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Drug Development China
2008年9月16～18日 美国旧金山 The Fairmont
第1日目: 2008年9月17日 (三)
8:00 am Coffee and Conference Registration
8:30 Organizer's Welcome and Chairperson's Opening Remarks
Introductory Keynotes
8:45 A New Way to Discover Innovative Medicine:Approach from the East
Li Chen, Ph.D., Chief Scientific Officer, Roche R&D Center (China) Ltd
We have been facing a tremendous challenge in drug discovery and development during the last two decades while we have experienced some major advancement in life science and technology. The disconnection between R&D productivity and scientific innovation in pharma industry is somehow accepted as the nature of our business, which leads companies to spend more or to diversify. Is there a different way to discover innovative medicine? We are working to address this question in my presentation by looking at:
- The challenges to innovative drug discovery
- Roche's strategy in achieving high R&D productivity
- Roche China research will approach it differently
- Take the best from both worlds: pharma and biotech
9:30 Aligning Business, Corporate, and International Tax Strategy
Rickey Pate, MBA, JD, Director of Global Tax, Eli Lilly and Company
- Key challenges in the developing world:
- Anti-corruption laws from US and local authorities that have unintended consequences
- Lack of meaningful intellectual property protections
- Application of protectionist anti-dumping laws; compared to ...
- Key opportunities in the developing world:
- Economic growth in untapped markets like China
- Social responsibility = good business
- Brand loyalty in many markets, meaning different product life cycles than in US and Europe, etc.
- Understanding the tax differences of working with a 3rd-party CRO versus either a wholly-owned or JV-owned R&D center
- This part of the discussion will focus primarily on the transfer pricing issues showing the need to obtain 3rd party comparable data to satisfy the local Asian tax authorities
- Avoiding seconding corporate people to local country affiliates to avoid what is known as "permanent establishment" and thus making the parent company subject to taxation in the local Asian country - thus double taxation
- Clarifying the scarier areas of tax that India seems to be headed to - i.e. declaring permanent establishments when a small team of parent company scientist visit a 3rd party CRO just in a liason capacity
10:15 Networking Coffee Break
China's Current Biotech and Partnering Landscape
11:00 Looking to the Future of China Biotech: An Examination of China's Advancing Drug Development Industry and Opportunities for Partnerships
Greg B. Scott, President and Founder, ChinaBio® Accelerator/Life Science Angels
China is the fastest growing market for pharmaceuticals in the world and will soon be the 2nd largest market after the U.S. Now, with billions of dollars of government and private investment, China is transforming itself into a world leader in biotech innovation. This session will examine the opportunities for cross-border partnerships and investment in China biotech, and its unique set of risks and challenges.
INTERACTIVE PANEL
11:30 The Next Generation of Chinese Drug Development Partnerships
Facilitator: Greg B. ScottThis discussion will explore how the latest generation of China's biotech and service companies are changing global drug development at “China speed.” Leaders of these companies and those they partner with will share their experiences and views and discuss with the audience:
- Opportunities most suited for partnership in China
- Overcoming hurdles in a country new to global drug development
- What companies are looking for from their China partners
- How to create collaborations that lead to true value-add
12:00 pm Sponsored Luncheon Workshop (sponsorships available, please contact Arnie Wolfson +1.781.972.5431, awolfson@healthtech.com) or Lunch on Your Own
Collaborations and Business Models:
Examples from Biotechs and Start Ups Effectively Leveraging China's R&D Resources
1:00 Partnership for Biologics R&D in China: Perspective from a Global Biotech Company
Canwen Jiang, M.D., Ph.D., Head of Genzyme Science (R&D) China, Genzyme
Genzyme is expanding in China and is building a major new research and development
center in Beijing. The initiative is an important element in Genzyme's ongoing global expansion and commitment to establishing a long-term presence in China. The new facility will be used for research and development activities involving many of Genzyme's key areas of focus, including orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. The facility, which will feature an innovative green design, will also include laboratory-scale operations for the MACI® (matrix-induced autologous chondrocyte implantation) cell therapy and polyclonal antibody operations. This presentation will share the current and ongoing experience of Genzyme's R&D partnerships from a unique biotech perspective.
- Capabilities and resources for biologics R&D in China
- Regulatory environment/public acceptance of certain biologics
- Benefits and risks of partnering with local companies
1:30 US Biotech Perspective – Critical Roles by a China Subsidiary in Ascenta NCE Drug R&D
Ming Guo, Ph.D., Vice President, Pharmaceutical Sciences & Manufacturing;General Manager, Ascenta (Shanghai) R&D Center; Ascenta Therapeutics, Inc.
Ascenta, a development stage biotech company focused on oncology NME drug development, has been relying on its wholly-owned R&D center in Shanghai in both biology and chemistry for their NCE drug R&D from late discovery to IND enabling stages. This presentation will discuss Ascenta's efficient business model and provide a case study on the combination of outsourcing and a subsidiary approach to increase the overall productivity.
2:00 Leveraging the Best of the US and China for Innovative Drug Discovery: Case Study from a Start Up
Sofie Qiao, Ph.D., President and COO, LEAD Therapeutics, Inc.
Almost all biotech and pharmaceutical companies have some type of drug discovery and development work done in China, but there has not been a systematic discussion on evaluating the strengths, weaknesses, opportunities and threats of the Chinese life science industry, or what is the most effective strategy in leveraging China to conduct high-quality drug discovery. Using LEAD as a case example, the speaker will elaborate on a unique and innovative way to do drug discovery in China - all designed to maximize the advantages that China offers and minimize the company's exposure to some of the perceived or real disadvantages and risks associated with today's China, while being well-positioned to benefit from any improvements in China. There are questions that one should ask before committing to doing drug discovery in China, including but not limited to the following:
- What type of drug discovery is best suited for today's China? - novel targets or clinically-validated targets? Small molecule or biologics?
- What stage of the drug discovery and development process is ideally suited for China? From target identification all the way to late phase trials or a specific period within this whole process?
- What type of operational arrangement should one consider in China? - Build vs. Buy vs. Strategic partnering with a Chinese company vs. Pure Outsourcing?
2:30 Afternoon Refreshment Break
3:00 Drug Discovery Collaboration with Profit Sharing: A Focus on Medicinal Chemistry
Joong Myung Cho, Ph.D., President & CEO, CrystalGenomics, Inc. (South Korea)
We are working with two Chinese medicinal chemistry-based companies for novel drug discovery. We are going to share a profit with these two companies and are paying a reduced FTE payment when compared with a regular CRO for win-win collaboration. They have ownership, thus there is speed-up of projects and increased productivity. This kind collaboration is a new business model with Chinese chemistry CROs and we will share our experience during this process with the audience.
3:30 Effective Integration of Chinese Creative Research Talent into Overall Research Strategy: A Case Study
Zhengyu Yuan, Ph.D., President and CEO, MicuRx Pharmaceuticals, Inc.
MicuRx business strategy seeks to capitalize on the global opportunities emerging through the combination of biotech pharma innovation in the USA and the enterprise-friendly infrastructure and scientific resources of China. This approach affords MicuRx with utmost efficiency in the drug discovery and development process. Importantly, the strategy also sets the stage for expedited access of MicuRx products to the global pharmaceuticals markets. In this presentation our story will be shared, as will the challenges we are facing and adjusting to on a daily basis. Various business models currently pursued by virtual and large Pharma are compared and the strategies to maximize R&D efficiency will be discussed.
Private-Public Partnerships:
Working with State Institutes
4:00 Private-Public Partnership for the Development of the Japanese Encephalitis Vaccine in China
Mansour Yaïch, Ph.D., Vaccine Development Director, PATH
This presentation will describe our 4-year experience of the private-public partnership for the development of the Japanese Encephalitis Vaccine produced in Chengdu Biological Institute in association with the China National Biotech Group (CNBG), where we have invested in new vaccine production facilities, clinical trials, marketing and new licensure in the region and the WHO licensure process. It is a great experience and project with a lot of learning experiences on different levels that could benefit all participants of the meeting.
- Why we partnered with CNBG in China
- How we initiated the co-development project and the challenges we faced early on
- Later stage challenges in the partnership and project
- What other research groups and companies can learn from this alternative business and development model
- Key challenges and opportunities for vaccine development in China today
4:30 Building an Integrated Biomedical Institute for Innovative Medicine in China
Ling Chen, Ph.D., Director General, Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences
Academia is currently the driving force in China. R&D models that can maximize utilization of resources will be able to capitalize on China-based R&D. Guangzhou Institute of Biomedicine and Health (GIBH) is a newly established biomedical R&D organization that is comprised of scientists from China, North America, and Europe. GIBH has selected developing vaccines and drugs for infectious diseases, cancer, and metabolic diseases as one of its top priorities. Efforts to develop innovative vaccines and drugs for unmet medical needs in China will be described.
Break-out Roundtable Discussions
| 5:00 The close of the first day will consist of a set of concurrent roundtables hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a roundtable of interest to them and become an active part of the discussion at hand. The topics will be developed further with the input of faculty and attendees (please email desired topics or points for topics to mlieberman@pharmaseries.com). |
Roundtable 1: Partnering and Collaborations Roundtable 2: Regulatory Landscape and Drug Registration Challenges Roundtable 3: Accessing, Keeping and Managing Talent in China's Competitive Landscape Roundtable 4: Drug Discovery: A Focus on Integrated Projects Roundtable 5: Intellectual Property Issues, Trends and Strategies Roundtable 6: New Paradigms for Improving Preclinical Safety Assessment Roundtable 7: Translational Medicine and the Difference in Emerging Regions vs. US and Europe Roundtable 8: Global Clinical Trials Operations and Strategic Allocation of Clinical Sites |
5:45 Networking Cocktail Reception
6:45 Close of Day
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