CHI, Cambridge Healthtech Institute - Drug Development in China 2006

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Register by September 29th and Save up to $200!

Day One: October 30th

PRE-CONFERENCE TUTORIAL*: October 30, 2006
*Separate Registration Required

How to Protect Pharmaceutical Inventions in China
- Reality and Prospect

The success or failure of a pharmaceutical company in China is increasingly linked to its IP strategy. Yet there is much misunderstanding about the current state of IP protection for pharmaceutical inventions in China. This workshop will cover various aspects of protecting pharmaceutical inventions in China and enforcing drug patents there. The speakers will share their on-the-ground experience in China.

8:00 AM Coffee and Pre-Conference Registration

8:30 Facilitator’s Welcome and Opening Remarks

8:45 How to Obtain Pharmaceutical Patents in China

Patentable pharmaceutical inventions
Patent prosecution strategy
Patent ownership

9:15 How to Defend Pharmaceutical Patents in China

Patent invalidation procedure at Patent Reexamination Board
Anatomy of a real-life drug patent invalidation case
Defensive & proactive use of patent invalidation proceedings

9:45 Networking Coffee Break

10:15 How to enforce pharmaceutical patents in China

Litigation forum shopping in China
Pre-suit investigation and evidence collection
Remedies

11:15 Close of Pre-Conference Tutorial

*separate registration required

11:00 am Main Conference Registration

12:15 pm Chairperson’s Welcome:
China as a Key in Increasing Productivity of Western Companies

Keynote Presentation:
	12:30 pm Strategies and Tactics to Leverage China in Drug Discovery Li Chen, Ph.D., Head of Research, CSO, Roche R&D Center (China) Limited The Pharma and Biotech industries are facing a major challenge in drug discovery under the traditional thinking and operational model. With increasing pressure on profitability, many major pharma groups started with a cost-reduction approach and went to China to conduct manufacturing and R&D outsourcing. Roche is the 1st major pharma group that set up a wholly-owned R&D center in China as a part of the Roche Global Pharma Research organization to conduct drug discovery research with the aim to produce drug leads and clinical candidates. In my talk, I will discuss the landscape of drug discovery research in China, Roche's model of innovation in drug discovery, and our strategy and process to create a new site in China for drug discovery and development.


	1:15 pm Leveraging China’s Cultural Differences to more Efficiently Manage Your Preclinical and Clinical Studies Eric Morfin, PMP, Director, Project Management Office, Novartis Vaccines and Diagnostics This session will look at which best practices for developing and managing preclinical and clinical studies apply to China’s landscape. We will also discuss specific cultural differences and how you can leverage them to implement efficient trials. We will discuss these best practices based on several real trials, and review the lessons learned and the pitfalls to avoid. We will also discuss how the cultural differences affect the management of your trials, the development of your clinical plans and budgets, as well as your overall project management practices. Cultural differences and their impact on your product development efforts as well as the management of your clinical trials Learn to leverage these differences to achieve greater efficiencies Lessons learned and pitfalls to avoid from several real-life experiences How is China different from other Asian countries and how to adapt your management to each country’s culture? What phases and studies will benefit the most from being outsourced to China, and why?

	2:00 pm Building Strong Partnerships with Academia and Biopharma Companies in China Mao Mao, M.D., Ph.D., Associate Director/China Project Liaison, Oncology Clinical Research, Merck Research Laboratories This presentation will pull from experiences from both sides of the industry: the perspective of an academic investigator in China leading a million dollar collaborative project sponsored by a big pharma, and the perspective of a scientist representing the pharma industry seeking opportunities and building partnerships in China. This presentation will specifically address: Landscape assessment: Where are the opportunities? Internal and external challenges: How to overcome? Risks and benefits from partnerships Examples of successful stories

	2:30 pm Establishing a Translational Medicine Collaborative Network in China Jingsong Wang, M.D., Associate Director Translational Medicine, Wyeth Research Labs Translational Medicine is becoming an area of rapid growth across the biopharma industry. Western biopharma companies are starting to look to China to set up translational medicine research collaborations; such collaboration have great potential but have unique challenges as well. Challenges include: Identifying suitable sites Accessing top talent pool Interacting with existing clinical study infrastructure Protecting IP Following SFDA regulations on biosample processing These challenges can be overcome by utilizing a systematic and integrated approach. In this presentation I will: Familiarize attendees with the landscape for translational medicine in China Teach attendees how to access the talent pool of translational medicine in China Offer attendees strategies on how to overcome obstacles unique to translational research collaboration in China

3:00 pm Afternoon Refreshment Break (Sponsorship Available)

	3:30 pm Partnering and Investing in China: Current and Future Trends and Implications Jonathan Wang, Ph.D., M.B.A. General Manager (Greater China) Burrill & Company

	4:00 pm Deal-making in China: The Struggle up the Pharmaceutical Value Chain Jeffrey L. Winkelhake, Ph.D., Vice President, International Operations, Sino Biopharmaceuticals, Ltd., Beijing/ Hong Kong, PRC China lags somewhat behind India in producing pharmaceutical products for export to Western markets, and non-partnered, Chinese firms make no final drug products for sale to the West. However, China far outpaces India with its rapidly growing ‘middle class’ capable of, and very interested in, purchasing Western pharmaceuticals and adopting current ‘practices of medicine’ from the West. Large pharmaceutical firms are aware of this and have been in China for nearly 20 years making money. Chinese biopharmaceutical companies sorely need an infusion of novel, patented Western products and ideally want Western partners for exploring world markets together. Small to midsize Western pharmaceutical company have concerns about IP protection, expectations of huge licensing fees, cultural/language differences, and, sometimes, the lack of marketing- and manufacturing-experienced management teams, all which tend to inappropriately inhibit steps from West to East. These issues do warrant thoughtful consideration, but the list of concerns for partnering with Chinese pharmaceutical companies should really be headed by market strategy and the ability of the partners to put together lean, but high quality manufacturing capabilities, that will allow both sides to make money. The following challenges for doing this will be discussed: Exploring the risks and rewards of partnering in China Integrating a Western management style to Eastern drug development Cultural challenges Potential pitfalls Examples of successful tactics in making various aspects of a partnership in China work

4:30 pm	*Special Tianjin Government Presentation: A Government and Local Industry Perspective on Developing an R&D Center in China
	Great Growth Opportunities for Pharmaceutical and Biotech Companies in the Tianjin Economic Development Area (TEDA), China Tony Xiaogang AN, Chief of Biopharmaceutical Division, Investment Promotion Center, Tianjin Economic Development Bureau This session will discuss some motivations of foreign investment into TEDA, China and some important factors the investors need to take account of in the process of finding a suitable business opportunity in TEDA, China. It will compare the running costs, local incentives, human resources, etc. among major regions and cities of China. • The advantages of doing business in Tianjin Binhai New Coastal Area and the progress of development in this dynamic region. • The big picture of the Tianjin Bio-pharmaceutical Innovation Park sponsored by the central government of China and the Tianjin Municipal Government. • Why TEDA is becoming the gateway for pharmaceutical and biotech companies to China. How TEDA serves foreign investors.

	A Strategic Partner for Preclinical R&D Service in China Hongjun Yang, Ph.D., Vice President, Tianjin Biochip Company Tianjin Biochip Company is a leading biotech company located in Tianjin Economic Development Area (TEDA). The company has established a complete technical platform for pharmaceutical R&D services from genomics to bioinformatics. The company has recently reorganized its infrastructure to meet the challenges and opportunities of outsourcing. TBC has also accomplished several international collaboration programs. TBC has received strong support from central and local government in China. • Accomplished and experienced leadership • Efficient infrastructure and SOP mentality • State-of-art technical platform and skilled team • Track records proved accomplishments • TEDA advantages