PROGRAM AGENDA- AS OF JULY 28, 2008

Transcription

1 PROGRAM AGENDA- AS OF JULY 28, 2008 PLEASE NOTE THAT THIS CONFERENCE AGENDA IS SUBJECT TO CHANGE AS WE CONTINUALLY WORK TOWARDS BRINGING YOU THE BEST POSSIBLE TOPICS AND SPEAKERS. SUNDAY NOVEMBER 9, :00pm-4:00 Workshop & Early Conference Registration 4:00-7:00 3 Concurrent Workshops: Choose One WORKSHOP #1 (FOR GLOBAL & LOCAL MANAGERS) Talent Management of Clinical Trials Staff Availability of Qualified Staff General Training Strategies for Staff Strategies for Retention of Staff Making Site Personnel More Committed to the Trials Organizing a Successful Clinical Operations Department to Allow for Job Promotion & Rotation to Reduce Attrition WORKSHOP #2 (FOR CHINA-BASED CLINICAL RESEARCHERS) Essential Elements of Clinical Trials Design & Protocol Design & Use of Evaluation & Research Protocols Informed Consent & Subjects Characteristics Clinical Trials Designs for Drugs, Vaccines, and Medical Devices Medical Device Trial Design The Role of Clinical Statistics

2 WORKSHOP #3 (FOR COMPANIES NEW TO CHINA) Advantages of Conducting Clinical Trials in China for Emerging & Medium-Sized Biotechs History of Quality Clinical Trial Data Generated in China My Company s Interested in Doing Trials in China- Now What? A Comparison of China vs. India vs. Eastern Europe vs. Latin-America How Will the FDA & EMEA View Data Generated in China? What Types of Full & Niche CRO Services Are Currently Available in China? What Biotech Companies Need to Take Advantage of China Clinical Sites Workshop Leaders: Lan Huang, Ph.D. Chief Executive Officer BEYOND ML GROUPS Ying Tang, M.D., MBA Managing Director, Greater China PARAMAX INTERNATIONAL Speakers: Rae Yuan, Ph.D. Head, Global Pharma Development Center ROCHE CHINA Cong Ling Zuo, Ph.D. Vice President, Preclinical Development BEIJING JOINN LABORATORIES 7:00-8:30pm CRO Meet & Greet Welcome Reception Business development representatives from all the major CROs in China will be on hand for a meet and greet session. If you are a small or emerging biotech company, this is your opportunity to meet and schedule meetings and off-site visits for the coming week with potential local partners. Cocktails will be served and your peers from global big pharma are also invited!

3 MONDAY NOVEMBER 10, :00am-8:00 Registration, Breakfast & Exhibits 8:00-8:10 Chairperson s Opening Remarks Min Irwin, M.D., Ph.D. Medical Director of BSP BAYER HEALTHCARE 8:10-8:40 Opening Keynote Address #1 From Made in China to Discovered in China Perry Nisen, M.D., Ph.D. Senior Vice President, Clinical Pharmacology & Discovery Medicine GLAXOSMITHKLINE 8:40-9:10 OPENING KEYNOTE ADDRESS #2 Title TBA Shortly Jörg Möller, M.D. Senior Vice President- Head, Global Clinical Development BAYER HEALTHCARE AG 9:10-9:40 OPENING KEYNOTE #3 The Quality of Clinical Trials in China Frank Jiang, M.D., Ph.D. Vice President, Global R&D/Head, China R&D SANOFI-AVENTIS 9:40-10:30 Networking Break & Exhibits 10:30-11:30 Regulatory Review at the SFDA: Science, Quality, and Speed What is hidden behind discussion of CTA review time? The SFDA s move to being more science-based What the SFDA and industry can and should do to enhance the application process Zili Li, M.D., MPH Head of Asia Pacific Regulatory Policy MERCK & CO. Ling Su, Ph.D. Vice President, Clinical Development Asia-Pacific WYETH Charles Tong, Ph.D. Senior Principal Scientist- Global CMC PFIZER Weiping Li, M.D. Head of Regulatory Affairs JOHNSON & JOHNSON CHINA (invited) SFDA Representative (invited) 11:30am-12:30pm GLOBAL PHARMA KEYNOTE PANEL DISCUSSION Global Pharma Development in China How is the clinical development industry in China evolving? What can we expect in the next 2-3 years? What are the current challenges? Comparison of China and India s Clinical Industry Frank Jiang, M.D., Ph.D. Vice President, Global R&D/Head, China R&D SANOFI-AVENTIS James Cai, Ph.D. Vice President, Research & Development ASTRAZENECA Cezary Statuch, M.D. Executive Medical Director, Global Medical Affairs BRISTOL-MYERS SQUIBB (INVITED) 12:30-1:45 Expert Luncheon- See Next Page for Details 1:45-2:10 The Role of China in Global Trials In this session, I will discuss the benefits and risks of conducting global trials in China, from both a local and global perspective; will also share industry trends and discuss likely evolution. Rachel Lee Partner & Managing Director BOSTON CONSULTING GROUP

4 Expert Luncheon The learning and networking experience extends beyond the conference room. Each lunch table will have a different theme for discussion, led by one of our experts in China clinical development. Registered attendees will have up until two weeks before the event to suggest topics they d like to see covered. This is truly a unique opportunity to get your questions answered by experts in the field. For a complete list of topics that will be covered please visit the expert lunch page on the website at Sponsored By: Bayer Schering Pharma 2:10-3:10 Strategies for Successful Collaboration Between Global Pharma, Biotechs & CROs in China Frank Fan, M.D., MBA Medical Director, China/Hong Kong ABBOTT Lai-Lee Tan Head, Clinical Operations/General Manager- China QuINTILES MEDICAL DEVELOPMENT George Guo Hong Senior Clinical Research Manager NOVO NORDISK CHINA (INVITED) Carol Zhu, Ph.D. Head of Operations GLAXOSMITHKLINE R&D CENTER (INVITED) 3:10-3:40 Mid-Afternoon Refreshments Break 3:40-4:40 Integrating China Trials into Your Global Registration Strategy Min Irwin, M.D., Ph.D. Medical Director of BSP BAYER HEALTHCARE Wu Yan, M.D. Head of Clinical Operations BOEHRINGER-INGELHEIM CHINA James He, M.D. Head of Development Operations AMGEN ASIA Bradley Marchant, M.D. Executive Director, Head of Clinical Medicine Asia PFIZER CHINA R&D CENTER Jay Mei, M.D., Ph.D. Senior Director, Oncology Development NOVARTIS 4:40-5:05 Neuroscience Clinical Trials in China Clinical trials in Neuroscience can be different from other therapeutic areas because of the types of endpoint data collected from cognitive, functional and global assessment instruments. However, these assessments are impacted by language and culture differences. Therefore, these instruments must be translated and validated before they can be used in China. This presentation will present an approach to addressing this challenge. Juan Qiao, M.D., Ph.D. Director, Neuroscience Worldwide Development PFIZER CHINA R&D CENTER 5:05-5:30 Oncology Development in China 5:30-7:30 Off-Site Visit to Local Hospitals & Clinical Trial Sites Limited to 30 people. Sign up early to reserve your spot! 6:00-7:30 Networking Cocktail Reception

5 TUESDAY, NOVEMBER 11, 2008 TRACK A: FOR EMERGING BIOTECH & COMPANIES NEW TO CHINA 6:00-7:30pm Speakers Dinner Roundtable In this closed-door session, speakers and advisory board members are invited to partake in an informal roundtable discussion over served dinner and drinks. This will be a unique opportunity for the industry s leaders to share best practices and chart the course for clinical development in China. 7:00am-8:00 Breakfast & Networking 8:00-8:10 Chairpersons Opening Remarks Jay Mei, M.D., Ph.D. Senior Director, Oncology Development NOVARTIS 8:10-8:35 Acceptability of Foreign Data/Pharmacokinetic Studies in China: Differences Between West & East The ICH E5 guideline describes factors that could lead to different response in different ethnic groups, including differences in pharmacokinetics (PK) and pharmacodynamics (PD). The satisfactory foreign clinical data can be used to support approval in a new region if there is an additional bridging study. A bridging study will often provide a comparison of dose-response relationships between the 2 regions. Therefore, a bridging strategy in the new drug application between China and Western countries will be critical. The bridging strategy will be summarized and discussed. Bin Peng, M.D., Ph.D. Director, Clinical Pharmacology GLAXOSMITHKLINE lessons for the Emerging Markets? This presentation will also cover: Impact of European Clinical Trial Directive on Harmonization of clinical research in Europe and its Impact on Global Development EU s Clinical Trials Directive and its implementation into national laws Develop a harmonized approach to the approval and conduct of clinical trials across Europe, provisions and definitions, for instance, of investigational medicinal products Emerging markets ie China, Russia and India. The scope of clinical research, harmonization with EU and US studies and legislative balance and the new targets. Adnan Mahmood, M.D. Senior Regulatory & Clinical Consultant BIOGEN IDEC 9:00-10:00 A Look At How Emerging Biotechs Are Harnessing China for Clinical Development Joanne Jiang, Ph.D. Vice President, Business Development FOUNTAIN MEDICAL DEVELOPMENT James Garner, M.D. VP, Clinical Development & Medical Affairs PROGEN PHARMACEUTICALS 10:00-10:30 Networking Break & Exhibits 8:35-9:00 EU Clinical Trial Directive- A Step Towards Globalization In the early 1980s, Europe was seen by the United States as a mosaic of peoples, cultures, and medical practices. Contrary to the American multicenter clinical trial, the Europeans did not have enough in common to allow clinical data to be shared and collated. How was this harmonized and what are the learning

6 TUESDAY, NOVEMBER 11, :30-10:55 Experiences from a Chinese Innovative Discovery and Development Company: Bringing A New Chemical Entity into the Clinic Using Local Resources This presentation will discuss our experience, as a Chinese small molecular innovative drug discovery and development company, of successfully bringing two New Chemical Entities from lead to clinic currently at different stages. Our experience may assist your decision on how China fits as a part of global R&D activity to accelerate discovery and development of innovative treatments. The strategy to fully utilize our existing skills and capacities in China as a part of a worldwide R&D effort through license, joint-research, or as a fully-owned subsidiary could be an important factor in shortening development process and doing it more cost effectively. This enables us to innovate and remain competitive. Xian-Ping Lu, Ph.D. Chief Scientific Officer SHENZHEN CHIPSCREEN BIOSCIENCES 10:55-11:20 Partnering With A Local Company by Licensing or Co-Development Models in China Allan (Riting) Liu, Ph.D. Director, Business Development of the Group SHANGHAI FOSUN PHARMACEUTICAL GROUP 11:20am-12:00pm Biologics Clinical Trials in China What Impact Will Biologics Have on China Clinical Trials? Biologics vs. Small Molecules: Differences for Clinical Trials in China Exporting Biological Studies A Look At How Some Biologics Were Approved by SFDA Use of Central Labs for China Studies James He, M.D. Head of Development Operations AMGEN ASIA Joanna Zhang, M.D. Medical Director, Medical Affairs & Clinical Operations GLAXOSMITHKLINE Maria Song, M.D., Ph.D. President VPS CRO TRACK B: FOR COMPANIES ALREADY IN CHINA 7:00am-8:00 Breakfast, Networking & Exhibits 8:00-8:10 Chairpersons Opening Remarks Min Irwin, M.D., Ph.D. Medical Director of BSP BAYER HEALTHCARE 8:10-9:35 Enhanced Clinical Trial Design & Modeling -Proof beyond the reasonable doubts -Maximizing the likelihood of success, while minimizing consumer risk -Global vs. local trials: statistical considerations Bradley Marchant, M.D. Executive Director, Head of Clinical Medicine Asia PFIZER CHINA R&D CENTER William Wang, Ph.D. Assoc. Director, Scientific Staff, Biostatistics MERCK RESEARCH LABS 9:35-10:00 Patient Recruitment & Retention in Global and China Clinical Trials -Challenges in patient recruitment and retention in global and China trials -Identification and selection of trial sites and investigators - recruitment strategies -Maximization of patient recruitment and enrollment - increasing productivity in trials -Enhancing patient compliance and retention 10:00-10:30 Networking Break & Exhibits

7 10:30-11:30 Safety Assessment for Conducting Clinical Trials in China Current status and challenges to effectively collect safety data in China A look at how the US & EU handles safety as a model for China Establishing a safety infrastructure in China to support global safety requirements Safety issues with regards to Investigational New Drugs (INDs) How to implement a Data Safety Monitor Board (DSMB) in China Dan Zhang, M.D. Chief Executive Officer FOUNTAIN MEDICAL DEVELOPMENT Frank Jiang, M.D., Ph.D. Vice President, Global R&D/Head, China R&D SANOFI-AVENTIS Zili Li, M.D., MPH Head of Asia Pacific Regulatory Policy MERCK & CO. Wu Yan, M.D. Head of Clinical Operations BOEHRINGER-INGELHEIM CHINA SFDA REPRESENTATIVE (INVITED) 11:30-11:55 Choosing the Best Investigators in China Ying Tang, M.D., MBA Managing Director, Greater China PARAMAX INTERNATIONAL 11:55am-12:25pm Required Post-Marketing Studies in China Mark Engel Chairman & President EXCEL PHARMASTUDIES GENERAL SESSIONS- EARLY PHASE & EXPLORATORY STUDIES IN CHINA Session Chair: Jian Zhao, M.D. Head, Governance Affairs NOVARTIS CHINA 1:25-2:25 Biomarker Discovery & Development & Translational Medicine in China What is Available in China for Biomarker Development and Translational Medicine Collaboration? Advantages in Linking Translational Medicine Collaborations with Clinical Trials Local Providers vs International CROs for Biomarker Analysis Patient Sample Collection and Exportation Challenges Jingsong Wang, M.D. Director, Discovery Medincine & Clinical Pharmacology BRISTOL-MYERS SQUIBB Jean-Pierre Wery, Ph.D. Executive Vice President of Translational Medicine CROWN BIOSCIENCE Mao Mao, M.D., Ph.D. Director China/Project Liaison MERCK RESEARCH LABS Jason (Gang) Jin, M.D., Ph.D. President & CEO SHANGHAI BIOCHIP CORPORATION (US) 2:25-2:50 Early-Stage Studies in China: What is Possible Today? Qi Yin, M.D. Regional Manager, Exploratory Development CHINA NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH 12:25-1:25 Networking Lunch

8 2:50-3:15 Early-Stage Studies in China: From the Investigator Perspective Haiyan Li, M.D. Director of Drug Clinical Trial Center PEKING UNIVERSITY THIRD HOSPITAL 3:15-3:40 Networking Break 3:40-4:05 Medical Device Trials in China An Update and Overview of the Field SFDA Requirements for Medical Device Approval Dalvin Ni Vice President, Operations FOUNTAIN MEDICAL DEVELOPMENT 4:05-4:30 Vaccine Trials in China William Xiong Chief Executive Officer EXCEL PHARMASTUDIES 4:30-4:55 Putting it All in Perspective: Balancing the Healthcare Books Brief overview of the historical development of healthcare in China today Drivers for increasing healthcare costs - system, demographics, disease patterns Drivers for decreasing healthcare costs - government initiatives, increased payer contribution, reduced provider profit Likely future scenarios - market dynamics, health insurance, infrastructure, industry growth Robert W. Pollard Director, Healthcare China SYNOVATE 4:55-5:00 Closing Remarks 5:00pm Conference Concludes