会议介绍
Previous and current speakers as below,
Audrey Jia,M.D., Ph.D, Former FDA biological product CMC Reviewer, Division of Monoclonal Antibodies, Office of Biotechnology Products,CDER, USFDA, USA
Huijun Gao,Deputy Director,Shanghai FDA
Stefan Schmidt, Ph.D., MBA, Vice President, GMP Operations, Rentschler Biotechnologie GmbH
Peter F. Moesta, Ph.D., Senior Vice President, Biologics Development & Operations, Bristol Myers Squibb Co.
Robert Friesen, Ph.D.,Vice President and Global Head of Biologics Research, Biotechnology Center of Excellence, Janssen R&D, LLC (Johnson & Johnson), USA
Rene Hoet, Ph.D.,Vice President Global Biologics, Antibody Lead Discovery,
Bayer Healthcare, Germany
Johannes Salzbrunn,Head of GMP Downstream / Fill & Finish, Boehringer Ingelheim Shanghai Pharmaceuticals, China
Satoru Noguchi,Vice President, Emerging Market Business Unit Area Head of Greater China,Chairman,Takeda (China) Holdings
Kim Wong,Director, Facilities & cGMP Support, BioProcess Research & Development,Sanofi Pasteur, Canada
James Sayer,Director, Global Product Quality,Amgen, United States
Scott Wheelwright,CEO,Complya Asia, China
Zhiwei Song,Principal Scientist, Expression Engineering, Bioprocessing Technology Institute, A*STAR, Singapore
Jong Seo Lee, CEO,AbClon, Korea
Weijun Li, Ph.D.,Senior Staff Development Scientist, Analytical Development and Support, Global Biological Development,Bayer HealthCare LLC, USA
Yanrong Dong, M.D.,Senior Scientist/Group Leader, Cell Biology,AlphaMab Co. Ltd., China
Qibin Liang,Chief Operation Officer,MabPlex International, China
Wen Ryan, Ph.D., Vice President of Technical Operations, Livzon Mabpharma, Inc., China
Wenjie Cheng, Ph.D., Principal Scientist, Process Science and Engineering, Immunogen, Inc., USA
Yunpeng Su, D.Phil., Scientific Director, NovoMab Biopharmaceutical, Inc., China
Doug Chen, Director of Process Development, Shanghai Benemae Pharmaceutical Co., China
Jian Ni, CEO, The National Engineering Research Center of Antibody Medicine (CMAB), China
Sheldon Cao, CEO, Zova Biotherapeutics Inc., China
Bruce Nian He Han, Chief Scientific Officer, NewBio Therapeutics, China
Wenzhi Tian, Founder and President, ImmuneOnco Biopharma, China
Frederic Rohmer,General Manager,Lilly Suzhou Manufacturing, China
Hang Zhou,Director of Biologics,Wuxi AppTec Biopharmaceuticals, China
Claudia Lin,Vice President of Quality and Compliance,Innovent Biologics, China
Yanshan Huang,CEO,Zhejiang Doer Biologics, China
Qing Qiao Robin Tan,Head of Analytical Science,Shanghai CP Guojian Pharmaceutical, China
Jason Li,Vice President,Genor Biopharma, China
Xueming Qian,Chairman and CEO,MabSpace Biosciences, China
Amy Que,Executive Director, Protein Analytical Science, Biologics and Bioprocess, Wuxi AppTec
Dr Jincai Li, Executive Director, Biologics Process Development, Wuxi AppTec, China
Changlin Dou,Deputy General Manager, BoAn Biotechnology
Company, A Subsidiary of Luye Pharma Group, China
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世界生物制药工艺流程领袖中国峰会做为聚焦发展中的中国生物制剂市场的综合性学会，以挖掘出卓越制程开发策略和制造策略，以及获得加速生物制剂商品化的协助上受到高度评价。吸收因应各种生物治疗药物上下游制程开发、生物药品制造技术和设备、分析和品质管理等新手法相关知识的宝贵机会，千万不要错过。
有效的细胞株、细胞培养技术/培养液的开发与上游制程
下游制程的开发与精制之瓶颈的克服
利用特性化和规格详述的新手法强化分析能力与品质管理能力
生物仿制药开发与生产的新数据
生物药品制造设施的新技术与设计
生物制剂的规范环境与IND申请的期间缩短
会议名称：世界生物制药工艺流程领袖峰会2016
会议时间：2016年6月16-17日
会议地点：上海博雅酒店
如果您期望与亚洲生物制药领域的决策者们会面及交流学习，这里将是您唯一正确的选择。令您及您的团队始终处于亚洲生物制药发展最前沿，尽在2016年6月16-17日的世界生物工艺流程领袖中国年会，期待您的参与！
届时峰会将有国际主题演讲，产业及学术报告，众多交流机会，将为高端科技及商业探讨打造一个互动的平台。
World BioProcess Leaders China summit provides you with practical tools, technologies and strategies to drive efficiencies in your process development and biomanufacturing activities so you can accelerate your biologics to commercialization. Benefit from multiple case studies and industry experts who will share strategies to save you time and money while reducing the development timeline from IND to market.
You will learn how to navigate the CMC studies and regulatory challenges of biological products developed in China and compare requirements from the CFDA and US FDA. You will also learn about new approaches for upstream and downstream development, biomanufacturing facility readiness, analytical and quality control for a wide-range of biotherapeutics including ADCs, bispecifics, next-generation mAbs and biosimilars.
No other conference in China provides a more comprehensive update of the technical, scientific and strategic innovations across all phases of bioprocess development.
With over 40 speakers and estimation to bring over 180 Biopharma professionals, the key congress topics will cover:
Upstream: Cell Line and Cell Culture Processing
Downstream: Recovery, Purification and Viral Safety/Clearance
Navigating Regulatory Interactions with CFDA and US FDA
Portfolio Updates on Innovative Biologics R&D in China
Analytical Methods and Formulation Strategies and Technologies
Quality Control, Quality Assurance and QbD
Biomanufacturing, Facility Readiness and GMP Compliance
Biosimilars: Regulatory Experiences and Risk-based Strategies