BIO KOREA 2008




Conference Program

  • Please click on the Track Title for the details.
  • To view the abstract, please click on the Presentation Title.

컨퍼런스

Track 01. Recent Advances of Regenerative Medicine
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

 

Track 01. Recent Advances of Regenerative Medicine

Session 1. Regenerative Medicine for Hard Tissue

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.
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.
Session 2. Regenerative Medicine for Soft Tissue

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.
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
Session 3. Commercialization Trends of Regenerative Medicine for Global Market

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.
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.

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Track 02. Biorefinery

Session 1. Processing of Lignocellulosic Biomass for Biorefinery

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.
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
Session 2. Microbial Catalysis and Engineering

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.
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
Session 3. Enzyme Catalysis and Engineering

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.
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.

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Track 03. Micro/Nano-biotechnology

Session 1. Micro/Nano-fluidics Technology of UK/KOREA

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
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.
Session 2. Micro/Nano-biotechnology of UK/KOREA I

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.
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
Session 3. Micro/Nano-biotechnology of UK/KOREA II

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.
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

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Track 04. Medical Devices

Session 1. Biocompatable Materials for Medical Implants
                (Including Injectable Material and Nanofiber Coating)

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.
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
Session 2. Cardiovascular Device

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.
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.
Session 3. Musculorskeletal Implants

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.
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

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Track 05. Vaccine

Session 1. Special Speech

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
Session 2. Core Elements and Current Status of Cancer Vaccine

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.
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.
Session 3. New Trend of Vaccine Development

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.
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

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Track 06. Smart Drug Delivery Strategy

Session 1. Optimization of Drug Delivery Efficiency

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.
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.
Session 2. Disease-Oriented Drug Delivery

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.
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.
Session 3. Advances in Drug Delivery Technology

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.
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.

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Track 07. Regulatory and GMP Compliance

Session 1. Regulatory Update

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.
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
Session 2. GMP Compliance

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.
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
Session 3. Quality Control and Quality Assurance

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.
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.

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Track 08. Business Development

Session 1. Special Speech

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.
Session 2. Benchmarking Globally Commercialized Innovative Therapeutics & Technologies

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.
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.
Session 3. Solutions to Complicated Dilemmas of Funding-investment Opportunities & Business Development

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
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
Session 4. Technological Innovation Strategy for Biotechnology

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.
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.

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Track 09. Technology Licensing

Session 1. Preparation of successful licensing

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
Oct. 8
14:30-15:00
Beyond Licensing
-Becoming Global Player

Hideki MITANI, Managing Director, Roberts Mitani, LLC
Session 2. Case Studies - Strategies for Successful Technology Transfer

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.
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.

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Track 10. Therapeutic Antibody

Session 1. Recent Advances in Therapeutic Antibody R&D

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.
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.
Session 2. Process Development of Therapeutic Antibodies

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.
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.
Session 3. Forecasts by Industries in Therapeutic Antibody Development

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
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

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Track 11. Botanical New Drug Development

Session 1. Research and Development of Botanical Drug

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.
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.
Session 2. Global Herbal Market

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.
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
Session 3. Regulations and Prospects on Natural Products

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
Oct. 10
16:05-16:50
Regulatory Perspectives on Botanical Supplements
Oran KWON, Director, Division of Nutrition & Functional Food Standards, Korea Food & Drug Administration

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Track 12. Clinical Drug Development

Session 1. Enhancing Competitiveness in Multinational Clinical Trials

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
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
Session 2. Clinical Trial Expert Education and Training Ⅰ

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
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