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Friday
September 8, 2006
Session I Molecular Imaging 10:00 - 11:30
Molecular imaging is shorthand for a number of techniques that let researchers watch genes, proteins, and other molecules at work in the body. Molecular imaging has exploded, thanks to advances of BT, NT, and IT such as cell biology, biochemistry, material science, and computer analysis. Molecular imaging techniques to study the molecular interactions that underlie biological processes and to detect a particular molecule in the midst of cellular activity will be presented and discussed in this session.
| Chair |
| Kuiwon Choi, Ph.D., Director, Biomedical Research Center, KIST |
| Speakers |
J.Paul Robinson, Ph.D., SVM Professor of Cytomics, Basic Medical Sciences & Biomedical Engineering, Purdue University
“Confocal Fluorescene Microscopy” |
Ick Chan Kwon, Ph.D., Principal Research Scientist, Biomedical Research Center, KIST
“Optical Molecular Imaging” |
Hyesin Byun, Ph.D., Product Manager, Technical Sales, GE Healthcare Bio-Sciences
“Molecular Imaging Systems in Pre-clinical Study” |
Session II Functional Neuromuscular Stimulation 13:30 - 15:00
Electrical stimulation can provide a useful means to generate body functions such as hearing, grasping, walking and so forth. This methodology was made possible by integrating all of the related areas such as electrophysiology, computer science, biomaterial engineering, biomechanics, electronic engineering, and so forth. This session discusses the state-of-the-art technologies in the area, focusing on functional recovery of the elderly as well as the physically disabled.
| Chair |
| Gon Khang, Ph.D., Professor, Department of Biomedical Engineering, College of Electronics and Information, Kyung Hee University |
| Speakers |
Paul Meadows, Senior Principal Engineer, Neurological Devices Division, Advanced Bionics Corporation
“Advanced Bionics Neurostimulation Systems: a Decade of Cutting Edge Technology” |
Gwang-Moon Eom, Ph.D., Professor, Biomedical Engineering, Konkuk University
“Electrical Stimulation System for the Exercise and Mobility Improvement” |
Hye-Jung Lee, Ph.D., O.M.D., Professor, Oriental Medicine, Kyung Hee University
“Development of New Acupuncture Therapy” |
Session III Micro- and Nano- Technologies in Biological Systems 15:20 - 16:50
Technologies developed in the semiconductor industry have become enabling technologies in experimental neurobiology and rehabilitation medicine. Microfabricated multielectrode arrays (MEA’s) are used in brain-machine interface research in vivo and in vitro. These transducers coupled to VLSI circuit interfaces in an integrated package are demanded for final customization of neural interface, neural prosthesis, brain-machine interface and neuromorphic systems. The key developments have been processing technologies for semiconductor and flexible polymer substrates and low power design techniques that are particularly suited for biomedical applications.
| Chair |
| Kyehan Rhee, Ph.D., Professor, Division of Mechanical Engineering, Myongji University |
| Speakers |
Nitish Thakor, Ph.D., Professor, Biomedical Engineering, Johns Hopkins University
“Innovative Micro and Nanotechnologies for Medical Research and Clinical Applications” |
Sung June Kim, Ph.D., Professor, Electrical Engineering and Computer Science, Seoul National University
“Micro and Nano Technologies for Neural Interfaces” |
Chanil Chung, Ph.D., Director, Department of R&D, Digital Biotechnology
“Micro-fluidic Plastic Chips for Biological/Chemical Experiments” |
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Wednesday
September 6, 2006
Session I Bio-Clusters Policy and Strategy 13:30 - 15:00
Historically, the clustering of businesses has often been the key to higher productivity, increased competitiveness and industrial take-off in developed countries. Indeed, interaction among innovation entities (university, research, industry) is the most important factor for development in bioindustry. So, not only most of the developed countries but also Korea are supporting bio-clusters policies as a part of bioindustry development at present. This session will provide the domestic and foreign status of bio-clusters policies and development plans to go ahead with policies efficiently and systematically.
| Chair |
| Kee-Bom Nahm, Ph.D., Professor, Urban Sociology, University of Seoul |
| Speakers |
Takaaki Matsuzawa, MSc, MEng., Professor, Headquarters for Innovative Cooperation and Development, Kobe University
“Bio-Clusters Policies for Regional Innovation in Japan” |
Joohan Kim, Ph.D., Senior Research Fellow, Leading Industries division, Korea Institute for Industrial Economics and Technology(KIET)
“Achievements and Challenges of Bio-Clusters in Korea” |
Session II Bio-Clusters Cases in Korea 15:20 - 16:50
There are 27 bio-clusters in Korea. It is very important to coordinate and support the bio-clusters for the development of bioindustry. So, it is necessary to work out some innovation factors and success conditions and additionally, how to promote bioclusters through analysis of the major domestic bio-clusters. This session will provide the current status of the main bio-clusters such as Osong Bio-health Science Technopolis, Bio-Hub Center, Daedeok Science Town and guide you through their role, function, and principles for operating successfully.
| Chair |
| Moon Hi Han, Ph.D., CEO & President, Kyeonggi Bio-Center |
| Speakers |
Bryan Byeong-ik IM, Director,Osong Bio Technopolis Development HQ, Ministry of Health and Welfare
“Innovative Bio-Cluster, Osong Bio-Technopolis" |
Young Je Yoo, Ph.D., Director, Korea Bio-Hub Center, Seoul National University
“The Role of Korea Bio-Hub Center and its Implication of Bio-Clusters in Korea” |
Kyong Hoon Suh, Ph.D., Professor, Life Science & Biotechnology, Pai Chai University
“Daedeok Science Town” |
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Thursday
September 7, 2006
Session I Future of BT Research and Protection of Human Subjects 10:00 - 11:30
When developing Biotechnology (BT) in a civilized society, we can not help but consider bioethics as an essential element. In this session, the role of bioethics in the future and its implications on society will be reviewed. In particular, protection of the human subjects will be considered an important issue of BT research. “Biolaw” is also a crucial tool for society to ensure the safety and soundness of research, and its role will be examined.
| Chair |
| Sang-Goo Shin, M.D., Ph.D., Director, Clinical Research Institute, Seoul National University Hospital |
| Speakers |
Thomas H. Murray, Ph.D., President, The Hastings Center
“Bioethics and the Future of BT Research” |
Young Min Chang, Ph.D., Director, Institute for Law and Bioethics, Ewha Womans University
“Role of Biolaw and Bioethics in Advancing Biotechnology” |
Ock-Joo Kim, M.D., Ph.D., Assistant Professor, Department of History of Medicine and Medical Humanities, Seoul National University College of Medicine
“Protection of Human Subjects in BT Research” |
Friday
September 8, 2006
Session II Research Ethics in a World of Globalization
13:30 - 15:00
Diverse regulating and overseeing of bodies has been suggested to ensure ethical research practice. In this session, the role of regulating bodies in Korea will be reviewed, and the importance of research ethics is to be stressed. Ethical ways to use human body materials will be suggested since it has often been dismissed in research field. Finally, the necessity and manner of international cooperation for bioethics will be presented.
| Chair |
| Kee-Hyun Chang, M.D., Ph.D., Professor, Department of Radiology, College of Medicine, Seoul National University |
| Speakers |
In-Young Lee, Ph.D., Professor, Division of Law, Hallym University
“Research Ethics and Regulating Bodies for BT research” |
Ivo Kwon, M.D., Ph.D., Professor, Department of Medical Education, College of Medicine, Ewha Womans University
“Ethical Use of Human Materials in BT Research” |
Darryl Macer, Ph.D., Regional Adviser in Social and Human Sciences for Asia and the Pacific, UNESCO Bangkok
“Global Bioethics” |
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Friday
September 8, 2006
Session I Emerging Issues for Korean Companies 10:00 - 11:30
This session delivers overall operating issues and brings up strategic directions of Korean biotechnology companies. In order to best address the topic, rules of the game in the Korean biotechnology market will be discussed in terms of stakeholders, value chains, etc. We will also discuss the KOSDAQ market which is to finance Korea’s small and medium-sized enterprises in a multitude of high-tech industries.
| Chair |
| Seok Won Yoon, MSc., General Manager, Hanwha VC Corp. |
| Speakers |
Sang Joon Seo,Team Leader,Listing Examination TeamⅡ, Korea Exchange
"KOSDAQ : The Market of Opportunity" |
Chris S. Lee, MBA, CFO/COO, Oscotec Inc.
“Rules of the Game in Korean Biotechnology Market (Entrepreneur’s Point of View)” |
Session II The Emerging “Chindia” Market 13:30 - 15:00
Goldman Sachs calculates that a third of total domestic demand in the world economy over the past five years has come from the so-called BRICs countries (Brazil, Russia, India and China). In particular, China and India represent two of the fastest growing economies in the world. Together, they account for one-third of the world’s population. Chindia’s expanding economies are also representative of their pharmaceutical and biotechnology markets, which have recorded double-digit growth over the past several years. Both countries have established a presence in the Asia-Pacific and global markets, combining regulated markets with an educated labor force. With both markets forecasted to post further impressive growth, China and India offer significant investment and partnering opportunities to international companies with outsourcing needs. This session will provide insight into the pharmaceutical and biotechnology markets in these two countries. Presentations will discuss the need for international partnerships as well as an overview to opportunities in each country.
| Chair |
| Donghoon Lee, CFA, Partner, Corporate Finance, Samjong KPMG FAS Inc. |
| Speakers |
Donghoon Lee, CFA, Partner, Corporate Finance, Samjong KPMG FAS Inc.
“The Emerging Chindia Market” - Overview of Chindia - |
Hitesh Gajaria,Pharmaceutical Sector leader,Partner,BSR & Co.
"The Changing Indian Pharmaceutical Market" |
Michael Chin, Senior Manager, China Practice, Samjong KPMG FAS Inc.
“China at the Forefront of Asian Biotechnology” |
Session III A Global Perspective of Business Development
15:20 - 16:50
In this increasingly globalizing world, biotechnology can not remain an exception. Indeed, biotechnology is by its scientific origins and by market necessity a truly global industry, and therefore unthinkable within the traditional confines of national or economic boundaries. This session will discuss the advantages and disadvantages of small biotech-big pharma drug development alliances and how to manage alliances to maximize the chances of success.
| Chair |
| Chris S. Lee, MBA, CFO/COO, Oscotec. Inc. |
| Speakers |
Seung-il Shin, Ph.D., Chairman, Scientific Advisory Board, Celltrion, Inc.
“Global Business Strategy for Korean Biotechnology Industry” |
Rich Driansky, J.D., Managing Director, Roberts Mitani Advisors, LLC
“Big Pharma-Small Venture Company Deals: How to Get Married and Avoid Divorce” |
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Thursday
September 7, 2006
Session I Important Issues in Early Phase Clinical Trials
10:00 - 11:30
Early phase clinical trials involve the process of evaluating the safety and efficacy of new drug candidates in humans with non-clinical data and making important decisions on “Go-No go” or dosage regimen, etc. This session will review the overall strategy and critical technologies of early phase clinical trials. This includes issues such as designing early phase clinical trials, QT studies, clinical trials in special populations, and analysis of the dose-effect relationship, etc.
| Chair |
| Min Soo Park, M.D., Ph.D., Assistant Professor, Clinical Pharmacology, Yonsei University |
| Speakers |
Min Soo Park, M.D., Ph.D., Assistant Professor, Clinical Pharmacology, Yonsei University
“Special Population Clinical Trials” |
Kyung-Sang Yu, M.D., Ph.D., Assistant Professor, Clinical Trial Center, Seoul National University
“Thorough QT Evaluation” |
Young-Ran Yoon, M.D., Ph.D., Assistant Professor, Clinical Trial Center, Kyung-pook University
“Design Issues in First-in-Human Trials” |
Session II Clinical Trials with Biomarkers 13:30 - 15:00
During early phase clinical development, it is very important to identify and use biomarkers. In particular, utilizing the biomarkers of current technologies such as pharmacogenomics and functional imaging allows us to skip many unnecessary clinical trials and develop drugs more efficiently. This session will discuss how pharmacogenomics and imaging biomarkers are used in clinical trials and how those biomarkers are best utilized by modeling and simulation.
| Chair |
| In-Jin Jang, M.D., Ph.D. Associate Professor, Clinical Pharmacology, Seoul National University Hospital |
| Speakers |
In-Jin Jang, M.D., Ph.D. Associate Professor, Clinical Pharmacology, Seoul National University Hospital
“Modeling and Simulation Using Imaging Data” |
Arthur Atkinson, M.D., MACP, Adjunct Professor, Molecular Pharmacology and Biochemistry, Feinberg School of Medicine, Northwestern University
“Biomarkers and Surrogate Endpoints, for What Purposes are They Fit?" |
Richard Hargreaves, Vice President, Department of Imaging, Merck & Co., Inc.
“Imaging in Drug Development” |
Session III New Methods for Clinical Trials: Design and Analysis 15:20 - 16:50
It is important to elevate efficiency of clinical trials with the help of new clinical trial methods related to clinical trial design, data analysis and data management using information technology (IT). This session will discuss issues related to Web-based technologies such as electronic-case report forms (e-CRF) and new statistical methods such as Bayesian adaptive designs.
| Chair |
| Byung-Joo Park, M.D., Ph.D., Professor, Preventive Medicine, Seoul National University |
| Speakers |
Byung-Joo Park, M.D., Ph.D., Professor, Preventive Medicine, Seoul National University
“Web Based Clinical Trials” |
Masahiro Takeuchi, Ph.D., Professor, Clinical Pharmacology, Kitasato University
“Adaptive Clinical Trial” |
Allen D. Roses, M.D., Senior Vice President, Genetics Research, GlaxoSmithKline
“Pharmacogenomics in Drug Development” |
Dong-Seok Yim, M.D., Ph.D., Associate Professor, Pharmacology, Catholic University
“Modeling and Simulation” |
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Thursday
September 7, 2006
Overview
More than 100 million patients worldwide suffer from a combined disorder characterised by insulin resistance and the presence of obesity, abdominal fat, high blood sugar and triglycerides, high blood cholesterol, and high blood pressure. There are two main types of diabetes: type 1 diabetes classically develops during childhood, is caused by an autoimmune attack on the insulin-secreting cells of the pancreas, and is associated with a lifetime of insulin injections. Type 2 diabetes has classically been perceived as a disease of the elderly. This perception is being challenged. Diabetes mellitus is therefore a major health problem at all ages which places a significant burden on health services, the family, and governments. A combination of several factors including increased life expectancy, increased obesity, less exercise and urbanisation is leading to an alarming increase in the number of people with type 2 diabetes. Globally, it is estimated that the number of people with type 2 diabetes will increase by 46% between 2000 and 2010. This presents serious challenges in terms of increased morbidity and mortality.
Session I Diabetes and cardiovascular Diseases 10:00 - 11:30
Cardiovascular disease is the most common complication of people with diabetes, with a risk two to five times that of non-diabetic individuals, and accounting for at least 66% of all deaths. Currently, however, our understanding of the complications and burden associated with diabetes in populations is unsatisfactory. Selection bias and the inability to identify a true random sample of all diabetic patients in the community have created major problems in previous studies. The challenge is to provide effective, population based diabetes care.
| Chair |
| Hyun Chul Lee, Professor, Yonsei Univ. |
| Speakers |
Andrew Morris, M.D., Professor, Diabetic Medicine, University of Dundee
“Opportunities for Translational Medicine in Scotland: a diabetes case study” |
Kyong Soo Park, M.D., Associate Professor, Endocrine, Seoul National University
“PPARgamma and Atherosclerosis in Diabetes Mellitus” |
Alan Harvey, Pharmalinks
“Reversing vascular damage in diabetes” |
Session II Obesity and Energy Metabolism 13:30 - 15:00
Obesity can be defined as a disease in which excess body fat can induce adverse effects on health, including a predisposition to type 2 diabetes mellitus, coronary heart disease, hypertension and certain forms of cancer. Obesity is a common, and increasing, condition in modern society. Leptin and insulin are circulating hormones, secreted from fat and pancreatic -cells respectively, which act in the central nervous system to regulate food intake and body weight. Mutations in leptin and its receptor result in profound obesity and symptoms of type 2 diabetes in rodents and humans. However, it is unclear exactly what defect, in the vast majority of cases, results in human obesity. Most obese humans have a surfeit of leptin (and insulin) and many investigators deem this indicative of "leptin resistance", which is considered significant in the pathogenesis of obesity. Therefore, it is important to elucidate the mechanisms by which these hormones signal within cells.
| Chair |
| Andrew Morris, M.D., Professor, Diabetic Medicine, University of Dundee |
| Speakers |
Michael Ashford, Ph.D., Professor, Neuroscience, University of Dundee
“The PI3K pathway and leptin and insulin signaling in hypothalamic Neurons” |
Min-Seon Kim, M.D., Assistant Professor, Endocrine, University of Ulsan
“A role for the transcriptional factor FOXO1 in the regulation of food intake and body weight” |
Stephen Hammond, Scottish Biomedical
“Finding new therapies for Type-II Diabetes” |
Session III Diabetes and Nuclear Receptor 15:20 - 16:50
Many chemicals that are present in our diet and the environment promote the progression of diseases such as heart disease, diabetes, cancer and dementia. These chemicals mimic endogenous signalling molecules leading to inappropriate cellular responses. Fatty acids are detected at the cellular level by members of the steroid hormone/nuclear receptor superfamily known as peroxisome proliferator activated receptors (PPARs). These receptors are responsible for the tight regulation of the intracellular concentrations of free fatty acids, which can be highly toxic; however it appears that PPARs also have important roles in modulating inflammation, cellular growth and differentiation. PPARτ is a crucial factor in the development of adipocytes and is the target of insulin-sensitizing drugs known as thiazolidenediones. Thiazlidenedione drugs are effective in the management of non-insulin dependent diabetes and the PPARτ gene is polymorphic in populations that have a high prevalancy of non-insulin dependent diabetes.
| Chair |
| Andrew Morris, M.D., Professor, Diabetic Medicine, University of Dundee |
| Speakers |
Colin Palmer, Ph.D., Senior Lecturer, Biomedical Research Center, University of Dundee
“PPARdelta: a Drug Target for Diabetes and Cardiovascular Disease” |
Jae Bum Kim, Ph.D., Associate Professor, Biological Science, Seoul National University
“Multiple Roles of LXRs in Lipid Dysregulation and Metabolic Diseases” |
Tom Shepard, CXR Biosciences Ltd.
“New Trends in Drug Safety Evaluation: Case study of PPAR agonist” |
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Wednesday
September 6, 2006
Session I Pre-formulation & Formulation from the Viewpoint of Industrial Pharmaceutics 13:30 - 15:00
Generally, a candidate drug undergoes the pre-formulation stage prior to nomination into full development. However, some companies like to conduct detailed characterization studies, whilst others prefer to do the minimum amount of work required to progress compounds as quickly as possible into development. It is hard to say which is the right answer. This session will provide real situations of leading-companies. Through this session, we would like to consider the importance of pre-formulation and formulation again for globalization of Korean Pharma companies.
| Chair |
| Don Sun Kweon, Ph.D., Director, Medical team, Yungjin Pharm.Co. |
| Speakers |
Jae Hwi Lee, Professor,College of Pharmacy,Chung Ang University
“Bridging and Integrating New Drug Discovery and Development” |
Jeong Hoon Kim, Ph.D., Senior Research Manager, Formulation Team, Dong-A Pharma
“Development of Oral Formulation Strategy in New Compound” |
Hee-Jong Shin, Ph.D., Principal Executive Director, Research Institute, Chong Kun Dang Pharmaceutical Corporation
“Strategies in Incrementally Modified Drug(IMD) Development in Pharmaceutical Industry” |
Session II Recent Advances in the Development of Drug Delivery Systems 15:20 - 16:50
Recently, many investigators in academia and industry have shown interest in the development of novel drug delivery systems. The aims of developing novel drug delivery systems are to improve the efficiency and to reduce the side effects of a drug. The area is very competitive these days among pharmaceutical industries since developing a new chemical entity is very expensive and requires long development time. This session will discuss recent trends, development strategies and many creative ideas in the development of novel drug delivery systems.
| Chair |
| Hoo-Kyun Choi, Ph.D., Professor, College of Pharmacy, Chosun University |
| Speakers |
Ashim K. Mitra, Ph.D., Chair & Professor, Division of Pharmaceutical Sciences, University of Missouri-Kansas City
“Drug Delivery Trends and Emerging Technologies” |
Sang-Cheol Chi, Ph.D., Professor, College of Pharmacy, SungKyunKwan University
“Formulation and Biopharmaceutical Evaluation of Paroxetin Patch” |
Hyo-Kyung Han, Ph.D., Assistant Professor, College of Pharmacy, Chosun University
“Implication of Drug Transporters in the Development of Drug Delivery Systems” |
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Friday
September 8, 2006
Session I Top-Notch Trends in Drug Discovery 10:00 - 11:30
In this session, we focus on two trends in discovery. One is In-silico library design technology and the other is Recombinant proteins and monoclonal antibodies. In spite of the bright future of drug discovery after the announcement of human genome sequences, major pharmaceutical companies still suffer from the lack of pipeline products. Therefore, the effectiveness has been the most important issue in drug discovery and development. During the last decade, the drug discovery paradigm has shifted from the number of compounds to drug-likeness for increasing success rate in drug development. In order to select the right molecules, the pharmaceutical industry uses various tools such as in-silico library design technology. Recombinant proteins and monoclonal antibodies have been demonstrated to be safe and effective human therapeutics. Projections forecast a fast rate of growth in this market. New and novel technologies will contribute to the growth rate in the future. Many of these novel technologies (aptamers, nucleic acid therapeutics) will complement the growing list of successful recombinant protein and monoclonal antibodies.
| Chair |
| Bongyong Lee, Ph.D., Managing Director, Life Science R&D Center, SK Chemicals |
| Speakers |
Kyoung Tai No, Ph.D., Professor, Department of Biotechnology, Yonsei University
“In-silcio Library Design and Its Application” |
Christine Smith, Ph.D., Senior Director, Head, Protein Therapeutic Center of Emphasis, Pfizer Global Research and Development
“New and Novel Biotechnology Approaches to Disease Modification Monoclonal Antibodies and Other Non Small Molecular Approaches” |
Session II Trimming New Drug Candidates 13:30 - 15:00
This session will be focused on the assessment of desired activity profile for a candidate and the making druggable molecule selection by screening pharmacokinetics. Unlike lead discovery in which many compounds of unknown activity are screened against one single molecular target, candidate profiling involves testing of one or several leads with known activity against multiple molecular and functional assays. In this session, various issues will be discussed for candidate profiling that ensures a compound meets a set criteria (synthesis, biopharmaceutics, ADME, potency, pharmacology and safety) in order to identify the most druggable candidate and avoid costly late attrition.
| Chair |
| Jong Wook Lee, Ph.D., President & CEO, Daewoong Pharmaceutical Co. |
| Speakers |
Peter J.S. Chiu, Ph.D., Pharmacology Director, Research Fellow & Chief Scientific Officer, MDS Pharma Services
“Why Candidate Profiling?” |
Saeho Chong, Ph.D., Associate Director, Metabolism & Pharmacokinetics, Bristol-Myers Squibb PRI
“Challenges in Optimizing ADME Properties of New Drug Candidates - Enabling Drug Developability” |
Session III Recent Trends in Drug Development 15:20 - 16:50
This session will discuss global trends in clinical. This includes points to be considered in clinical researches of bio products and specific requirements on clinical researches of bio products set by the US/EU health authorities. It will give you a perspective of global trends in clinical development. Non-clinical study packages are an essential part of the registration of newly developed pharmaceuticals. In this session, the improvement of the quality of non-clinical study data in Korea will also be discussed. The discovery of drugs that are effective in the central nervous system has always been an attractive research target for major pharmaceutical companies. With the recent advances in combinatorial chemistry and high throughput screening systems, the discovery and development of new blockbuster drugs effective in the central nervous system may be an attainable goal. In this session, academic perspectives will be discussed on the assessment methodologies for brain permeability in order to realize rapid screening.
| Chair |
| Woo-Ick (Paul) Jang, M.D., Ph.D., Medical Director, MSD Korea |
| Speakers |
Jorge G Puente, M.D., Vice President, Pfizer
“Clinical Development in a Globalized Era” |
Suk-Jae Chung, Ph.D., Associate Professor, Department of Pharmaceutics, College of Pharmacy, Seoul National University
“Academic Perspectives for the Assessment of the Brain Permeability of Drugs “ |
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Wednesdy
September 6, 2006
Session I Biotech Financing Model 15:20 - 16:50
While the financing environment currently appears to be more favorable, financing becomes more challenging for startup companies as well as biotech companies with pre-clinical and early clinical stage compounds. Early biotech companies that had undergone financing hurdles for their R&D are now facing how to finance product development programs. In the session, financing environments and some of the financing cases of Korean biotech companies will be introduced. With rapidly growing numbers of biotech companies, the fundraising status of Japanese biotech companies and biotech investment strategies of JAFCO will be presented. Finally, novel project financing will be discussed as alternatives that offer early stage project financing capital, development resources and royalty securitization at varying levels of risk, scope and terms.
| Chair |
| Hyosun Kim, Ph.D, Professor, College of Business Administration, Chung Ang University |
| Speakers |
Joo Yeun Kim, Ph.D., MBA, CEO, Korea Biotech Investment Capital
"Korean Biotech Financing" |
Hisaji Agata, Managing Director, Investment Group III, JAFCO Co., Ltd.
"JAFCO Biotech Financing in Japan" |
Thursday
September 7, 2006
Session II Methods of Financing for Biotech Companies
10:00 - 11:30
Financing comes in all shapes and sizes. From Initial Public Offerings (IPO) to Private Investment In Private Equity (PIPE) to Venture Capital (VC) funding, financing is an inevitable route, especially in the ever-changing dynamic biotech industry. Yet, very few companies are able to successfully obtain financing. Of the companies who are able to obtain financing, a majority are not fully satisfied with the terms of the agreement. Lack of strategy or negotiation skills, improper valuation of technology and inadequate sourcing of potential investors are just a few reasons why companies remain discontented with funding. This session will provide an overall view of financing approaches, examining the benefits of certain methods over others. Speakers will discuss the decisive factors that investors look for in a company, and provide insight into the confusing process of obtaining financing.
| Chair |
| Kwangwoo Park, Ph.D., Division Chair and Associate Professor of Finance, KAIST, Graduate School of Finance |
| Speakers |
Donghoon Lee, CFA, Partner, Corporate Finance, Samjong KPMG FAS Inc.
“Financing & Capital Markets” |
Si-Won Noh,Manager,Corporate Finance,Samjong KPMG FAS Inc.
"IPO Guidelines for Biotech Firms" |
Toshihiro Oguri, C.M.A., Partner & Director, Biotech Healthcare Partners, Inc.
“Strategic Investors, Foreign VC Investors and Funding” |
Session III Issues in Valuations 13:30 - 15:00
There exist numerous methods to valuing a company. These varying approaches provide an assortment of outcomes, creating a situation where the company must make a strategic decision as to which method to utilize. There are countless “rules” to consider when deciding which methodology to use. Whereas the methodology must be credible and respectable from a theoretical and practical perspective, there may need to be a trade off between intellectual rigor of the methodology and the inherent degree of subjectivity. Consideration must be given to the quality and quantity of information available, but underlying parameters must be clear and easy to apply. This session aims to unravel the mystery behind valuations and provide a clear understanding of the process and its importance. Speakers will discuss the different methods of valuation, and more specifically, on the approaches used for biotechnology firms.
| Chair |
| Donghoon Lee, CFA, Partner, Corporate Finance, Samjong KPMG FAS Inc. |
| Speakers |
Peter Min, Team Leader, M&A/Principle Investment Division, Macquarie Securities Korea Limited
“Overview of Valuations & Its Importance” |
Mike Kang, Associate, M&A/ECM, ABN Amro
“Valuation Methodologies” |
Min-Chol Shin, Ph.D., Investment Manager, Venture Investments, Tong Yang Venture Capital Corp.
“VC’s Approach to Valuation of Biotech Firms” |
Session IV Alternative Biotech Financing Strategies - Global Trends 15:20 - 16:50
Because the Biotech industry is unique compared to other industries, the fundamentals of biotech financing and related strategies should be considered differently from other industries. Often, investors and biotech executives have different predictions of the industry’s fast moving global trends. This session offers the various global perspectives of leading investors and bio/pharma executives.
| Chair |
| Hideki Mitani, J.D., Founder & Managing Director, Roberts Mitani Advisors, LLC |
| Speakers |
Bruce Roberts, J.D., Managing Partner, Roberts Mitani Advisors, LLC
“The Death of the Blockbuster Biotech IPO? New Exits and the Impact on Financing Strategies” |
Peter M. Kash, Chairman, Two River Group Holdings, LLC.
“Future of American Biotech Industry and Its Financing Trends” |
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Friday
September 8, 2006
Session I Assessment of Scientific Data for Claims on Foods 13:30 - 15:00
Due to the beneficial health effects of many foods, manufacturers of such foods have been interested in developing health-related claims. And governments from many countries have been providing different approaches to approve claims on foods to assure a high level of confidence among consumers. Session I will discuss a scheme to link claims for foods to solid scientific evidence and the regulatory framework for approval of claims on foods based on scientific data.
| Chair |
| Yoonhwa Jeong, Ph.D., Associate Professor, Department of Food Science and Nutrition, Dankook University |
| Speakers |
Linda S. Pellicore, Ph.D., Acting Division Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA)
“Scientific Substantiation of Claims on Foods: Current Status in US” |
Kazuhiko Yamada, Ph.D., Program Director, Food Function & labeling Program, National Institute of Health and Nutrition
“Scientific Substantiation of Claims on Foods: Current Status in Japan” |
Oran Kwon, Ph.D., Senior Scientific Officer, Health/Functional Food Standard Team, Korea Food & Drug Administration (KFDA)
“Scientific Substantiation of Claims on Foods: Current Status in Korea” |
Session II Importance of Human Data and Biomarkers for Claims on Food 15:20 - 16:50
It is globally accepted that human studies are often the final piece of evidence for a claim on food after data have been gathered from observational and other types of study. And biomarkers are widely used in human studies whenever the true endpoint cannot be measured directly. This session will discuss the importance of human intervention studies and biomarkers for claims on foods, and the standards of research governance and laboratory practice, statistical design and ethical probity.
| Chair |
| Mi-Kyung Sung, Ph.D., Professor, Department of Food and Nutrition, Sookmyung Women’s University |
| Speakers |
Leila G Saldanha, Ph.D., Managing Member/President, NutrIQ LLC
“Importance of Human Data for Claims on Foods” |
Nico Van Belzen, Ph.D., Executive Director, International Life Sciences Institute, Europe
“Biomarkers for the Assessment of Scientific Support for Claims on Foods” |
Yongsoon Park, Ph.D., Professor, Department of Food and Nutrition, Hanyang University
“Integration of in Vitro and in Vivo Studies into Human Intervention Studies” |
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Wednesday
September 6, 2006
Session I HUPO Disease Biomarker Initiative (DBI) 13:30 - 15:00
Protein biomarkers, which provide molecular signatures of certain diseases, can be used for diagnosis (early detection), prognosis (staging detection), determining efficacy (transnational research), monitoring of toxicity, and screening of drug targets. The most valuable biomarkers are highly sensitive, specific, reproducible and predictable. Efficient separation of clinically relevant proteins that may define disease stages and/or predict disease development is the most crucial aspect of biomarker discovery. In this context, HUPO recently decided to launch HUPO Disease Biomarker Initiative (DBI), which is chaired by Dr. Samir Hanash of Fred Hutchinson Cancer Research Center, Seattle, Washington. This session will focus on the update progress in searching for biomarkers from cancer (Samir Hanash and Ki-Baik Hahm) and respiratory diseases (Choon-Sik Park).
| Chair |
| Samir Hanash, M.D., Ph.D., Professor, Molecular Diagnostics, Fred Hutchinson Cancer Research Center |
| Speakers |
Samir Hanash, M.D., Ph.D., Professor, Molecular Diagnostics, Fred Hutchinson Cancer Research Center
“The Wide-World of Proteomics Technologies for Cancer Biomarker Discovery” |
Ki-Baik Hahm, M.D., Ph.D., Professor, Genome Research Center for Gastroenterology and Department of Gastroenterology, Ajou University School of Medicine
“HUPO DBI; Role as Fortune Teller in Gastroenterology” |
Choon-Sik Park, M.D., Ph.D., Chairman, Professor, Genome Research Center for Allergy and Respiratory Diseases, Soon Chun Hyang University Bucheon Hospital
“The Potential of Genomics and Proteomics for Allergy and Asthma Research” |
Session II Human Disease Glycomics/Proteomics Initiatives (HGPI) 13:30 - 15:00
The Human Disease Glycomics/Proteome Initiative (HGPI) is to define community standards for data representation in functional glycomics in relation to diseases. The goal is to facilitate data comparison, exchange and verification. The HGPI will be comprised of a number of researchers and collaborators throughout the world who are dedicated to fostering and accelerating research progress in disease glycomics by pursuing collaborative and interdisciplinary research. This initiative will connect the other initiatives in HUPO more tightly and will permit the exchange of information of mutual interest. In order to avoid diluting efforts by other on-going related activities, this initiative will focus exclusively on disease glycomics. Dr. Naoyuki Taniguchi is responsible for this project and leads this session along with Drs. Miyako Nakano and Jeong Hun Ko.
| Chair |
| Naoyuki Taniguchi, M.D., Ph.D., Professor, Department of Biochemistry, Osaka University School of Medicine |
| Speakers |
Naoyuki Taniguchi, M.D., Ph.D., Professor, Department of Biochemistry, Osaka University School of Medicine
“Dysregulation of TGF Beta Signaling Leads to the Lung Emphysemas in the Core Fucose Deficient Mice” |
Miyako Nakano, Ph.D., Post Doctoral Fellow, Department of Biochemistry, Osaka University Graduate School of Medicine
“Fucosylated Haptoglobin as a Marker for Pancreatic Cancer” |
Jeong Heon Ko, Ph.D., Principal Scientist, Korea Research Institute of Bioscience and Biotechnology (KRIBB)
“Functional Proteomic Study Reveals that N-acetylglucosaminyltransferase V Reinforces the Nvasive/Metastatic Potential of Colon Cancer through Aberrant Glycosylation on TIMP-1” |
Session III Human Plasma Proteome Project (HPPP) 15:20 - 16:50
Since clinically relevant biomarkers provide a snap shot view of a specific disease stage, it is important to capture intact or modified forms of specific plasma proteins at the earliest step in the discovery process. Biomarker discovery from serum or plasma is challenging because it involves searching for extremely low abundance proteins (present at ng/ml to pg/ml). HUPO HPPP has had a big impact on the plasma proteome project by identifying 3020 proteins with high confidence, establishing standard methods for collecting blood and preparing plasma. This symposium focuses on several technical issues that have recently emerged from the use of various multi-dimensional fractionation systems (Young-Ki Paik, Co-Chair of HPPP), protein chips (Daniel Chan), and PTM issues (Jong Shin Yoo) in plasma-driven biomarker discovery.
| Chair |
| Young-Ki Paik, Ph.D., Professor, Department of Biochemistry, Yonsei University |
| Speakers |
Daniel W. Chan, Ph.D., DABCC, FACB, Professor of Pathology, Oncology, Radiology & Urology, Director of Clinical Chemistry Division, Department of Pathology, Director, Center for Biomarker Discovery, Johns Hopkins Medical Institutions
“Human Plasma Proteome: The Opportunities and Challenges of Biomarker Discovery and Validation” |
Young-Ki Paik, Ph.D., Professor, Department of Biochemistry, Yonsei University
“Plasma-derived Biomarker Discovery Using Multi-Dimensional Fractionation System” |
Jong Shin Yoo, Ph.D., Director, Instrument Development Division, Korea Basic Science Institute
“High Throughput Discovery of PTM in the Human Plasma Proteome by Mass Spectrometry” |
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Thursday
September 7, 2006
Session I White Biotechnology 10:00 - 11:30
Biotechnology offers new ways to treat and prevent disease and holds the promise of better and cleaner industrial processes. Although healthcare and agriculture have dominated so far, industrial or “white” biotechnology is likely to become as important. Conventional processes in chemical and textile industries are being transformed, and bio-fuels make an important contribution to our overall energy needs. Use of biotechnology to replace existing processes is making many industries more efficient and environmentally friendly and contributes to industrial sustainability.
| Chair |
| Sunghoon Park, Ph.D., Professor, Department of Chemical and Biochemical Engineering, Pusan National University |
| Speakers |
Erick Vandamme, Ph.D., Professor, Department of Biochemical and Microbial Technology, Ghent University
“Industrial Biotechnology and Sustainable Chemistry: a View from Europe” |
Sunghoon Park, Ph.D., Professor, Department of Chemical and Biochemical Engineering, Pusan National University
“Industrial Biotechnology in Korea: Challenges and Future Perspective” |
Jae-Gu Pan, Ph.D., Director, Systems Microbiol. Res. Center, KRIBB
“Enabling Platform Technologies for Industrial Biotechnology” |
Session II Biopharmaceutical Manufacturing 13:30 - 15:00
Animal cell culturing technology is commonly employed by the biopharmaceutical industry to produce the various recombinant proteins for diagnostic and therapeutic applications. This session will provide a general overview of recombinant therapeutic protein production from animal cell cultures in large-scale. Requirements for the commercial production of therapeutic proteins under cGMP, technology transfer for successful commercial productions, and case studies will be presented.
| Chair |
| Gyun Min Lee, Ph.D., Professor, Department of Biological Sciences, KAIST |
| Speakers |
Gyun Min Lee, Ph.D., Professor, Department of Biological Sciences, KAIST
“Mammalian Cell Culture Technologies for the Production of Biopharmaceuticals” |
Yong-Jick Kim, Ph.D., Vice President, Manufacturing, Celltrion Inc.
“Technology Transfer for Successful Commercial Production of Biopharmaceuticals and Case Studies” |
Sam Soo Lee, Team Leader, cGMP Project Team, Pharmaceutical BU, CJ Corp.
“Wise Approach for the Preparation of a cGMP Compliant Facility in Korea” |
Session III Bioprocess Engineering 15:20 - 16:50
Bioprocess engineering plays a crucial role in biotechnology, especially in commercializing the ideas and products developed in the sector of basic science, so called upstream biotechnology. Process optimization in bioindustry, including production, and separation and purification, will be the main part of the discussions. The current activities of the Engineering Research Center in bioseparation and the top industry in prep bioseparation will also be introduced as examples.
| Chair |
| Yoon-Mo Koo, Ph.D., Professor, Biological Engineering, Inha University |
| Speakers |
Dewey D.-Y. Ryu, Ph.D., Professor and Director, Biochemical Engineering Program, Department of Chemical Engineering and Material Science, University of California
“Bioprocess Optimization for Production of Recombinant Proteins” |
Yoon-Mo Koo, Ph.D., Professor, Biological Engineering, Inha University
“Advanced Bioseparation Technologies for Bioindustry” |
Young Hoon Park, Ph.D., Senior VP, R&D Center for Bioproducts, CJ Corp.
“Bioprocess Engineering Researches at CJ” |
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Thursday
September 7, 2006
Session I New Drug and Biological Products - A Regulatory Perspective 13:30 - 15:00
Newly developed drugs and biological products are introduced to the global market at high speed. This session will provide a regulatory perspective of these new products. Presentations will discuss the review and management system in USA, the regulatory process of biotechnological products in Europe, and the review and approval process of drugs in Korea.
| Chair |
| Yeowon Sohn, Ph.D., Director, Recombinant products team, Korea Food & Drug Administration (KFDA) |
| Speakers |
Peter Richardson, Ph.D., Scientific Administrator, Quality of Medicines Sector, Human Unit Pre-Authorisation, European Medicines Agency (EMEA)
“Regulatory Process of Biotech Products in Europe” |
Zili Li, M.D., MPH, Director, Clinical Research Operations-Asia Pacific, Merck & Co., Inc.
“IND/NDA Review and Management at US FDA - A Clinical Perspective” |
Youngchan Kim, Ph.D., Director, Pharmaceutical Safety Policy Team, Korea Food & Drug Administration (KFDA)
“Review and Approval Process of New Drug in Korea” |
Session II Regulatory Issues in Biotechnology Derived Products Developments 15:20 - 16:50
With the evolution of technology, many types of innovative biotechnological products are being developed. This session will discuss the regulatory aspects of newly developed BT products including gene therapy products and cell therapy products. Pharmacogenomics offer the possibility of influencing nonclinical and clinical information for pharma, CROs and regulatory authorities in the strategic planning in drug development. This session will also discuss about the application of pharmcogenomicss in drug evaluation.
| Chair |
| Sunyoung Kim, D.Phil., Professor, Department of Biological Sciences, Seoul National University |
| Speakers |
Won Shin, Ph.D., Director, Gene Therapy Products Team, Korea Food & Drug Administration (KFDA)
“Regulatory Perspectives of Gene Therapy Products” |
Chiyoung Ahn, Ph.D., Director, Cell and Tissue Engineering Products Team, Korea Food & Drug Administration (KFDA)
“Regulatory Challenges for Cell Therapy Products” |
Hye Joo Chung, Ph.D., Director, Molecular Pharmacology Team, National Institute of Toxicological Research (NITR)
“Application of Pharmacogenomics in Drug Evaluation” |
Friday
September 8, 2006
Session III Policies & Strategies of the Korean Government for Development of Bioindustry 10:00 - 11:30
The Korean biotechnology industry is growing through R&D investment, enhancing bio-clusters, consolidating legal framework, and promoting direct foreign investment. The Korean government’s R&D expenditure for biotechnology has increased significantly during the last 10 years. It also established a new national R&D system and new strategies for biotechnology last year. In 2006, Korea is planning to formulate a 2nd basic national biotechnology plan following the expiration of the 1st plan’s term.
| Chair |
| Chang-Jin Suh, Ph.D., Korea Health Industry Development Institute |
| Speakers |
Jeong-Seok Kim, Director, Health Industry Policy Team, Ministry of Health and Welfare (MOHW)
“Health Industry Developement Strategy” |
Chung-Won Park, Director, Bio & Nano Tech Industries Division, Ministry of Commerce, Industry and Energy (MOCIE)
“Strategies to Create New Frontiers in Biotechnology” |
Sung-Goo Han, Ph.D., Senior Deputy Director, Life Sciences and Oceanology Bureau, Ministry of Science and Technology (MOST)
“National R&D Policy for Biotechnology in Korea” |
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Wednesday
September 6, 2006
Session I Business Development in Cell Therapy 15:20 - 16:50
Considerable progress has been made in the discovery and early clinical development of a variety of cell therapy products. This session will cover the success case of heart regeneration in the USA and the success case of immunotherapy in Japan. Also, this session will discuss the importance of science-based regulation. Effective regulation requires that regulators recognize the careful balance of potential but unproven benefits against real or theoretical risks. Clear regulatory pathways and requirements are critical to future successes.
| Chair |
| Kook In Park, M.D., Ph.D., Professor, Department of Pediatrics, Yonsei University College of Medicine |
| Speakers |
Kristin Comella, Director, Bioheart, Inc.
“Myoblast Transplantation for Heart Repair - A Review of the State of the Field” |
Kohji Egawa, M.D., Ph.D., Chairman, Japan Research Association for Immunotherapeutics
“Current Status and Prospect of Immunotherapeutics Market in Japan” |
Jong Won Kim, Ph.D., DKBT, Deputy Director, Pharm/Tox & Clinical Reviewer of Biologics, Cell and Tissue Engineering Products Team, Korea Food and Drug Administration (KFDA)
“KFDA Reviewer Perspectives of Cell Therapy Products in Korea” |
Thursday
September 7, 2006
Session II Drug Screening & Stem Cells 10:00 - 11:30
Stem cells can proliferate in vitro and can also be induced to differentiate into a desired cell lineage. These abilities make stem cells an appealing source for cell replacement therapies, the study of developmental biology, and drug/toxin screening studies. In general, stem cell research has been focused on the field of regenerative medicine. However, the commercial application of stem cells in drug screening has also been explored. In this session, the potential usage of embryonic and adult stem cells in screening for candidates regulating certain cell signaling pathways and enhancing differentiation will be introduced and discussed.
| Chair |
| Dong-Wook Kim, Ph.D., Professor, Department of Physiology, Yonsei University College of Medicine |
| Speakers |
Yee Sook Cho, Ph.D., Senior Research Scientist, Center for Development and Differentiation, Korea Research Institute of Bioscience and Biotechnology (KRIBB)
“Applications of Embryonic Stem Cells in Drug Discovery” |
Ki-Chul Hwang, Ph.D., Associate Professor, Yonsei Cardiovascular Research Institute, Yonsei University College of Medicine
“Modification of Mesenchymal Stem Cells: Proliferation, Amplification and Adhesiveness” |
Sheng Ding, Ph.D., Assistant Professor, Departments of Chemistry and Cell Biology, The Scripps Research Institute
“Chemical and Functional Genomic Approaches toward Regenerative Medicine” |
Session III Application of Stem Cells to Disease Models
13:30 - 15:00
Stem cells can be applied to current incurable diseases because they may play an important role in activating host cells or replacing cells lost in many obstinate diseases. Embryonic stem cells are pluripotent and thus can differentiate into a certain lineage under certain condition. Currently, the study on the differentiation and application to animal disease models are actively being performed. Adult stem cells have advantages and disadvantages compared to embryonic stem cells. They could be safer and cause less immune problems than embryonic stem cells after transplantation. This session will cover the multilineage differentiation of embryonic stem cells into neuronal phenotypes for application to various central nervous system disorders and the use of adult stem cells for tissue regeneration.
| Chair |
| Hyo-Soo Kim, M.D., Ph.D., Director of National Research Laboratory for Cardiovascular Stem Cell/ Professor, Department of Internal Medicine, Seoul National University Hospital |
| Speakers |
Youngsook Son, Ph.D., Director, Musculoskeletal Bioorgan Center, Korea Institute of Radiological and Medical Science (KIRMS)
“Adult Stem Cells for Tissue Regeneration:Skin and More” |
Dong-Wook Kim, Ph.D., Professor, Department of Physiology, Yonsei University College of Medicine
“Differentiation of Embryonic Stem Cells for Applications to Neurological Disorders” |
James J. Yoo, M.D., Ph.D., Associate Professor, Wake Forest Institute for Regenerative Medicine, Wake Forest University Health Sciences
“Cell Based Approaches for Tissue Regeneration” |
Session IV Clinical Aspects of Stem Cells 15:20 - 16:50
Neurodegenerative diseases, cardiovascular diseases, type-I diabetes, liver failure, and some cases of arthritis are just a few areas for which stem cells have therapeutic potential. Cell transplantation for the treatment of patients with the neurodegenerative diseases such as Parkinson's disease involves the use of dissected fetal tissues, which contain various cell types. Because of the shortage of donor fetal tissues and ethical problem, cell transplantation requires alternative sources. Many of the adult stem cell preparations are currently being developed in the clinical laboratories. In the case of some diseases such as cardiovascular diseases, initial clinical applications have been tried. In this session, the efficacy and safety of clinical application with stem cells will be discussed.
| Chair |
| Youngsook Son, Ph.D., Director, Musculoskeletal Bioorgan Center, Korea Institute of Radiological and Medical Science (KIRMS) |
| Speakers |
Hyo-Soo Kim, M.D., Ph.D., Director of National Research Laboratory for Cardiovascular Stem Cell/Professor, Department of Internal Medicine, Seoul National University Hospital
“Vasculogenesis by Adult Stem Cells or Vascular Progenitor Cell (Cell Biologic Mechanistic Analysis)” |
Hyun Soo Kim, M.D., CEO, Pharmicell
“Clinical Applications of Adult Stem Cells” |
Koji Hasegawa, M.D., Ph.D., Director, Division of Translational Research, Kyoto Medical Center, National Hospital Organization
“Signaling Pathways that Mediate Differentiation of Mouse and Monkey ES Cells into Cardiac Myocytes. -Toward Application of ES Cell Therapy for End-staged Heart Failure-” |
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Friday
September 8, 2006
Session I Regenerative Medicine 10:00 - 11:30
Regenerative medicine nowadays offers to restore, maintain or enhance tissues and organs. The potential impact of this field, however, can be far broader. In the near future, regeneative medicine, including embryonic and adult stem cell therapy, tissue engineering, growth factor and cell delivery system, biomaterials and matrics is projected to heal the organ malfunctioned diseases, reduce the need for organ replacement, and to greatly accelerate the development of new drugs that may cure patients, hence eliminating the need for organ transplants altogether. In this session, the status of recent development situation in Germany and Korea in the regenerative medicine field will be presented.
| Chair |
| Khang, Gilson, Ph.D., Associate Professor, Chonbuk National University |
| Speakers |
Christof Stamm, M.D., Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin
“Cell-based Regenerative Medicine for Heart Disease” |
Oh, Il-Hoan, M.D., Ph.D., Director, Catholic High-Performance Cell Therapy Center, The Catholic University of Korea
“Engineering and Transplantation of Hematopoietic Stem Cell” |
Christof Stamm,Deutsches herzzentrum Berlin
"Cell-based Regenerative Medicine for Heart Disease" |
Session II Tissue Engineering 13:30-15:00
Tissue engineering offers an alternative technique to whole organ and tissue transplantation for diseased, failed or malfunctioned organs. To reconstruct a new tissue by tissue engineering, triad components such as (1) cells (2) biomaterials, and (3) growth factors are needed. Among of these three key components, scaffolds as biomaterials might play a very critical role in tissue engineering. The function of scaffolds is to direct the growth of cells seeded within the porous structure of the scaffold or of cells migrating from surrounding tissue, eventually mimicking a natural extracellular matrix. This section focuses on tissue engineered hard tissues as bone, cartilage, disc, teeth, etc, and soft tissues as skin, nerve, muscle, and so on for commercialization.
| Chair |
Kim, Moon Suk, Ph.D., Senior Research Scientist, Medicinal Science Division, Korea Research Institute of Chemical Technology |
| Speakers |
Kim, Soo Hyun, Ph.D., Head, Biomaterials Research Center, Korea Institute of Science & Technology (KIST)
“Tissue Engineering of Blood Vessel” |
Michael Sittinger, M.D., Ph.D., Laboratory for Tissue Engineering, Charité – University Medicine
“Product development in tissue engineering: Example bone and cartilage regeneration” |
Yang, Young-Il, M.D., Ph.D., Paik Institute for Clinical Research & Department of Pathology, School of Medicine, Inje University
“3-Dimensional Organotypic Culture Method of Adipose Tissue for Isolation Adult Stem Cells” |
Session III Bio-Clusters for Regenerative Medicine 15:20 - 16:50
Recently, we have seen various activities surrounding Bio-Clusters or Bio-Metropolis amongst the leading nations of Life Science field. Bio-clustering of research and development for regenerative medicine can be very critical for effectively promoting the entire value chain, from basic research, thru animal and human clinical trial, finally, to products. This session will cover and introduce the recent development situation of Bio-Clusters in Germany and Korea.
| Chair |
Peter Goetz, Professor , Bioprocess engineering, Tech. Univ. Berlin |
| Speakers |
Khang, Gilson, Ph.D., Associate Professor, Chonbuk National University
“Regeneration of Spinal Cord using Bone Marrow Stromal Stem Cells and Functional Scaffolds” |
Kai U. Bindseil, Ph.D., CEO, BioTOP Berlin-Brandenburg
"BioCapital Berlin & Berlin Center for Regenerative Therapy" |
Leo W Tristan, CEO, RiNA GmbH
"RiNA GmBH; Core Facility of the RNA Network” |
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Thursday
September 7, 2006
Session I Important Topics in Technology Transfer and Licensing - Industry and University Case Studies 10:00 - 11:30
Technology companies should use global markets most efficiently, as a source of talent pool, R&D center, funding, and distribution channel. This session will explain how two concepts, “Global Technology Arbitrage” and “Knowledge Supply Chain Management System.”, work with various real cases and necessary mind-set to execute such concepts in the real world. The university is very active in promoting collaboration with strategic partners. Joint projects facilitate development of innovative products and revenue generation. Columbia’s organizational structure enables the university to promptly review and patent important inventions as well as identify technologies with synergistic potential, thereby maximizing the value of basic research. This session will provide Columbia University’s system of collaboration with strategic partners.
| Chair |
| Bruce Roberts, J.D., Managing Partner, Roberts Mitani Advisors, LLC |
| Speakers |
Hideki Mitani, J.D., Founder & Managing Director, Roberts Mitani Advisors, LLC
“How to Make Successful Cases Using Global Technology Arbitrage (GTA) & Knowledge Supply Chain Management (KSCM)” |
Jerry M. Kokoshka, Ph.D., Associate Director, Science & Technology Ventures, Columbia University
“University’s Case Study-Advancing Basic Research is Key to Increase in Valuation and Commercialization” |
Session II Legal Issues Regarding Technology Transfers
13:30 - 15:00
The technology transfer of biotechnology is very active in today’s society. There has been a large build up of technologies by universities, research institutions, and start-up companies that could be integrated into the market, and as a bridge from the bench to the market, technology transfers of this kind have been rapidly increasing. There are many important steps that need to be followed to make worldwide technology transfers successful. In this session, we will review what legal issues are frequently raised during technology transfers and what we can learn from past experiences.
| Chair |
| Sang Jo Jong, Ph.D., Professor of Law, Seoul National University, Director, SNU Center for Law and Technology |
| Speakers |
Anthony C. Chen, J.D., Of Counsel, Department of IP, Jones Day
“Cross-Border Licensing Strategy for Emerging Asian Biotechnology Companies” |
Boh Young Hwang, LL.M., Partner (Attorney at Law), Intellectual Property, Bae, Kim & Lee
“Licensing and Fair Trading” |
Session III Intellectual Property Issues in Biotechnology
15:20 - 16:50
Intellectual property is an important aspect of technology transfers since it defines “what technology” is transferred from the licensor to the licensee. In order to protect technology worldwide, it is necessary to obtain patent rights in countries where the technology is going to be practiced. Every country has an established legal system to protect the intellectual property of biotechnology inventions; however, unlike other fields of technology, biotechnology is where the laws between countries become varied and complicated, even though there have been continuous efforts to harmonize the standards. Understanding the standards for the protection and the legal issues raised therefrom would make it easier to plan better strategies resulting in successful technology transfers.
| Chair |
| Yeah-Sil Moon, Esq., Patent Attoney, Jones Day |
| Speakers |
Min Son, Ph.D., Representative Patent Attorney, International Intellectual Property Group, Hanol Law Offices
“Intellectual Property Issues Regarding Biotechnology in Korea” |
Andrew L.Chuk,Senior Legal Director, International Patent Counsel, Legal Affairs, Asia North , Merck Sharp & Dohme (Asia) Ltd
“A Few Suggestions Related to Patents in the Pharmaceutical/Biotechnology Business in Korea"” |
Friday
September 8, 2006
Session IV Technology Licensing - Global Perspective
10:00 - 11:30
Global partnerships and alliances have emerged as essential strategies for the purposes of product development as well as corporate development for pharmaceutical & biotech companies. Who are the best partners around the world to combine their strengths to form successful relationships? Critical dimensions of planning and executing such alliances will be addressed, including identification, formation and management of successful relationships. Also, this session will discuss the cases of Merck and LG Life Sciences.
| Chair |
| Jay Jangyoung Lee, Ph.D., MBA, Corporate development/Bio&Pharma, AmorePacific Corporation |
| Speakers |
James Jungkue Lee, Vice President,Business Development,CrystalGenomics, Inc.
" How to Get the Right Partnering Deal: From Biotech's Perspectives" |
Robert J. Gould, Ph.D., Vice President, World Wide Licensing & External Research, Merck Research Labs.
“Partnering with Merck: What Do We Look for in Partners?” |
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