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. 

Prof. Howard Lee was featured in a broadcasting news show by Arirang TV, entitled "COVID-19 Pandemic", on August 5, 2021. Prof. Lee joined this TV show remotely since he was in the US. Below are several comments Prof. Lee made in the show, emphasizing and introducing recent activities of new drug development against COVID-19, particularly antiviral agents. 

"Developing a new vaccine every time variant viruses emerge is like going round in circles. Simply, this kind of endless chasing the tail is not going to work in a situation like the COVID-19 pandemic."

"... more and more COVID-19 drug developers are being redirected to treatments that can be taken orally or even nasally!"

"Molnupiravir... is a fake, dysfunctional building block that the virus uses to copy itself... it can be taken orally in early COVID-19 test-positive patients before they get sick or hospitalized."

A full YouTube videoclip for Prof. Lee's comments can be watched by clicking the following links. 

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. 

Prof. Howard Lee was invited to a seminar sponsored by the Samsung Science & Technology Foundation in association with the Future Technology Study Forum, held on August 28 at the SNU Hoam Faculty House, where he summarized the current status and future prospects of treatment and vaccine developments against the COVID-19 pandemic. Prof. Lee further discussed how the pandemic could change the way new drugs are developed in the post-pandemic era, characterized by social distancing and stay-at-home orders, often termed as "Untact".

Prof. Lee forecast the new drug development paradigm will be characterized as remote and virtual, particularly for clinical drug development in that many research activities should be performed off-clinic. "These changes will eventually facilitate and fasten the adoption of new information and communication technologies, for example, remote data entry and life-log data", Prof. Lee emphasized. According to Prof. Lee, urgency cased by the public unprepared-ness such as the COVID-19 pandemic will also encourage researchers to welcome more innovative technologies, one of which is the application of artificial intelligence algorithms to reposition new therapies, which could save tons of R&D time and expenses. 

Jung-Hyun Won, a summer intern at CCADD, has significantly contributed to the final presentation slide deck. Jung-Hyun and Prof. Lee will be writing one or two reviews/commentaries, which could be published in peer-reviewed journals.   

Three months ago, CCADD was awarded an intramural grant to present an AI forum to develop new research ideas, hopefully leading to an extramural grant application, for the efficient use of AI technologies for new drug development. Concluding this interdisciplinary endeavor, Prof. Howard Lee talked at the X+AI Workshop 2020 on August 24, along with 10 other PI's. The AI  forum Prof. Lee has led consisted of an interdisciplinary team of seven professors at SNU, and they have met weekly or biweekly a total of 8 times, all virtual due to the Corona pandemic, which is utterly unheard of. 

At the Workshop, Prof. Lee summarized what objectives the team has accomplished in various research areas in drug development where AI technologies can be adopted. Furthermore, Prof. Lee emphasized what hurdles needed to be overcome if more AI technologies could be employed to make the current drug developments practices faster, less costly, and more efficient. Prof. Lee's talk was well received, and he was approached by several PIs in other fields after the Workshop, who would like to extend their research network. 

CCADD is currently working on an extramural grant application based on the insights gained at the forum. In addition, Prof. Lee's presentation can be watched at YouTube below. 

This year's American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 was held in San Antonio, Texas, on November 3 - 6, 2019. AAPS PharmSci 360 is a conference that provides a dynamic forum for the exchange of knowledge among pharmaceutical scientists. Around 6,500 attendees gathered from all over the world to attend this year's conference, where ~1,500 abstracts were presented and >100 individual sessions were provided. Tae Kyu Chung and Siun Kim, two students at CCADD, also joined the conference as a poster author and presenter.

Tae Kyu's poster contained the result of a population pharmacokinetic (PK) modeling exercise of GC1118, a fully human IgG1 monoclonal antibody that is currently under clinical development for the treatment of solid tumor, entitled 'A Target-Mediated Drug Disposition Population Pharmacokinetic Modeling of GC1118, a Novel Anti-Epidermal Growth Factor Receptor Antibody, in Patients with Refractory Solid Tumors.'  He proposed a two-compartment target mediated drug disposition model, which adequately characterized the PK characteristics of GC1118. On the other hand, Siun proposed a population pharmacokinetic-pharmacodynamic (PK-PD) model that adequately described the concentration-time-kPCD (1000 * % ¹³Carbon dose excreted per minute) profiles of orally administered YH12852, a 5-hydroxytryptamine receptor 4 agonist currently under clinical development for the treatment of gastrointestinal motility disorders. Based on the final PK-PD model, Siun found that YH12852 improves one's gastrointestinal motility, resulting in an accelerated gastric emptying and early rise in kPCD values. The poster presentation by Tae Kyu and Siun were well received: many poster-goers, including professors, Ph.D. students, pharmacists, pharmacometricians from Pfizer and Merck, came along and questioned the nitty-gritty details about the models summarized in the posters.

By participating in the conference, Tae Kyu and Siun were able to better understand the recent trend in drug development, state-of-art technologies adopted and implemented in new drug development, and regulatory perspectives on clinical pharmacology strategies. Joining the conference was a great opportunity for learning, networking, and developing their professional careers. 

The best model for humans is human. Drug development has long been suffering from the lack of translatability and predictability of the preclinical animal experiments to humans. Dr. Richard Klausner, former Director of the US National Cancer Institute, commented in 1998, “the history of cancer research has been a history of curing cancer in the mouse. … and it simply didn’t work in humans.” Twenty years fast forward, drug development scientists are still struggling with the same issue.

Microtracing/microdosing is an innovative technology that can revolutionize the current paradigm of clinical drug development. Typically, a very small amount of the drug, i.e., ‘microdose’, which is less than 100 micrograms (or 30 nmoles for proteins), is administered to humans. Since this is much smaller than 1/100 of the pharmacologically active dose, microtracing/microdosing technology can be employed at a very early stage of clinical drug development even when there is limited animal toxicology data. Furthermore, in order to trace minute doses, an accelerator mass spectrometer (AMS) is required and the compound should be labeled, typically with ¹⁴C. The microtracing/microdosing study allows clinical drug development scientists for generating the intravenous pharmacokinetics, mass balance, metabolite profiling, and absolute bioavailability data much easier, faster, and at a lower cost.  

Dr. Howard Lee has spearheaded the employment of microtracing/microdosing technology for drug development in Korea since 2012, supported by three government grants. Dr. Lee has successfully d a new research ecosystem for the microtracing/microdosing study, which helped him perform the first microtracing/microdosing study under a full investigational new drug (IND) application in 2014. The result of this study was published at the most reputable journal in the field. Dr. Lee has conducted two additional microtracing/microdosing studies, and has recently won a two-year grant of $1 mil, in which microtracing/microdosing technology will be applied to a new drug development study with biologics.

The Center for Convergence Approaches in Drug Development (CCADD) is delighted to welcome Dr. Kyeong-Ryoon Lee as its newest member. Starting February 2018, Dr. Lee has started his new position as a visiting professor in CCADD at the Graduate School of Convergence Science and Technology, Seoul National University. Dr. Lee received his PhD degree in Pharmaceutical Science at College of Pharmacy, Seoul National University in 2011 and completed his two-year postdoctoral fellowship at Korea Research Institute of Chemical Technology (KRICT), followed by another at Rutgers University, New Jersey, USA. Dr. Lee also spent four years getting hands-on real-world drug development experience at Daewoong Pharmaceuticals, Korea, during which Dr. Lee spent a year at RIKEN, Japan's largest and most prestigious research institutes. Currently, Dr. Lee is a research scientist at Korea Research Institute of Bioscience and Biotechnology (KRIBB). 

Joining CCADD, Dr. Lee emphasized the importance of an evidence-based decision-making to meet the challenges of today's new drug development. Dr. Lee said, "I would like to carry out a joint research with CCADD on AI-based modeling approach to accelerate drug discovery in both clinical and non-clinical studies." Prof. Howard Lee welcomed Dr. Lee by praising his broad research experience in drug development. "CCADD is very pleased to announce this research collaboration with Dr. Lee, which will foster a greater understanding of drug development in more insightful ways", Prof. Lee added. 

More details about Dr. Lee's previous experience and research interests can be found here.

Two undergraduate students (Left: Min Ji Kim, Right: Ara Cho) will spend the next eight weeks (January - February, 2018) at CCADD, working as a team through the winter internship program at the Graduate School of Convergence Science and Technology, Seoul National University. Min Ji will graduate in February 2018 with a bachelor's degree in Bioscience and Biotechnology at Hankuk Univeristy of Foreign Studies. Ara is a fourth-year undergraduate student at the School of Biotechnology and Environmental Engineering, Catholic University of Korea with a major in Life Science.

This intensive research internship program aims to provide student interns with hands-on research experience in drug development and regulatory sciences, helping them further build their academic achievements. Min Ji and Ara will delve deeply into various aspects of new drug development. Please join us to welcome Min Ji and Ara!