
| Track 01. | Recent Advances of Regenerative Medicine |
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| Track 02. | Biorefinery |
| Track 03. | Micro/Nano-biotechnology |
| Track 04. | Medical Devices |
| Track 05. | Vaccine |
| Track 06. | Smart Drug Delivery Strategy |
| Track 07. | Regulatory and GMP Compliance |
| Track 08. | Business Development |
| Track 09. | Technology Licensing |
| Track 10. | Therapeutic Antibody |
| Track 11. | Botanical New Drug Development |
| Track 12. | Clinical Drug Development |
| Track 13. | Ubiquitous Healthcare |
Regenerative medicine seeks to devise new therapies for patients with severe injuries or chronic diseases in which the body's own responses do not suffice to restore functional tissue. Prerequisite factors to accomplish new organ/tissue are (1) cells, (2) scaffolds, and (3) bioactive molecules. In this session, we will present the recent advances of the application of regenerative medicine for hard tissues
Chair : Moon Suk KIM, Principal Research Scientist, Korea Research Institute of Chemical Tech.
| Oct. 10 10:00-10:30 |
Regenerative Medicine for Dental Application Soon Jung HWANG, Associate Professor, School of Dentistry, Seoul Nat’l Univ. |
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| Oct. 10 10:30-11:00 |
Novel Biomaterials for Bone Regeneration Mark VAN DYKE, Assistant Professor, Regenerative Medicine, Wake Forest Univ. School of Medicine |
| Oct. 10 11:00-11:30 |
Biomechanical Effect for Tissue Regenerations Soo Hyun KIM, Senior Researcher, Korea Institute of Science and Tech. |
Among the three factors for the regenerative medicine as cell, scaffold and bioactive molecules, cell might be the most important factor. It can be large divided three types according to cell source as (1) embryonic stem cell, (2) adult stem cell and (3) primary cell. Embryonic/adult stem cell might be differentiate/dedifferentiate to desired primary cell by the controlling the culture condition. In this session, we will introduce the types of cell for the soft tissue applications as spinal cord regeneration, bio-artificial liver and Parkinson's diseases.
Chair : Dong Keun HAN, Research Scientist, Korea Institute of Science and Technology
| Oct. 10 13:30-14:00 |
Bioartificial Liver System Jung-Keug PARK, Professor, Dongguk Univ. |
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| Oct. 10 14:00-14:30 |
Spinal Cord Regeneration by Regenerative Medicine Moon Suk KIM, Principal Research Scientist, Korea Research Institute of Chemical Tech. |
| Oct. 10 14:30-15:00 |
Embryonic Stem Cell for Regenerative Medicine - Recent Advances in Embryonic Stem Cell Research Dong-Wook KIM, Director/Professor, Stem Cell Research Center / Yonsei Univ. College of Medicine |
Final goal of engineering with medicinal science might be the human application, that is, commercialization. For the success of commercialization, medical products must be approved by government at each country system. Notably, Korean Food and Drug Administration already approved eight products as cell therapy, whereas Japan has only one product. In this session, we will discuss the strategy of global marketing for the tissue engineered and regenerative medicine products.
Chair : Gilson KHANG, Professor, Chonbuk Nat'l Univ.
| Oct. 10 15:20-15:50 |
From Bench Side to Clinical Application and Industrialization for Regenerative Medicine; Our Experience in Japan Ken-ichiro HATA, Director, Research & Development, Japan Tissue Engineering Co., Ltd. |
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| Oct. 10 15:50-16:20 |
Bone Tissue Regeneration Taek-Rim YOON, Professor, Dept. of Orthopedic Surgery, Chonnam Nat'l Univ. Hwasun Hospital |
| Oct. 10 16:20-16:50 |
Recent Progress of “Cell-sheet Engineering” Clinical Researches and Our Grand Design of “Medical Value-chain” for Global Regenerative Medicine Mime EGAMI, Visiting Professor, Institute of Advanced Biomedical & Science, Tokyo Womans Medical Univ. |
With increasing concerns over shortage of oil supply, serious works are under progress to develop alternative routes to produce fuels and chemicals from renewable biomass. Lignocellulosic materials are regarded as a promising or an ultimate feedstock because of the cheap cost, abundance and renewable property. However, to utilize the lignocellulosic biomass as raw material, efficient and cost-effective saccharification technology should be developed which is dependent upon the proper pretreatment of biomass. In this session, recent progress in the pretreatment of lignocellulosic biomass is introduced. Major effort in three countries, Korea, USA and Japan, will be overviewed.
Chair : Jin-Seok LEE, Principal Researcher, Korea Institute of Energy Research
| Oct. 9 10:00-10:30 |
Research Activities of Nat'l Institute of Advanced Industrial Science and Tech. - Pretreatment Tech. of Woody Biomass for Bioethanol Production Seung-Hwan LEE, Research Scientist, Biomass Tech. Research Center, Nat'l Institute of Advanced Industrial Science & Tech. |
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| Oct. 9 10:30-11:00 |
Biomass to Hydrocarbons Mark HOLTZAPPLE, Professor, Texas A & M Univ. |
| Oct. 9 11:00-11:30 |
Biorefinery of Cellulosic Biomass -Concept and Practice in Korea Jin-Suk LEE, Principal Researcher, Korea Institute of Energy Research |
Industrial Biotechnology is an emerging technology for the production of chemicals and biofuels by using biomass as raw material. The products include primary or secondary metabolites of microorganisms and various biopolymers such as bioethanol, biohydrogen, glycerol, lactic acid, amino acids, PHA, PLA, etc. The technology is based on biocatalysis; both enzymatic and microbial. This session focuses on the development of microbial biocatalysis. Recent progress in microbial-pathway engineering and its application to development of microbial biocatalysts will be covered by three well-known scientists from Korea, USA, and Japan.
Chair : Sung Hoon PARK, Professor, Pusan Nat'l Univ.
| Oct. 9 13:30-14:00 |
Harnessing the Microbial Fermentation of Glycerol - A New Path to Biofuels and Biochemicals Ramon GONZALEZ, Assistant Professor, Chemical & Biomolecular Engineering, Rice Univ. |
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| Oct. 9 14:00-14:30 |
Systems Metabolic Engineering for the Production of Chemicals Hyohak SONG, Research Professor, Dept. of Chemical & Biomolecular Engineering, Korea Institute of Science and Tech. |
| Oct. 9 14:30-15:00 |
Production of Biofuels/Biochemicals from C6 & C5 Sugars by the RITE Bioprocess Hideaki YUKAWA, Director/Chief Researcher, Molecular Microbiology & Biotechnology Group, Research Institute of Innovative Tech. for the Earth |
Enzymes play a key role as a workhorse in the field of biorefinery. As an example, cellulases, used for the degradation of cellulose to glucose, have been considered one of the most important components for the success of biorefinery. The activity and economical production of cellulases have been an issue and improved significantly during last decades. However, further improvements are still needed to materialize biorefinery processes. Strategies can be found in a variety of approaches in the enzyme technology, such as enzyme discovery, production, engineering, and modification. This session will be dedicated to general discussion on recent progress in the field of enzyme catalysis and engineering, which can be employed in the development of biorefinery processes.
Chair : Jungbae KIM, Associate Professor, Korea Univ.
| Oct. 9 15:20-15:50 |
Engineering of Industrial Enzymes Using High Throughput Cell-free Protein Synthesis System Dong-Myung KIM, Associate Professor, Dept. of Chemical Engineering, Chungnam Nat’l Univ. |
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| Oct. 9 15:50-16:20 |
Nanobiocatalysis and Its Potential Applications Jungbae KIM, Associate Professor, Dept. of Chemical & Biological Engineering, Korea Univ. |
| Oct. 9 16:20-16:50 |
Enzymatic Processes which Replaced Some of Already Established Chemical Processes Yasuhisa ASANO, Director/Professor, Biotechnology Research Center, Toyama Prefectural Univ. |
Recent years have seen considerable progress in the development of microfabricated systems for use in the chemical and biological sciences. Much development has been driven by a need to perform rapid measurements on small sample volumes in areas such as chemical synthesis, DNA/Protein analysis, drug discovery, pharmaceutical screening, proteomics and medical diagnostics. However, at a more primary level, interest in miniaturized analytical systems has been stimulated by the fact that physical processes can be more easily controlled and harnessed when instrumental dimensions are reduced to the micrometre scale. For example, it is well recognized that when compared to macroscale instruments, micro/nano-fluidic systems engender a number of distinct advantages with respect to speed, analytical throughput, reagent usage, process control, automation and operational and configurational flexibility. In general terms, such systems define new operational paradigms and provide predictions about how molecular synthesis and analysis might be revolutionized in the coming years. This session will introduce some of the key features and benefits of micro/nano-fluidic systems and describe the use of such devices for performing ultra-fast biological and chemical analysis. Specifically, the following areas will be highlighted with respect to relevant chemical and biological applications. In this session several approaches will be described regarding the development and application of nanofluidic devices for single molecule binding studies in UK and KOREA.
Chair : Soo-Ik CHANG, Professor, Chungbuk Nat'l Univ.
| Oct. 8 14:00-14:25 |
Microfluidic Approaches to Quantitative Point-of-Care Diagnostics Andrew J. deMello, Professor of Chemical Nanosciences, Chemistry, Imperial College London |
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| Oct. 8 14:25-14:50 |
Nano-bio and Systems-bio Platform Technologies for Diagnosis and Therapy Sang Yup LEE, Distinguished Professor, Chemical Engineering, Korea Advances Institute of Science and Tech. |
| Oct. 8 14:50-15:15 |
Biological Experiments in Microfluidic Microdroplets Florian HOLFELDER, Lecturer, Dept. of Biochemistry, Univ. of Cambridge |
| Oct. 8 15:15-15:40 |
Highly Sensitive Biological Analysis Using Optical Microfluidic Sensor Jaebum CHOO, Professor, Dept. of Applied Chemistry, Hanyang Univ. |
Micro/nanobiotechnology is a rapidly advancing area of scientific and technological opportunity that applies the tools and processes of micro/nanofabrication to build devices for studying biosystems. Researchers learn from biology to create new micro-nanoscale devices to better understand life processes at the nanoscale. Micro/nanotechnology on a chip is a new paradigm for total biological analysis systems. The ability to make chemical or biological information easier and less costly to obtain will impact molecular binding analysis, diagnostics and high through screening for drugs. Some examples of devices are micro/nanofluidic chips and protein nanobiochips. These devices can be adapted for point-of-care use. One of the more promising uses of nanofluidic devices is isolation and analysis of individual biomolecules, such as protein or DNA. This capability could lead to new detection schemes for disease as a cancer. Protein microarrays for the study of protein function are not widely used, in part because of the challenges in producing proteins to spot on the arrays. In these sessions some of the key features and benefits of micro/nano-biotechnology systems and its fabrication & application for biological research will be presented.
Chair : Robin J. LEATHERBARROW, Head/Professor , Imperial College London
| Oct. 8 16:00-16:25 |
High-throughput Screening of Antibody-mimic Peptides by Using a Protein Microarray Chip
Soo-Ik CHANG, Professor, Dept. of Biochemistry, Chungbuk Nat’l Univ. |
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| Oct. 8 16:25-16:50 |
New Techniques in Electrochemistry -From Selectivity to Flow Danny O'HARE, Reader, Bioengineering, Imperial College London |
| Oct. 8 16:50-17:15 |
Biomedical Imaging and Therapy Using Nanomaterials Bong Hyun CHUNG, Director, BioNanotechnology Research Center, Korea Research Institute of Bioscience and Biotech. |
| Oct. 8 17:15-17:40 |
Wireless Biosensor Devices -Extending the Lab-on-a-Chip Concept into Smart Diagnostics Jon M. COOPER, Professor, Bioengineering, Univ. of Glasgow |
Micro/nanobiotechnology is a rapidly advancing area of scientific and technological opportunity that applies the tools and processes of micro/nanofabrication to build devices for studying biosystems. Researchers learn from biology to create new micro-nanoscale devices to better understand life processes at the nanoscale. Micro/nanotechnology on a chip is a new paradigm for total biological analysis systems. The ability to make chemical or biological information easier and less costly to obtain will impact molecular binding analysis, diagnostics and high through screening for drugs. Some examples of devices are micro/nanofluidic chips and protein nanobiochips. These devices can be adapted for point-of-care use. One of the more promising uses of nanofluidic devices is isolation and analysis of individual biomolecules, such as protein or DNA. This capability could lead to new detection schemes for disease as a cancer. Protein microarrays for the study of protein function are not widely used, in part because of the challenges in producing proteins to spot on the arrays. In these sessions some of the key features and benefits of micro/nano-biotechnology systems and its fabrication & application for biological research will be presented.
Chair : Andrew J. deMello, Professor of Chemical Nanosciences, Chemistry, Imperial College London
| Oct. 9 10:00-10:30 |
Recent Advance in ProteoChip Technology - Chip-based Profile Study of Differential Protein Experssion in Cells In-Cheol KANG, Professor/Director, Dept. of Biological Science, Hoseo Univ. |
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| Oct. 9 10:30-11:00 |
Biomolecules and Nanomaterials -Engineering the Hard/Soft Interface Tony CASS, Professor, Chemical Biology, Imperial College London |
| Oct. 9 11:00-11:30 |
Bioconjugation and Biofunctionality of Surface Immobilized Proteins for Biochip Applications Eun Kyu LEE, Director/Professor, Bionanotechnology BK21 Program/Dept. of Chemical Engineering, Hanyang Univ. |
| Oct. 9 11:30-12:00 |
Attachment of Chemical Labels to the N-terminus of Proteins by Protease Digestion and Native Chemical Ligation Robin J. LEATHERBARROW, Head/Professor, Biological and Biophysical Chemistry/Dept. of Chemistry, Imperial College London |
| Oct. 9 12:00-12:30 |
- Athanasios Mantalaris |
With the growing needs for superior implants, prosthetics, and scaffolds, biomaterials have become a highly explored field. These artificial materials are an integral part of this research effort, allowing for the study of cell attachment, growth, differentiation, functioning, viability, and matrix degradation. Biomaterials must fulfill 3 criteria; they must be biofunctional (suitable physical and chemical properties for replacing the tissue), biocompatible (no negative interaction between materials and biological environment), and inert to the biological environment or degradable by the system.
Chair : Jong Chul PARK, Associate Professor, Yonsei Univ.
| Oct. 9 10:00-10:30 |
Functional Medical Adhesives Suong-Hyu HYON, Associate Professor, Frontier Medical Sciences, Kyoto Univ. |
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| Oct. 9 10:30-11:00 |
Current Status of Biocompatible Polymeric Materials Ki Dong PARK, Professor, Dept. of Molecular Science and Tech., Ajou Univ. |
| Oct. 9 11:00-11:30 |
The Review and Approval of Medical Device in Korea Gyu Ha RYU, Director, Medical Device Safety Bureau, Korea Food & Drug Administration |
Cardiovascular disease is an important cause of morbidity and mortality world wide. Biocompatibility problems are encountered with the use of implanted cardiovascular devices such as artificial hearts, ventricular assist devices, heart valves, small diameter vascular grafts, and stents. Novel cardiovascular prosthetic devices or implants having many useful cardiovascular applications comprise a porous surface and a network of interconnected interstitial pores below the surface in fluid flow communication with the surface pores. Tissue forms a smooth thin adherent coating or self-determining thickness on the porous surface making it resistant to the formation of the blood clots normally associated with the presence of foreign bodies in the blood stream.
Chair : Dong Joon CHUNG, Professor, SungKyunKwan Univ.
| Oct. 9 13:30-14:00 |
Robotics-based Vascular Engineered Tissue Fabrication Takehisa MATSUDA, Professor, Genome Biomed Lab., Kanazawa Institute of Tech. |
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| Oct. 9 14:00-14:30 |
Vascular Closure Device Yangsoo Jang, Professor, Division of Cardiology, Yonsei Univ. College of Medicine |
| Oct. 9 14:30-15:00 |
Spray Coating Techniques for Medical Implants Il Keun KWON, Assistant Professor, Dept. of Oral Biology, Institute of Oral Biology, Kyung Hee Univ. |
Current tissue engineering strategies focus on the replacement of pathologically altered tissues by the transplantation of cells in combination with supportive biocompatible scaffolds. Scaffolds for tissue engineering strategies in musculoskeletal research require an appropriate mechanical stability. Dental surgical implant treatment modalities continue to be relatively successful within musculoskeletal restorative systems. Because available systems include a wide range of metallic and ceramic biomaterials plus multiple designs for the implant body, transgingival abutment, and intraoral crown constructs, failure analyses of explanted devices must include comprehensive information. In orthopedics, the regeneration and repair of cartilage or bone defects after trauma, cancer, or metabolic disorders is still a major clinical challenge.
Chair : -
| Oct. 9 15:20-15:50 |
Current Trends on Endosseous Implant Bulk and Surface Design - Enhancing Early Biological Response Paulo G. COELHO, Adjunct Professor, Dept. of Biomaterials and Biomimetics, School of Arts & Science, New York Univ. |
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| Oct. 9 15:50-16:20 |
Biomimetic Surface Modifications of Medical and Dental Implants - Evolution of Implant Surface Modification Seong-Joo HEO, Professor, College of Dentistry, Seoul Nat’l Univ. |
| Oct. 9 16:20-16:50 |
Transplantation of Artificial Meniscus with Cells Myung Chul LEE, Professor, Dept. of Orthopedic Surgery, Seoul Nat’l Univ. Hospital |
Chair : Soo-Ki KIM, Director, Institute of Basic Medical Science, Yonsei Univ.
| Oct. 8 14:00-14:50 |
Hepatitis C Virus -Challenge and Advancement of Viral Vaccine Development Jang H. HAN, Director, HVC Vaccine Research, Novartis |
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Cancer vaccine is no longer a dream but a reality. This advance has been in debt to the revolutionary discovery of core technologies in tumor immunology. In that context, fashioning cancer vaccine is more simplified. However, cancer vaccine has been diversified and tailorized in real application. This session will cover core elements and current status of cancer vaccine. Specifically, immunologic adjuvant and antigen discovery is essential requirement for powerful cancer vaccine. In parallel, we'll touch the cutting-edge application of cancer vaccine in clinic.
Chair : Soo Ki KIM, Professor, Institute of Basic Medical Science, Yonsei Univ.
| Oct. 8 14:50-15:15 |
Discovery of Tumor Antigen for Cancer Immunotherapy Sang Yull LEE, Associate Professor, Dept. of Biochemistry, College of Medicine, Pusan Univ. |
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| Oct. 8 15:15-15:40 |
Cell-based Radioimmunotherapy and Chemoimmunotherapy for Treatment of Human Cancer Chi-Duk KANG, Professor, Pusan Univ. School of Medicine |
| Oct. 8 15:40-16:05 |
Immunologic Adjuvant for Cancer Vaccine & Ganglioside Antigen Cancer Vaccine Soo-Ki KIM, Director, Institute of Basic Medical Sciences, Yonsei Univ. |
As the main entry of most environment pathogens, mucosal surfaces such as respiratory, gastro-intestinal, and genital tracts as the first line of defense against pathogenic antigens such as AIDS, influenza virus, salmonella, shigella, TB, cholera, and HPV. Therefore, vaccination targeting mucosal tissues capable of effectively inducing both mucosal (secretory IgA Ab) and systemic immune responses (IgG Ab), thereby resulting in two layers of host protection. We would like to introduce new concept of mucosal delivery routes and current status of development of mucosal adjuvants in this session.
Chair : Mi-Na KWEON, Chief, Mucosal Immunology Section, Int'l Vaccine Institute
| Oct. 8 16:25-16:50 |
Commercialization Based on Scientific Excellence -HPV Vaccine & Others Walter STRAUS, Executive Director, Scientific Affairs, Merck Vaccine Division, Merck & Co., Inc. |
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| Oct. 8 16:50-17:15 |
Mucosal Adjuvant Activity of Flagellin, the TLR5 Agonist - Flagellin, a New Mucosal Vaccine Adjuvant Joon Haeng RHEE, Professor, Dept.of Microbiology, Chonnam Nat'l Univ. Medical College |
| Oct. 8 17:15-17:40 |
The Sublingual Mucosa: An Efficient Delivery Route for Inducing Protective Immune Responses -Efficacy of Sublingual Mucosa Mi-Na KWEON, Chief, Mucosal Immunology Section, Int'l Vaccine Institute |
A major challenge to pharmaceutical scientists in new drug development is in the optimization of drug delivery properties to improve the therapeutic effectiveness of drugs. Many studies have supported that poor pharmacokinetic properties heavily contribute to compound failure or at a minimum, difficulty of the compound to progress through drug development. Therefore, in this session, several case studies are illustrated to enlighten the current approaches for improving oral drug delivery efficiency and ultimately for maximizing the therapeutic benefits of drugs.
Chair : In Koo CHUN, Professor, Dongduk Women's Univ.
| Oct. 9 10:00-10:30 |
Delivery of Drugs to Target Tissues -Project Supports and BBB Initiative in Drug Discovery Dooman OH, Associate Director, Clinical Pharmacology, PPD Inc. |
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| Oct. 9 10:30-11:00 |
Microenvironmental pH and Crystal Behavior of Ionizable Drug by Alkalizers in Solid Dispersions Beom-Jin LEE, Professor, College of Pharmacy, Kangwon Nat’l Univ. |
| Oct. 9 11:00-11:30 |
Preparation of Cyclosporine A Lipid Emulsion Using Membrane Emulsification Method Eun-Seok PARK, Professor, College of Pharmacy, Sungkyunkwan Univ. |
Efficient drug delivery to target tissue is prerequisite for disease control by chemotherapy. Target tissue characteristics should be taken into consideration in strategy development for effective drug delivery and maximum drug efficacy. Solid tumors represent a particular interest in term of unique histophysiology and intrinsic chemo-resistance, which makes it important to develop selective drug delivery systems and to study pharmacokinetics in avascular region of solid tumors. This session will focus on recent research trends regarding vascular and avascular delivery of anticancer drugs using novel drug delivery systems or 3-dimensional cell culture models.
Chair : Hyo Kyung HAN, Professor, Chosun Univ.
| Oct. 9 13:30-14:00 |
Tumor Priming to Promote Nano- and Micro-particle Delivery to Solid Tumors Jessie L.S. AU, Distinguished Univ. Professor, College of Pharmacy, The Ohio State Univ. |
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| Oct. 9 14:00-14:30 |
Drug Delivery and Activity in Solid Tumors -A Pharmacokinetic Perspective Hyo-Jeong KUH, Associate Professor, College of Medicine, The Catholic Univ. of Korea |
| Oct. 9 14:30-15:00 |
Targeted Drug Delivery via Surface-modified Nanoparticles Chang-Koo SHIM, Professor, College of Pharmacy, Seoul Nat’l Univ. |
Development of novel technology of drug delivery system might be more efficient compared with conventional novel synthetic drug in terms of the invest money and duration, especially Korea which is coupled with Korea-USA FTA and inferior basement of discovery of new drug. Also, developed novel DDS technology can be applied to several drugs and various symptoms that is platform technology. In this session, we will discuss profoundly for the nanobiomaterials for tissue engineering and drug delivery, nucleic acid delivery using nanotechnology and micro needle system for macromolecular drug.
Chair : Beom Jin LEE, Professor, Kangwon Nat'l Univ.
| Oct. 9 15:20-15:50 |
Peptide Based Nanobiomaterials for Drug Delivery and Tissue Engineering Purpose Yoon Jeong PARK, Assistant Professor, School of Dentistry, Seoul Nat’l Univ. |
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| Oct. 9 15:50-16:20 |
Delivery of Nucleic Acid-Based Medicines Using Nanotechnology Yu-Kyoung OH, Associate Professor, School of Life Sciences and Biotechnology, Korea Univ. |
| Oct. 9 16:20-16:50 |
Recent Advances on Microneedle System for Drug Delivery Gilson KHANG, Professor, Dept of PolymerNano Sci. & Tech., Chonbuk Nat’l Univ. |
Korea Food and Drug Administration (KFDA) continuously improves its regulations and guideline to secure the efficacy and safety of drug products. Recent enforcement of the validation requirement is evaluated as a essential step to prepare Korea-US FTA and to export the drug products to advanced countries. Therefore, it is very important to update recent development in the KFDA regulations. In this session a plan of KFDA for CTD (Common Technical Document) which ICH had implemented in its State Parties, Global GMP training, and regulations of cell bank control and validation for biologics manufacturing.
Chair : Chan Wha KIM, Professor, Korea Univ.
| Oct. 10 10:00-10:30 |
Efficient and Practical Training Program for Vaccine Manufacturer and National Regulatory Authority Personnel Chung Keel LEE, Special Advisor/Adjunct Professor, Biopharmaceutical Bureau, Korea Food & Drug Administration/Life Sciences & Biotechnology, Korea Univ. |
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| Oct. 10 10:30-11:00 |
Implementation of the Common Technical Document (CTD) in Korea -Biotechnological/Biological Products Sookyung SUH, Senior Scientific Officer, Recombinant Products Division, Korea Food & Drug Administration |
| Oct. 10 11:00-11:30 |
Safety Evaluation and Validation of Cell Substrates and Managing Contamination for Production of High Quality Biotechnological Products such as Biopharmaceuticals - Current Trends in Cell Banking Technologies Sue Nie PARK, Director, NITR, Division of Genetic Toxicology, Korea Food & Drug Administration |
GMP compliance is one of the most important tasks in the drug manufacturing. Therefore, drug manufacturing companies allocate significant portions of their resources to improve levels of GMP. In this session industrial experts will present PAT in manufacturing processes and quality control in biopharmaceutical manufacturing. In addition, GMP compliance in research institute will be presented.
Chair : Doo Hong PARK, Director, Green Cross Corp., Korea
| Oct. 10 13:30-14:00 |
Validation of Sterile Filtration Systems Chan-Wha KIM, Professor, Division of Life Sciences & Biotech., Korea Univ. |
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| Oct. 10 14:00-14:30 |
GMP-compliant Testing of Biopharmaceuticals Guy BERG, Senior Vice President, Business Development, NewLab BioQuality AG |
| Oct. 10 14:30-15:00 |
GMP Application in Research & Development Institute - Quality Management in Research & Development Phase Do Yeon LEE, Manager, CJ CheilJedang Corp. Pharmaceutical Bureau R&D QA |
With rapid growth of the monoclonal antibody therapeutic market, technological demand of quality control and quality assurance of therapeutic monoclonal antibody manufacturing increases. In this session, validation of analytical method and quality assurance for monoclonal antibodies will be presented by industrial experts. In addition, quality assurance in vaccine manufacturing will be presented.
Chair : Gyun Min LEE, Professor, Korea Advanced Institute of Science and Tech.
| Oct. 10 15:20-15:50 |
Validation of Analytical Method for Monoclonal Antibody Products KC CHENG, Associate Director, Analytical and Formulation Development, Medarex Inc. |
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| Oct. 10 15:50-16:20 |
Quality Assurance of Monoclonal Antibody Manufacturing Processes Brian KIM, Vice President, QA & Regulatory Compliance, Celltrion Inc. |
| Oct. 10 16:20-16:50 |
Continuous Improvement and Modern Quality System Sang Jeom AHN, CEO/President, Berna Biotech Korea Corp. |
This is to show the strategy of an exemplary research-based global leading pharmaceutical company in successful business development by collaboration and partnerships with smaller companies with innovative technologies.
Chair : Kyu Chan KIM, Science Ambassador, Merck & Co., Inc.
| Oct. 9 10:00-11:00 |
Merck's Partnering Strategy in the Asia-Pacific Region Greg WIEDERRECHT, VP/Head, External Scientific Affairs, Worldwide Licensing & External Research, Merck & Co., Inc. |
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For successful global commercialization, primary and most important element should be technological excellence and innovation, which could be secured only from years of focused refinement and innovative challenges.
Chair : Kyu Chan KIM, Science Ambassador, Merck & Co., Inc.
| Oct. 9 11:00-11:30 |
Success Elements in R&D Strategies for Competitive Therapeutics - Hybrid R&D Sung Chun KIM, CTO, LG Life Sciences Ltd. |
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| Oct. 9 11:30-12:00 |
Maximizing Value Through Business Development-Worldwide and Regional Strategies Douglas E. ONSI, Partner, HealthCare Ventures |
| Oct. 9 12:00-12:30 |
CrystalGenomics’s Competitiveness in Drug Discovery -Structural Chemoproteomics-based Drug Discovery Joong Myung CHO, President/CEO, CrystalGenomics, lnc. |
Realization of technologies in commercial use needs financial instruments. Experienced capitalists explain how and why venture capitals decide where to invest the funds in this high risk, high return industry.
Chair : Byung Hwan RYU, CEO, Seoul Pharma Co., Ltd.
| Oct. 9 13:30-14:00 |
VCs’ Perspective of What Emerging Companies Should Be Doing Hui-Hsing MA, Venture Partner, Life Sciences, TVM Capital |
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| Oct. 9 14:00-14:30 |
Novartis Strategy of Global Funding in the Drug Discovery Reinhard J. AMBROS, Executive Director/Head, Novartis Venture Funds, Novartis International |
| Oct. 9 14:30-15:00 |
Recent Trends and Strategies for Biopharmaceutical Financing in the Current Capital Market H. Michael KEYOUNG, Director, Private Equity-Venture Capital Group, Burrill & Company |
Market readiness and commercial acumen should be well wrapped up in addition to technological excellence, for successful licensing deals.
Chair : Sung Chun KIM, CTO, LG Life Sciences Ltd.
| Oct. 9 15:20-15:50 |
Integration of Expertise, Research and Partnering -Winning Strategy Sung-eun YOO, Director, The Center for Biological Modulators, Korea Research Institute of Chemical Tech. |
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| Oct. 9 15:50-16:20 |
- |
| Oct. 9 15:20-16:20 |
Harnessing Korean Biotech for the Markets - The Importance of IP Protection & Technology Transfer Lawrence A. KOGAN, President/CEO, Institute for Trade, Standards & Sustainable Development Inc. |
This session is to re-visit on the expeditions of innovative technology development consistent of multidisciplinary interactions and collaborations, in the highly competitive environment.
Chair : Chris Soo-Sung LEE, Managing Director, Roberts Mitani Advisor LLC.
| Oct. 8 14:00-14:30 |
Opportunities and Challenges for Follow-on Biologics in the U.S. Joo Mee KIM, Partner, Rothwell, Figg, Ernst & Manbeck, p.c |
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| Oct. 8 14:30-15:00 |
Beyond Licensing -Becoming Global Player Hideki MITANI, Managing Director, Roberts Mitani, LLC |
Learn from experienced leaders the critical issues on how to make proprietary technologies be successfully licensed to global market.
Chair : Moon Hee HAN, CEO, Proteogen, Inc.
| Oct. 8 15:50-16:20 |
Creating a Position of Strength for Successful Marketing Michael S. MURRAY, Director, Business Development, Sosei R&D Ltd. |
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| Oct. 8 16:20-16:50 |
Strategy of Korean Pharmaceutical Company for New Drug Development Jeiman RYU, Head, Research Laboratories, DongWha Pharmaceutical Co. |
| Oct. 8 16:50-17:20 |
Strategic Alliances for Global Drug Development Soo-Hee YOON, Director, Business Development, LG Life Sicences Ltd. |
As a major part of recombinant protein therapeutics, antibody therapeutics have made a remarkable progress of industry while the whole pharmaceutical market has been in stagnant growth rate. First session will provide latest updates in global R&D in antibody therapeutics regarding engineering antibodies for improved efficacy, and the therapeutic significance of human antibodies. Monoclonal antibodies and novel targets discovery will be discussed and the development of monoclonal antibody for the treatment of B-cell Malignancy will be presented as an example. The last topic in the first session is R&D of therapeutic antibodies which include past experience, current trend and future direction of this field.
Chair : Se-Ho KIM, Research Director, Readearch Center, Green Cross Corp.
| Oct. 10 10:00-10:30 |
Therapeutic Antibodies and Their Target Discovery Youngwoo PARK, Principal Research Scientist, Korea Research Institute of Bioscience & Biotech. |
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| Oct. 10 10:30-11:00 |
Development of Monoclonal Antibody for the Treatment of B-Cell Malignancies Sang Hoon LEE, Senior ScientistII, Molecular & Cellular Pharmacology, Exelixis |
| Oct. 10 11:00-11:30 |
Generation of Therapeutic Antibodies - Past Experience, Current Trend and Future Direction Naoya TSURUSHITA, Cofounder, JN Biosciences LLC. |
Although Therapeutic antibody field has shown rapid growth, limitation of validated target raised the interest in efficacy enhancement through the antibody engineering. This second session will discuss in depth about current status of local and global antibody manufacturing capacities, problem and checkpoint in the process development for eventual antibody development. The first time will be addressed assessment of cell engineering strategies for improved therapeutic antibody production in CHO cells. What will follow is ADCC and CDC enhancement technology for next generation therapeutic antibodies. The final topic is the role of the analytical tools in the development of therapeutic antibodies.
Chair : Hosung MIN, Head, Samsung Electronics
| Oct. 10 13:30-14:00 |
Assessment of Cell Engineering Strategies for Improved Therapeutic Antibody Production in CHO Cells Gyun Min LEE, Professor, Dept. of Biological Sciences, Korea Advanced Institute of Science and Tech. |
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| Oct. 10 14:00-14:30 |
ADCC and CDC Enhancement Technology for Next-Generation Therapeutic Antibodies Kenya SHITARA, Director, Antibody Business Office, Kyowa Hakko Kogyo Co., Ltd. |
| Oct. 10 14:30-15:00 |
The Analytical Role in the Development of Therapeutic Antibodies Zheru ZHANG, Director, R&D, Celltrion, Inc. |
Due to advantage of the cost-effective and shorter development time, many Korean pharmaceutical companies are trying to develop the therapeutic antibody. This session will discuss on the global forecast of antibody therapeutics market in the short and long term from the viewpoint of therapeutics industries in Korea. The developmental programs of therapeutic antibodies will be presented by Hanwha Chemical Corp., Korea Greencross Corp., and Samsung Advanced Institute of Technology.
Chair : Young Woo PARK, Senior Researcher, Korea Research Institute of Bioscience and Biotechnology
| Oct. 10 15:20-15:50 |
Strategy of New Mab Therapy in Hanwha group Soon Jae PARK, Senior Vice President, Bio, Hanwha Group |
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| Oct. 10 15:50-16:20 |
HBV Neutralizing Human Monoclonal Antibody: From Bench to Clinic - HBV Neutralizing Human Antibody Se-Ho KIM, Research Director, Research Center, Green Cross Corp. |
| Oct. 10 16:20-16:50 |
Beyond Antibodies -Possibilities and Limitations Hosung MIN, Head, Antibody Engineering, Bio & Health Group, Samsung Electronics |
Extensive experience and abundant clinical data have been accumulated in traditional Korean medicine for thousands of years. Basic and clinical research in traditional Korean medicine (TKM) constitutes a potentially rich source for drug discovery and development. How can we use the information of TKM for the development of new drug? The strategy of botanical new drug development from TKM will be presented by Dr. Kim. Strategy of new phytomedicine development have been derived based upon various experinces of preclinical and clinical develpments in industry, Dong-A Pharm, and will be presented by Dr. Son. Research studies in all fields of medicine are known as clinical trials. These studies are conducted with an eye to the future, in hopes of finding safer or more effective methods to screen for, prevent, diagnose, or treat a variety of diseases. However, botanical new drug approval process is little bit simpler for the approval by the national regulatory authority. Therefore strategic approach for clinical trials for natural Products reduces time and cost of Clinical trials for botanical new drug and dietary supplement which will be presented by Dr. Chae.
Chair : Eun Bang LEE, Professor Emeritus, College of Pharmacy, Seoul Nat'l Univ.
| Oct. 10 10:00-10:30 |
Strategy of Botanical New Drug Development from Traditional Korean Medicine Hocheol KIM, Professor/CEO, Dept. of Herbal Pharmacology, College of Oriental Medicine, Kyung Hee Univ./NeuMed Inc. |
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| Oct. 10 10:30-11:00 |
Strategy of New Phytomedicine Development - Dong-A's Key Area in Research Miwon SON, Senior Research Manager, Research Center, Dong-A Pharmaceutical Co., Ltd. |
| Oct. 10 11:00-11:30 |
Clinical Trial Strategy of Botanical New Drug and Dietary Supplement Soo-Wan CHAE, Professor, Clinical Trial Center, Chonbuk Nat'l Univ. |
Functional Botanical Food New opportunities emerge for traditional Chinese medicine (TCM) based botanical drug as pharmaceutical industries are faced with challenges of increasing costs, time and risk in new drug development. The market trend and sourcing strategy of functional botanical food will be presented by Dr. Kim. In Dr. Guo's presentation, the overall strategies and regulatory considerations for the development of a modernized TCM product will be discussed, using Cardiotonic pills from Tasly as an example. Germany harbors a large number of phytomedicine companies of which Dr. Willmar Schwabe is the largest one, nationally and world-wide. An example for a successful herbal medicinal product (HMP) developed by Schwabe is the Ginkgo biloba extract EGb 761® for the treatment of dementia, peripheral arterial occlusive disease, tinnitus and vertigo. Extensive research is done to identify the active components of medicinal plants and to find the most suitable way to extract them. To establish safety and efficacy, pharmacological, toxicological and clinical studies (phases I-IV) have to be conducted. Standards of evidence-based medicine and controlled clinical trials which fulfill the criteria of GCP have also become the gold standard for evaluating the efficacy of HMP. Finally, phytomedicines are manufactured according to GMP requirements. As a result, doctors and patients in Germany have much more trust in HMP than they have in other countries, where these products are regulated as dietary supplements. In particularly, phytomedicines are seen as safer alternatives to synthetic drugs in many indications.
Chair : Ho Cheol KIM, Professor/CEO , Kyung Hee Univ. & NeuMed Inc.
| Oct. 10 13:30-14:00 |
MARKET TREND OF NATURAL INGREDIENTS & STRATEGIES
Sangbae KIM, Executive Director, Health Food Division, Korea Ginseng Corp. |
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| Oct. 10 14:00-14:30 |
Placing TCM Based Botanical Drugs On The Global Market Ruoling GUO, Senior Scientist, Global Regulatory Affairs, Tasly Pharmaceuticals Co., Ltd. |
| Oct. 10 14:30-15:00 |
Development of High Quality Herbal Medicine and Global Herbal Market Isabelle BUSCHULTE, Head of Pharmacovigilance, Clinical Research, Dr. Willmar Schwabe Pharmaceuticals |
This session review the efficacy and safety of natural new drugs, herbal medicinal products according to Regulation of the Efficacy and Safety Evaluation of Drugs, etc at KFDA. Herbal medicinal products are distinctly different from conventional medicines in origin of herbal plants, structure, components of herbal medicinal products, physicochemical and phytochemical properties, standardization and specification of drugs. Chemistry, manufacturing and quality control of drugs should be considered first and important in new drug development. There are several regulatory affairs as KFDA notifications to provide information to help product license applicants determine the evidence required to support the quality. This presentation will also analyze changing environment from industry, regulatory, and scientific perspectives. The number of new functional ingredients for dietary supplements has been increased since the enactment of Health/Functional Food Act in 2004. Among them, botanical supplements have limited history of safe use as foods and need special consideration in the respect of safety evaluation. The regulatory perspectives on the evaluation of botanical supplements will be presented by Dr. Kwon at KFDA.
Chair : Hyeong Kyu LEE, Professor/Director, Univ. of Science and Tech. & Natural Medicine Research Center
| Oct. 10 15:20-16:05 |
Herbal Medicinal Products Regulations in Korea Changhee CHO, Reviewer/Scientific Officer, Dept. of Herbal Medicine Evaluation, Herbal Medicinal Products Team, Korea Food & Drug Administration |
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| Oct. 10 16:05-16:50 |
Regulatory Perspectives on Botanical Supplements Oran KWON, Director, Division of Nutrition & Functional Food Standards, Korea Food & Drug Administration |
As the pharmaceutical market becomes globalized, more countries from around the world are participating in clinical trials. While previous trials were confined to Europe and North America, Asia has become an important player in international trials. Not only does Asia have good science and relative low costs, but also the potential to grow into one of the largest pharmaceutical markets. Although India and China are strong competitors, Korea is fast growing to become a clinical trial hub. In this session, a overview of the drug development process will be provided with considerations on how Korea should enhance its competitiveness.
Chair : Dong Ho LEE, Professor, Asan Medical Center
| Oct. 10 10:00-10:30 |
Modern Drug Discovery -Dengue Paul L. HERRLING, Professor/Head, Corporate Research, Novartis International AG |
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| Oct. 10 10:30-11:00 |
Enhancing Competitiveness in Multinational Clinical Trials So-Ra LEE, Head of Clinical Operations, Medical Dept., Pfizer Pharmaceutical Korea Ltd. |
| Oct. 10 11:00-11:30 |
Shortening the Gap on Attaining the Computerized Clinical System Validation Environment Kyungsub CHOI, Assistant Professor, Computer Information Systems, Manhattan College |
Clinical trials require the professionality from multi-disciplinaries; investigators, statisticians and industries always endeavour in developing protocols, coordinating trials and managing data. In this session, various aspects of clinical trials will be provided by professionals with different parts in this area. Each speaker will talk about the roles and responsibilities of their profession; and also discuss about the shortage of professionals and the methods in educating them.
Chair : Jae Gook SHIN, Professor/Director , College of Medicine, Inje Univ. & Pharmacogenomics Reasearch Center
| Oct. 10 13:30-14:00 |
Clinical Investigator Education and Training Program Young Kyoon KIM, Professor, Dept. of Internal Medicine, Division of Pulmonary and Critical Medicine, Kangnam St. Mary's Hospital, The Catholic Univ. of Korea |
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| Oct. 10 14:00-14:30 |
Education and Training Program for Experts in Pharmaceutical Medicine Hye-Young KANG, Associate Professor, Graduate School of Public Health, Yonsei Univ. |
| Oct. 10 14:30-15:00 |