Sino-American Pharmaceutical Professionals Association
SAPA
P.O. Box 282
Nanuet, NY 10954
www.sapaweb.org
首届中国美中药协制药及生物技术大会
- 将中国制药和生物技术产业引向国际市场
当前新药开发是一个极具挑战性，复杂而且昂贵的过程。在一个全新
的化合物从早期开发到最后进入市场的过程中，企业往往需要投入超
过十亿美元的巨额资金。所以要在未来十到二十年之间进军国际市
场，中国医药企业将面临巨大挑战。就现阶段的发展状况，中国的医
药工业急需提高与国际同行的竞争力。目前中国制药业的大部分产值
主要源于国内市场及为国外厂商提供原料药。要想真正抢占国际市
场，中国制药工业需要大力加强新药研究，生物技术以及通用名药产
品开发的能力，在安全和药效两方面都能达到国际标准。
尽管中国的制药和生物技术企业面临很大的挑战，但销售额还是实现
了连续三年的持续增长，年增长率超过百分之二十。预计到2010年，
中国将成为世界第四大医药市场。这将促使众多跨国药物公司进入中
国。所以此次会议将邀请多位专家在新药开发，临床前和临床研究，
知识产权，产品申报及市场销售等各个领域进行讨论。这将不仅促进
中国制药和生物技术产业走向国际市场，同时也能帮助国外企业进入
中国市场。为了能达到这样的目的，我们首先要准确地认识当前的
“挑战与机遇”，并且学习真正的现代药物开发的经验。
正是因为认识到了药品开发在全球范围内不断增加的挑战以及中国在
未来十年持续增长的医药市场，我们才通过组织 2007 年首届美中药协
中国制药及生物技术大会，来讨论制药和生物技术创新及全球化的机
遇和挑战。这次会议将系统详细地介绍现代药物开发的过程: 从基础研
究，药物筛选，临床前剂型设计，毒理实验，分析方法的建立，直到
生产，报批及市场销售。本次会议将帮助医药企业中的管理及技术人
员开阔视野，在原创药和通用名药的产品开发中制定更好的战略，增
强在未来国内及国际市场的竞争能力。
会议日程
时间: 2007年7月3日至5日
地点: 银河宾馆, 上海中山西路888号 邮编：200030
电话：86-21-62755888 网站： www.galaxyhotel.com
分组会1 - 药物化学 (从早期实验到临床的实例研究)
时间: 2007年7月3日 (周2) 08:30-5:30
主持人:
Mingde Xia, Ph.D. SAPA PR Director; Principal Scientist, Johnson &
Johnson
Yusheng Wu, Ph.D. SAPA Immediate-Past President; Senior Principal
Scientist, Schering-Plough
演讲人:
Yun He, Ph.D., Director, Roche R&D China
Lihu Yang, Ph.D., Director, Merck
Mingde Xia, Ph.D., Principal Scientist, Johnson & Johnson
Suhui Chen, Ph.D., Chief Scientific Officer, Wuxi Pharmatech
Weiguo Su, Ph.D., Vice President, Hutchison MediPharma
Yusheng Wu, Ph.D., Senior Principal Scientist, Schering-Plough
Guoxin Zhu, Ph.D., Chief Scientific Officer, Lilly R&D China
分组会2 - 生物研究 (靶标签定，基因组合等)
时间: 2007年7月3日 (周2) 08:30-5:30
主持人:
Jisong Cui, Ph.D. SAPA EC Member and Senior Fellow, Merck
Peng Wang, Ph.D. SAPA Member; Fellow, Schering-Plough
演讲人:
Cardiovascular biology (Jisong Cui, Merck)
Target validation (Peng Wang, Schering Plough)
Assay development and high throughput screening (Yong Jia, Abbott)
Target engagement markers in CNS antiobesity drug discovery (Xiaoming
Guan, Merck)
Anti-cancer and anti-viral drug discovery (Zhi Hong, Ardea Biosciences)
Therapeutics antibodies: discovery and development (Zhiqiang An, Merck)
……
分组会3 - 药物产品开发 (毒理，药动，制剂，分析，合成，临床和报
批)
时间: 2007年7月3日 (周2) 08:30-5:30
主持人:
Charles Ying Wang, Ph.D. SAPA President, Principal Scientist, J&J
Rick Xu, Ph.D. M.D., SAPA BD Member, Director, Roche
演讲人:
Jianji Wang, PhD, Senior Research Investigator, Bristol-Myers Squibb.
"Pharmaceutical Process Research and Development".
Min Li, Ph.D. Manager, Global Quality Services - Analytical Sciences,
Schering-Plough Corporation. "Analytical method development and
validation strategies in pharmaceutical industry".
Xiaohui Mei, PhD, Principal Scientist and Project Leader, Pharmaceutics
Department, Boehringer Ingelheim Pharmaceuticals, Inc. "Pharmaceutical
Formulation Development".
Handan He, PhD, Associate Director, Head of Preclinical PK/PD, DMPK,
Novartis Pharmaceuticals Corporation. "Drug Metabolism and
Pharmacokinetics considerations in an IND".
Charles Ying Wang PhD, DABT, Principal Scientist, Jonhson & Johnson
PRD. "Non-clinical Safety Evaluation in Drug Development: Regulatory
Requirement and Strategy of Toxicology Study Design".
Zhi-Xin Xu, MD, PhD. Clinical Director, Department of Clinical
Pharmacology, Hoffman-La Roche. "The Values of High Degree Surrogacy
Information in Supporting Clinical Trial Design and Future Drug
Development".
Ling Su, PhD, Medical and Pharma Development Director, Shanghai Roche
Pharmaceuticals Ltd. "Regulatory affairs and clinical trials in China".
分组会4 - 美国新药审批，通用名药及质量控制
时间: 2007年7月3日 (周2) 08:30-5:30
主持人:
George Xiao, Ph.D. SAPA EC Member; Manager, Schering-Plough
Jerry Huang, SAPA EC Member; Scientist, Pfizer
演讲人:
George Xiao, Ph.D., Manager, Schering-Plough
Jerry Huang, Pfizer
分组会5 - 原料药与成品药的外包及项目引进
时间: 2007年7月3日 (周2) 08:30-5:30
主持人:
Mike Liu, Ph.D., MBA., SAPA EC Member; Associate Director, Alexion
Pharmaceuticals
Bill Wei, Ph.D., SAPA BD Member; Head of Research, NexMed
演讲人:
Jinn Wu, Ph.D., President, XenoBiotic Laboratories, Inc.
Steve Yang, Ph.D., Head of Research, Pfizer Asia (ex-Japan)
Susan Capie, President, PharmaVantage
Tony Zhang, Ph.D., Managing Partner, BizPro International
Mike Liu, Ph.D., MBA, Associate Director, Global Commercial
Development, Alexion Pharmaceuticals
Bill Wei,, Ph.D., Head of Research, NexMed
分组会6 - 中药和保健品
时间: 2007年7月3日 (周2) 08:30-5:30
主持人:
Qunyi Zheng, Ph.D. President, Kent Financial Services
Weizhu Yu, Ph.D., SAPA EC Member; Scientist, Kraft Food
演讲人:
Explore for Treasure from Natural Products and Traditional Chinese
Medicine (TCM)
Rui Hai Liu, M.D., Ph.D.
Associate Professor
Department of Food Science
Cornell University
FDA review procedure and how to successfully submit a TCM drug
application to FDA.
Dr. Ruyi He
Medical Team Leader
Division of Gastroenterology Products
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA) in the United States.
Strategy for TCM to enter western market through modernization in product
development and marketing
Dr. Weizhu Yu
Manager, Product Development Center
Caravan Ingredients Company
CSM Corporation
Research, Development and North American Market of TCM
Dr. Qun Yi Zheng
President
Kent International Holdings, Inc.
Development of Botanic Drugs in US. From Pre-IND meeting to IND filing
and Clinical Trials
Dr. Simon Li
VP of Medical Research
Neuromed Pharmaceuticals, Ins
2007 年 7 月 3 日(周 2) 2:00 – 5:30 pm, Zhangjiang Hi-Tech Park
美中生物/医药合作与发展圆桌讨论会
主持人:
Han-Cheng Zhang, Ph.D., SAPA President-elect, Principal Scientist,
Johnson & Johnson
Kai-Xian Chen, Ph.D., Academician, Chinese Academy of Sciences
Jason Jin, Ph.D., President, MaxyBio Corporation, USA and Sr.Vice
President, Shanghai Biochip Corporation, China
Attendees: US pharma/biotech leaders, VC investors, business development
people, and top managers from Chinese government, pharma/biotech
companies/parks, research institutes, and SAPA leaders/members, et. al.).
大会报告
时间: 2007年7月4日(周3) 08:30-5:30
地点: 银河宾馆, 上海中山西路888号 邮编：200030
电话：86-21-62755888 网站： www.galaxyhotel.com
演讲嘉宾:
Mr. Guangdi Xu, President, Chinese Academician, Chinese Academy of
Engineering Sciences (Invited)
Mr. Yong Sang, Vice Minister, Ministry of Science and Technology China
(Confirmed)
Dr. Zhu Chen, VP, Chinese Academy of Science (Confirmed)
Dr. William Greenlee, VP, Chemical Research, Schering-Plough (Invited)
Dr. Dr. Mark Powell, VP, Pharmaceutical Development, Bristol-Myers
Squibb (Confirmed)
Dr. Lily Lee, VP, Global Clinical Operation, Johnson & Johnson.
Developing Pharmaceutical R&D in China: Challenges and Promises.
(Confirmed)
Dr. Steven Krill, VP, Pharmaceutical R&D, Boehringer-Ingelheim
(Confirmed)
Dr. Samuel D. Wright, VP & WW Basic Franchise Head, CV, Merck
(Invited)
Dr. Philip Bentley, VP and Global Head, Profiling and Safety Assessment,
Novartis (confirmed)
Dr. Frank Jiang, Associated VP, Global Clinical Operations and Head of
China Clinical Research, Sanofi-Aventis (Confirmed)
……
时间: 2007年7月5日(周4) 08:30-5:30
地点: 银河宾馆, 上海中山西路888号 邮编：200030
电话：86-21-62755888 网站： www.galaxyhotel.com
主讲人:
Dr. Li Chen, CSO, Roche R&D China
Dr. Ge Li, President & CEO, Wuxi Pharmatech
Dr. Guohua Zhang, President & CEO, NOVAST Pharmaceuticals
Dr. Samantha Du, Managing Director, Huchitson MediPharma
Mr. Hua Bai, President & CEO, Zhejinag Hisun Pharma.
Mr. Huacheng Wei, President & CEO, Beijing Pharmaceutical Groups
Mr. Guangchang Guo, President & Chairman, Fosun
Dr. Linshi Tan, General Manager, Pfizer China
Dr. Zhi Hong, VP, Drug Discovery, Valeant Pharmaceuticals
Dr. En Li, VP of Research, Novartis China
Dr. Kewen Jin, President & CEO, BioExplorer
……
组织委员会
Dr. Yusheng Wu, SAPA Immediate-Past President; Senior
Principal Scientist, Schering-Plough
共同主席: Dr. Charles Ying Wang, SAPA President; Principal Scientist,
Johnson & Johnson
Dr. Huayi Tong, SAPA BD Chair; Director, Ciba Special
Chemicals
主席:
秘书长:
Dr. Xiaohui Mei, SAPA EC Member; Principal Scientist,
Boehringel-Ingelheim
组委会成员:
 Dr. Li Chen, SAPA BD Member; CSO, Roche R&D China
 Dr. Jisong Cui, SAPA EC Member; Senior Fellow, Merck
 Ms. Helena Feng, SAPA Treasurer; Group Leader, Wyeth
 Dr. Junyan Hong, SAPA BD Member; Professor, Rutgers University
 Dr. Jingshan Hu, SAPA-West President; Research Leader, Roche
Polo Alto
 Dr. John Hu, SAPA AC Chair and BD Member; VP, U.S.
Pharmacopeia
 Mr. Jerry Huang, SAPA Membership Director; Scientist, Pfizer
 Mr. Kewen Jin, SAPA BD Member; CEO & President, Shanghai
BioExplorer, Inc.
 Ms. Jenny Li, SAPA BD Member; Scientist, Pfizer
 Mr. Kechun Li, SAPA BD Member; General Manager, Chiral Quest
China
 Dr. Jian Li, SAPA-GP President; Principal Scientist, Johnson &
Johnson
 Dr. Min Li, SAPA BD Member; Manager, Schering-Plough
 Dr. Mike Liu, SAPA EC Member; Associate Director, Alexion
Pharmaceuticals, Inc.
 Dr. Xiaohui Mei, SAPA EC Member; Principal Scientist, BoehringerIngelheim
 Dr. Li Shi, SAPA AC Member; Associate Director, Merck
 Dr. Huayi Tong, SAPA BD Chair; Director, Ciba Special Chemicals
 Dr. Tsang-Bin Tzeng, SAPA EC Member; Senior Director, SanofiAventis
 Dr. Charles Ying Wang, SAPA President; Principal Scientist,
Johnson & Johnson
 Dr. Jin Wang, SAPA AC Member; Manager Partner, MCG
 Dr. Bill Wei, SAPA BD Member; Head of Research, NexMed
 Dr. Yusheng Wu, SAPA Immediate-Past President and BD Member;
Senior Principal Scientist, Schering-Plough
 Dr. Mingde Xia, SAPA PR Director; Principal Scientist, Johnson &
Johnson
 Dr. George Xiao, SAPA EC Member; Manager, Schering-Plough
 Dr. Rick Xu, SAPA BD Member; Director, Roche
 Dr. Ning Yan, SAPA EC Member; Director, Wyeth
 Dr. Weizhu Yu, SAPA EC Member; Scientist, Kraft Food
 Dr. Hancheng Zhang, SAPA President-Elect; Principal Scientist,
Johnson & Johnson
 Dr. Qunyi Zheng, SAPA EC Member; President, Kent Financial
Services
 Gui-Bai Ling, Sr. Fellow, Merck
***Note:
EC Member = Executive Committee Member
AC Member = Advisory Committee Member
BD Member = Board of Directors Member
大会顾问委员会:
Mr. Guangdi Xu, President, Chinese Academician, Chinese Academy of
Engineering Sciences
Mr. Yong Shang, Vice Minister, Ministry of Science and Technology China
Dr. Zhu Chen, VP, Chinese Academy of Science
Dr. William Greenlee, VP, Chemical Research, Schering-Plough
Dr. Dr. Mark Powell, VP, Pharmaceutical Development, Bristol-Myers
Squibb
Dr. Johan Van Hoof, Senior VP, Global Clinical Operation, Johnson &
Johnson
Dr. Steven Krill, VP, Pharmaceutical R&D, Boehringer-Ingelheim
Dr. Samuel D. Wright, VP & WW Basic Franchise Head, CV, Merck
Dr. Yi-Ping Li, Chairman, Science & Technology Commission of Shanghai
Municipality
……