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7:45am Morning Coffee and One-on-One Meetings
8:25 Chairperson’s Remarks
SESSION C: Drug Discovery and Preclinical Development
8:30 Building a Lead Optimization Capability in Emerging Markets: Singapore and India
• Identifying an opportunity to increase productivity
• Comparing resources required and available
• Pros and cons of Singapore as a market to conduct to drug discovery activities
• India: unique challenges and opportunities in preclinical drug discovery
Dr. Canwen Jiang, Scientific Dir Applied Discovery Research, Applied Discovery Research,Genzyme Corp.
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9:15 Opportunities for Drug Discovery in China:
Roche Shanghai’s R&D Centre
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• A model for conducting research in China today...and tomorrow
• Logistical challenges
- transferring technology
- transferring data
- training staff
• Integrating efforts in China with all other worldwide research activities
Gianni Gromo, M.D., Head of Discovery Research
Basel, F. Hoffman La Roche
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10:00 Why Conducting Preclinical Work in China is the Future
• Overview of intellectual property regulations and China’s commitment to IP enforcement
• Improvements of efficiencies through the use of systems biology and outsourcing
• Comparing the SFDA and FDA
• Summary of results
Glenn Rice, President and Chief Executive Officer, Bridge Pharmaceuticals
10:45 One-on-One Meetings and Coffee Break
SESSION D: Clinical Development
11:15
Value Creation and Offshore Opportunities: Successful Establishment of a Clinical Development Unit in India
Dr. Mukund Chorghade, President & CSO, Pharmaceutical Sciences, D&O Pharmachem Inc.
12:00pm Conducting Clinical Trials in India and China: Why It Makes Sense and is a Win-Win Situation
• Our clinical trial experience to date
• Plans for expansion and associated requirements:
- Infrastructure and resource needs (site, local affiliate office, headquarters)
- Communications
- Site identification
- Earlier planning and regulatory filings
- Site monitoring and data collection
• Remaining challenges
Robert Maguire, M.D., Vice President Clinical Development and Chief of Operations,
Wyeth Pharmaceuticals
John Gwynne, M.D., Vice President Clinical Pharmacology, Wyeth Pharmaceuticals
12:45 Networking Luncheon
SESSION E: IP and Operational Issues
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Interactive
Panel |
2:00 China IP Strategies: How to Minimize the IP Risk and Maximize the IP Protection in this Rapidly Developing Legal Landscape
• Understand differences between the US and Chinese systems
• Identify IP risks of the China market
• Hear the experiences of other players in the China market
• Learn these solutions to minimize IP risks and maximize IP protection
• Understand the current IP enforcement strategies in China
Moderator: Michael J. Wise, Partner, Perkins Coie
Panelists: Gianni Gromo, M.D
Satish Tripathi, Director, Worldwide Regulatory Strategy, Pfizer Inc.
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2:45 The Regulatory Landscape in Asia: Opportunities for Multi-National Companies
• Regulatory dynamics in Asia
- China
- India
- Singapore
• Benefits and challenges in conducting development activities in Asia
Satish Tripathi
3:30 Close of Executive Forum
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