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2008/ISTWG35/020 Agenda Item: SM3.1

Evaluation Report – APEC Biotechnology Conference - Bio-Connection Construction

Purpose: Information

Submitted by: Chinese Taipei

35th Industrial Science and Technology Working Group Meeting

Ha Noi, Viet Nam8-9 September 2008

Evaluation Report on APEC Projects

Project number: Date received by Secretariat:

Name of Committee/Working Group/Taskforce: Industrial Science and Technology Working Group Title of Project: APEC Biotechnology Conference-Bio-connection Construction

Proposing APEC Economy: 1) Chinese Taipei

Co-sponsoring APEC Economy(ies): 2) New Zealand; 3) Thailand; 4) Vietnam; 5) Australia; 6) Canada; 7) US; 8) Korea; 9) Republic of the Philippines

Project Overseer: Name, Title and Organization (M/F) Dr. Gia-Fen Tsai (F), Deputy Director, International Business Center, Industrial Technology Research Institute Ms. Esther Wu (F), Business Manager, International Business Center, Industrial Technology Research Institute Postal address: Room 607, Bldg. 51, 195, Sec. 4, Chung Hsing Rd., Chutung, Hsinchu 310, Chinese Taipei

Tel: +88635913500 Fax:+88635840464 Email: estherwu@itri.org.tw

Financial Information

Total cost of proposal (US$):67,000 Amount being sought from APEC Central Fund (US$): 9,000

Type of Project: ■ seminar/symposium short-term training course survey or analysis and research database/website others (Please specify)

Project start date: January 2008 Project end date: December 2008

Brief description of Project : its purpose and the principal activities (including when and where) : The purpose of this project is to gather various professionals who are highly involved in the biotech related activities to jointly examine the current biotechnology development and further discuss the plan for building a collaborative network within the APEC member economies. With the theme of “Exploring the Approaches to Enhance and Build Bio-connection in the APEC Region,” the Conference is designed to be annually held for four years. The organizing committee will initially identify the major topic of the annual Conference based on the unmet or future needs and invite the opinion leaders from the member economies in the APEC region to present their point of views as well as share experience, either successful or unsuccessful. In addition, this Conference is expected to serve as a platform, encouraging the participants to share experience or perspectives into the biotechnology industry. Further, a comprehensive series of presentations and discussion, such as the impact of the launched plan, the analysis of business opportunities and challenges, the resource allocation and application, or the potential development across the APEC region, will be provided for a wide range of participants to learn from each other. The ultimate goal is to explore the approaches of linking East and West and better discover business opportunities. The conference will bring together representatives from the government, institutes, academia and private sectors to explore the scope and nature of the challenges in the field of biotechnology. The conference was held successfully in the past six years and has attracted more than 1700 participants from 11 member economies (Australia, Canada, Hong Kong China, Malaysia, New Zealand, Peru, the Philippines, Singapore, Chinese Taipei, Thailand and United States), as well as Germany, India, Israel, the Netherlands and United Kingdom joined the conference in Chinese Taipei, and shared valuable information and experiences.

We believe that continuing to conduct the conference will be helpful for APEC members in nurturing the biotechnology industry and further make the region become a collaborative cluster. The conference was held in conjunction with “BioTaiwan International Exhibition” and “BioBusiness Asia Conference”, making an entire week of July becomes “Bio-Week.” It is believed that the “3 in 1” gatherings will generate new channel for collaboration between member economies and speed up the development of the biotech industry in the region. In addition, such plan can attract more participants to get involved in the events and discuss Signature of Project Overseer: Esther Wu (Separate written confirmation acceptable for email submission) Date: 2008/8/18 Signature of Committee Chair/WG Lead Shepherd: (Not applicable to Progress Report and Evaluation Report) (Separate written confirmation acceptable for email submission) Date:

Evaluation of Outcomes. Framework (for all projects) Project Overseer’s comment This conference has successfully gather various professionals in the field to jointly examine the current development in bio-medical translational researches and discuss building a collaborative network within the APEC regions. It served as a platform for participants from member economies to present their ideas and share their experiences to foster business and collaborative opportunities in APEC region. Most of the questionnaire respondents indicated that this conference is very informative and the new ideas and visions presented in the speeches was useful and innovative. Several of participants expressed that this conference not only inspired them to examine their current operation situation but also encourage them to adopt learnt models or strategies for future reference. Participants assessed this conference on overall effectiveness with higher value. Also, the organizing committee was very organized and efficient in response to participant requests based on general comments. Some respondents pointed out that this meeting shall be held regularly so as to create interpersonal bonding. In addition, some people added that a certain task shall be created and the conference outcomes shall be followed to see if any ideas discussed at the meeting move forward. Some participants suggest to start collaboration with small projects that have regional significant such as dengue and liver diseases since we cannot prevent diseases from crossing border. This Conference attracted 130 participants 9 member economies (Australia, Canada, China, Chinese Taipei, Indonesia, Japan, Korea, Thailand, and USA) and Germany, Austria, Benin and from a variety of biotech industries, including academia, research institute, industry, government, consulting group, venture capitals, and association. The speeches were involved in a wide range of topics by which the participants could learn the structures and models for promoting clinical and translational science, the global business opportunities in biomedical translational research, and the challenges in the new discipline. Thus, the conference intended to discuss the topics which most participants are concerned with. Signature: Name: Esther Wu

APEC Biotechnology Conference July 21st, 2008, Taipei

Summary Report Conference Background

The APEC Biotechnology Conference was held in Taipei at the Taipei International Conference Center on July 21st, 2008. It was sponsored by APEC and organized by the Ministry of Economic Affairs (MOEA) and Industrial Technology Research Institute (ITRI) in Chinese Taipei. With the theme of “Adding Value to Biomedical Translational Research in the APEC Region., this year’s Conference is intended to explore the structures and models for promoting clinical and translational science, global business opportunities in biomedical translational research, and the challenges in the new discipline.

Conference Objective

The purpose of this project is to gather various professionals who are highly involved in the biotech related activities to jointly examine the current biotechnology development and further discuss the plan for building a collaborative network within the APEC member economies. Based on the unmet or future needs, the organizing committee has identified the theme “Adding Value to Biomedical Translational Research in the APEC region” to bridge the gap between scientific findings and clinical practices, so as to nurture the biotechnology industry, and invite the opinion leaders from the member economies in the APEC region to present their point of views as well as share experiences, either successful or unsuccessful. In addition, the Conference served as a platform, encouraging the participants to share experience or perspectives in the biotechnology industry. Further, a comprehensive series of presentations and discussion, such as the impact of the launched plan, the analysis of business opportunities and challenges, the resource allocation and application, or the potential development across the APEC region, were provided for a wide range of participants to learn from each other. The ultimate goal is to explore the approaches of linking East and West and better discover business opportunities. This conference signifies an important effort of the Asia-Pacific Region in promoting biotechnology R&D and its applications, which was augmented by a series of related events immediately afterwards, including the BioBusiness Asia Conference and BioTaiwan International Exhibition.

Facts & Figures

About 130 participants enrolled in the APEC Biotechnology Conference 2008. These participants came from a variety of places including some from nine of the APEC member economies (Australian, Canada, China, Chinese Taipei, Indonesian, Japan, Korea, Thailand and the United States); as well as Austria, Germany, and Benin. Chia-Yuh Ling, Deputy Director General of Department of Industrial

Technology of Economic Affairs , Yen-Jen Sung, Deputy Minister of Department of Health, and Dr. Johnsee Lee, President of ITRI, gave opening remarks at the meeting.

Presentation Summary

Insights into Adding Value to Biomedical Translational Research in the APEC Region were well presented.

Dr. Stanley Chang is the CEO of Medigen Biotechnology Corp, Chinese Taipei.

Dr. Stanley Chang from Chinese Taipei points out that scientists and clinicians are increasingly aware that biomedical translational research is a two-way street. Basic life scientists provide clinicians with innovative tools for clinical assessments, and clinicians make novel observations and fancy ideas about the nature and progression of disease that stimulate basic research.

Facing ahead for medical professionals are challenges not only in relation to malnutrition and infectious diseases, but also chronic disabling disorders and cancers of regional significance that have to be tackled with by each Health Authority. Over the next decades, developing member economies in Asia Pacific are expected to face an unprecedented healthcare burden out of the demographic changes of the aging of population. Finding an innovative, legitimate and doable joint consortium for biomedical translational research across the board in Asia is the very first step APEC members should consider to facilitate competitiveness towards the global challenges.

Dr. Roman Szumski is the VP of National Research Council, Canada

Dr. Roman Szumski addresses that the first step in a successful commercialization is an idea. This is followed by a proof of principle, and then by a prototype version. At this stage the scientist or engineer feels that most of the work has been done. Wrong. The real work has just begun. Early in the process application for a patent must be made in order to protect the intellectual property. Without protection it is very difficult to raise funds to move the concept forward. He exemplify this process by the story of the Canadian company IMRIS, which collaborated with Calgary Alberta Foothills hospital and other medical research unit, to a company with over 100 employees and a market value of 150 million dollars.

Dr. Kanyawim Kirtikara is the Acting Deputy Executive Director of National Center for Genetic Engineering and Biotechnology (BIOTEC), Thailand.

Dr. Kanyawin Kirtikara expresses that in developed economies, other components of the process such as regulatory agencies and related industries are already well established and experienced; however, for developing economies, mechanisms for supporting new health treatments or health related products are not always in place or functioning properly. In addition, human resources of the required disciplines and financial resources to undertake such tasks are often insufficient. These are likely to be compounded by the inability or reluctance of local industries to take economic risks with

research and development. These obstacles by no means should deter developing economies from taking up these challenges. By learning from developed economies and identifying suitable niches for operating with limited resources, Thailand has made significant progress in translating research results into medical products and creating new industries.

Jeong Hyop Lee is the Research Fellow of Science & Technology Policy Institute, Korea

In this presentation, Dr. Jeong Hyop Lee shares the achievements and limitations of the research hospital program, which has been formulated and executed to promote translational research and to create medi-clusters in Korea since 2006. Two cases of research hospital, IICR and IRICT, were diagnosed according to the review criteria drown out by conceptualization of research hospital program and cluster dynamics. The government-initiated research hospital program is facilitating the transformation of hospitals to be more research-oriented and to lead cluster-based networks with basic research institutes and business actors in Korea.

Alan T. Remaley is the Section Chief of Lipoprotein Metabolism Laboratory, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.

Coronary heart disease (CHD) is world wide a growing problem and in many countries it is the number one cause of mortality and morbidity. Dr. Alan Remaley explicitly shares his experiences in the development of two new agents, which was a major breakthrough in the treatment of CHD, to increase HDL, the main anti-atherogenic lipoprotein, which promotes the removal of excess cholesterol from peripheral cells and its delivery to the liver for excretion by the Reverse Cholesterol Transport (RCT) pathway. He talks about issues related to the barriers in the transition from identifying promising new agents in pre-clinical animal studies to the development of such agents for clinical trials by pharmaceutical companies and in conjunction with two different biotechnology companies these agents are now currently being developed by his laboratory as possible therapeutic agents.

Yuko Ito is Life Sciences Unit Leader of NISTEP, Japan

Dr. Yuko Ito expresses that it is desirable that clinical researchers possess the fundamental knowledge and skills of physicians and also have received training as researchers. In Japan, several universities have already begun programs for training human resources in clinical research. The "Initiatives for Attractive Education in Graduate Schools" program (MEXT) supports human resources training programs in graduate schools including training of human resources in the field of clinical research. Promotion of the training program at high level is important for securing the human resources with a high level expertise that Japan will require in the future. From this viewpoint, it is necessary to expand programs which support young researchers in coordination with these human resources training programs.

Hubert Renauld is Ph.D. of Medical University of Vienna, Vienna, Austria

Based on his experience with the implementation of a Bioinformatics platform in the framework of AKIM (Information Management at the Vienna General Hospital), Dr. Hubert Renauld argues that fragmentation of knowledge and its rate of change are not the single issues at stake. Informatics solutions, combining interconnected sets of services, and commercially and publicly available software, can be developed or are already available, that will permit the user transparent search, request, manipulation, integration and delivery of information. To fully realize the vision of translational medicine, human personalities and relations are not to be underestimated. Interpersonal skills are crucially required, to bridge the gap between the worlds of genomic research and clinical practice, so as to build intensive collaborative efforts between the various users (medical and IT staff).

Panel Discussion Summary：What can the APEC members do to enhance the discipline of translational research

Panelists: Stanley Chang, Jeong Hyop Lee, Kanyawim Kirtikara, Roman Szumski, Yuko Ito, Alan T. Remaley, Hubert Renauld

The topic of the panel discussion is “What can the APEC members do to enhance the discipline of translational research,” the panelists shared their thoughts on the possibility of a global biotechnology consortium to help facilitate collaborative clinical trials and shared information database. This panel discussion was hosted by Dr. Chung-Cheng Liu, General Director of Biomedical Engineering Research Laboratories of ITRI. Most of the panelists agreed that the regulatory process for such a project will be challenging, but they believed that both developed and developing economies could benefit from such co-operation.

Dr. Chang proposed that it would be beneficial for different economies to do collaborative clinical trials and work out a harmonized regulatory system between various economies for information sharing. He suggested that the APEC members should work together to fund a common regulatory body to approve an agent for diseases of Asia significance. He emphasized that this may not happen now but should be considered as a direction 20 years down the road. The aim would be to start with collaborative research projects, then identify a clinical trial that is important to the treatment of a disease to most Asian Pacific economies, and finally figure out the best scheme for all Asian Pacific econimies to work together to reach a harmony of drug regulation as we see in the European model.

Dr. Lee also felt that certain diseases were under-addressed in the scientific community and business activities in the Asian region. He attributed this to the lack of buying power of certain APEC members as poor investment would lead to the inability to secure a market mechanism in the capitalist economy. He believed that there was a discrepancy between technology and the actual result owing to the lack of system integration-an APEC common platform. He observed that members like Korea and Chinese Taipei work in an advanced system similar to the western world, however with very limited resources as developing economies. “If products want to be sold in the APEC region, more investment in biotech companies, research institutes, and universities would be necessary,” he stated. He urged that Asian members should work together and enlarge the pie, hence to bring more benefits and incentives for members from other regions to participate in the biotechnology industry.

Dr. Kirtikara considered cost to be the main issue. She pointed out that a US$1 billion drug may be a piece of cake for western pharmaceutical companies but a very difficult target to achieve for companies from smaller economies like Thailand. For example, malaria is one of the major concerns among Asian economies, but very limited resources had been put into related research due a common conception that it is the disease of the poor. Thus very limited outside funding had been given to studies in this area despite the advance technology and clinical experiences Thailand already

possess. Nevertheless, she believed that with strength in different areas, small Asian economies could work together and compliment one another in the therapeutic sector.

Dr. Szumski was surprised to find that the only overlapping disease of importance between the Asia region and North American was lung cancer from Dr. Kirtikara’s list. But he believed that collaborative work between North American and Asian parties against challenging and lengthy regulatory processes could be beneficial to SMEs. He indicated that unlike large companies who set their eyes on US1 billion projects, small-mid sized or specialty pharma would be happy to develop a US$250 million drug. SMEs would work on diseases that would be important to the Asian region, but it would be nearly impossible to do clinical trials in Canada. Also new drugs related to these diseases would never find a market domestically. It would only make sense for these companies to be established so they could dig out small parts of the market that the big companies were less involved with. This would be a classic situation of disruptive technology.

Dr. Ito also used a project involving economies such as Vietnam, China, Kenya, and Singapore, which took place in Japan as prime examples of how collaborative work could enhance current clinical research. She believed that even in the same region, Asian economies all have different medical needs and therapeutic targets. Through overseas sharing programs, starting on the educational level, Asian economies could better understand one another’s social needs and help to improve drug development efficiency.

Dr. Remaley felt that the industry had witness significant change and relaxation of policies, and through frequent communication between interested parties, much could be done on a global scale.

Dr. Renauld believed that collaborative research and information sharing would be doable on a technical level. It would just involve all parties to participate: the scientist, the biologist, and the computer engineer, to set up a database of information.

Satisfactory Outcomes During the past few years the APEC Biotechnology Conference has hugely accumulated credits towards its achievements and objectives among the member economies. The conference attendees participated actively in the discussions and their feedback was very positive. The conference, as regarded by the attendees, has achieved its goal for exchanging experiences and building network among the economies.

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APEC Biotechnology Conference Project

September 08, 2008ISTWG

Sub Group B

ContentsProject Theme Facts about the conferenceConference ProgramConference SummaryOutcome

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Project Theme and Objectives

Exploring the Approaches to Enhance and BuildBio-connection in the APEC Region

Discuss the plan for building a collaborative network within the APEC member economiesIdentify biotechnology business opportunity, competitive landscape, and market growth dynamics in APEC regionDiscuss the strategic and novel approaches to nurture current biotechnology industry

Examine the current problems or issues discouraging the improvement of biotechnology industry

2008 APEC Biotech ConferencePlace: Taipei International Conference CenterTime: July 21st,2008Form: One day conference eventTheme:Organizer:

MOEA (Ministry of Economic Affairs)ITRI (Industrial Technology Research Institute)

Co-sponsorship:Australia, New Zealand, Thailand, Korea, Vietnam, Canada, US, and the Philippines Participants: APEC Member Economies: 130 people enrolled (Australia, Canada, China, Chinese Taipei, Japan, Korea, Malaysia, Thailand, the United States.), as well as Austria, Germany.In conjunction with

BioBusiness Asia ConferenceBioTaiwan International Exhibition

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2008 Conference Theme & Program

2008 APEC Biotech Conference

Dr. Stanley Chang from Chinese Taipei points out that scientists and clinicians are increasingly aware that biomedical translational research is a two-way street. Facing ahead for medical professionals are challenges not only in relation to malnutrition and infectious diseases, but also chronic disabling disorders and cancers of regional significance that have to be tackled with by each Health Authority. Finding an innovative, legitimate and doable joint consortium for biomedical translational research across the board in Asia is the very first step APEC members should consider to facilitate competitiveness towards the global challenges.Dr. Roman Szumski addresses that the first step in a successful commercialization is an idea. Most scientists think that most of their work has been done when the concept is proof and the prototype is made. However, the real work has just begun. He points out that patent must be made in early stage of development because without protection it is very difficult to raise funds to move the concept forward. He exemplify this process by the story of the Canadian company IMRIS, which collaborated with Calgary Alberta Foothills hospital and other medical research unit, to a company with over 100 employees and a market value of 150 million dollars.Dr. Kanyawin Kirtikara points out that the developing economies are lacking well-established regulatory agencies, related industries, and mechanisms for supporting new health treatments or health related products or they don’t function properly. In addition, human and financial resources to undertake such tasks are often insufficient. However, by learning from developed economies and identifying suitable niches for operating with limited resources, Thailand has made significant progress in translating research results into medical products and creating new industries.

Summary

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2008 APEC Biotech Conference

In this presentation, Dr. Jeong Hyop Lee shares the achievements and limitations of the research hospital program, which has been formulated and executed to promote translational research and to create medi-clusters in Korea since 2006. Two cases of research hospital, IICR and IRICT, were diagnosedaccording to the review criteria drown out by conceptualization of research hospital program and cluster dynamics. The government-initiated research hospital program is facilitating the transformation of hospitals to be more research-oriented and to lead cluster-based networks with basic research institutes and business actors in Korea.Dr. Alan Remaley explicitly shares his experiences in the joint development of two new agents, which was a major breakthrough in the treatment of CHD, to increase HDL, the main anti-atherogenic lipoprotein. He talks about issues related to the barriers in the transition from identifying promising new agents in pre-clinical animal studies to the development of such agents for clinical trials by pharmaceutical companies and in conjunction with two different biotechnology companies these agents are now currently being developed by his laboratory as possible therapeutic agents.Dr. Yuko Ito expresses that it is desirable that clinical researchers possess the fundamental knowledge and skills of physicians and also have received training as researchers. In Japan, several universities have already begun programs for training human resources in clinical research and the "Initiatives for Attractive Education in Graduate Schools" program (MEXT) supports human resources training programs in graduate schools. Promotion of the training program at national level is important for securing the human resources with a high level expertise that Japan will require in the future.Based on his experience with the implementation of a Bioinformatics platform in the framework of AKIM (Information Management at the Vienna General Hospital), Dr. Hubert Renauld argues that informatics solutions can be developed or are already available. But to fully realize the vision of translational medicine,interpersonal skills are crucially required, to bridge the gap between the worlds of genomic research and clinical practice, so as to build intensive collaborative efforts between the various users (medical and IT staff), and between centers of excellence, member economies and non-member economies.

Summary

2008 APEC Biotech Conference

Outcome During the past few years the APEC Biotechnology Conference has hugely accumulated credits towards its achievements and objectives among the member economies. The conference attendees participated actively in the discussions and their feedback was very positive. The conference, as regarded by the attendees, has achieved its goal for exchanging experiences and building network among the economies.

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