SAPA
P.O. Box 282
Nanuet, NY 10954
www.sapaweb.org
SAPA China Pharmaceutical & Biotechnology Conference
/Bio-Forum 2007
“Moving China Pharmaceutical and Biotech Industry into International Market Place in Next Decade”
Current drug development for unmet medical needs is a very challenge and complicated process which cost the developers $800-$1200 millions to bring a qualified product from discovery to the market. China pharmaceutical industry is facing the great challenge of moving into international market place in next one or two decades. The current status of pharmaceutical industry and medicine development in China has signaled the need of increased power of competing with international drug makers. Currently, the dominated revenue of China pharmaceutical industry is mainly originated from manufacturing of drugs targeting domestic medicine market and API supplies and drug discovery support for international drug makers. To compete with world modern drug developers for international market, China pharmaceutical industry would need to build strong drug development potential that is able to facilitate China’s current innovated drug discover, biotech advancement and generic candidates to renovate into the medicine dosage form with competitive quality and meet international safety and efficacy standards.
Although Chinese pharmaceutical and biotech industry is facing the great challenge, the sale of pharmaceutical products in China has been increased for three consecutive years with an annual increase rate of more than 20%. It is estimated that China will be in No. 4 place in global pharmaceutical market by 2010. These are driven force for many global pharmaceutical companies to enter the Chinese pharma market. The conference will invite executives and experts of pharmaceutical and biotech industry to discuss the innovated drug discovery, preclinical and clinical development, IP, license, regulatory, marketing, etc., which will not only facilitate China pharmaceutical and biotech industry moving into international market place, but also promote global drug makers moving into China pharmaceutical and biotech market.
The first step to achieve this goal is to accurately recognize the true “Opportunities and Challenges” and learn “The Real World Experiences” of modern medicine development process.
With the believe of increasing challenges in drug development worldwide and China’s continue growth in medicine market in next decade, SAPA is organizing its “SAPA China Pharmaceutical & Biotechnology Conference 2007” to discuss the Opportunities & Challenges: Pharmaceutical and Biotechnology Innovation and Globalization and to introduce the Modern Process of Medicine Development in details step-by-step from discovery research and candidate selection, to preclinical development for dosage form design, toxicity evaluation, process and analytical development, to clinical development for safety assessment, clinical evaluation, and stability studies, and all the way to manufacturing, regulatory filing for license application as well as commercialization. Learning of modern drug development from SAPA Conference and workshops will help pharmaceutical industry managers and officers to develop a better vision and strategy in both innovated and generic medicine development with competitive quality for both domestic and international market in next decade.
Location: Shanghai Galaxy Hotel (Main Conference)
Pre-Conference Workshops: (Location: Shanghai Fenglin Biopark)
Date: 7/3-7/5/2007
Preliminary Program
7/3/2007 Pre-Conference Parallel Workshops***
Location: Shanghai Fenglin Biopark
Time: 8:30 AM-5:30 PM
Ø Workshop I: Medicinal Chemistry (Real Case Studies from scratch to the clinic)
Moderators:
Mingde Xia, Ph.D. SAPA PR Director; Principal Scientist, Johnson & Johnson
Yusheng Wu, Ph.D. SAPA Immediate-Past President; Senior Principal Scientist, Schering-Plough
Presenters:
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
Ø Workshop II: Discovery Biology (Target Validation, Gen Chips/Genomics, RNAi)
Moderators:
Jisong Cui, Ph.D. SAPA EC Member and Senior Fellow, Merck
Peng Wang, Ph.D. SAPA Member; Fellow, Schering-Plough
Presenters:
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)
……
Ø Workshop III: Drug Development (Toxicology, ADME, Clinical Development, Regulatory /NDA Filing), Formulation, Analytical Development, Chemical Development)
Moderators:
Charles Ying Wang, Ph.D. SAPA President, Principal Scientist, J&J
Rick Xu, Ph.D. M.D., SAPA BD Member, Director, Roche
Presenters:
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".
Ø Workshop IV: U.S. Regulatory Affairs, Generic & cGMP (IND, NDA, DMF, ANDA, OTC, QA & GLP/GMP auditing/inspection and Generic Drugs)
Moderators: George Xiao, Ph.D. SAPA EC Member; Manager, Schering-Plough
Jerry Huang, SAPA EC Member; Scientist, Pfizer
Presenters:
George Xiao, Ph.D., Manager, Schering-Plough
Jerry Huang, Pfizer
Jerry Huang, Pfizer
Xiaoyin Zhang, Ph.D. Alpharma
JosephZhou, Ph.D., Par Pharmaceuticals
Alfred Melvin, Ph.D., Par Pharmaceuticals
George Xiao, Ph.D., Schering-Plough
Chris Yan, Ph.D., Forrest Lab.
Ø Workshop V: Business Development in R&D Outsourcing, API/Generics Sourcing, and Licensing
Moderators: Mike Liu, Ph.D., MBA., SAPA EC Member; Associate Director, Alexion Pharmaceuticals
Bill Wei, Ph.D., SAPA BD Member; Head of Research, NexMed
Presenters:
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
Ø Workshop VI: Traditional Chinese Medicine (TCM) & Nutraceutics
Moderators: Qunyi Zheng, Ph.D. President, Kent Financial Services
Weizhu Yu, Ph.D., SAPA EC Member; Scientist, Kraft Food
Presenters:
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
………………..
SAPA Round-Table Summit
2:00-5:30 PM
Location: Zhanhjiang HighTech Park
Moderator:
Han-Cheng Zhang, Ph.D., SAPA President-elect, Principal Scientist, Johnson & Johnson
Kai-Xian Chen, Ph.D.,中科院院士, 原上海药物研究所所长
Jason Jin, Ph.D., Sr.Vice President, Shanghai Biochip Corporation, China and President, MaxyBio Corporation, USA
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.).
Dinner Reception
“Fenglin Night”
7:00-9:00 PM
Galaxy Hotel
7/4/2007 (Wednesday)
Plenary Keynote Session
Time: 8:30 AM-5:30 PM
Location: Shanghai Galaxy Hotel
Keynote Presentations:
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)
……
Dinner Reception
7:00-9:00 PM
Galaxy Hotel
7/5/2007 (Thursday)
Parallel Sessions
Time: 8:30 AM-5:30 PM
Location: Shanghai Galaxy Hotel
Session I “Innovation and industrialization of Biotechnology”
Session II “New drugs and the internationalization of TCM”
Session III “Biotechnology and pharmacy investment and cooperation opportunity”
Session IV “Agricultural biotechnology and biopesticide”
Session V “Pharmacy economic information and policy trend ”
Session VI “Biotech & Pharmaceutical Opportunity & Challenge”
Presentations:
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. 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. Guoxin Zhu, Chief Scientific Officer, Lilly R&D China
Dr. Kewen Jin, CEO, BioExplorer
……
SAPA Conference Committee
Chair: Dr. Yusheng Wu, SAPA Immediate-Past President; Senior Principal Scientist, Schering-Plough
Co-Chairs: Dr. Charles Ying Wang, SAPA President; Principal Scientist, Johnson & Johnson
Dr. Huayi Tong, SAPA BD Chair; Director, Ciba Special Chemicals
General Secretary: Dr. Xiaohui Mei, SAPA EC Member; Principal Scientist, Boehringel-Ingelheim
Organization Committee (alphabetical):
§ 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. Gui-Bai Liang, SAPA EC Member, Sr. Fellow, Merck
§ Dr. Mike Liu, SAPA EC Member; Associate Direcotr, Global Commercial Development, Alexion Pharmaceuticals
§ Dr. Xiaohui Mei, SAPA EC Member; Principal Scientist, Boehringer-Ingelheim
§ 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, Sanofi-Aventis
§ 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
***Note:
EC Member = Executive Committee Member
AC Member = Advisory Committee Member
BD Member = Board of Directors Member