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Track 1.	BioIndustry in UK & Korea
Track 2.	Issues to Address in Life Science BD & Funding
Track 3.	Technology Transfer and Licensing
Track 4.	Traditional Medicine
Track 5.	Korea-Scotland Joint Symposium
Track 6.	Recent Advances of Stem Cell Differentiation
Track 7.	APEC Harmonization Center Biosimilar Workshop
Track 8.	Regenerative Medicine
Track 9.	Pharmaceutical Strategy for Incrementally Modified Drug
Track 10.	Strategy for Overseas Generic Marketing
Track 11.	Therapeutic Antibody
Track 12.	u-Health
Track 13.	Recent Trends on Biochip Technology
Track 14.	Clinical Drug Development
Track 15.	Bioactive Medical Implants
Track 16.	Regulatory and GMP Compliance
Track 17.	Vaccine
Track 18.	Next-generation Sequencing
Track 19.	Botanical New Drug Discovery and Development

Track 1. BioIndustry in UK & Korea

This track will bring together experts on micro/nano-biotechnology and Stem cell technology for cell therapy from UK and Korea in order to catch up with the recent developments and suggest business strategy for future plan in Korea. The track will cover the nanomaterials, nanobio platform technologies, and various applications of nanobiotechnology, and processing and application of stem cell. Also, the recent results on the basic and applied aspects of nanobiotechnological studies including the nanomaterial manufacturing, nanofabrication processes, nanoelectronics, nanoanalysis, nanomedicine, and microfluidics involving biomolecules will be presented. This track will be a very fruitful congregation in learning the most updated status of biotechnology and establishing strong friendship among the participants.

Session 1. Microfluidics System

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, Prof., Biochemistry, Dept. of Biochemistry, Chungbuk Nat'l Univ.

Sep. 16 14:00~14:30	Microfluidic Routes to Point-of-Care Diagnostics: Moving from the Large to the Small Andrew J. deMELLO, Prof., Dept. of Chemistry, Imperial College London
Sep. 16 14:30~15:00	Highly Sensitive Immunoassay Using Surface-enhanced Raman Scattering Microfluidic Sensor Jaebum CHOO, Prof., Dept. of Bionano Engineering, Hanyang Univ.
Sep. 16 15:00~15:30	Lab-on-a-Chip for Cancer Studies from Point of Care Diagnostics to Therapeutic Investigations Jon M. COOPER, Prof, Bioengineering, Univ. of Glasgow

Session 2. High Throughput Analysis for Diagnosis and Drug Discovery

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, Prof., Chemistry, Imperial College London

Sep. 16 16:20~16:50	Targeting Protein-protein Interactions for Therapeutic Intervention Robin J. LEATHERBARROW,Head & Prof., Chemical Biology, Chemistry, Imperial College London
Sep. 16 16:50~17:20	Targeted New Lead Screening Technology in Application of Microwell-Chip Platform Moon Hi HAN,CEO, Proteogenm Inc.
Sep. 16 17:20~17:50	Microsensor Array Technology Danny O'HARE, Co-founder, Medermica Ltd. / Leader, Imperial College London

Session 3. Stem Cell and Biologics

Stem cell and Biologics are certainly promising areas for research. In recent years, the potential of stem cell research for tissue engineering-based therapies and regenerative medicine clinical applications has become well established. Certain types of stem cells are already used to restore blood-forming and immune system function after high-dose chemotherapy for some types of cancer, and several other restorative uses have been demonstrated. This session aims to address the principles required for successful stem cell bioprocessing and biologics so that they can be applied deftly to clinical applications.

Chair : Robin J. LEATHERBARROW, Professor, Chemistry, Imperial College London

Sep. 17 10:00~10:30	Adoptive Transfer of Immune Cells as a Cancer Therapy : Development of NK Cell Therapy Yeup YOON, Director, Mogam Biotechnology Research Inst.
Sep. 17 10:30~11:00	Derivation of Vascular Angiogenic Progenitor Cells from hES Cells and Its Application Hyung-Min CHUNG, President, CHABio&Diostech Co., Ltd.
Sep. 17 11:00~11:30	Mass Production of Stem Cell Using by Bioreactor Athanasios MANTALARIS, Co-founder, MedCell Ltd. / Leader, Imperial College London

Session 4. UK/Korea Bio-Opportunities

The UK, where the first IVF baby was born and Dolly the sheep was cloned, is very well established in terms of drug discovery, stem cell research and clinical trials. UK Trade & Investment, as a government organisation, is therefore committed to support bilateral investment and R&D exchange between Korea and the UK. The session includes ‘Life Science in the UK and R&D Opportunities’, ‘The Gateway to European Capital Market’, and ‘Healthcare and Life Science Expertise and Commercial Opportunities in North East of England’. Case study by Sewon Cellontech, in particular, is worth noticing as it tells you the actual experience of a Korean biotech company successfully established in the UK.

Sep. 17, 13:30~13:40
Welcome Speech
Jonathan KNOTT, Charge d’Affaire, British Embassy, Seoul

Chair : Dominic MCALLISTER, Head of Sci. & Innovation, Sci. & Innovation Section, British Embassy, Seoul

Sep. 17 13:40~14:10	R&D Opportunities in the UK Nigel Whittle, R&D Specialist, UKTI R&D Programme, UK Trade & Investment
Sep. 17 14:10~14:40	Gateway to European Capital Markets Naomitsu ABE, Senior Manager, Primary Markets, London Stock Exchange - Hong Kong
Sep. 17 14:40~15:10	Commercial Healthcare Opportunities in the North East of England Fabian SEYMOUR, Innovation Manager, Cels Group
Sep. 17 15:10~15:40	UK Investment and UK Government: The Crucial Factors in Successful Investment Sangdeok HAN, Director & Chief Secretary, Chairman’s Secretary Office, Sewon Cellontech Co., Ltd.

Track 2. Issues to Address in Life Science BD & Funding

The development of clinically applicable life science technologies is a high risk business with long development periods and high development costs. Successful initial and follow-up investments, therefore, are vital but difficult. Even so, the global demands for creative innovations in life science are higher than ever before, and hence more investment opportunities have to be offered despite the recent hardship in global economy. These changes pose both challenges and opportunities for bio technology industry as a whole. In this track, experts with years of experiences in direct investments and consultations will address essential and specific issues that are pertinent and imperative for successful investment and funding.

Session 1. Update on Changing Trends in Venture Investments

The development of clinically applicable life science technologies is a high risk business with long development periods and high development costs, due to the inherent hurdles of the use in the human. Successful initial and follow-on investments, therefore, along the course of the developmental stages from basic research to clinical trials are so critical as well as difficult. The growing global needs for creative bio- and pharmaceutical innovations offers challenges and opportunities, and it is encouraging for Korean life science industry that both the domestic and global funding mechanisms have increasing interests in innovative opportunities from Korea, thanks to the higher likeliness of commercially successful innovations when adjusted to the total mass and investments. Keeping abreast with the changing trends in investment mechanisms is deemed among critical elements for bio- and pharma businesses and their leaders that are pursuing commercial successes of their innovations.

Chair : Stephen LEE, Principal, Bio-Strategies Consulting

Sep. 16 14:00~14:30	Introduction to Global Bio Technology Markets, Licensing Needs and Trends of Investments and Fundings Mike MURRAY, Managing Director, Sosei R&D Ltd.
Sep. 16 14:30~15:00	Strategic Changes of European Venture Capitals - Increasing Interests Focused on Bio Technology Innovations in the East Asia Hui-Hsing MA, General Partner, Life Sciences, TVM Capital
Sep. 16 15:00~15:30	Investment Trend in Korea Biotech Jeong Hyun KIM, Executive Director, E&Networks Venture Investment

Session 2. Critical Issues for Successful IR of Life Science Venture Companies

Considering the wealth scale produced by life science industry and its proposition in the economy of Korea and the world, investments in life science R&D have to be expanded and accelerated. The difficulties in successful funding for life science technologies, which are further aggravated by the chaotic global economy, have to be overcome in one way or another. It is timely and relevant not only for business leaders of small life science companies but for scientists, who are planning for startups to have a chance of earning an insight in and a better recognition of the strategy, methodologies, exit plans, and other specific issues, which are pertinent to successful IR. This session is organized to deliver important information and facts about the strategy and specifics regarding starting-up a venture, R&D, intellectual property issues, portfolio management, business development, professional consultations, funding mechanisms, analyses and decisions for funding and exit plans, which are based on the cumulative expertise of the speaker panel.

Chair : Kuchan KIMM, Science Ambassador, Merck Research Laboratories & MSD Korea

Sep. 16 16:20~16:50	Early Stage Biotech VC Investing - Lessons on Strategy, Evaluation, Syndication Nelson TENG, Managing Partner, Charter Life Sciences
Sep. 16 16:50~17:20	Capitalizing on Early Value Creation: Lessons from Public and Private Biotech Companies Adam BRISTOL, Portfolio Manager, Biotechnology Value Fund, LP
Sep. 16 17:20~17:50	Deal Structures of Funding and Understanding the Funding Mechanism Stephen LEE, Principal, Bio-Strategies Consulting

Track 3. Technology Transfer and Licensing
:Technology Innovation and Commercialization for Life Science

Technology transfer for Innovation and Commercialization, as the term is commonly used, describes the process of moving high-tech innovations from laboratories to markets. Activities encompassed by the term include innovation and research; patents, licenses, and copyrights; product engineering; entrepreneurship (venture capital, start-ups, etc.); and manufacturing and marketing. But while technology transfer is all this, it also involves much more. This track proposes to offer analytical essays and articles that focus on the range of strategic factors that form the context within which this process takes place. These include: Building and Enforcing IP Value in Korea; Develop IP portfolio, Minimize exposure to IP infringement, Safeguard trade secrets and know-how, Optimize negotiations, etc The Journey from Discovery to the Market in the Life Sciences; technology transfer policy, for technology commercialization and R&D Communization, Impact of Strategic Alliances and Partnerships etc. Supporting Activities for Technology Transfer; Useful business tools, Management of Confidential Information, Distribution and Licensing of Drug Discovery Tools, International Negotiation Strategy etc.

Session 1. Building and Enforcing IP Value in Korea

Find out how today's leading IP professionals are successfully protecting their patents, trademarks, copyrights and trade secrets and aging business opportunities in Life Science technologies, At this session, you will learn how to: Develop and maintain a suitable IP portfolio, Minimize your company's exposure to IP infringement through comprehensive patent procurement, Safeguard your trade secrets and know-how in the market, Optimize negotiations with technology buyer or investor, Launch operational and financial agreements, Launch operational and financial agreements with international companies to protect IP investment, Copy with the prevailing legal environment to operate optimally, etc.

Chair : To be announced

Sep. 16 14:30~15:00	Strategic Management of Intellectual Property Rights : Planning, Assessment, and Implementations Sunhee (Sunny) LEE, Partner, SughrueMion, PLCC
Sep. 16 15:00~15:30	Strategies for Reinforcing IP Portfolio in Bio Industry Kyujeong AHN, Patent Examiner, Biotechnology Examination Div., Industrial Property Office
9월 16일 15:00~15:30	Global Worldwide Responsibility for IP Enforcing and Regulatory Development Richard CHIN, CEO, Inst. for OneWorld Health

Session 2. The Journey from Discovery to the Market in the Life Sciences

This session will include a general discussion of the technology commercialization in NIH/US as a leader of Life science technology management, along with discussion of technology transfer policy for technology commercialization and contribute to the improvement and strengthening of R&D Communization through technical support and capacity building in key lines of action such as technology transfer and innovation policies. Also included will be a discussion of the availability of the Impact of Strategic Alliances and Partnerships in Pharma companies as well as: Protection of trade secrets through contractual obligations, Necessary legal information and public policy, How to create more effective allies, etc.

Chair : Ike Whan Lee, CEO, Alopax and AnC Bio

Sep. 16 16:20~16:50	Products, Partners and Public Health : Commercialization of New Technologies From the National Institutes of Health (U.S.) Steven M. FERGUSON, Deputy Director, Licensing & Entrepreneurship, Office of Tech. Transfer, Nat'l Institutes of Health (U.S.)
Sep. 16 16:50~17:20	What is Technology Transfer Policy of NIH Ann M. HAMMERSLA, Director, Div. of Policy, Office of Tech. Transfer, Nat’l Institutes of Health (U.S.)
Sep. 16 17:20~17:50	Impact of Strategic Alliances and Partnerships Sung-Joo E. LEE, Deputy General Manager, R&D Strategic Planning, LG Life Sciences, Ltd.

Session 3. Supporting Activities for Technology Commercialization

Introducing new products is becoming less a technical process left to the product R&D department. Currently, there is an increasing focus on marketing, finance and operations. Also, many technical employees lack business skills; this usually leads to communication barriers between technology and business arenas. The author presents useful business tools that can help bridge this gap. Management of Confidential Information for Technology Transfer is thus added as company distribution, some kind of Distribution and Licensing of Drug Discovery Tools will be included, and International Negotiation Strategy is more accurately planned.

Chair : To be announced

Sep. 17 13:00~13:30	Management of Confidential Information for Technology Transfer Ann M. HAMMERSLA, Chief, Office of Tech. Transfer, Nat'l Institutes of Health (U.S.)
Sep. 17 13:30~14:00	Distribution & Licensing of Drug Discovery Tools : NIH Perspectives Steven M. FERGUSON, Deputy Director, Licensing & Entrepreneurship, Office of Tech. Transfer, Nat'l Institutes of Health (U.S.)
Sep. 17 14:20~14:50	Facing the Market: Securing Investment in Biotechnology Ventures Dianne GLENN, DI , Corelli Consulting
Sep. 17 14:50~15:20	International Negotiation Strategy Benjamin P. CHEN, Managing Director, Burrill & Company

Session 4. View of Negotiation for Investment & Cooperation

This session will include a general discussion of the investment trends of global venture fund emerging as an issue recently and portfolio strategy, along with discussion of negotiation strategy that is important internationally for attracting investment and technology transfer.

Chair : Min-Sick PARK, Director, STIC Investments Inc.

Sep. 17 15:20~15:50	Portfolios Strategy of Global Health Venture Capital Nancy T. CHANG, Chairman & Sr. Managing Director, Asia, OrbiMed Advisors
Sep. 17 15:50~16:20	Developing a Negotiation Strategy and Collaborative Plan in Technology Transfer Stephen M. SAMMUT , Venture Partner, Burrill & Company / Senior Fellow, Wharton School
Sep. 17 16:20~16:50	International Negotiation Strategy Benjamin P. CHEN, Managing Director, Burrill & Company

Track 4. Traditional Medicine : R&D on Traditional Medicine

The world healthcare market is undergoing a major paradigm shift. The world community is quickly shedding the concept of the supremacy of Western medicine and is increasingly appreciating the nature-friendly approach of traditional medicine. Traditional medicine, whose most advanced examples are found in Asia, is today gaining ground in Europe and the U.S, in other words, in the original geographical sphere of Western medicine. The share of the world healthcare market, claimed by traditional medicine, also is rapidly expanding. The global traditional healthcare market seems to have already surpassed US $ 200 billion in value. Traditional healthcare sectors around the globe are currently racing to seize the initiative in this rising market offering a gigantic growth. National Center for Complementary and Alternative Medicine under the U.S. National Health Institute (NIH) is known to inject over US $ 0.2 billion each year in research and development of traditional medicine. Meanwhile, China Academy of Chinese Medical Sciences is devoting an annual budget of more than US $ 40 million to R&D to give China a head-start in the new era of resurgence for traditional medicine. The governments of each nation have been strategically fostering traditional medicine to increase efficiency of their healthcare system and transform traditional medicine into one of the national growth engines. At this track, the speakers will cover the current status of research and development in Asian countries, and present the research methodology and strategies of representative research institutes from each country; lastly they will discuss the government policy on promoting traditional medicine.

Session 1. Recent Trends of R&D for Traditional Medicine in East-Asia

Among the various traditional medicines at the globe, especially Traditional Korean Medicine (TKM), Traditional Chinese Medicine (TCM) and Japanese Oriental Medicine historically have a lot in common and contemporary researches of these traditional medicines also represent similar tendencies. It is those countries’ assignment to develop traditional medicine and at the same time make efforts to globalize oriental medicine. In this session, three representatives of traditional medicine research institutes in East Asian countries (Korea, China, and Japan), Korea Institute of Oriental Medicine (KIOM), China Academy of Chinese Medical Sciences (CACMS), Oriental Medicine Research Center of Kitasato University will make presentations on recent research status and progress. Through presentations on R&D of traditional medicine that each institute is pursuing, we will discuss common assignment and collaboration plan on developing traditional medicine.

Chair : Hyun-Kyu SHIN, Vice President, Korea Inst. of Oriental Medicine

Sep. 16 14:00~14:25	R&D Strategy of Traditional Chinese Medicine in China Hong Xin CAO President, China Academy of Chinese Medical Sci.
Sep. 16 14:25~14:50	Pharmaceutical Technology Management Strategies: Understanding Legal Issues Hiroshi ODAGUCHI Chief, EBM Center, Oriental Medicine Research Center, Kitasato Univ.
Sep. 16 14:50~15:15	Recent Trends of Traditional Medicine in Taiwan Yun-Lian LIN, Research Fellow & Deputy Director, Medicinal Chemistry, Nat'l Research Inst. of Chinese Medicine
Sep. 16 15:15-15:40	R&D Strategy of Traditional Korean Medicine Ki-ok KIM, President, Korea Inst. of Oriental Medicine

Session 2. Recent Policy Trends of Traditional Medicine in East-Asia

At this session, the speakers will discuss policy trends of the governments of East Asian countries on fostering traditional medicine. China, Taiwan and Korea have government departments related to traditional medicine and fostering plan and the speakers of those countries will present policy trends of each nation on traditional medicine. State Administration of Traditional Chinese will make a speech on promoting and modernizing plan of TCM. Committee on Chinese Medicine and Pharmacy of Taiwan will cover the future plan on developing TCM in Taiwan. Lastly, Bureau of TKM in Korea will present the role of TKM in national health and medicine system and plan of transforming TKM into future growth engine.

Chair : Seung-Hoon CHOI, Dean, College of Oriental Medicine, Kyung-hee Univ.

Sep. 16 16:30~16:55	Policy Trends of Traditional Chinese Medicine in China Zhiren XU, Director-general, Dept. of Medical Affairs Management, State Administration of Traditional Chinese Medicine
Sep. 16 16:55~17:20	Environment of Clinical Trial for Traditional Chinese Medicine and Regulations in Taiwan I-Hsin LIN, Chairperson, Committee on Chinese Medicine and Pharmacy, Dept. of Health/Taiwan
Sep. 16 17:20~17:45	Policy Trends of Traditional Korean Medicine Yong-ho KIM, Director General, Bureau of Traditional Korean Medicine, Ministry for Health, Welfare and Family Affairs

Track 5. Korea-Scotland Joint Symposium (Inje Univ. - Univ. of Dundee)

The Inje University was established 30 years ago by Paik Hospital Foundation. The Inje University has the founding mission of 'Indukjese', meaning to save the world through humanity. Inje University emphasizes the spirit of honesty, sincerity, and diligence in providing humanistic and holistic education. Inje University aims to broaden its horizon by stressing the advantage of globalized education. As the Inje University was established by the Paik Hospital Foundation it has strong research capacity on medical and biological sciences and has research centers for pharmacogenomics, biomedical engineering, neuroscience etc. The life sciences industry in Scotland has experienced rapid growth in recent years. High levels of biotechnology expertise, a culture of innovation, and continuing research and technology excellence have all contributed to the success of life sciences in Scotland. The Scottish Life Science Strategy was launched to bring together academia, commercial organisations, NHS Scotland and policy makers to enhance further growth. In terms of life science, Scotland can boast groundbreaking research and development in several fields, including drug discovery, stem cell research, medical technologies, translational medicine, CRO and bioinformatics. The biotech industry currently generates £2.8billion for the Scottish economy and enjoys growth of 8 per cent per annum. Scotland has a mature infrastructure including world-class life science research facilities and a disproportionately high number of life science graduates. Celebrating the year 2009 as 30th Anniversary of Inje University, Korean-Scotland Joint Symposium will be held and the speakers from Inje University and Scotland will discuss broad topics from the basic science to development of therapeutics.

Sep. 16 14:00~14:05	Welcome Speech Tony BAKER, Director of Life Sciences, Scottish Development Int'l

Session 1. Diabetes and Pharmacogenomics

Pharmacogenomics should be a solution for the questions which medical doctors have asked for a long time: Why does the same drug cause different responses in various patients? Environmental factors do also influence to the response and dosage of drugs among patients. Pharmacogenetics and pharmacogenomics added lots of new information to understand the genetic factors influencing on the drug responses of individual patients for the last 30 years. This information has opened a new era of personalized pharmacotherapy. Information from pharmacogenomics is already applied to the medical practice in some hospitals and very important in drug discovery and development for identifying optimal patient populations to be treated by a particular drug. Type 2 diabetes is characterised by poor tissue sensitivity to insulin, combined with insufficient insulin secretion to overcome this ‘insulin resistance’. Dr. Sutherland will discuss the current knowledge of molecular insulin signalling and how that, combined with improved health informatics of the diabetic population, could be used to develop better sub-classification of diabetes, diagnostic tests for Pre-diabetes, and more targeted therapies. Dr. Shin from Inje University will introduce the basics and applications of pharmacogenomics for therapeutic strategies. Dr. Palmer will present an example for application of pharmacogenomics from diabetic patients improving the usage of the statin. With the genetic information of the patients Dr. Palmer's group could develop very sophisticated genetic tests to optimise statin treatments in the general population.

Sep. 16 14:05~14:35	Translation of a Detailed Knowledge of Molecular Insulin Action into Improvements in the Prevention, Diagnosis and Treatment of Type 2 Diabetes Calum SUTHERLAND, Reader, Biomedical Research Inst., Univ. of Dundee
Sep. 16 14:35~15:05	How Close Are We to Use the Pharmacogenomics for the Personalized Pharmacotherapy? Jae-Gook SHIN, Prof., Dept. of Pharmacology and Clinical Pharmacology, Pharmacogenomics Research Center, College of Medicine, Inje Univ.
Sep. 16 15:05~15:35	Pharmacogenomics: The Right Medicine for the Right Patient Colin N.A. PALMER, Chair of Pharmacogenomics, Biomedical Research Inst., Univ. of Dundee

Session 2. Diabetes and Therapeutics

There should be various approaches to cure a specific disease. Therapeutic strategy to cure diabetes should be from small molecules to cell therapy. Dr. Hammond will present data about the discovery of novel small molecules for the treatment of type 2 diabetes and obesity acting via signalling pathways. Dr. Shin from Inje University will discuss the utilization of stem cell for therapeutics. Especially his research focuses on how to control and measure the stem cell responses when the stem cells are implemented in human body. He will discuss the optimization of conditions to culture and differentiate the stem cells. Dr. Gibson's presentation will focus on the therapeutic potential of Human Embryonic Stem cells (hES) and its regulatory perspective about the biosafety challenges in the path of researchers attempting hES therapeutics.

Sep. 16 16:25~16:55	Pre-clinical Drug Discovery Service in Diabetes Stephen M. HAMMOND, Prof., Yoshitomi Inst. in Neurosciences, Univ. of Glasgow
Sep. 16 16:55~17:25	The Potential Contributions of Engineering Knowledge to Stem Cell Researches Jung-Woog SHIN, Prof., Dept. of Biomedical Engineering, Inje Univ.
Sep. 16 17:25~17:55	Biosafety Concerns in the Use of Pluripotent Human Embryonic Stem Cells for Allogeneic Cell Therapy Steve GIBSON, Director , Vitrology Ltd.

Track 6. Recent Advances of Stem Cell Differentiation

Biotechnology, a representative field of science in 21st century, is expected to show tremendous development because it may be only way to solve the several problems faced in the aspects of medicine as well environment and so on. Especially, in the field of regenerative medicine such as cellular, tissue and organ regeneration, there is serious shortage in supplies increased by the demanding of old people and cultural improvement. Therefore, regenerative medicine, including the research on embryonic, adult stem cells and recently developed induced pluripotent stem cells, has aroused people’s interest all over the world. In fact, cures for diabetes, heart diseases, spinal cord injuries, Parkinson’s, Alzheimer’s, and many other diseases via stem cell research is expected within the next 10 years. Human Embryonic Stem Cells (hESCs) have pluripotency to be able to differentiate into over 200 different types of cells and tissues and have potentials to be used as powerful tool for cell and gene therapy in the future. In this track, we will introduce recent advance of cellular differentiation into functional cells including hemangioblast, VAPC and Endodermal cells. In addition, another approach was developed that new alternative stem cell sources for ethically safe and immunocompatible is germline stem cells and induced pluripotent stem cells. So, in another session, we will introduce the outstanding results of stem cell derivation from gonadal tissue and somatic cells.

Session 1. Cell Differentiation from Human ES Cells

Human embryonic stem (hES) cells are working to devise treatments for some of most intractable diseases. Since 1998 which first discovery of hES cells, hES cells have become an important vehicle for learning about tissue and cell development and discovering the genes involved in self-renewal. And researchers have learned how to coax hES cells to form many kinds of cells in the human body, including various neurons, heart cells, vascular cells, and beta-cells. With the knowledge and knowhow gained in the past decade, hES cell research is more promising than ever. In this session, several progresses related to hES cell differentiation into functional specific cells and development of cell based therapy will be reviewed.

Chair : Hyung-Min CHUNG, President, CHABio&Diostech Co., Ltd.

Sep. 16 14:00~14:30	Cellular Differentiation into Vascular Angiogenic Progenitor Cells from Human ES Cells and Development of Cell Therapy Hyung-Min CHUNG , President, CHABio&Diostech Co., Ltd.
Sep. 16 14:30~15:00	Turning Pluripotent Stem Cells into Clinically Relevant Somatic Cells Jong-Hoon KIM, Associate Prof., Lab. of Stem Cell Biology, College of Life Sciences & Biotechnology, Korea Univ.
Sep. 16 15:00~15:30	Directed Differentiation of Human ES Cells to Functional Hemangioblastic Cells Shi-Jiang LU, Senior Director, Stem Cell & Regenerative Medicine Int'l

Session 2. Tissue Specific Stem Cell and Cell Reprogramming

Past 10 years, many clinical trials were conducted to treat the incurable and degenerative diseases using various types of stem cells. And now, US FDA approved clinical trial for treating acute spinal cord injuries using human ES cell derived oligodendrocyte. At this time, we are needed more available stem cell sources for clinical applications. Recently, several stem cell sources, capable of high proliferation and differentiation potential, are reported. Among them, germline stem cells and induced pluripotent stem cells are strong candidates for alternative cell sources without any ethical problem. In this session, we will introduce the recent progress on the derivation of ovarian stem cell and iPS cells.

Chair : Jeong-Mook LIM, Prof., Dept. of Agricultural Biotech., Seoul Nat'l Univ.

Sep. 16 16:20~16:50	Derivation of Histocompatible Stem Cell from Ovarian Tissue Jeong Mook LIM , Prof., Dept. of Agricultural Biotech., Seoul Nat'l Univ.
Sep. 16 16:20~16:50	Generation of Pluripotent Stem Cells from Adult Unipotent Germline Stem Cells without Exogenous Reprogramming Factors Kinarm KO, Research Associate, Dept. of Cell and Developmental Biology, Max Planck Inst. for Molecular Biomedicine
Sep. 16 16:20~16:50	Sox2 Regulates Metastable Pluripotency of Mouse Epiblast Stem Cells Dong Wook HAN , Post Doc., Dept. of Cell and Developmental Biology, Max Planck Inst. for Molecular Biomedicine

Track 7. APEC Harmonization Center Biosimilar Workshop

The APEC Harmonization Center (AHC) is established under the authority of the APEC Life Sciences Innovation Forum (LSIF) to provide a platform to address and solve priority concerns of APEC member economies on regulatory harmonization. In 2008, APEC Ministers specifically endorsed the AHC in the annual Ministerial Joint Statement.

This September Workshop is the second series of the APEC Harmonization Center Workshop - Advancing the Regional Economic Integration through Regulatory Harmonization. The Workshop will focus on the area of Biosimilars. Experts from Regulatory Authority, Industry, and Academia will provide their insights on Biosimilar including its status and future trend.

Track 8. Regenerative Medicine

Research and development area for tissue regeneration including regenerative medicine and tissue engineering have extensively carried out in terms of academic and industrial area in the world. The changes of innovation technologies for the manufacturing of cell line might be the faster than other research areas. The induced pluripotent cell is a good example. In this track, we will introduce recent advances of (1) basic research for embryonic and stem cell research in Korea and the strategies of stem cell research area will be suggested for the globalization, (2) the commercialization of cell therapy products in Japan and Korea has been introduced, and (3) development and research situation of tissue engineered products and FDA and KFDA approval in the world will be discussed.

Session 1. Recent Advances of Stem Cell

The one of the most important key factors for the tissue regeneration is cell sources. Cells for the tissue regeneration are largely divided into (1) embryonic stem cell and (b) adult stem cell which have the advantage and disadvantages simultaneously. Very recently, the induce pluripotent cell (iPS) has been widely tested and investigated for the cell sources for the next generations. In this session, three prominent scientists have a lecture for the recent advances of stem cell such as embryonic stem cell, induced pluripotent stem cell and adult stem cell.

Chair : Youngsook SON, Prof., College of Life Sci., Kyung Hee Univ.

Sep. 17 10:00~10:30	Differentiation of Human Embryonic Stem Cells into Mesodermal Lineage Cells Yong-Mahn HAN, Professor, Dept. of Biological Sciences, KAIST
Sep. 17 10:30~11:00	A Novel Role of Substance-P in MSC Mobilization from Bone Marrow Youngsook SON, Prof. , College of Life Sci., Kyung Hee Univ.
Sep. 17 11:00~11:30	Overcoming Differences in Differentiation Propensity among Human ES and iPS Cells by Modulation of Signaling Pathways Dong-Wook KIM, Professor, Stem Cell Research Center, Yonsei Univ.

Session 2. Global Development Trends for Cell Therapy

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 ten 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. Recent advances of commercialization trends for cell therapy will be introduced in the area of umbilical cord derived stem cell, adipose derived stem cell and cell-sheet engineering.

Chair : Byung Hyun MIN, Professor, College of Medicine, Ajou Univ.

Sep. 17 13:00~13:30	Stem Cell Therapy Using Umbilical Cord Blood Derived Mesenchymal Stem Cells (UCB-MSC) Wonil OH, Director, Biomedical Research Institute, MEDIPOST, Co., Ltd.
Sep. 17 13:30~14:00	The Recent Progress of Cellsheet Engineering and Its Clinical Application Yukio HASEGAWA, President & CEO, CellSeed Inc.
Sep. 17 14:00~14:30	Development of Cell Therapy Products Using Autologous Differentiate Adipocyte Mi Hyung KIM, CTO, Research Center, Anterogen Co.

Session 3. Recent Advances of Tissue Engineering

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 using tissue engineering techniques. Recent advances of tissue engineered products for articular cartilage, connective tissue and teeth engineering will be introduced for the goal of clinical trials

Chair : Gilson KHANG, Professor, Dept. of PolymerNano Sci. & Tech., Chonbuk Nat'l Univ.

Sep. 17 15:20~15:50	New Approaches for Regeneration of Connective Tissues Rui REIS, Professor, 3B' Research Institute, Univ. of Minho
Sep. 17 15:50~16:20	Recent Advances of Cartilage Tissue Engineering Byung Hyun MIN, Professor , Orthpeadic Surg., Ajou Univ. Medical School
Sep. 17 16:20~16:50	The Future Possibilities of Teeth Pulp Stem Cell for Tissue Engineering Therapy Minoru UEDA, Professor, Maxillofacial Dept., Nagoya Univ. Medical & Dental School

Track 9. Pharmaceutical Strategy for Incrementally Modified Drug

Nowadays, the scale of pharmaceutical market is increasing according to the increase in the population of older people, the care for the health, the income of earnings due to the advent of an aging society. The establishment of strategies developing incrementally modified drugs (IMD), as well as developing new drugs, is crucial to achieve the globalization and to strengthen the competitiveness of domestic pharmaceutical companies. These strategies will be one of the major power sources leading the growth of national economy. Currently, in response to social and timely needs, government is actively making efforts to foster the development of desirable and improved IMD and the growth of pharmaceutical industry, as well as to rationalize the price of medicine. This track, focused on the IMD technologies of current and future, is composed of three sections: efficient drug delivery for IMD strategies, IMD strategies for biopharmaceuticals and advanced IMD technologies for the next generation. All three sessions introduce success stories in developing IMD and the technologies crucial for the IMD development. The purpose of this track is to contribute to setting up the strategies in the research and development in the field of IMD development in order to strengthen the competitiveness of pharmaceutical companies. This track will provide a forum where the people interested in the IMD technologies discuss with professionals who have studied and developed IMD technologies for a long time.

Session 1. Efficient Drug Delivery for IMD Strategies

In addition to the technologies directly modifying drug compounds as a new salt form, prodrug, drug complex, and/or a new crystalline form in order to improve the physicochemical properties of drugs such as aqueous solubility, technologies developing delivery systems for loading drugs to provide fast-acting or sustained-acting drugs is also very important in the field of IMD development. Recently, since the interest in the wellbeing medicines is becoming a matter of concern due to the increase in the population of older people, the importance of developing IMD technologies that can provide more convenient medication method is increasing. In this session, the advanced technologies and principles of developing IMD and delivery systems such as solubilization of poorly-soluble drugs and modification of drug particulates as well as targeting strategies for anticancer agents are shared and discussed. This session will provide a forum where the strategies to develop IMD more effectively.

Chair : Beom-Jin LEE, Professor, College of Pharmacy, Kangwon Nat'l Univ.

Sep. 17 10:00-10:30	Solubilization of Natural Products to Improve Bioavailability Hoo-Kyun CHOI, Professor, College of Pharmacy, Chosun Univ.
Sep. 17 10:30-11:00	Delivery Systems for Anticancer Drugs Soo-Jeong LIM, Associate Professor, Dept. of Bioscience & Bioengineering, College of Bioscience, Sejong Univ.
Sep. 17 11:00-11:30	IMD Technology Using Solid-State Nanoparticle of Poorly Water-Soluble Drugs Sung Joo HWANG, Professor, College of Pharmacy, Chungnam Nat'l Univ.

Session 2. IMD Strategies for Biopharmaceuticals

The category of biopharmaceuticals include hormones, blood factors, anticancer molecules, antibiotics, growth factors and vaccines produced by biotechnologies such as genetic recombination, cellular fusion and culture methodology, as well as gene therapy medicines. Despite the difficulty in developing biopharmaceuticals, it is widely accepted that biopharmaceuticals will contribute to treating currently incurable diseases, including CNS-related diseases such as Alzheimer disease, cardiovascular diseases, cancer and osteoporosis, in the near future. Therefore, it is crucial that domestic pharmaceutical companies actively participate in the development of new and/or IMD biopharmaceuticals for survival and fostering their competitiveness. Most of currently marketed biopharmaceuticals are protein drugs. Since it can be prospected that the introduction of overseas technologies will become more difficult due to the keen competition among pharmaceutical companies, this session will be focused on the advanced technology and principle of developing delivery systems for diverse biopharmaceuticals such as siRNA and peptide, proteins that are recently of interest. This session will discuss IMD strategies and ideas to develop new biopharmaceuticals.

Chair : In Koo CHUN, Professor, College of Pharmacy, Dongduk Women's Univ.

Sep. 17 13:00-13:30	Challenges and Opportunities of siRNA Delivery Systems Tae Gwan PARK, Professor, Dept. of Biological Sciences, KAIST
Sep. 17 13:30-14:00	Fusion Protein Delivery Systems for the Treatment of Ischemic Heart Diseases Yong-Hee KIM, Associate Professor, Dept. of Bioengineering, College of Engineering, Hanyang Univ.
Sep. 17 14:00~14:30	Development of In Vivo Protein Delivery System Moon Suk KIM, Professor, Dept. of Molecular Science and Tech., Ajou Univ.

Session 3. Advanced IMD Technologies for Next Generations

Recently, innovative technologies such nanotechnology and biotechnologies have been introduced as technologies to support the growth of national economy in the next generations. Multinational pharmaceutical companies are moving fast toward fusing these new technologies with IMD technology. By introducing nanotechnology in the IMD development field, research from these companies have shown that the drug molecules could be targeted to the site where they should exert pharmacological effects, thereby maximizing therapeutic efficacy while minimizing the side toxic effects. Either they could achieve prolonged circulation of drugs after administration, allowing reduced frequency of medication. Therefore, it is highly expected that fusion technologies will provide the driving force in the field of new IMD development in the next generations. In this session, by introducing nanotechnologies and innovative technologies for formulation and delivery system development, strategies and ideas are discussed to develop IMD for the next generations.

Chair : Hyo Kyung HAN, Professor, College of Pharmacy, Chosun Univ.

Sep. 17 15:20~15:50	Nanoformulation Technology Jonghwi LEE, Professor, Dept. of Chemical Engineering and Materials Science, Chung-Ang Univ.
Sep. 17 15:50~16:20	PEGylation: Successful Technology to Develop the 2nd Generation of Therapeutic Biologics Myung-Ok PARK, CEO, BiopolyMed Inc.
Sep. 17 16:20~16:50	Tailored Material-based Drug Delivery Systems Seongbong JO, Assistant Professor, Dept. of Pharmaceutics, School of Pharmacy, The Univ. of Mississippi

Track 10. Strategy for Overseas Generic Marketing

The world faces severe global economic crisis that has to overcome in reasonably short period of time. Recently world-wide pharmaceutical giants trend to invest less money for basic research and development (R&D), but rather depend on manipulative business operation such as merging and acquisition of other promising biotech firms. Science-based R & D is costly and unpredictable to produce profitable safe and effective new drugs. Generic and bio-similar drugs are also popular in many parts of the world for cost-cutting and quick return strategy; Korea is vulnerable because many Asian countries are catching up hardware industries that Korea has enjoyed as one of the front-runners for the last few decades. For instance, Korean automobile and electronic industries have to share with a fair portion of her market with China and India. Korea still has well-trained human resources, which is the national asset for the future of competitive pharmaceutical industry in Asia, although the two countries above are moving rapidly in this industry, too. Thus, productions of quality active pharmaceutical ingredients and profitable marketing of safe and effective final drug products must be national survival issues for Korea and her people. Korean pharmaceutical leaders should explore and identify the key factors that can turn around from the traditionally small domestic pharmaceutical market to international partners and collaborators to achieve her primary economic goals in pharmaceutical industry. Bio Korea 2009 Conference is a unique event that can provide not only practical procedure of U.S. ANDA filing for Korean pharmaceutical industry, but also for the formulation of innovative national strategy of her future health support policy. That is why the name of this tract is “National Innovative Strategies for the Effective Control of World Generic Drug Market”. It is clear that the world is no longer affordable to enjoy "The Brand Drugs" because of unreachable cost, which is a big national economic dent. Every country including U.S.A. and many well-to-do European countries have to depend more on generic drugs and biologic preparations. To achieve the specific goal, nine domestically and internationally outstanding scientists in the generic pharmaceutical industry will gather together to resolve the serious and complex global economic problems so that Korean firms can be successful in international generic market. Better understandings on current global status of generic drugs in Korea and U.S. markets will positively affect not only generic market, but for the production of innovative new chemical entities in future because Korean firms have to bear the unbearable cost of new drug research and development for the production of safe and effective drug for the world.

Session 1. Innovative and Specific Strategy for the Participation of Korean Generic Industry for the World-market

The purpose of this session is to provide innovative strategic information to Korean generic firms and CROs for the active participation of the world generic pharmaceutical markets. As an introductory presentation of 9 speakers in this track, Dr. Ram Murty will discuss in depth the detail methods and procedures for the filing of abbreviated new drug application to U.S. FDA, using Common Technical Document (CTD). He will also touch the overall operational aspects on how to work with the Office of Generic Drug (OGD) of U.S. FDA to get U.S. FDA generic approval. Professor Beom Jin Lee will elaborate global, but specific strategies for the gainful research and development for competitive and fruitful generic drug research and production in Korea, utilizing PK data from the early phase of drug development so that painful and costly termination of drug development in the late phase would be minimized. Dr. Gwan Sun Lee, as the last speaker of the first session, will analyze the status of Korean generic market. In order to play a significant role in international generic market, Korean firms have to know where they are and how swiftly they can turn around from domestic operation to generic drug exports to control securely the complex and competitive international generic market.

Chair : Herman RHEE, Principal Investigator, Int'l Scientific Standard, Inc.

Sep. 17 10:00~10:30	How Can Korean Firms Be Successful in Generic Drugs in U.S. Market? Ram MURTY, President, Murty Pharmaceuticals, USA
Sep. 17 10:30~11:00	Global Strategy for Korean Pharmaceutical Industry R & D Beom-Jin LEE, Professor, KangWon Nat'l Univ. College of Pharmacy
Sep. 17 11:00~11:30	Analysis of Korean Generic Drug Market for the World Market Competition Gwan Sun LEE, CEO, Hanmi Pharmaceutical Co., Ltd.

Session 2. Market Analysis and Measures for Korean Generic Drug Export to the World Market

On top of the domestic analysis of generic drug market from the session 1, a focal stress will be given to the regulatory perspective generic development and approval requirements for the world competition of the generic market in this second session. Dr. Soo Youn Chung will identify the main regulatory issues of Korean generic drug approval and development for the export of Korean quality generic drug to international competitive market. Dr. Chung Keel Lee deals with GMP issues for the production of quality generic drugs in Korea from raw materials and/or relevant active pharmaceutical ingredients (APIs). Of course, his main topic would be how Korean firms can prepare for the filing of U.S. FDA abbreviated new drug application (ANDA) including cGMP requirements. Dr. Sang-Joon Lee will pick up cost-controlled aspects for the production of quality raw drugs and/or APIs to compete many Asian counterparts, which is essential for profitable operation of generic drugs.

Chair : Sung Eun YOO, Director, Korea Research Institute for Chemical Tech.

Sep. 17 13:00~13:30	Current Status of Bioequivalence Study Soo Youn CHUNG, Chief, Bioequivalence Div., Korea Food & Drug Administration
Sep. 17 13:30~14:00	US Drug Law, FDA & the Desirable Future of KFDA Chung Keel LEE, Special Advisor to the Commissioner, Korea Food & Drug Administration
Sep. 17 14:00~14:30	Quality of Korean Drug Substances and Their Cost Competition to Asian Countries Sang Joon LEE, Vice President, Kolon Life Science

Session 3. For the Development of Generic Drug Patent Strategy

Success in introducing new generic products hinges on overcoming patent barriers as well as obtaining regulatory approval in a target country. This session will discuss patent litigation cases and strategies for generic companies to overcome the patent barrier. First, Joo Mee Kim, Esq., U.S. patent attorney specializing in Hatch-Waxman Litigation, will discuss several important patent litigation cases that illustrate patent strategies used by multinational generic companies in the U.S., which has the biggest generic market in the world. The second speaker, a Korea Institute of Patent Information (KIPI) director will speak about Information Technology strategies for generic development. Lastly, Dr. So Young Ahn, a Korean patent attorney specializing in patent disputes in Korea, will discuss patent strategies for Korean generic companies to succeed in the Korean market.

Chair : Yun Taek JUNG, Director, Korea Health Industry Development Institute

Sep. 17 15:20~15:50	Lessons from Success and Failure of Generic Companies in Challenging Patents in the U.S. Joo Mee KIM, Partner , Rothwell, Figg, Ernst & Manbeck, P.C.
Sep. 17 15:50~16:20	Strategies Using Patent Information for Generic Drug Development Kyung Ae YOON, Director, Korea Institute of Patent Information (KIPI)
Sep. 17 16:20~16:50	Patent Strategies for Generic Drug Development So Young AHN, Patent Attorney, Dr. Ahn Int'l Patent Law Office
Sep. 17 16:50~17:20	Emerging Global Strategies for Established Products Eun-Ju RYU, Director, Emerging Market Business Unit, Pfizer Inc. New York

Track 11. Therapeutic Antibody

Therapeutic antibodies, which is the new paradigm of drug development, currently occupies 37% of total biological drugs that are being developed and 20% of drugs in FDA approval process. The growth rate of therapeutic antibody market is up to 20% each year and it is estimated by Global Industry Analysts that market will reach 303 billion dollars by 2010. Since it is apparent to many that this therapeutic antibody drug market will grow constantly, Korean companies are putting lots of effort in developing therapeutic antibodies that work more efficiently and with less side effects. From this track, it will be possible to hear about therapeutic antibody development in big international pharmaceutical companies. Heads of antibody engineering department at Novartis and Medimmune, Dr. Zhenping Zhu and Dr. Herren Wu will be presenting. Also, Korean companies focusing on therapeutic antibodies, Celltrion, Abxign, Hanwha group, Isu Abxis, Samsung, and Green cross will present up-to-date antibody engineering developments. Launching of Korean Scripps Institute, the world renowned institute, will also be done in this track.

Session 1. Therapeutic Antibody 1

Antibody therapeutics is the fastest growing area in drug development. From Novartis, from which Xolair and Lucentis was marketed, Dr. Zhenping Zhu, vice president of Protein Sciences and Design department and Global Head, will share with us up-to-date research in antibody therapeutics. Development of monoclonal antibody biosimilar by Celltrion and development of anti-HGF antibody from leading antibody engineering company, Abxign, will be closely examined.

Chair : Junho Chung, Prof., Biochemistry and Molecular Biology, School of Medicine, Seoul Nat'l Univ.

Sep. 17 10:00~10:30	Development of Antibody-based Cancer Therapeutics: An Insider's Perspective Zhenping ZHU, Vice President & Global Head, Protein Sciences & Design, Novartis Biologics
Sep. 17 10:30~11:00	Development of mAb Biosimilar Shin-Jae CHANG, Vice President, Celltrion, Inc.
Sep. 17 11:00~11:30	Development of HGF Neutralizing Humanized Antibody Kum-Joo SHIN, Director, Research, Abxign

Session 2. Therapeutic Antibody 2

In this session, therapeutic antibody field will be analyzed in more practical and commercial aspect. Vice president of R&D, head of technology & lead generation and hear of antibody discovery & protein engineering, Dr. Herren Wu, will present excellent talk about anti-RSV antibody, palivizumab and motavizumab. Dr. Kyong E Kim from Hanwha Group and Dr. June-young Park from Isu Abxis Co., Ltd., who are leading scientists in Korea’s antibody engineering field, will show us some great ideas about strategies targeting of Korean biological drug market.

Chair : Shin-Jae CHANG, Vice President, Celltrion, Inc.

Sep. 17 13:00~13:30	Immunoprophylaxis of RSV Infection: Advancing from RSV-IGIV to Palivizumab and Motavizumab Herren WU, Vice President & Global Head of Tech. and Lead Generation, Antibody Discovery & Protein Engineering, MedImmune
Sep. 17 13:30~14:00	Effort on Therapeutic Antibody Development at Hanwha: How to Enter the Value Chain Kyoung E. KIM, General Manager, KIM, General Manager, BIO Businee Team, Hanwha Group/Dream Pharma
Sep. 17 14:00~14:30	The Development Strategy of Antibody Therapeutics in Korea June-Young PARK, Director, Business Development, Isu Abxis Co., Ltd.

Session 3. Therapeutic Antibody 3

Dr. Seho Kim from Green Cross will present development state of HBV neutralizing human monoclonal antibody. As our last talk of the antibody track, plans of Scripps Institute, which will be launched in Korea soon, will be presented and positive effects of this launch on Korean scientific field will be discussed.

Chair : YJune-Young Park, Director, Business Development, Isu Abxis Co., Ltd.

Sep. 17 15:20~15:50	A Case Study of a Manufacturing Process Based on Ready to Use Technology Henrik IHRE, Program Manager Antibodies, Life Sciences Div., GE Healthcare
Sep. 17 15:50~16:20	Antibody-Maytansinoid Conjugates: Next Generation Antibody Therapeutics Peter PARK, Senior Director, Discovery Research, ImmunoGen, Inc.
Sep. 17 16:20~16:50	HBV Neutralizing Human Monoclonal Antibody (GCAB01) for Liver Transplantation & Chronic Hepatitis B Treatment : HBV Neutralizing Human Antibody Se-Ho KIM, Research Director, Green Cross Corp.
Sep. 17 16:50~17:20	Heading to World Leading Institution, SKAI Dae Hee KIM, Principal Investigator, Scripps Korea

Track 12. u-Health

This track is for Information sharing about Policies, Technologies, Standards, and Business Models to promote and commercialize u-Health.

Session 1. Policies and Vision

The medical industry has been remarkable development to protect the human health. In spite of these developments, the medical industry has lots of problems as high cost, low accessibility, no choice, low quality and dissatisfaction about service. So in this session will show you vision and policies for introduce and promotion of u-Health in order to solve the problems. And inform you national u-health services by the public and private, and the ways that are how to expand the world market by policies of Japan.

Chair : Jeong Eun KIM, RN, Informatics Nurse Specialist, College of Nursing, Seoul Nat'l Univ.

Sep. 18 10:00~10:30	The State of Policies and Promotion for u-Health by Government Young Hae KIM, Director , Nat'l Information Society Agency
Sep. 18 10:30~11:00	The State and Vision of u-Health Service Duk Won KIM, Team Manager, Marketing Team, Evercare
Sep. 18 11:00~11:30	Ubiquitous Healthcare Activity in Japan Sasaki KENICH, Senior Consultant, Nomura Research Institute

Session 2. Technology and Standardization

In this session, we will have chances to exchange information related to be developed the technologies, standards by companies, institutes, organizations. So, we are going to introduce the u-Health Forum Korea that is established to promote and lead u-Health industry with companies, institutes and hospitals. And present an updated u-Health system that reduce work of the hospital staff and support users based on algorithms as step by step reasoning, auto calculation by applying AI to u-Health system.

Chair : Peom PARK, Professor, Div. of Industrial & Information Systems Engineering, Ajou Univ.

Sep. 18 13:00~13:30	u-healthcare and Future Medicine Suk Wha KIM, Prof. , Dept. of Plastic Surgery, College of Medicine, Seoul Nat'l Univ.
Sep. 18 13:00~13:30	u-Health System Technology Based on AI Woo Kyeong SEONG, Director, Korea Electronics Technology
Sep. 18 13:00~13:30	Overview Internal and External Technology of u-Health Kyung Soo JIN, Ph.D., Dept. of Medical Electronics, Chungbuk Provincial College

Session 3. Business Models

The medical industry will be faced big changes from new environment by globalization, consumerism, component rate of population, and increase disease. So we introduce intelligent solutions about customized medical and health service after studying the innovation scenarios to apply the future environment. In addition, this session is going to inform you necessary information to develop new business models through presentation current cases Diabetes management service of Catholic Medical Center and Healthcare service in Songdo, Incheon by Uracle as systems and solutions are provided for u-health service by hospitals and companies.

Chair : Woo Jae LEE, Manager, Business Team, Biospace

Sep. 18 15:20~15:50	Urgent Need of u-healthcare System for the Chronic Disease Focused on Diabetes Kun-Ho YOON , Prof., Dept. of Endocrinology & Metabolism, The Catholic Univ. of Korea
Sep. 18 15:50~16:20	Smart Ubiquitous Healthcare System for Custom Medical(care) Service Young Woo PAE, Manager, IBM Ubiquitous Computing Lab., IBM Korea
Sep. 18 16:20~16:50	Commercialization of u-Health - Today and the Future Tae Il KWON, Director, Healthcare Business Div., Uracle

Track 13. Recent Trends on Biochip Technology

This track covers special topics on recent trends in biochip technology and consists of three sessions, including recent progress in protein and DNA chips, nano and biomedical sensor technologies, and microfluidic chips for cells. Each session invites three foreign speakers from Singapore, Germany, and USA, respectively, as well as six well-known Korean speakers. Session 1 focuses on the peptide microarrays, protein expression profiling, and predictive medicine. In addition, session 2 deals with highly sensitive medical biosensor technology based on nanotechnology. Finally, the third session will discuss the applications of microfluidic cell chips such as regenerative medicine, disease model and cell-based assays.

Session 1. Recent Progress in Protein and DNA Chips

Recently, protein and DNA chips have emerged as key technologies in a diverse range of researches, including genomics, proteomics, and pharmaceuticals. These chips are essentially miniaturized laboratories that can perform hundreds or thousands of simultaneous biochemical reactions for biomedical researches and disease diagnosis. Advances in these fields can provide new methods for unraveling the complex biochemical processes occurring inside cells, with the larger goal of understanding and treating human diseases. In this session, recent progress in protein and DNA chips will be discussed, including new applications of peptide and protein microarrays in catalomics and protein expression profiling, and predictive and diagnostic genomics. These new approaches will promote chip technologies and their applications in basic and clinical researches.

Chair : Kwon-Soo HA, Professor, Dept. of Molecular and Cellular Biochemistry, School of Medicine, Kangwon Nat'l Univ.

Sep. 18 10:00~10:30	Peptide Microarray Applications in the Emerging Field of Catalomics Shao Q. YAO, Associate Professor, Dept. of Chemistry, Nat'l Univ. of Singapore
Sep. 18 10:30~11:00	Expression Profiling of Proteins Using Protein Microarray Hak-Sung KIM, Professor, Dept. of Biological Sciences, KAIST
Sep. 18 11:00~11:30	Predictive and Diagnostic Genomics through Expression Analysis Suk Woo NAM, Associate Professor, Dept. of Pathology, School of Medicine, Catholic Univ.

Session 2. Nano and Biomedical Sensor Technologies

A nanobiosensor is a nanotechnology-based biosensor, which is an integrative system of bioreceptor, physicochemical sensor, and nano-materials or -devices. It enables to provide a highly miniaturized device with specific detection of various materials such as proteins, DNAs, injurious materials, viruses and pathogens, and has been applied to medical diagnosis, environmental monitoring, food safety, and bioterror monitoring. In this session, recent trends of medical-nanobiosensor technology will be discussed, and the biosensors developed by specialists in this area are introduced. Special topics include cells, nanomaterials, and microcantilever-based biosensors.

Chair : Min-Gon KIM, Director, BioMonitoring Research Center, Korea Research Institute of Bioscience and Biotech.

Sep. 18 13:00~13:30	Approaches and Application of Cell-based Biosensor Hagen THIELECKE, Head, Dept. of Biohybrid Systems, Fraunhofer Institute for Biomedical Engineering
Sep. 18 13:30~14:00	Immunoaffinity Biosensors Based on Nanomaterials Jae Chol PYUN, Assistant Professor, Dept. of Materials Science and Engineering, Yonsei Univ.
Sep. 18 14:00~14:30	Microcantilevers with Nanochannels for Immunosensors Sangmin JEON, Associate Professor, Dept. of Chemical Engineering, Pohang Univ. of Science and Tech.

Session 3. Microfluidic Chips for Cells

Microfluidic technology was first applied to analytical chemistry in late 90’s, but nowadays it has been spread to various applications, including point-of-care testing, synthesis of chemicals, micro FACS (fluorescence activated cell sorter), and even optofluidics, owing to its small volume consumption, large surface ratio, and laminar flow. Research in cell-based microfluidic chips has been studied for several years and it has been published many fruitful results in manipulation, culture and analysis of cells. These chips are advantageous in the control of microenvironment of cells that was impossible in conventional culture plate. The unique techniques in microfluidic cell culture include the precise regulation of perfusion, arbitrary concentration gradient generation and three-dimensional cell cultures. They have been applied to single cell analysis, cytotoxicity test, quantitative chemotaxis, signal pathway analysis, and regeneration of cells. Although these chips are in the early stage to test their feasibility now, however, it is expected that they will make many biological, medical and pharmaceutical experiments more effective since they can provide more in-vivo-like microenvironment to the cells. This session will introduce cell-based microfluidic chips for regenerative medicine, neuronal disease model, and cell-based assays, which will help the understanding of the roles of microfluidic technology that induces the proliferation and differentiation of cells through the regulation of microenvironment.

Chair : Ji Yoon KANG, Principal Researcher, Nanobio Research Center, Korea Institute of Science and Tech.

Sep. 18 15:20~15:50	Microengineered Hydrogels for Regenerative Medicine Ali KHADEMHOSSEINI, Assistant Professor, Harvard Medical School / Brigham and Women's Hospital
Sep. 18 15:50~16:20	Microfluidic Platform for Investigating Neurodegenerative Disease and Spinal Cord Injury Noo Li JEON, Associate Professor , School of Mechanical and Aerospace Engineering, Seoul Nat'l Univ.
Sep. 18 16:20~16:50	Cell-based Assays in a Microfluidic Device Je-Kyun PARK, Professor, Dept. of Bio and Brain Engineering, KAIST

Track 14. Clinical Drug Development

The first session of this tract will host speakers from Australian organization QCTN. They will introduce various infrastructures for early development of new drug. Those infra will be utilized by domestic bioventure companies for their overseas drug development program. The second session speakers will introduce new tools being developed by the support of government R&D fund "KoNECT". This will provide domestic and global pharma industries with opportunities to collaborate with institutes developing new technologies to be utilized for rapid and efficient new drug development. The introduction of domestic non-clinical test institute and its successful experience with biologic drug development will provide an excellent opportunity for collaboration for bioventure companies.

Session 1. Early Phase Product Development: Helping Korean Companies to Access Western Markets

Many biotech/pharmaceutical companies have an interest in undertaking phase III trials involving large number of patients in Australasia. However, the possibilities for extending clinical development programs in Australia to include preclinical and early phase clinical trials provide small and medium-sized biopharmaceutical companies with unique opportunities to explore alternative development pathways for their early clinical trial programs which meet international GxP standards but at a competitive cost and greater speed without compromising quality. Shorter time to product profiling and Go/NoGo decision-making can thus be achieved by incorporating Australasia in the very early part of the product development program. Australia provides a unique opportunity to serve as a stepping stone or gateway for biotech companies to Western markets and to gain insight in the product profile at a very early stage of development with more than 50% of early phase clinical trials being conducted for non-Australian sponsors. Australia has established a competitive and professional industry for the conduct of early phase trials to world-class standards with a sustainable growth path. This session provides case studies from Australia. Australia is seen as an excellent location in terms of quality, performance & cost; it has a vibrant Biotech and Pharmaceutical Sector; Australian companies are keen to work with international partners; and Governments are strongly supportive of the life sciences industry and innovation. The current competitive advantages are a regulatory system that is seen as safe, open, transparent and efficient; quality of work and standards of medical care & clinical research infrastructure; cost effectiveness compared to US/Western Europe. This session will characterize the Australian early phase clinical sector and provide the audience with the strategies for the efficient conduct of studies in Australian Model.

Chair : A. J. Tony WEBBER, CEO, CNS Pty Ltd. / President, QCTN Inc.

Sep. 18 10:00~10:30	High-Quality, Cost-Effective Preclinical Product Development Solutions Maree SMITH, Professor, Univ. of Queensland / Executive Director, Tetra-Q
Sep. 18 10:30~11:00	Is There a Quicker Way of Getting to “First in Human”? Suzanne ELLIOTT, Deputy CEO, Q-Pharm
Sep. 18 11:00~11:30	Early Phase Clinical Trials: Opportunities for Korean Biotech Companies from the Regulatory Perspective Dianne Jackson-Matthews, CEO, ERA Consulting

Session 2. New Tools for Early Phase Clinical Drug Development

In the phase 0 clinical trials for new drug development session, speaker will introduce how phase 0 concept will enable rapid and efficient drug development. The regulations related to phase 0 clinical trials will be also introduced. Microdosing, one of important items of phase 0 trials will help scientific and rapid selection of candidate drug from optimized leads. PKPD model can be established from very early phase of clinical drug development by utilization of non-clinical data of in vivo/vitro AMDE, toxicokinetics, pharmacology, efficacy data and available clinical data including those of previously developed same class drug. The model can be incorporated to clinical trial simulation which applies various scenarios and "what if" questions. The simulation results can be important data in the process of critical decision by providing fine characterization of properties and differentiation points of candidate drug. The simulation will also enable optimal design of next phase clinical trials. Pharmacogenomic considerations in early phase trials will cover how pharmacogenomic data can be obtained from the FIH trials applying the previous information obtained in non-clinical development phase. This talk will also cover how the pharmacogenomic information can be used in the later phase clinical development and finally in the clinical practices. The three talks will provide a chance to domestic and global pharma industries with good opportunities to collaborate with institutes developing new technologies to be utilized for optimal drug development.

Chair : In-Jin JANG, Professor, Dept. of Pharmacology / Director, Clinical Pharmacology, Seoul Nat'l Univ. & Hospital

Sep. 18 13:00~13:30	Phase 0 Clinical Trials for New Drug Development Kyung-Sang YU, Professor, Clinical Pharmacology, Seoul Nat'l Univ. Hospital
Sep. 18 13:30~14:00	Role of PKPD M&S in Designing Early Phase Trials KyungSoo PARK, Professor, Pharmacology, Yonsei Univ.
Sep. 18 14:00~14:30	Pharmacogenomic Considerations in Early Phase Trials Hyeong-Seok LIM, Professor, Ulsan Univ.

Session 3. Strategies for Successful Development of Biopharmaceuticals

A recent trend in new drug development industry in Korea was the change from small molecule drugs to biopharmaceuticals including biosimilar products as well as original products. Biopharmaceutical industry represents the use of various biotechnology techniques to discover and manufacture potential new medicines and to test their safety and value in preventing or treating disease in humans and animals. Therefore, it represents one of the industries that get the best out of the scientific and human resources accumulated for a past couple of decades. A pre-approved capitalized cost estimate for development of a new biopharmaceutical has recently been estimated at over 1 billion dollars with 615 million estimated for all R&D costs, including basic research and preclinical development prior to initiation of clinical testing and 626 million dollars for clinical testing. An unfounded expectation that the cost of biopharmaceutical development will be lower than that of small molecules should be reconsidered in this industry. This session was prepared to introduce the procedures and techniques required in the development of biopharmaceuticals and to share know-hows through case studies.

Chair : In-Suk KIM, Staff, Public Relations Team, Korea Institute of Toxicology

Sep. 18 15:20~15:50	Hurdles in the Development of Biosimilar Medicinal Products Seok H. LEE, Senior Advisor, Celltrion, Inc.
Sep. 18 15:50~16:20	Preclinical Studies for Recombinant Protein Drugs Woo S. KOH, Director, Div. of Toxicology, Korea Institute of Toxicology
Sep. 18 16:20~16:50	Selecting Optimal Biotherapeutic Drug Candidate for Development Chulho PARK , Head, Process Sciences, Pre-Clinical Development, aTyr Pharma

Track 15. Bioactive Medical Implants

The scope of the track covers topics related to the inter-disciplinary areas of medical devices, especially bioactive medical implants. Biocompatible and bioactive implants are without doubt the most successful examples of integrated medical devices. Recently, biological functionality can be integrated into artificial devices, thereby endowing them with the improved biological function and biocompatibility of implants. A successful integration of biological functionality with devices requires control of the nano-bio interface, development of functional biomaterials and integration of drug delivery system. Much of the recent developments in biocompatible implants in various areas, synthesis of novel drug delivery systems and novel functional biomaterials also require a molecular level understanding of the nano-bio interface for more effective design and control. This track is intended for the dissemination of the recent development in these areas. Topics that will be covered in the track include various approaches for the development of novel biocompatible implants. Furthermore, nanobio interfaces, surface chemistry, and integrated drug delivery system involved in the functionalization of surfaces and matrices for the immobilization and application of biocompatible biomaterials will also be covered.

Session 1. Biocompatible Implants in Medicine

In general a medical device consists of a variety of materials. These materials are one of the factors that play an important role in the question whether a medical device meets the requirements for human use. Biocompatibility plays an essential role in the development of medical devices even for scientific purposes and refers to more empirical clinical success of a whole device in which the material or materials feature. This session will cover the researches and approaches in subject of Nanobio interfaces and biocompatible polymeric implants, and will also cover the currently used medical device and its approval in Korea. The Nanobio Interface in design and control of molecular functionality, quantifying behavior of individual molecules, and interactions at organic/inorganic interfaces to establish the foundation for understanding the interface of physical and biological systems. Biocompatible polymeric materials are intended to interface with biological systems to evaluate, treat, augment or replace any tissue, organ and function of the body. To improve the interaction with host cells and tissues without any toxicity, the improvement of biocompatibility in the design and fabrication of polymeric biomaterials has been a crucial subject in material area, and many implants made of those developed biocompatible polymeric materials have been developed.

Chair : Jong Chul PARK, Professor, Biomedical Engineering, School of Medicine, Yonsei Univ.

Sep. 18 10:00~10:30	Combination Medical Devices: New Opportunities to Improve Device Performance with On-board Drug Delivery Technologies Dave GRAINGER, Professor, Dept. of Pharmaceutics & Pharmaceutical Chemistry, College of Pharmacy, Univ. of Utah
Sep. 18 10:30~11:00	In Vivo Evaluation of Medical Implant Hun Kuk PARK, Professor, Dept. of Bioengineering, School of Medicine, Kyung Hee Univ.
Sep. 18 11:00~11:30	Biocompatible Polymeric Implants Ki Dong PARK, Professor, Div. of Applied Chemistry & Biological Engineering, College of Engineering, Ajou Univ.

Session 2. Cardiovascular Implants

Cardiovascular implant applications include pacemakers, coronary stents and heart valves and others. Each of these life sustaining components has specific surface property requirements. Cardiovascular implants are fabricated from various biomaterials such as alloys and polymers to provide enhanced biocompatibility and hemocompatibility, and also functionally improved polymeric devices, cell hybrid cardiovascular implants, and drug eluting stent has been recently developed for improving the biocompatibility of devices. The scope of this section covers topics related to tissue engineered cardiovascular implants, drug eluting stents and nanofibrous polymeric devices. Tissue engineering is an emerging discipline that applies engineering principles to create devices for the study, restoration, modification, and assembly of functional tissues and organs from native or synthetic sources. In the cardiovascular field, tissue engineering is being applied to the development of heart valves, heart valve leaflets, and vascular grafts by from degradable polymer scaffolds and various cell sources. In other approaches, in order to achieve more empirical clinical success of cardiovascular stents, various drug eluting stents have been developed, and novel developed nanofiber fabrication technique has been applied to develop functional nanofibrous polymeric devices related to cardiovascular implants.

Chair : Il Keun KWON, Assistant Professor, Oral Biology, School of Dentistry, Kyung Hee Univ.

Sep. 18 13:00~13:30	Cardiovascular Cell Sheet Tissue Engineering Dehua CHANG, Assistant Professor, Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Mediclal Univ.
Sep. 18 13:30~14:00	History, Present and the Future of DES Donghoon CHOI, Professor, Div. of Cardiology, Yonsei Cardiovascular Hospital, College of Medicine, Yonsei Univ.
Sep. 18 14:00~14:30	The Review and Approval of Medical Device in Korea Yang Ha CHO, Director , Medical Device Standardization, Medical Device Evaluation, Korea Food & Drug Administration

Session 3. Skeletal (Spinal, Orthopedic, and Dental) Implants

Increasing demand for better-performing implantable devices such as spinal, orthopedic and dental implants is leading the development of new technology, ranging from materials (metals, plastics and ceramics) to assembly technology. The goal of these research areas and new biomaterials is to improve the life of the implants. The scope of this section covers topics related to bioactive dental implant, surface treatment of artificial joint and spinal devices. Dental implants replace single or multiple missing teeth due to cavities, decay, trauma or disease and are designed to help preserve bone structure and natural facial contours. Extensive researches in this field are focusing on development of bioactive dental implants with polymers and ceramics that would help and restore the defect more efficiently. Surface treatment and surface functionalization provide a way to transform a bio-inert material into a biomimetic or even bioactive material by coupling of protein layers to the surface, or coating the surface with various bioactive molecules or functional groups to the surface of implants to provide bioactivity to implants. In these areas related to orthopedic, spine and dental implants, major advances have based on the development of novel biomaterials and processing techniques that may be combined with bioactive molecules or cells for an order of magnitude improvement in bone and other tissue growth.

Chair : Chun Ho KIM, Senior Researcher, Korean Institute of Radiological & Medical Science

Sep. 18 15:20~15:50	Development of Bioactive Dental Implant Young KU, Professor, Dept. of Periodontics, School of Dentistry, Seoul Nat'l Univ.
Sep. 18 15:50~16:20	Surface Treatment of Artificial Joint Yongsik KIM, Prof. & Chairman, Dept. of Orthopedics Surgery, Seoul St. Mary’s Hospital, The Catholic Univ. of Korea
Sep. 18 16:20~16:50	Spinal Devices Sang Ryong JEON, Prof., Dept. of Neurological Surgery, ASAN Medical Center, College of Medicine, Univ. of Ulsan

Track 16. Regulatory and GMP Compliance

Regulatory agencies in the world continuously improve their regulations and guidelines to secure the efficacy and safety of drug products, including the global effort to harmonize regulations (ICH). Korea Food and Drug Administration (KFDA) also recently enforced the validation requirement to evaluate as an essential step to prepare Korea-US FTA and to export the drug products to advanced countries. In this track, global regulatory up-date will be presented in the first session. In addition, GMP compliance will be discussed in the area of GMP facility design, process design, and GMP facility operation in the second session. Quality control (QC) and quality assurance (QA) is also very important areas in GMP compliance. In the third session, GMP compliance for QC/QA will be presented with the case studies for the therapeutic monoclonal antibody products.

Session 1. Updated Regulatory Issues for Biologicals

Regulatory issues for biologicals are a little more complicate than those of chemical drugs. Recent interest in the biosimilar products provides more attention to the regulatory update in biologicals. In this session, recent regulatory issues in WHO will be introduced by Dr. Jung Keel Lee, WHO GMP Inspector. In addition, Director Le Van Phung is invited to present the regulatory up-date for biologicals in Viet Nam (National Center for Control of Vaccine and Biologicals). In addition, Dr. Sung Hwa Hong from Korea FDA (KFDA) will present regulatory up-date for biosimilar products.

Chair : Chan-Wha KIM, Professor, Korea Univ.

Sep. 18 10:00~10:30	Harmonization of CGMP & Biosafety Regulations for Biologics Chung Keel LEE, Special Advisor to the Commissioner, Korea Food & Drug Administration
Sep. 18 10:30~11:00	Regulatory Update for Biologicals in Viet Nam Younjoo PARK, Director, Biologics Research Div., Nat’l Inst. of Food & Drug Safety Evaluation, Korea Food & Drug Administration
Sep. 18 11:00~11:30	Regulatory Update for Biologicals in Korea Sung Hwa HONG, Team Leader, Korea Food & Drug Administration

Session 2. GMP Facility Design and Operation

Design of GMP facilities is one of areas limited in experts in many countries. In this session we invited a world-wide well known expert in GMP facility design, Director Luke Mayo from Middough, USA. He will present GMP facility and process design. Use of disposable technologies recently becomes more popular to reduce cost and effort for cleaning and its validation as well as capital investment. Manager Mathias Bayru at Satorius Stedim Biotech S.A., Germany, will discuss recent information on the single use technology in GMP environment. In addition, Mr. Young Ok Back will present cGMP practices in the KBCC cGMP facility.

Chair : Soon Hee PARK, Team Leader, Korea Food & Drug Administration

Sep. 18 14:00~14:30	GMP Facility and Process Design Luke DeMAYO, Senior Technical Manager, Process Tech., Middough, Inc.
Sep. 18 14:30~15:00	Next Generation of Bio-manufacturing Using Single Use (Disposable) Technology Thomas PAUST, Director, Marketing Single-Use Manufacturing Concepts, Satorius Stedim Biotech
Sep. 18 15:00~15:30	GMP Practices in KBCC Young Ok BACK, Team Leader, KBCC

Session 3. QC/QA

With rapid growth of the biotechnological therapeutic market, technical demand of quality control (QC) and quality assurance (QA) for biologicals increases. In this session, case studies for the validation of analytical method for monoclonal antibody products will be presented by Dr. KC Cheng at Medarex, USA. Dr. DoYun Lee, CJ, Korea, as an industrial expert, will discuss various quality assurance aspects for the stability test. In addition, Vice President Brian Kim, Celltrion will present recent global regulatory environment for the biosimilar products.

Chair : Kyung Nam PARK, Senior Managing Director, Berna Biotech Korea Corp.

Sep. 18 16:15~16:45	Validation of Analytical Method for Monoclonal Antibody Products KC CHENG, Associate Director, Medarex
Sep. 18 16:45~17:15	Quality Assurance for Stability Test Do Yeon LEE, Team Leader, CJ
Sep. 18 17:15~17:45	Developing the Next Generation of Biosimilars MinYoung SOH, Senior Vice President, Celltrion, Inc.

Track 17. Vaccine

Human beings are threatened by the emergence of new infections such as SARS, AI (avian influenza), and SI (swine influenza) that could possibly culminate in dreadful pandemic. Thanks to the quantum leap achievement in modern biotechnology, specific as well as safe therapeutics against many intractable diseases came out to market and serve big cash cows for pharmaceutical companies. However, the inevitable high price of the state-of-the-art new therapeutics prevents impoverished population, which might desperately need the new drugs, from being treated by the fruits of modern science. In this token, the importance of effective vaccine in public health care is even more emphasized. Vaccine industry, being supported by the development in biotechnology, shows consistent annual growth more than 10% thanks to the expansion in the global vaccine market. Added value of the industry is also growing tremendously after marketing 'premium' vaccines cost more than $100 per dose. It is a very timely attempt for both industry and academia to open a forum discussing productive strategy to cope with challenges and opportunities in the 21st century vaccine industry.

Session 1. Vaccine Industry in Asia: Challenge and Opportunity

Asian vaccine companies are late comers to the global vaccine market and followers to the well established Western multinational vaccine companies. The former companies have depended upon strategic alliances with the latter companies and taken advantage of old technologies, no longer protected by intellectual properties. However, the current situation that newly emerging infections are most prevalent in Asian countries, urges Asian vaccine companies to harness with original technologies of their own to meet the local needs timely. The newly emerging infections are treated as national security issues in most countries. Asian vaccine companies are developing their own vaccine R&D, manufacturing pipelines, and systems for clinical tests, and consequently emerging as under dogs in the global vaccine market. In 1997, the International Vaccine Institute (IVI) was launched in Seoul, Korea under the leadership of UNDP. More than 40 countries agreed with the necessity for a new independent international institution for a holist approach to distribute effected vaccines to children in developing countries. More than 7 million children less than 5 years of age die of infectious diseases in those developing countries. IVI plays a strong leadership in introducing newly developed and effective vaccines to the public health care systems of developing countries. This session, Vaccine Industry in Asia: Challenge and Opportunity, will deal with the recent IVI success story of a new effective economical cholera vaccine efforts of representative vaccine companies of China, Vietnam, and Korea.

Chair : Byung Geon RHEE, Executive Vice President, Green Cross Corp.

Sep. 18 10:00~10:30	Killed Oral Cholera Vaccines : New Wine in an Old Bottle John CLEMENS, Director General, Int'l Vaccine Inst.
Sep. 18 10:30~11:00	Opportunities and Challenges from SARS, H5N1 and H1N1 Giang GAO, CTO, Sinovac
Sep. 18 11:00~11:30	Vaccine Industry in Vietnam - Experience and Challenges Thu Van NGUYEN, Director General, Vaccine, The Company for Vaccine and Biological No.1
Sep. 18 11:30~12:00	Vaccine Industry in Korea: Experience and Challenge in the Green Cross Co. Byung Geon RHEE, Executive Vice President, Green Cross Corp.

Session 2. Prospective Vaccine R&D

Thanks to the outstanding scientific achievements in biotechnology and immunology, it became quite possible to improve tremendously the efficacy of existing vaccine and to develop new paradigm vaccines against a wide spectrum of diseases. Since vaccines are primarily used by children and populations with higher susceptibilities to diseases, the approval authorities in every country are very conservative in allowing companies to market new vaccines, which consequently became an intractable hurdle in vaccine industry and most important attributes to the high price of new generation vaccines. However, new vaccines came through the hurdle, saved lives of human beings and became block buster items based upon their unprecedented efficacy and safety. In this context, this session inviting world-leading scholars in the vaccine field, will be operated to have in-depth vital discussions concerning the R&D trend for next generation vaccines.

Chair : Joon Haeng RHEE, Prof., Dept. of Microbiology, Medical School, Chonnam Nat'l Univ.

Sep. 18 13:30~14:00	Oral Live, Attenuated Typhoid-Shigella Multivalent Vaccine Development Dennis KOPECKO, Lab Chief, Div. of Bacterial, Parasitic and Allergenic Products, FDA-CBER
Sep. 18 14:00~14:30	Live Attenuated H5N1 Avian Influenza Vaccine Baik Lin SEONG, Prof., Yonsei Univ.
Sep. 18 14:30~15:00	Mesenchymal Stem Cell-based Cancer Vaccine Young Chul SUNG, Prof., Dept. of Life Sci., Pohang Univ. of Sci. and Tech
Sep. 18 15:00~15:30	Adjuvant-antigen Fusion Vaccine Joon Haeng RHEE , Prof., Dept. of Microbiology, Medical School, Chonnam Nat'l Univ.

Track 18. Next-generation Sequencing
: Next-generation Sequencing Towards Personalized Medicine

With the advent of next generation sequencing technologies, high throughput genome analysis is providing the new and fundamental tools for genomics research and commercial applications. The next generation sequencing technologies mean that the sequencing is becoming cheaper and faster, the amount of the sample needed is becoming smaller and the preparation cost of the sample is becoming cheaper. The applications of next generation sequencing are being actively developed, encompassing the areas such as human genome sequencing, transcriptomics and epigenomics. The technology will eventually lead us to the personalized medicine. This track, we will discuss the current applications of next-generation sequencing in personal genomics, present of next generation genome sequencing in Korea and introduction of three next-generation sequencing platforms to gain an appreciation of the breadth and depth of their potential.

Session 1. Application of Next-generation Sequencing to Personal Genomics

In this session, we will discuss on the application of Next-generation sequencing technologies that will provide a comprehensive picture of human genome variation in the personal genomic field. The three talks will provide a chance to understanding in human genomic variation, disease genomics and epigenomics fields.

Chair : Jeong-Seon SEO, Prof., College of Biochemistry a Classroomne, Seoul Nat'l Univ.

Sep. 18 10:00~10:30	Understanding Human Disease and Disorders through Structural Genomic Variation: 1000 genome Charles LEE, Prof., Harvard Cancer Center, Harvard Univ.
Sep. 18 10:30~11:00	Resequencing of Entire HLA Region to Identify Haplotype Structure and Disease-susceptibilities Ituro INOUE, Prof., School of Medicine, Tokai Univ.
Sep. 18 11:00~11:30	Computational Analysis of the Next Generation Sequencing Data for Cancer Epigenomics Study Sun KIM, Prof., School of Informatics, Indiana Univ.

Session 2. The Present of Next-generation Genome Sequencing in Korea

The individual genome sequence of American biologist Craig Venter was published in 2007, followed by those of DNA pioneer James Waston in April. Chinese scientist Yang Huanming the first Asian to have his genome sequenced in end of 2008. Recent personal genome sequencing results from Korean genome found 3.23 million SNPs (genetic variations) comparison with the NCBI genome sequence. We discuss on the personal genome sequencing as a main research tool for the personal genomic studies in Korea.

Chair : Jong-Young LEE, Chief, Div. of Functional and Genomics, Korea Nat'l Inst. of Health

Sep. 18 13:00~13:30	Fine-mapping Using NGS Technology to Identify Causal Variants of T2D and Lipid-related Traits Yoon Shin CHO , Principal Research Scientist, Center for Genome Sci., Korean Nat'l Inst. of Health, KCDC
Sep. 18 13:30~14:00	Diploid and Haploid Genome Sequencing of Altaic Korean Individuals Kap-Seok YANG, CTO, Macrogen Inc.
Sep. 18 14:00~14:30	Human Genome Re-sequencing Using NGS: Experimental and Analytical Aspects Yong Sung KIM , Principle Investigator, Medical Genomic Research Center, Korean Research Inst. of Biosci. and Biotech.

Session 3. Introduction of Next-generation Sequencing Technology to Personal Medicine

In past four years, Genomics research has been revolutionized by the NGS technology. Three platforms for massively parallel DNA sequencing read production are in reasonably widespread use at present: Roche/454 FLX, the Illumina/Solexa Genome Analyzer, and the Life Technologies SOLiD system. This session, three speakers will introduce fundamental principles of commercially available NGS platforms and its application. The introduce of future technology "Next-generation sequencing" is to make people more aware of personal medicine era in the near future that ambitious target of $1,000 or less to make genome sequencing a routine diagnostic tool in medical care.

Chair : Sung-Min AHN, Prof., Lab. of Genomics, Gachon Univ. of Medicine and Sci.

Sep. 18 15:20~15:50	New Generation Sequencing Technology Enables Revolution in Genomics Research - A Review of Customer Success Yafei LIU, Head, Sequencing Business, Illumina
Sep. 18 15:50~16:20	Application of 454's Next Generation Sequencing Technologies in Biological Discovery Chinnappa KODIRA, Director, Genomics, 454 Life Sciences Corp.
Sep. 18 16:20~16:50	SOLiDTM System a Revolutionary Tool for System Biology Mike PAYNE, Regional Lead Applications Support, Applied Biosystems

Track 19. Botanical New Drug Discovery and Development

Botanical drugs, simply defined as clinically validated pharmaceuticals of plant origin, typically contain a multi-component composition derived from herbal practices. An obvious advantage of botanical drugs is their history of use and hence, that the therapeutic window has already been understood through experience. Following vigorous scientific validation and appropriate regulatory procedures, some of the ancient remedies may prove to be useful in mitigating certain ailments (e.g., Alzheimer's disease, schizophrenia, metabolic syndrome, etc.) where contemporary therapies often lack desired effectiveness. Such a complementary approach has received tremendous attention among medical professionals, governmental agencies and the general public across the world. A few recently approved botanical prescriptions in the USA and Europe, albeit for topical application, have opened a window of opportunity in terms of regulatory passages in the West. One of the major challenges we face is the standardization of biological materials from natural sources. New technologies to modernize traditional herbs into mainstream pharmaceutical products are being evaluated with the ultimate goal of maximizing the opportunities and overcoming the challenges. The safety and efficacy of botanical products, as well as quality control, have become important concerns for both health authorities and the public. This track introduces development, regulation and global market of botanical products.

Session 1. Development of Botanical New Drug

Plants have been a source of therapeutic agents for more than 5000 years. Approximately 25% of the modern medications are developed from plants. 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 experienced scientists in the field of natural products development. The mechanisms of action of natural extracts and supplements which is currently studied and developed will be presented. The procedure for developing a botanical drug will be introduced and the status and prospect of botanical new drug development in Korea will be also presented in this session.

Chair : Hyouk JOUNG, Director, Plant Diversity Research Center, Korea Research Inst. of Biosci. and Biotech.

Sep. 18 10:00~10:30	Strategy of Botanical New Drug Development from Traditional Korean Medicine Hocheol KIM , Prof. / CEO, Dept. of Herbal Pharmacology, College of Oriental Medicine, Kyung Hee Univ. / NeuMed Inc.
Sep. 18 10:30~11:00	Current Status and Development Strategies for New Botanical Drugs Bongyong LEE, General Manager, Life Sci. R&D Center, SK Chemicals
Sep. 18 11:00~11:30	Research of Therapeutic Agents Development for Chronic Respiratory Inflammation Diseases Bongyong LEE, R&D General Manager, Life Sci. R&D Center, SK Chemicals

Session 2. Regulation of Botanical Products

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 and 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 KFDA. This session reviews the quality control of botanical products, and the efficacy and safety of new botanical drugs and functional foods according to Regulation of the Efficacy and Safety Evaluation of Drugs, etc at KFDA.

Chair : Hocheol KIM, Prof., Dept. of Herbal Pharmacology, College of Oriental Medicine, Kyung Hee Univ. / CEO, NeuMed Inc.

Sep. 18 13:00~13:30	Importance of Quality Control in Botanical Drug Development Sang Hyun SUNG, Assistant Prof., College of Pharmacy, Seoul Nat'l Univ. / CEO, Elcom Science Co., Ltd.
Sep. 18 13:30~14:00	Importance of Quality Control in Botanical Drug Development Shin Jung KANG, Director, Medicinal Herbal Products Div., Korea Food & Drug Administration
Sep. 18 14:00~14:30	The Regulations and Evaluation on Fuctional Foods Hye Young LEE, Senior Scientific Officer, Functional Food Standards Div., Food Safety Bureau, Korea Food & Drug Administration

Session 3. Global Market of Botanical Products

Global market of natural products including botanical new drugs, herbal supplements and cosmetics are growing up with the increasing needs for well-being and the scientific evidence of the effects of the natural products. Current situation of botanical products including an overview of consumer and business markets of natural products and dietary supplements in United States, China and Japan will be introduced. Also, scientific requirements, opportunities and challenges for development of dietary supplements under rapidly changing global market trend and regulation will be discussed. Quality standards, criteria and development procedures for a botanical drug or functional food in these countries will be introduced by the experienced experts from each country.

Chair : Seung-hoon CHOI, Dean, College of Oriental Medicine, Kyung Hee Univ.

Sep. 18 15:20~15:50	U.S. FDA Botanical Drug Guide: U.S. FDA Botanical Drug Guide for World Marketing Hee Min RHEE, Principal Investigator, Int'l Scientific Standard, Inc.
Sep. 18 15:50~16:20	Botanical Drugs: Challenges and Opportunities Ming-Wei WANG, Director, The Nat'l Center for Drug Screening
Sep. 18 16:20~16:50	Regulation and Development of Botanical Functional Food or Drug in Japan Hirobumi OHAMA, Chairman of the Board, The Japanese Inst. for Health Food Standards