2020 Plenary Lecturers

Plenary Lecture Ⅰ
June 25 (Thursday), 2020 09:35-10:20

Building Up Unique Bio-convergence Research Platform for 4P Medicine

Future medicine is symbolized by “4P” medicine in which “4P” represents precision, predictive, preventive and participatory. To bring 4P medicine into reality, more new drug targets and biomarkers are needed and the new therapeutic and diagnostic tools are needed to be converged with cutting edge technologies. BIOCON was established to develop the first-in-class drug target for precision medicine and to identify biomarkers for predictive and preventive medicine. Moreover, the research recruited diverse technologies such as microfluidics, MEMS, optics and mechanical engineering to innovate biomedical researches. This lecture will introduce current pipeline of BIOCON for novel therapeutics, diagnosis and technologies.
Sunghoon Kim, Ph.D.
Professor and Director
CV
Horace G. Underwood Distinguished Professor
College of Pharmacy & School of Medicine
Yonsei University

Director
Medicinal Bioconvergence Research Center

Korea

Plenary Lecture Ⅱ
June 25 (Thursday), 2020 10:20-11:05

Overview of COVID-19 diagnostics: technical issues and global regulations

The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. The diagnostic methods of COVID-19 can be divided into molecular diagnostics and immunological diagnostics, and both methods have advantages and disadvantages.
Most countries have adopted molecular diagnosis as a confirmatory method. However, RT-PCR diagnosis of COVID-19 has its limitations. Detecting COVID-19 from pharyngeal swabs requires high-quality specimens that contain a sufficient amount of intact viral RNA. Yet, COVID-19 loads in the respiratory tract have shown to vary considerably. This has not only led to high false-negative rates, with probable cases remaining negative after multiple swabs, but is further exposing healthcare workers to risk of infection.
In recent clinical papers, the antibody serology test is effective as a diagnosis due to the clinical characteristics of COVID-19 that many patients are asymptomatic. Health authorities in many countries including WHO have recommended IgM & IgG antibody test depending on their healthcare environments for COVID-19 diagnosis.
South Korea experienced one of the world's largest initial outbreaks of COVID-19 outside China, and this could make Korean diagnostic companies with core technology and manufacturing systems rapidly develop the products and preoccupy the global market.
Unlike before, WHO has lost its leadership as a world health organization for infectious diseases, and health authorities in countries, including the FDA, are responding to the current situation for all possible products and technologies based on different regulation standards. WHO opened EUL late, and FDA is conducting EUA, starting with molecular diagnostics including RT-PCR, followed by antibody testing and recently antigen testing for COVID-19 diagnosis.
In this presentation, I will introduce COVID-19 diagnostic technologies and regulations for the approval of global health authorities and hope this is going to be helpful to approach the market and prepare for the upcoming post-corona era.

KeywordsCOVID-19, Diagnosis, Antibody Test, FDA EUA(Emergency Use Authorization),WHO EUL(Emergency Use Listing)

CEO Mi Jin Sohn CV
Sugentech, Inc., Korea

2020 생물공학 혁신기술 대상 수상

Plenary Lecture Ⅲ
June 26 (Friday), 2020 10:15-11:00

Development of Various Diagnostic tool of SARS-COV-2 Infection

In December 2019, a cluster of pneumonia patient reported in Wuhan, China. Finally, the causative pathogen was severe acute respiratory syndrome Corona virus, it named SARS-COV-2. Diagnosis of SARS Coronavirus 2 infection disease (COVID-19) divided in PCR, antigen test and serological antibody test.
PCR test is laboratory-based molecular assays for the detection of SARS-CoV-2 and reference standard for COVID-19 diagnosis. However, there are some false negative result in convalescent phase patient in PCR testing. Serological antibody test is supplementary tool for PCR testing.
In case of some pandemic area and poor circumstance area for PCR test, Point of care testing of antigen test and serological antibody test are another good tool for diagnosis of COVID-19.
We have developed SARS-COV-2 PCR test for laboratory use and one-step POC molecular testing system similar to Cepheid system for the detection of SARS-COV-2. SD Biosensor have launched POC SARS-COV-2 antigen rapid test, POC SARS-COV-2 antibody rapid test and FIA SARS COV-2 antigen test. We have developed SARS-COV-2 total antibody ELISA for mass screening.

KeywordsCOVID-19, SARS-COV-2 PCR test, POC SARS-COV-2 antigen rapid test, POC SARS-COV-2 antibody rapid test, FIA SARS-COV-2 antigen test, SARS-COV-2 total antibody ELISA

Chairman Young-Shik Cho CV
SD Biosensor, Inc., Korea

2020 생물공학 혁신기술 대상 수상

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