Session 1: Overview of the Drug Development System in China
Session leader: Chloe Liu, Ph.D., Managing partner, Modular R&D
- SFDA regulatory approval process
- Hospital system and designated trial sites
- Sponsors, PIs and CRAs
- Landscape of the Chinese CRO industry
Session 2: Development Strategy Design
Session leader: Irene Deng, Head of Drug Regulatory Affairs, Oncology Business Unit, Novartis China
- Overview of regulatory pathways
- Panel discussion of case study
- Do I go to China solo or as part of an Asia-Pacific strategy?
- Local registration or part of a global trial?
- Do I manufacture in China?
- How long will different development options take?
Session 3: Selecting the right CRO
- Summary of the CRO selection process and example molecule research results
- Discussion with selected CROs
- Key factors in CRO selection
- Project management and quality system
- Communication between CRO and sponsor
- The pricing structure, a comparison with the global standard
- Case study
Session leader: Yan Wu, Medical and Clinical Development Director, Biogen Idec China
Conclusion: Summary Presentation and Q&A
Session leader Bio:
Irene Deng, Head of Drug Regulatory Affairs, Oncology Business Unit, Norvartis China
Ms. Irene Deng is head of DRA, oncology business unit, at Novartis China, and is responsible for the development of strategic plan and regulatory submissions of oncology products to the SFDA. Prior to joining Novartis, Irene worked in similar roles in Pfizer and GlaxoSmithKine and worked on successful filing of a variety of applications including class I and class 3 IND and NDA, global multicenter trials, site transfer, labeling and packaging and renewal. During over ten year’s experience, she gained solid experience in many therapeutic areas such as immunology, oncology, CNS, anti-infection, ophthalmic etc. Aside from pharmaceuticals, Irene is intimately familiar with the medical device industry as the head of regulatory affairs for Advanced Medical Optics (Now Abbott Medical Optics Inc.) and in regulatory filings in other Asian pacific countries, especially Korea. Irene graduated from Peking Chemical Engineering University majoring in biochemical engineering, and is a certified pharmacist.
Yan Wu, Director of Medical Affairs, Biogen Idec China
Dr. Yan Wu is the medical director for Biogen Idec China where he supports medical affairs and clinical trials in China and Asia. Dr. Wu has been in Clinical Research Management for the last 16 years. He started to take the role as project manager for international trials in Astra. After that he joined Quintiles as both clinical manager and project manager, where he has successfully supervised many international trials and a few local trials and led the set up of CTS facility. After 8 years excellent work in Astra and Quintiles, he joined Boehringer Ingelheim as Head of Clinical Research where he led a team of regional project managers for global clinical studies and set up the Asia hub for global clinical research. He was both the member of Steering Committee and Trial management committee for a global neurology mega trial. He has been also responsible for CRO selection for many trials and has rich experience in cooperating with CRO.
Chloe Liu, Ph.D., Managing Partner, Modular R&D
Dr. Chloe Liu is the founder and managing partner of Modular R&D, overseeing corporate development as well as leading the research effort and consulting business. Before founding Modular, she was the Director of Business Development for Shanghai Sunway Biotech Company, and worked in a variety of capabilities including coordinating the company’s series C private placement in the U.S. and building a strategic Genzyme-sunway partnership in China. Previously, she worked as a research analyst in New York-based information service firm OneMedPlace, and as a consultant in Shanghai-based life-science consulting firm General Biologics. Dr. Liu has a Ph.D. in Molecular and Cellular Biology from the University of Minnesota.
Last update October 18, 2010. Agenda subject to change depending on the drug candidate identified.