CCADD welcomes new interns!

Starting from January 4th, Minjung Kim, Du-Hyeong Lee, and Chaeyun Cho have participated in the 2021 Winter Internship Program at CCADD. David Seung-U Lee, a prospective student of the Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, has also joined the program as an intern before his semester starts.

Minjung is currently a Hispanic Language and Literature major at Seoul National University and pursues biology as a double major. Her research interest lies in policy analysis of Korea’s integrated clinical research system.

Du-Hyeong is a rising junior at Korea University, focusing on mathematics and statistics. He plans to delve into statistical methods and machine learning for clinical trials and PBPK (physiologically based pharmacokinetics) modeling during his internship.

Chaeyun studies chemical and biological engineering at Korea University, and she joined the team to study clinical drug evaluation and nano drug toxicity.

Last but not least, David has studied English Literature. He is interested in pharmacometrics and drug-drug interaction.

Living up to its motto, CCADD plans to have the new members fully immersed in and orientated to diverse activities including research, studies, and daily routines of a graduate student. As CCADD is gearing toward a new journey, with new members on board, the contribution from the interns and synergy between them and the current members is greatly expected. CCADD also hopes to find gold nuggets in the interns as much as they would do from the program.

Once again, welcome to CCADD!

Prof. Lee was invited to the 6^th Gaucher Regional Forum -virtual edition, where he talked about the biosimilarity in the orphan world, particularly in the drug development for Gaucher disease. Prof. Lee also moderated the session. A year ago, Prof. Lee joined the 5^th of its kind, held in Kuala Lumpur, Malaysia. 

The Forum entailed a series of dynamic and exciting discussion around the diagnosis, patient management and the safety and well-being of patients with Gaucher Disease. In his speech, Prof. Lee contrasted the differences between small molecule drugs and biologics, and how these differences could translate into something every clinician has to understand when she prescribes a biosimilar to her patients. Prof. Lee went further to explain why intended copies are not true biosimilars although almost all of them have been promoted and marketed as they were. For example, Abcertin by ISU ABXIS is not a true biosimilar to its reference biologic, which is imiglucerase by Genzyme®. Knowing the difference between true biosimilars and intended copies is very important not only for every practicing physician, patient, but for regulators to ensure each patient gets a biologic of high quality, which underwent the regulatory review and scrutiny. 

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.

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.