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Day One: Monday, September
10, 2007
8:15 am Coffee and Conference Registration
8:45 Organizer’s Welcoming Remarks
Micah Lieberman, Conference Director, Pharmaceutical Strategy Series,
Cambridge Healthtech Institute
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Introductory Presentations
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| 9:00 – 9:45
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PART I:
Overcoming Politics and Culture:
Optimizing Business Strategy and Realizing Commercial Opportunity in
China Today
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PART II:
Planning a Global Strategy Around Intellectual Property
Legislation,IP Barriers, and Trends in China
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(Sponsorship Available for this
Strategic Solutions Presentation. Contact Arnold Wolfson at awolfson@healthtech.com
or 781.972.5431) |
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OPENING KEYNOTES
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| 9:45 China as a Key in Increasing Productivity of Western Companies
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Whaijen Soo, M.D., Ph.D., Senior Vice President, Medical Research, Biogen Idec
With fast growth in commercial opportunities, R&D talent pools and
cost effectiveness, and improvement in business environment, China can no
longer be ignored by any biopharmaceutical companies in their expansion of
global reach. The strategic planning process for entering China, remaining
questions, as well as challenges for implementation, will be discussed.
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- Strategic overview of the
pharmaceutical value chain environment
- Evaluating the economic, political and
business opportunities and obstacles
- Regulatory environment in the U.S. and
China:1) SFDA 2)Intellectual property
- Portfolio considerations
- Execution challenges
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10:15 Networking Coffee Break
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| 11:00 Pharmaceutical R&D in China: Leveraging Collaboration & Managing Risk for Maximum Value
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Guoxin Zhu, Ph.D., CSO / Head of China Chemistry, Discovery Chemistry Research & Technology, Eli Lilly Asia, Inc., Shanghai Rep. Office
Multinational corporations are increasingly realizing that China is not
just a vast market or even a production base
— it is a critical focus for research and
development (R&D) functions as well. This session will discuss the
opportunities and challenges conducting pharmaceutical R&D in China.
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- Current realities of drug discovery
& development
- The role of Chinese CROs
- Pharma R&D models in China
- Transition trend for global
pharmaceutical R&D
- Lilly current R&D in China
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| 11:30 R&D Strategic Sourcing in China: A Dynamic View
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Steve Q. Yang, Ph.D., Head of Research, Asia, Pfizer Global Research & Development
Strategic sourcing of pharmaceutical R&D services in China is
expanding at a rapid pace. This is shaped by several factors such as China’s
market growth potential, a large talent pool of experienced leaders and
diligent scientists, and increasing demands from pharmaceutical and
biotech companies. Navigating through such a dynamic environment requires
a flexible and agile strategy and a collaborative partnership approach.
Topics that will be covered in this presentation include:
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- Strike proper balance between
bold experiments and carefully planned execution
- Strengthen R&D partnership
through alliance management and coordination
- Analyze recent trends in
strategic sourcing of R&D services in China
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| 12:00
pm Interactive Panel Discussion #1:
Keynote Q&A with Audience
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| Panelists: |
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Steve
Q. Yang, Ph.D., Head of Research, Asia, Pfizer Global Research &
Development |
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Guoxin
Zhu, Ph.D., CSO / Head of China Chemistry, Discovery Chemistry
Research & Technology, Eli Lilly Asia, Inc. Shanghai Rep. Office |
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Whaijen
Soo, M.D., Ph.D., Senior Vice President, Medical Research, Biogen
Idec |
| Special
Inclusive Luncheon Workshop |
Hosted by:
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| 12:30
Regulatory Overview of Counterfeit Drugs in China |
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Matthew Levy,
M.S., M.B.A., Director, Global Market Development, Applied
Biosystems
Intellectual property rights are a major issue in China,
which becomes more severe when patented drugs are copied and
distributed on the open market without any regulatory control.
The presentation will focus on current initiatives that the
SFDA is undertaking to address this issue and create a safer
environment for novel therapeutics. The objective is to
provide data to demonstrate why counterfeit drugs is a growing
concern and what multi-national pharma companies can
anticipate when entering the China market. Furthermore, it
will outline new technologies the SFDA is using to identify
and eliminate counterfeit drugs within the market. |
- Why counterfeit drugs are
a major problem in China
- What steps can a
multi-national pharma take control the problem
- How the SFDA can help to
address this issue
- What can be expected in
the future as the pharmaceutical
market in China continues to grow
*
Applied Biosystems Group, an Applera Corporation business,
develops and markets instrument-based systems, consumables,
software, and services to the life science industry and
research community. |
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| 2:00 Accelerating Drug R&D by Taking Advantage of China Resources
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Samantha Du, Ph.D., Managing Director, Hutchison MediPharma Ltd., Chief Scientific Officer & Executive Vice President, Hutchison China Meditech Limited
The capital- and time-consuming nature of drug R&D has become a huge problem for the healthcare industry. That coupled with the high attrition rate has threatened to dampen the enthusiasm for the industry to make large investments from earlier discovery to proof of concept. However, the recent ascent of China in the world economy created opportunities for the industry to re-think its strategy in reducing time and cost by taking advantages of China resources. This presentation will share HMPL’s R&D strategies and how to best manage R&D operations in China to maximize productivity. The author will also describe the opportunities and risks in investing in China. This presentation will:
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- Highlight a successful story of a drug R&D company growing from a start-up to a leading R&D company in China and also an int’l public company within four years
- Provide a real case study by analyzing China strategies and best ulitizing China resources for the successful global drug development
- Share first-hand experiences in drug R&D development and company
management in China
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| 2:30 Alliances as the New Imperative for Survival
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Lorenz Ng, M.D ., Managing Partner, Global Ng Associates, LLC and former Vice President, Research & Alliance & Business Development, Asia Pacific, Eli Lilly & Co. (Asia)
The need to increase productivity at lower cost is driving big Pharmas to capture the current arbitrage potential of Asia through outsourcing/contract work. A second wave is building with players actively seekingstrategic alliances and partnership opportunities globally across the R&D value chain. Will this meta-national innovation process become the new imperative for survival in the 21st Century? Will this lead to “creative destruction” of our vertically-integrated multi-national model and emergence of a new model with meta-national advantage?
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| 3:00
Networking Refreshment Break
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| 3:45 How to Create Win-Win Situations with Academic Centers in China and Taiwan
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Michael N. Liebman, Ph.D., Executive Director, Windber Research Institute
Significant opportunities exist within China and Taiwan for development of research and development facilities in both China and Taiwan, but issues exist because of regulatory and cultural perspectives that need to be considered in both the planning and execution of such activities, especially as they may differ amongst molecular, clinical and computational research areas.
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- How to evaluate risk vs. opportunity in each of the three areas:
molecular research, clinical research and computational research
- How to explore partnerships to facilitate success in working in China and Taiwan
- How to manage US vs. international regulatory issues in working in China and Taiwan
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| 4:15
CASE STUDY: Conducting Translational Medicine & Biomarker Validation in China
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Andrew Branca, SVP, Strategic Research, Cambridge Healthtech Associates
- Needs in translational medicine & biomarker validation
- Strategic opportunities in China
- Establishing requirements and specifications for potential partners and vendors
- Approaches to identifying and assessing potential partners and vendors
- Challenges to establishing relationships in emerging markets – regulatory issues (including sample import/export), logistical and distance considerations, cultural differences, and other considerations affecting planning
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4:45 Interactive Panel Discussion
#2:
Partnership and Outsourcing Deals in China – Successes and Failures
- Overcoming cultural differences and infrastructure obstacles
- Key cost drivers and less obvious budgetary pitfalls
- Choosing a worthy partner and performing capability assessment
- Making the most of your partnerships
- Addressing IP concerns and ensuring patent protection
- Training staff and transferring technology
- Effectively controlling quality
Panelists:
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Mao Mao, M.D., Ph.D.,
Associate Director/China Project Liaison,
Oncology Clinical Research,
Merck Research Laboratories |
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Michael N. Liebman, Ph.D.,
Executive Director,
Windber Research Institute |
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Ming Guo,
Vice President,
Pharmaceutical Science and Manufacturing,
Ascenta Therapeutics, Inc. |
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Rajiv Gulati,
Director,
China-India Strategy, Corporate Strategic Planning,
Eli Lilly & Co. |
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Lorenz Ng, M.D., Ph.D.,
former Vice President,
Research & Alliance & Business Development,
Asia Pacific, Eli Lilly & Co (Asia) |
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5:45 Networking Cocktail Reception and
One-on-One Meetings (Sponsorship Available)
6:45 Close of Day One
View
Day 2
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