9th Annual Biomarkers Congress
3rd Annual Partnerships in Clinical Trials Asia
Grand Hyatt Shanghai
Jin Mao Tower, 88 Century Avenue, Pudong, Shanghai, People's Republic of China 200121 Tel: +86 21 5049 1234 Fax: +86 21 5049 1111
Shanghai, China
http://www.iirusa.com/clinicaltrialsasia/event-welcome.xml
The largest concentration of clinical decision makers specializing in clinical development, operations and outsourcing meet to provide you the opportunity to establish benchmarks, standards and next practices in the development and commercialization of products in a global marketplace. The agenda is filled with in-depth case studies on strategic partnering and effective outsourcing to ensure quality, control costs and accelerate cures to market.

Schedule of Presentations:

Wednesday, October 12, 2011
08:50:00 PRE-CONFERENCE DAY WORKSHOPS
09:00:00 A: Optimize Oncology Clinical Trials: Strategies to Shorten Oncology Drug Development in Asia Emily Tan, Melvin K.M Toh
10:00:00 B: Improve Strategic Collaborations in Asia Christopher Albani
11:00:00 C: Partnering with Japan for Clinical Trials
11:15:00 Part I: Regulatory Overview of Japan
11:30:00 Part II: Operational/Clinical Development Strategies for working with Japan
12:00:00 Part III: Cultural Considerations of Doing Business with Japan
13:00:00 D: Clinical Trial Materials Supply Chain Management and Distribution
13:15:00 Part I: Risk Mitigation in Choosing the Best Packaging Solution Janelle A. Sabo
13:30:00 Part II: Building Effective Drug Distribution Networks in Asia Janelle A. Sabo
13:45:00 Part III: Best Practices for Working with Central Labs Janelle A. Sabo
14:00:00 Part IV: Dealing wtih Customs: Overcoming Import/Export Obstacles IP Handling Janelle A. Sabo
Thursday, October 13, 2011
08:55:00 MAIN CONFERENCE DAY ONE
09:00:00 Chairperson's Opening Remarks Stephen Porter
09:15:00 New Business Opportunities in Clinical Development in Asia Ling Su
09:45:00 PHARMA PERSPECTIVE: Considerations for Inclusion of Asia into Global Drug Development Strategies
10:15:00 CRO PERSPECTIVE: Integrating China into the Global Drug Development Strategy Emily Tan
10:45:00 Networking Break
11:30:00 Keynote: Innovative Strategies and Partnering Models: What Will Work for You?
12:00:00 Innovative Strategies for Accessing Clinical Capabilities in Asia – Responding to Challenges in Global Development Environment Carl Firth
12:30:00 PANEL DISCUSSION: Overcome the Biggest Challenges in Partnering for Late Phase Trials Allan (Riting) Liu, James Cai
13:10:00 Networking Luncheon
14:05:00 THERAPEUTIC CLINICAL TRIALS
14:05:00 INNOVATIVE PARTNERING FOR DRUG DEVELOPMENT Li Ding
14:10:00 THERAPEUTIC CLINICAL TRIALS | CASE STUDY: AstraZeneca's Strategic Use of Clinical Biomarker in Developing Oncology Clinical Trial Programs
14:15:00 INNOVATIVE PARTNERING FOR DRUG DEVELOPMENT | Ensuring Drug Development Success with Your Chinese Partners- Working with Global CROs vs. Local CROs
14:40:00 THERAPEUTIC CLINICAL TRIALS | CASE STUDY: CNS Clinical Trials in Asia
14:40:00 INNOVATIVE PARTNERING FOR DRUG DEVELOPMENT | CASE STUDY: A New Integrated CRO Model for Managing Pharmaceutical Trials in Asia Rudi Ladenius
15:10:00 THERAPEUTIC CLINICAL TRIALS | CASE STUDY: Explore Opportunities in Traditional Chinese Medicine
15:10:00 INNOVATIVE PARTNERING FOR DRUG DEVELOPMENT | Asia's Driving Innovation in Biopharma Partnering
15:40:00 Networking Break
16:10:00 THERAPEUTIC CLINICAL TRIALS | CASE STUDY: Chinese Biotech's Clinical Studies for an HIV Fusion Inhibitor
16:10:00 INNOVATIVE PARTNERING FOR DRUG DEVELOPMENT | Overcome Challenges in Setting Up Early Phase Work in Asia
16:40:00 CEO Keynote Panel: Identifying New Business Opportunities in Biosimilars Drug Development in Asia Joe Zhou, Chris Chen
17:20:00 Day One Concludes; Networking Reception sponsored by: Esoterix and Clearstone in the Exhibit Hall
19:00:00 Shanghai Huangpu River Night Cruise (optional)
Friday, October 14, 2011
08:55:00 MAIN CONFERENCE DAY TWO
09:00:00 Chairperson's Recap of Day One
09:15:00 KEYNOTE: SFDA Update on Clinical Safety and Monitoring Guidelines and the Current Regulatory Climate in China
09:40:00 QUALITY MANAGEMENT, PATIENT SAFETY, AND PROACTIVE RISK ASSESMENT
09:40:00 THE DISCUSSION DEN
09:45:00 THE DISCUSSION DEN | Roundtable 1: Standard of Care and Ethical Issues in Clinical Trials
09:45:00 QUALITY MANAGEMENT, PATIENT SAFETY, AND PROACTIVE RISK ASSESMENT | Safety Monitoring and Risk Management of Clinical Trials in China
10:15:00 Networking Break
11:00:00 QUALITY MANAGEMENT, PATIENT SAFETY, AND PROACTIVE RISK ASSESMENT | Create a Quality Management GCP System to Ensure Compliance in Asia
11:00:00 THE DISCUSSION DEN | Roundtable 2: Is it Feasible to Develop Protocols that Integrate Standards of Practice Globally for Multi-national Clinical Trials?
11:30:00 THE DISCUSSION DEN | Roundtable 3: Pan Asia Pacific Trials - Combining Local Knowledge with Global Insight
11:30:00 QUALITY MANAGEMENT, PATIENT SAFETY, AND PROACTIVE RISK ASSESMENT | Quality Oversight when Outsourcing in Asia: Striking the Right Balance
12:00:00 Networking Luncheon | Luncheon Roundtable: Overcome Regulatory Obstacles in China, Korea, India and Taiwan
13:30:00 Leverage the Use of Adaptive Clinical Trial Design to Cut Costs, Boost Operational Efficiency and Reduce Study Timelines Stephen Porter
14:00:00 Keynote Panel- Preparing for the Evolving Landscape of Clinical Research in Asia
14:40:00 Networking Break
15:15:00 DISCUSSION DEN CONTINUED
15:20:00 EXTENDED SESSION: Patient Recruitment and Retention in China
15:40:00 DISCUSSION DEN CONTINUED | Roundtable 4: Emerging Countries for Clinical Trials in Asia – Utilizing Academic SMOs to Overcome Challenges
16:15:00 DISCUSSION DEN CONTINUED | Roundtable 5: How does your local Chinese company create a strategy to expand its portfolio globally?
16:45:00 DISCUSSION DEN CONTINUED | Roundtable 6: Challenges in Working with Labs: Import/Export of Investigational Drugs
17:15:00 Conference Concludes
4th Annual Pharma R&D Asia Congress
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