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Agenda at a Glance

Agenda at a Glance

Main Conference will be simultaneously translated 主会场将提供同声传译

PRE-CONFERENCE DAY WORKSHOPS: Wednesday October 12, 2011
Workshops run from 9:00-12:30 and 1:30-4:30 with mid-morning/afternoon refreshment breaks. Lunch will be served for participants who attend a full day (morning + afternoon workshops). Registration begins 30 minutes prior to each session. Choose from among the following options:
A: Optimize Oncology Clinical Trials: Strategies to Shorten Oncology Drug Development in Asia LED BY: Melvin Toh, Vice President Pharma Development, CK Life Sciences, Hong Kong Matthew J. Bryant, Sr. Manager, Oncology Asia Pacific Clinical Project Management, DCOE AP - Eli Lilly Japan Emily Tan, Executive Director, Pharmanet
B: Improve Strategic Collaborations in Asia LED BY: Nadina C Jose, Regional Director, Global Clinical Site Management and Monitoring Asia-Pacific, Allergan Roshan Padbidri, SM, Clinical Operations, Takeda Global Research & Development Center (Asia) Rupesh Patki, PhD, Regional Area Manager-Asia, Allergan Chris Albani, Managing Director, PRTM
C: Partnering with Japan for Clinical Trials Part I: Regulatory Overview of Japan Part II: Operational/Clinical Development Strategies for working with Japan Part III: Cultural Considerations of Doing Business with Japan LED BY: Yutaka Natsumeda, Director of Office of Clinical Trials, Yokohama City University Hospital Hiroshi Sugii, Vice President Clinical Development, Novo Nordisk Tadashi Fujisawa, Chief Executive Officer, Mebiopharm
D: Clinical Trial Materials Supply Chain Management and Distribution Part I: Risk Mitigation in Choosing the Best Packaging Solution Part II: Building Effective Drug Distribution Networks in Asia Part III: Best Practices for Working with Central Labs Part IV: Dealing wtih Customs: Overcoming Import/Export Obstacles IP Handling LED BY: Janelle A. Sabo, PharmD, RPh, CA-AM, Sr. Director, Global Clinical Trial Materials Services (CTMS), Eli Lilly David Walsh, CEO, DGP Intelsius Jenny Zhang, MSc., MBA, Vice President, Global Laboratory Operations and Asia, Clearstone Central Laboratories, a LabCorp Company
MAIN CONFERENCE DAY ONE: Thursday October 13, 2011
9:00AM	Chairperson's Opening Remarks 主持人开幕词 R Stephen Porter, CEO, VDDI Pharmaceuticals
9:15AM	New Business Opportunities in Clinical Development in Asia 亚洲临床试验能力的创新策略—应对全球发展环境的挑战 Ling Su, PhD, Senior Vice President and Head of Development, Greater China, Novartis Pharmaceuticals Corporation
9:45AM	PHARMA PERSPECTIVE: Considerations for Inclusion of Asia into Global Drug Development Strategies 将亚洲纳入考虑全球药物研发战略部署 John Hubbard, SVP Worldwide Drug Development, Pfizer
10:15AM	CRO PERSPECTIVE: Integrating China into the Global Drug Development Strategy 主题演讲: 将中国融入全球药物开发策略促 Emily Tan, Executive Director, Pharmanet
10:45AM	Networking Break 进合作交流
11:30AM	Keynote: Innovative Strategies and Partnering Models: What Will Work for You? 主题演讲：创新策略和合作模式：什么适合您？ Shirley Zhao, Managing Director, China, Genzyme
12:00PM	Innovative Strategies for Accessing Clinical Capabilities in Asia – Responding to Challenges in Global Development Environment 应对全球发展环境面临的挑战－亚洲临床能力和新商机 Carl Firth, Chief Executive Officer, Aslan Pharmaceuticals
12:30PM	PANEL DISCUSSION: Overcome the Biggest Challenges in Partnering for Late Phase Trials 应对后期试验阶段合作的最大挑战 James Cai, Vice President for Clinical Development, Atyr Pharma (Moderator) Jimmy Bautista, Regional Medical Director, Eisai Asia Allan Riting Liu, Vice President, Fosun Pharmaceutical David Selkrik, Independent Consultant, Selkrik & Co. Sally Sha, Business Development & Project Director, Tigermed, China
1:10PM	Networking Luncheon 交流午宴

	INNOVATIVE PARTNERING FOR DRUG DEVELOPMENT 携手创新药物开发	THERAPEUTIC CLINICAL TRIALS 治疗临床试验
	Track Chair: Li Ding, Head of Trial Operations-China and Asia Pacific, Clinical Science and Operations, Sanofi-Aventis	Track Chair: Christina Bodurow, PhD, Senior Director, External Sourcing Development Center of Excellence, Eli Lilly
2:10PM	Ensuring Drug Development Success with Your Chinese Partners- Working with Global CROs vs. Local CROs 确保与您的中国合作伙伴的药品开发取得成功——与全球 CRO 合作较之与本地 CRO 合作 James Tsui, Contracts & Outsourcing, Roche Product Development Asia Pacific, China	CASE STUDY: AstraZeneca's Strategic Use of Clinical Biomarker in Developing Oncology Clinical Trial Programs 阿斯利康在肿瘤学临床试验计划中对临床生物标志物的战略性使用 Fred Zheng, MD, Ph.D. Research Clinical Scientist, AstraZeneca
2:40PM	CASE STUDY: A New Integrated CRO Model for Managing Pharmaceutical Trials in Asia 亚洲药品试验管理的全新综合 CRO 模式 Donald Russell, Senior Director, International Clinical Operations, Eli Lilly & Co Rudi Ladenius, PhD, Senior Director, Global Research Operations, PAREXEL International	CASE STUDY: CNS Clinical Trials in Asia 亚洲中枢神经系统临床试验 Joan Shen, MD, PhD Senior Medical Director Clinical Research, Primary Care Unit, Pfizer
3:10P	Asia's Driving Innovation in Biopharma Partnering 亚洲生物制药合作领域的创新驱动 Ross Horsburgh, Vice President, Clinical Development, Nycomed	CASE STUDY: Explore Opportunities in Traditional Chinese Medicine 迎接传染病及疫苗临床试验面临的挑战 Bradley Marchant, Senior Director, Unit Development Office, Asia-Pacific R&D, Sanofi-Aventis
3:40PM	Networking Break
4:10PM	Overcome Challenges in Setting Up Early Phase Work in Asia 应对在亚洲建立早期阶段工作的挑战 Helen Jiang, Head of Clinical Development, Hengrui Pharmaceuticals	CASE STUDY: Chinese Biotech's Clinical Studies for an HIV Fusion Inhibitor 生物技术在中国: 艾滋病病毒膜融合抑制剂的临床研究 Jingzong Qi, Vice President and Birector of Business Development, FusoGen Pharmaceuticals
4:40PM	CEO Keynote Panel: Identifying New Business Opportunities in Biosimilars Drug Development in Asia 主题专场: 发现亚洲生物仿制药开发的新商机 Chris Chen, Chief Executive Officer, Shanghai Celgen Biopharmaceuticals (Moderator) Scott Liu, Chief Executive Officer, Henlius Biopharma Joe Zhou, Chief Executive Officer, Genor BioPharma
5:20PM	Day One Concludes; Networking Reception sponsored by: Esoterix and Clearstone in the Exhibit Hall 第一天结束；展厅交流酒会
7:00PM	Shanghai Huangpu River Night Cruise (optional) 7:00 上海黄浦江夜游（可选）夜游黄浦江，欣赏上海著名的外滩和浦东美景。加入我们的游程，享受自助餐、当地的饮料和小吃，与您的同仁、当前和未来的业务合作伙伴进行交流！ Enjoy stunning views of Shanghai's famous Bund and Pudong as we sail the Huangpu River. Join our cruise and enjoy a small buffet with drinks and local snacks as you network with your colleagues and current and future business partners!

MAIN CONFERENCE DAY TWO: Friday October 14, 2011
9:00AM	Chairperson's Recap of Day One 主持人对第一天会议的小结 Chichang Lee, Executive Director, Simcere Pharmaceuticals
9:15AM	KEYNOTE: SFDA Update on Clinical Safety and Monitoring Guidelines and the Current Regulatory Climate in China 主题演讲: SFDA 最新的临床安全和监测指导方针，中国目前的监管环境 Wenmin Du, Executive Director, SFDA

	QUALITY MANAGEMENT, PATIENT SAFETY, AND PROACTIVE RISK ASSESMENT 质量管理，患者安全和积极的风险性评价	THE DISCUSSION DEN 讨论会 Roundtable discussions will be held in the exhibit hall with limited spaces available per topic.
9:45AM	Safety Monitoring and Risk Management of Clinical Trials in China 中国临床试验的安全监控和风险管理 Rebecca Wang, Head of Product Safety Operation, Shanghai Roche Pharmaceuticals	Roundtable 1: Standard of Care and Ethical Issues in Clinical Trials 圆桌会议一：以战略武器保护您的知识产权 Jon Lee, Vice President of Clinical Operations, Cerexa, Inc.
10:15AM	Networking Break
11:00AM	Create a Quality Management GCP System to Ensure Compliance in Asia 建立质量管理 GCP 系统，维护亚洲的合规 Xun Chen, Head of Clinical Science and Operations in China, Sanofi-Aventis	Roundtable 2: Is it Feasible to Develop Protocols that Integrate Standards of Practice Globally for Multi-national Clinical Trials? 圆桌会议二：开发整合多国临床试验的全球实践标准是否可行？ Ann Wang, Vice President of Clinical Operations and Data Management, Human Genome Sciences
11:30AM	Quality Oversight when Outsourcing in Asia: Striking the Right Balance 亚洲外包质量监督：达成适当的平衡 Vance Warren, Senior Study Logistics Manager Translational Medicine Clinical Pharmacology, Daiichi Sankyo Pharma Development Jon Lee, Vice President of Clinical Operations, Cerexa, Inc.	Roundtable 3: Pan Asia Pacific Trials - Combining Local Knowledge with Global Insight Dr. Malcolm Burgess, Executive Vice President, ICON Clinical Research, Hong Kong
12:00PM	Networking Luncheon
	Luncheon Roundtable: Overcome Regulatory Obstacles in China, Korea, India and Taiwan 克服中国、韩国、印度和中国台湾地区的监管障碍如果您愿意在午餐期间参与上述任何有关监管的圆桌会议，请游览 www.clinicalpartnershipsasia.com If you are interested in participating in this regulatory roundtable discussions during lunch, please contact dburakoff@iirusa.com
1:30PM	Leverage the Use of Adaptive Clinical Trial Design to Cut Costs, Boost Operational Efficiency and Reduce Study Timelines 利用适应自身特点的临床试验设计，降低成本，提高运营效率，缩短研究周期 Stephen Porter, CEO, VDDI Pharmaceuticals
2:00PM	Keynote Panel- Preparing for the Evolving Landscape of Clinical Research in Asia 主题演讲—准备应对亚洲临床研究的变化 Ross Horsburgh, Vice President Clinical Development, Nycomed (Moderator) Chichang Lee, Executive Director, Simcere Pharmaceuticals Vincenzo Teneggi, Head of Early Development & Clinical Pharmacology, Asia Pacific, Roche Dr. Malcolm Burgess, Executive Vice President, ICON Clinical Research, Hong Kong
2:40PM	Networking Break
	EXTENDED SESSION: Patient Recruitment and Retention in China 延长会议中国的患者招募和保留	DISCUSSION DEN CONTINUED 讨论会
3:20PM	Matthew J. Bryant, Sr. Manager, Oncology Asia Pacific Clinical Project Management, DCOE AP - Eli Lilly	3:40PM - Roundtable 4: Emerging Countries for Clinical Trials in Asia – Utilizing Academic SMOs to Overcome Challenges 圆桌会议四：亚洲新兴的临床试验国家—利用学术 SMO 应对挑战 Anita Pascarella-Hallett, Director, Clinical Diagnostic Services, Eli Lilly
4:15PM		Roundtable 5: How does your local Chinese company create a strategy to expand its portfolio globally? 圆桌会议五：您当地的中国公司如何制定其全球产品组合策略？ Yuqiang Wang, Chief Executive Officer, Magpie Biotech
4:45PM		Roundtable 6: Challenges in Working with Labs: Import/Export of Investigational Drugs 圆桌会议六：与实验室合作的挑战：验药物的导入/导出 Darshan Bhatt, MD, M.Phil., Director Cliical Drug Safety, Vanthys Pharmaceutical Development (P) Ltd
5:15PM	Conference Concludes

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