|Plenary Lecture Ⅰ|
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.
Professor and Director Sunghoon Kim CV
Medicinal Bioconvergence Research Center
and Yonsei University, Korea
|Plenary Lecture Ⅱ|
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|
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
PLENARY LECTURE II
A Regulatory Science Approach to Assess the Safety of Medical Devices Incorporating Nanotechnology
Dr. Peter L. Goering
Silver Spring, Maryland, USA
Nanotechnology is significantly impacting the design, development, and manufacture of next-generation medical devices, contributing to advances in disease diagnosis and treatment. Materials engineered at the nanoscale offer size-attributable characteristics, such as large surface area, enhanced optical and electrical properties, anti-microbial activity, and enhanced tissue integration, making them attractive candidates for use in the medical device industry. Nanomaterials have been incorporated into a variety of medical devices, including implantable devices (e.g., orthopedic and dental implants, stents), skin-contacting devices (e.g., wound dressings), and in vitro diagnostic devices. In parallel with the remarkable advances in the use of nanomaterials in medicine, research programs in industry, government agencies, and universities around the world are evaluating the safety of nanomaterials. A robust regulatory science research program to develop the safety profiles of medical devices incorporating nanotechnology includes physical-chemical characterization, in vitro/in vivo models for biological evaluations, and risk assessment. The research goals are to develop and advance the methods, tools, and approaches that will improve safety evaluations of medical devices that incorporate nanotechnology. Projects include safety assessment of discrete nanoparticles and immobilized surface nanostructures used in medical devices with the aim to improve physical-chemical characterization, optimize biological test methods (e.g., genotoxicity), and develop toxicological risk assessment approaches for nanomaterials.
PLENARY LECTURE Ⅲ
Cancer immunotherapy & IL-7: the past, present & future
Prof. Young Chul Sung
Department of Life Science, POSTECH, Pohang, Korea
Genexine, Korea Bio-park, building B-410,
Seongnam-si, Gyeonggi-do, Korea
Cancer immunotherapy began with application of cytokines ( IFN-α & IL-2 ) for treating cancers by boosting host immune system nonspecifically in 1980s. followed by commercialization of mAbs in 1997 (Rituxan for follicular lymphoma).
It is recently highlighted by introduction of immune checkpoint (IC) inhibitors such as anti-PD1, anti-PDL1, and anti-CTLA4.
However to our disappointment, most lymphopenic cancer patients with cold tumors such as pancreatic & colorectal tumors do not have any response to anti-PD1 treatment.
Even in cancer patients with hot tumors, a portion of patients showed durable response to anti-PD1, ranging from 35 to 45%.
So, there is a growing consensus that there are large rooms for IC inhibitor treatments to be improved and the number of T cells in blood & tumor can be a biomarker for predicting the response to anti-PD1 drug.
Here, I will present Hyleukin-7, long-acting IL-7 as a potential lymphopenia drug, which appears to have a strong capability for increasing CD4 & CD8 T cells, but not Tregs, in a dose-dependent manner. In addition, co-treatment of hyleukin-7 significantly enhanced anti-tumor effect of IC inhibitors, indicating a great synergy.
Immunotherapy, Hyleukin-7, Lymphopenia IC inhibitors, synergy
Cosmetic R&D case and future prospects with Biotechnology
LG Household & Health Care Institute of Technology, Seoul, Korea
Since the discovery of the double helix structure of DNA by J. Watson in 1953, biotechnology has been developed at a rapid pace, expanding beyond traditional medicine and food to a variety of fields including agriculture, electronics, the environment and chemistry. The cosmetics industry is also developing synergies with biotechnology, and has promoted the excellence of Korean cosmetics in the world under the name of "K-Beauty".
With the various brand portfolios such as the Royal palace premium cosmetics 'Whoo' which achieved annual sales of 2 trillion KRW for the first time in Korea, the natural fermentation cosmetics 'SU:M 37º' and the skin science cosmetics 'O HUI', LG Household & Health Care (LG H&H) has developed differentiated cosmetic technology based on the biotechnology and is leading K-Beauty as best cosmetic company in Korea since launching the Korea first skin care cosmetics, Lucky Cream (1947)1.
LG H&H is developing various differentiated cosmetic efficacy ingredients, include oriental medicine ingredients based on the systematic skin oriental medicine theory and the standardized oriental processing method, hypoallergenic fermentation ingredients, and bio-functional ingredients in relation to skin science theory. Furthermore LG H&H has presented new cosmetic technologies such as 'epidermal stem cell activation technology2', 'skin permeation activation technology3', and 'skin exfoliation activation technology4', to maximize efficacy based on biotechnology. Variety of products composed of unique efficacy ingredients and excellent technologies have given a real efficacy of sensory and satisfaction to domestic and overseas customers, resulting in 3 times sales and 4.6 times operating profit over the past decade.
LG H&H is leading the way in R&D as quickly recognizing 'Personalization', one of the future global consumption trends.5 Based on the latest biotechnology, genetic analysis technology, LG H&H is continuously strengthening abilities to analyze and comprehend individual genes/skin characteristics and correlations accurately. Utilizing the vast biological information collected, LG H&H is also trying hard to develop customized products with improved accuracy.
In this lecture, the achievements of LG H&H cosmetics R&D that have been developed with biotechnology are shared, and the current status of biotechnology research for the future cosmetic products is introduced.
References 1. History of Industrial Technology in Korea, Chapter4, 408 (2019)
2. Composition for improving skin (KR 10-1661288)
3. Skin Permeating peptide (KR-10-1329411)
4. S.-H. Lee, S.-H. Jun, K.Yeom, S.-G.Park, C.-K.Lee, N.-G.Kang, Optical clearing agent reduces scattering of light by the stratum corneum and modulates the physical properties of coenocytes via hydration(2018), Skin Research and Technology, 24(3), 371-378
5. Euromonitor, 20 most influential megatrends to shape the world by 2030(2017)
Biotechnology; Cosmetics; K-Beauty; LG H&H; Skin science; Personalization; Gene
Hyun Ho Jung
Stepwise evolution of Medytox from a start-up to global biotech
With continual in-house R&D, Medytox is the only company in the world to develop three different types of botulinum toxin products "Meditoxin", "Innotox", "Coretox", each with its own unique strengths. Along with these products, Medytox has introduced a synergistic hyaluronic acid filler "Neuramis" with its exclusive technology, successfully solidifying the new pipeline. Furthermore, we are now ready for a great leap forward, as all the establishment from Medytox Plant I, Plant II, and Plant III to Medytox R&D Center (Gwanggyo), and Medytox Building in Seoul was constructed.
As a young global biopharmaceutical company established in 2000, we set a goal of entering the 'Top 20 list of global biopharmaceutical companies'. Going forward, Medytox will strive to tackle the advanced markets and to directly penetrate and expand into the emerging markets. We will create meaningful performance with new businesses by increasing investment in R&D and pushing continuous commercialization.
We hope our website (www.medytox.com) can provide you with a chance to learn more about Medytox.
1. Our Products
2. Our Challenge in Global
3. Our Vision: Pipeline for Novel Biologics
Medytox; Botulinum toxin; Biopharmaceutical Company