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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

Introductory Presentations

9:00 – 9:45
PART I:
Overcoming Politics and Culture:
Optimizing Business Strategy and Realizing Commercial Opportunity in China Today
PART II:
Planning a Global Strategy Around Intellectual Property Legislation,IP Barriers, and Trends in China
(Sponsorship Available for this Strategic Solutions Presentation. Contact Arnold Wolfson at awolfson@healthtech.com or 781.972.5431)

OPENING KEYNOTES

9:45 China as a Key in Increasing Productivity of Western Companies

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.

  • 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

10:15 Networking Coffee Break

11:00 Pharmaceutical R&D in China: Leveraging Collaboration & Managing Risk for Maximum Value 

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.

  • 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
11:30 R&D Strategic Sourcing in China: A Dynamic View 
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:
  • 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
12:00 pm Interactive Panel Discussion #1:

Keynote Q&A with Audience

Panelists:
Steve Q. Yang, Ph.D., Head of Research, Asia, Pfizer Global Research & Development
Guoxin Zhu, Ph.D., CSO / Head of China Chemistry, Discovery Chemistry Research & Technology, Eli Lilly Asia, Inc. Shanghai Rep. Office
Whaijen Soo, M.D., Ph.D., Senior Vice President, Medical Research, Biogen Idec
Special Inclusive Luncheon Workshop  Hosted by:
12:30 Regulatory Overview of Counterfeit Drugs in China 

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.

2:00 Accelerating Drug R&D by Taking Advantage of China Resources

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:

  • 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
2:30 Alliances as the New Imperative for Survival

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?

3:00 Networking Refreshment Break
3:45 How to Create Win-Win Situations with Academic Centers in China and Taiwan

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.

  • 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
4:15 CASE STUDY: Conducting Translational Medicine & Biomarker Validation in China

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

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:
Mao Mao, M.D., Ph.D., 
Associate Director/China Project Liaison,
Oncology Clinical Research,
Merck Research Laboratories
Michael N. Liebman, Ph.D.,
Executive Director,
Windber Research Institute
Ming Guo, 
Vice President,
Pharmaceutical Science and Manufacturing,
Ascenta The
rapeutics, Inc.
Rajiv Gulati, 
Director,
China-India Strategy, Corporate Strategic Planning,
Eli Lilly & Co.
Lorenz Ng, M.D., Ph.D., 
former Vice President,
Research & Alliance & Business Development,
Asia Pacific, Eli Lilly & Co (Asia)

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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