PLENARY LECTURE II A Regulatory Science Approach to Assess the Safety of Medical Devices Incorporating Nanotechnology Dr. Peter L. Goering
Research Toxicologist
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.

CEO초청특별강연 Application of Bio Technology in Cosmetic Industry Myeong Sam Park
COSMAX R&I Center, #902, Pangyo inno valley E, 255, Pangyo-ro, Bundang-gu,
Seongnam-si, Gyeonggi-do, Korea

The Korea's cosmetic industry has grown rapidly since the 1990s and is currently leading the global cosmetic trends. Besides, it has created K-beauty trends since the 2010s. The characteristics of the Korean cosmetic industry are not only manufacturing but also cultural industry, which are new growth engines and future industries that can develop various industries connected together. The most dynamic and simultaneously new technologies are rapidly emerging in accordance with various technical and environmental regulations, the most noticeable of which is biotechnology. In the 2000s, as the technology including enzymes, microorganisms and bio-informatics has developed remarkably, the range of material selection applicable to cosmetic prescription has expanded dramatically. In addition, the development of dermatology has greatly contributed to raise the value of biomaterials and to the communication with customers. Based on these development, the biotechnology in the cosmetic industry has been able to derive the new functions that have not been achieved so far, and it is expected to lead cosmetic technology with mega trend for the time being. Global major cosmetic companies are integrating the genomic and medical technologies in detail as well as expanding the scope of cognitive and emotional area, which is a means to enhance the intrinsic value of cosmetics. Here, we focus on the technology trends and report the results of Cosmax's research for Fermentation, Human Skin Microbiome, Bio Factory and Bio Mimetic among various biotechnologies applied to the cosmetic industry.
1. Fermentation technology is gradually evolving into a customized fermentation technology that can modulate metabolites, and Solid State Fermentation is a useful technique for the production of microbial metabolites with skin physiological activity.
2. Human skin microbiome actively functions on the condition of skin moisturizing and aging.
3. In order to overcome the indiscriminate harvesting of natural resources, the mass production technology using microorganisms has been expanded recently.

Keywords
Cosmetic biotechnology; Fermentation; Skin microbiome; Bio factory & mimetic

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.

Keywords
Immunotherapy, Hyleukin-7, Lymphopenia IC inhibitors, synergy