2015亚洲临床试验领袖峰会

Day One December3,Thursday

0800 Registration&Coffee

0900 What are the Key Commercial Considerations for Successful Drug Development and Investment in Asia?

•Competitive outlook for the Asian pharmaceutical sector: Diversify or focus on core segments?

•Commercial challenges, issues and potential solutions for successful drug development in Asia

•Examining the Asian R&D and commercial pathway for a big pharma

•Incorporating changes in big pharma organizational structures for the integration of Asia R&D

•Establishing central trial coordination operating models for the Asia-Pacific R&D trial portfolio

•Exploring collaboration models in Asia for successful drug development

•Commercial and market challenges for profitable drug development and portfolio development in Asia

Moderator: 

John Choi, Chief Business Officer, Hua Medicine 

Panelists: 

Min Irwin,VP, head of China Medicine Development, 

GLAXOSMITHKLINE 

Dennis Wong, Associate VP, Head of Clinical Development, AP R&D, Sanofi

0930Successful Stories of Bringing / Developing Innovative Products in China 

• Defining Innovation and Innovative Pharmaceutical Products 

•Pathways for Development (Create from Scratch, In-license, Partner with China company for Development) 

• Examples of different approaches & Lessons 

• Case Study (Hua Medicine’s in-licensing of 4th Generation GKA asset from Roche) John Choi, Chief Business Officer, Hua Medicine 

1000 Biologics Development in Asia Dennis Wong,Associate VP, Head of Clinical Development, AP R&D,Sanofi

1030 Tea and Break 

1100 Recruitment 2016---Attracting and Retaining Key People in the Year Ahead 

Matthew Bulley,Director Asia Pacific, Barrington James

1130 Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients 

•Four-way relationship between sponsors, sites, CROs & patients - Realistic expectations, clear communications, shared understandings, practical policies, and efficient problem resolution 

•Quantitative analysis reveals rapid changes in the industry and trends for the future. How can sponsors, sites and CROs meet the challenges? 

•Choosing a partner who can take necessary steps to rectify the situation when things go wrong 

•Understanding sponsors principle for selecting the local clinical research organization 

•Identifying the anticipated advantages of a collaborative clinical trial alliance for greater efficiency and cost reduction 

•What are the current perspectives on the future of outsourcing in Asia?

Moderator: 

Shaojing Hu, VP & Chief Chemist, Betta Pharmaceuticals 

Panellists: 

Beat E. Widler, Managing Partner, Widler & Schiemann AG Robbie Chana, VP, Business Development – Europe & Asia Pacific, Bioclinica 

1200 Networking & Luncheon

1400 Bridging Gaps in Meeting Trial Timelines: Effective Communication Between Biometrics and Clinical Trial Operations 

•Ensuring data quality within given timelines 

•Need for effective communication between Biometrics and Clinical Operation teams 

•Establish the right teams to speed up trial timelines 

Dejun Tang, Site Head, Biometrics & Statistical Sciences and Methodology, Novartis Pharma China

1430New Drug Review Initiatives to Encourage Innovations by CFDA & global collaboration can do more Shaojing Hu, VP & Chief Chemist, Betta Pharmaceuticals 

1500 ICH GCP Revision: what is new, how may the revision impact the way we do clinical trials? 

Beat E. Widler,Managing Partner,Widler & Schiemann AG 1530Tea and Break 

1600 Conference Adjourn

Day Two December4,Friday

0800 Registration&Coffee 

0900 Innovative Approaches to Clinical Partnering 

• Case examples of different kinds of partnerships in clinical trials (eg. academia/pharma; pharma/pharma; pharma/CRO & more) 

• Determining pros and cons of partnering with local vs. global SMOs & CROs 

• Maintaining relationship and generating good quality supporting protocols

Moderator: 

Fangning Zhang, Partner , Greater China Office, Shanghai , 

McKinsey & Company 

Panelists: 

Shuling Wu, Associate Director, Data Management TA Lead, Pfizer (China) Research & Development 

Rebecca Wang, Executive Medical Director ; Global Regulatory Affairs and Safety; Bone Safety TA Head, Amgen 

David Yang,CEO,Microconstant

0930 Risk Based Safety Management in Clinical Trials Risk based safety management (RBSM) in clinical trials is widely credited for protecting human subjects during a clinical trial and ensuring integrity of study. Although the process of RBSM various significantly among pharmaceutical companies, the common elements include (1) commit to protect human subjects and integrity of safety information in the clinical trials – the organisational culture ensures that all the members of the organization give priority to patient safety; (2) understand hazards and evaluate risk – the foundation of a risk-based approach; (3) manage risk – the ongoing execution of RBSM; and (4) evaluation of effectiveness of RBSM system - learn from experience via metrics, incidents, audits and management reviews, provide direct feedback on the workings of the system, and improve it.

Rebecca Wang, Executive Medical Director ; Global Regulatory Affairs and Safety; Bone Safety TA Head, Amgen

1000Evaluating China as the Data Management Center for Global Projects

Wei Zhang, Associate Director, Data Management TA Lead, Pfizer (China) Research & Development

1030 Tea and Break

1100 The China effect on innovation and implications to pharma

China spent more than $200 billionon research and development in 2014, the second-largest investment by any country inabsolute terms (and about 2 percent of GDP). Its universities graduate more than 1.2 millionengineers each year—more than the next five countries combined. But how innovative is the Chinese economy? Does China have the innovative capacity to raiseproductivity, create more high value-added jobs, and achieve its economic aspirations?

Within pharma, China has significantly increased R&D spending, established multiple industry parks, attracted thousands of oversea returnees who bring years of industry experiences. But will China become a global leader on pharma innovation? What does it take to get there? Fangning Zhang, Partner , Greater China Office, Shanghai , McKinsey & Company

1130 Caveats in analyzing observational data – Examples and practice

In clinical development, after the drug is on the market, data collection usually switches to post-marketing studies, or real-world surveillance. Due to lack of comparator, lack of rigor in study set-up, the translation validity from data to information is often in question. Confounding is almost always an issue. Most of the literature simply ignores confounding,and most of the rest attempts to control confounding improperly. I will summarize common problems in data interpretation in this area, and use examples to show how we as an industry can do a better job in extracting real information. Ouhong Wang, Head of Biostatistics & Programming, China, Amgen

1230 Networking & Luncheon

1400 From a GCP Office to a Real SMO: A Data Quality

Perspective

Henry Yau, Managing Director and Honorary Assistant Professor of The University of Hong Kong Clinical Trials Centre

1430 e-Clinical Technology in China

Information Technology has been greatly implemented in clinical research from data processing and randomization. This presentation will cover

•Current status of e-clinical in China

•Challeges global pharma experienced

•Oppertunities for local Pharma

Hualong Sun, General manager, Meta Clinical Technology

1500 Tea and Break

1530 Conference Adjourn

3000元/位