DAY TWO: THURSDAY, SEPTEMBER 18, 2008
7:30 – 8:15 am Morning Coffee
8:15 Chairperson’s Remarks
Li Chen, Ph.D., Chief Scientific Officer, Roche Research and Development Center (China) Ltd.
Introductory Keynote
Large Company Perspective from within China
8:30 Drug Discovery R&D in China: From Functional Capacity Outsourcing to Integrative Partnership
Guoxin Zhu, Ph.D., Director, Discovery Chemistry Research & Technology, Eli Lilly & Company
China strategy is becoming a critical part of global pharmaceutical R&D for many international pharmas. Growing capacities and capabilities for drug discovery and development in China from local CROs, biotechs and academic research centers have been transforming the business models for international pharmas from pure outsourcing to integrated partnerships. This session will discuss the current state of drug discovery R&D in China.
Small Company Perspective from within China
9:15 Case Study from a Chinese Innovative Discovery and Development Company: Bringing a New Chemical Entity from Lead to IND and Into Phase II
Xian-Ping Lu, CEO & Chief Scientific Officer, Shenzhen Chipscreen Biosciences Ltd.
This presentation will offer a case study of a Chinese small molecular innovative drug discovery and development company with a successful experience of bringing a New Chemical Entity from lead to IND and moving forward into phase II. The broader story is understanding how China fits as a part of global R&D activity to accelerate discovery and development of innovative treatment. China is emerging as a significant market place for pharmaceutical companies worldwide. Meanwhile, its overall research and development talent, skill, capacity and quality have improved significantly in recent years. The strategy to fully utilize these skills and capacities as a part of WW R&D effort through either license, joint-research, or fully-owned subsidiaries could be an important factor in shortening the development process and doing it more cost effectively in order to innovate and remain competitive.
- Pro or con to start from early stage of discovery in China, either through academic or biotech companies
- Utility of Chinese preclinical or clinic data to support the US filing
- Business strategy through licence, research partnership or other
- Consideration of preclinical and clinic study design with potential global application
10:00 Networking Coffee Break
Interactions and Initiatives Taken for Drug Development between China and the Rest of Asia: A Focus on Oncology
10:30 Accelerate Oncology Clinical Development in Asia
Michael Shi, Director and Biomarker Project Leader, Exploratory Oncology Development, Novartis Oncology
Some Asian countries offer a highly attractive way to accelerate oncology clinical development programs. These countries have extra large centers by Western standards, rapidly growing clinical trial infrastructure and have been successful in contributing to global Phase II and Phase III clinical trials. An emerging opportunity is also on the horizon to conduct exploratory proof-of-concept studies in some Asian countries/regions.
- Key opportunities and challenges in oncology development in Asia-Pacific regions
- Incorporate Asia-Pacific countries into the global development plan
- Define key success factors in oncology development in Asian countries
- Select the optimal clinical sites for exploratory oncology trials
11:15 The Latest Insights from China into New Molecules to Fight Cancer: Translational Research Work with Cancer Stem Cells and Some Potential Immunol Lymphocytes
Jun Ren, M.D., Ph.D., Professor of Medicine, Director, Department of Medical Oncology, Chief, Breast Oncology, Director, Marrow Stem Cell Transplantation for Breast Cancer Program & Cytotherapy, Executive Director, Clinical Trials Coordination, Peking University School of Oncology/Beijing Cancer Hospital
Inhibiting downstream pathway of cancer cells explicite the novel directions when targeting therapy Cancer stem cells may play a critical and centralized role in the development, generation, and resistance of cancer cells. Therefore, novel directions for targeted gene therapy strategies to inhibit downstream pathways of cancer cells must be taken into consideration. Depending on the cancer stem cell pathway over expression of molecules are displayed in different tumor tissues types. Cancer management may soon lead to eliminating or differentiating cancer stem cells instead of killing cancer cells through:
- The downstream signaling pathway in tumor cells
- Experimental-specific molecules inhibits downstream pathway of cancer cells
- Cancer stem cells with drug resistance
- Novel downstream signaling proteins against cancer stem cells
12:00 pm Lunch on Your Own
DMPK and Preclinical Tox in China:
Reducing the Rate of Attrition During Drug Discovery and Development
1:30 How to Balance Internal and External Resources to Provide DMPK Support for Drug Discovery in China
Ji Zhang, Ph.D., Associate Director, DMPK, GlaxoSmithKline R&D China
GSK has established a new R&D research center in Shanghai, China to focus on research into neurodegeneration with the objective of creating new medicines for such severe disorders as multiple sclerosis, Parkinson’s disease, and Alzheimer’s disease. The main role that DMPK plays in drug discovery is the prediction of drug metabolism and pharmacokinetics in humans. Successful prediction can be expected to reduce the rate of attrition during drug discovery and development. This has led to the recognition that DMPK is an essential component of the drug discovery/development process. Both this and the need to screen greater numbers of compounds have led to major changes in both technology and the process of drug discovery. This presentation will discuss my experience in building up the DMPK organization in Shanghai and the strategy used to balance internal and external resources to provide effective DMPK support for the drug discovery activities.
2:00 Conducting High Quality, Cost Effective GLP Safety Studies in China -- Moving from If and When to HOW
Eric Meyers, President, China Preclinical Management Services
Haizhou Zhang, Ph.D., Vice President, China Operations, China Preclinical Management Services
- Why there is now an opportunity for Western companies to leverage China for western quality, cost effective safety studies
- Capacity that meets global standards –
- How much capacity exists presently
- What types of studies can be conducted with confidence today
- Projected service and capacity expansion over the next 12-24 months
- Key considerations before employing a “preclinical China” strategy
- Cost comparisons – Total Costs to sponsors
- Elements of total cost
- Projections of total cost 1, 5, 10 years
- Other considerations to address when placing preclinical studies in China
2:30 Changing Trends in Clinical and Related Work Being Placed in China
 Mr. Mark C. Engel, Chairman, Excel PharmaStudies Inc
- Clinical Trials in China Coming of Age in China
- Phase III Oncology Trials
- Phase IV PMS Studies
- Statistical Out-Sourcing
- A note on the relative lack of Phase I and Phase II Trials |
Solution Provider Presentation
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3:00 Afternoon Refreshment Break
CLOSING KEYNOTES:
Clinical Development Planning and Operations in China
3:30 Strategic Planning for Clinical Development Operations in China: Legal and Regulatory Considerations
Shaoyu Chen, Senior Counsel, Development & Regulatory Law Group, Amgen Inc.
A focused discussion of legal and regulatory considerations to enable the audience to:
- Achieve a clear understanding of FDA and SFDA regulatory requirements applicable to conducting clinical trials in China
- Adopt best practices to improve compliance with regulatory and legal requirements, focusing on practical ways to avoid common pitfalls in
- Regulatory submissions
- Clinical trial agreement negotiations
- Study site and investigator recruitment and relationship building
- Ethics committee review, patient recruitment, and informed consent
- Clinical trial operation, monitoring, and management
4:00 The Role of Academic Clinical Trials Units for Drug Development in Asia
Benny Zee, Ph.D., Assistant Dean of Research for the Faculty of Medicine, Directorof the Centre for Clinical Trials, School of Public Health, Chinese University of Hong Kong (CUHK)
The pharmaceutical industry in North America and Europe has been working with academic institutions in the drug development process for decades. When this process is extended to Asia, it generates growing needs in training, operation and ethical conduct of clinical trials within the academic institutions. In order to maintain high standards of Good Clinical Practice (GCP), it requires good understanding and communication between industry and Academic Institutions. There is enormous potential for partnering and quality research. Some key points to be discussed:
- Relation between pharmaceutical industry and academic institutions
- Advances in biotechnology industry and ways to make the process more beneficial
- How Asian cancer research contributes to global cancer treatment development
- The role and advantages of Cooperative Groups in Asia
4:30 Closing Remarks
5:00 pm Close of Day
Day 1