedical natural language processing or NLP!

On January 22^nd, 2021, CCADD was nominated by the Ministry of Food and Drug Safety to develop an NLP model that extracts core clinical information from unstructured data in the Korea Adverse Event Reporting System (KAERS). The total research fund amounts to two hundred million Korean won or a hundred and eighty thousand U.S. dollars. The project will be performed in collaboration with the Machine Intelligence lab in the Department of Electrical and Computer Engineering, Seoul National University (Prof. Gyo-Min Jung). 

For starters, CCADD will build a manually annotated dataset, which is indispensable to train and refine any machine learning algorithm including NLP. Next, CCADD plans to build the KAERS-BERT model, an NLP model specifically tuned to handle adverse drug events. The KAERS-BERT model will be pre-trained on KAERS text data, which then will be deployed to extract medical information from free texts, such as hand-written records of adverse events. Once complete, the KAERS-BERT model is expected to address many of the language ambiguities caused by the mixed use of English and Korean in medical domains already peppered with technical and medical jargons. The KAERS-BERT model will significantly improve the performance and the outcome of NLP tasks when extracting information from clinical notes written in English and Korean. 

Prof. Howard Lee, the PI of the grant, congratulated the team, saying "The grant awarding is timely and important since it will help CCADD enter a new area of biomedical NLP." At the conclusion of this project, CCADD will once again have secured its place as the leading lab in the field of convergence science between medicine, drug development, and machine learning including NLP. "This certainly provides CCADD with a momentum to transform into a frontrunner in the field", Prof. Lee added.

Prof. Howard Lee and some CCADD members including Yoomin Jeon, Yoona Choi, and YeSol Hong visited AstraZeneca Korea (AZK) on December 3, 2020. AZ is a research-intensive pharmaceutical company based in the UK and has recently developed a vaccine against COVID-19. AZK invited Prof. Lee to a big data seminar series, and he talked about the role of medical big data including real world data and artificial intelligence (AI) in drug discovery and development. Prof. Lee also discussed how pharmaceutical companies could prepare themselves for the active and efficient adoption of big data and AI technologies for the day-to-day drug development activities. 

Yoona and YeSol are actually a former employee to AZK, in the departments of medical affairs and marketing, respectively. Thus, this visit was a kind of homecoming, and everyone welcomed them.The visit was also a great opportunity for CCADD to introduce its research fields and capabilities to pharmaceutical companies. This opportunity will enable CCADD for exploring many collaboration projects with those who are involved in actual drug development, which will certainly fill a gap for CCADD such that academic research is well aligned with the reality.     

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.