Sino-American Pharmaceutical Professionals Association-New England (sapa-ne)
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- New Drug Approval and Innovative Atmosphere in China
- The Status and Development in Shanghai Biotech
- At the Crossroads: China’s Pharmaceutical Market
- SAPA-NE 2000-2001 Outstanding Contribution Award
AbstractThe current worldwide focus on containing health care expenditures and the highly competitive environment in the pharmaceutical industry have placed substantial pressure on drug manufacturers and regulators to improve efficiency and quality in the drug development process. Regulatory reform in many of the world’s major markets has created a new dynamic between drug firms and regulatory authorities. In the United States, the Prescription Drug User Fee Act of 1992 (PDUFA) has contributed to shorter FDA approval times, and with passage of the FDA Modernization Act of 1997 (FDAMA), FDA is focusing on reducing lengthy clinical development times. With Congressional hearings to reauthorize the collection of user fees scheduled for winter 2002, regulatory initiatives and industry practices are coming into sharper focus. These and other issues will be discussed in this presentation. Biography Dr. Kaitin is the Director of the Tufts Center for the Study of Drug Development at Tufts University, where he studies national and worldwide trends in pharmaceutical innovation, regulation, and public policy. He is also Assistant Professor of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine. Dr. Kaitin has written extensively on factors that contribute to the slow pace and high cost of pharmaceutical R&D, and the impact of regulatory and legislative initiatives to speed drug development and approval. His articles have been published widely in medical and policy journals. Dr. Kaitin has provided testimony before the U.S. Congress in hearings on FDA reform, and he has worked closely with the U.S. Council on Competitiveness in the preparation of their report on the pharmaceutical industry. He is a former President of the Drug Information Association, and he serves on the faculty of the European Center for Pharmaceutical Medicine. He is a member of the American Society for Clinical Pharmacology and Therapeutics, the New York Pharma Forum, the Drug Information Association, and Regulatory Affairs Professionals, and serves on the editorial boards of the American Journal of Therapeutics, Clinical Research and Regulatory Affairs, and the Drug Information Journal. Dr. Kaitin received a B.S. from Cornell University and an M.S. and Ph.D. in pharmacology from the University of Rochester. New Drug Approval and Innovative Atmosphere in ChinaMs. Rongling Deng, M.Sc., WHO Fellow Tufts Center for the Study of Drug Development 192 South Street, Suite 550 Boston MA 02111 Tel: 617-636-2184 Fax: 617-636-2425 Email: rongling.deng@tufts.edu Abstract In past ten years, Chinese pharmaceutical industry has made significant achievement. Since the pharmaceutical patents enacted on January 1, 1993, China has realized the importance and necessity of pharmaceutical and biopharmaceutical innovations. China authority has taken steps of measures and adjusted its strategies to develop a fairly competitive environment. Chinese pharmaceutical industry has taken responsibility for searching completely new therapeutics in a variety of disease areas. In this presentation, speaker will introduce new drug regulatory administration and application procedures in China, review new drug approval in past ten years and analyze current situation of new drug development in China. Biography Ms. Rongling Deng is a W.H.O Fellow at Tufts Center for the Study of Drug Development. Ms. Deng received her BS and MS in the Department of Pharmaceutics at West China Medical University. Before she came to Tufts Center for the Study of Drug Development, she was a senior reviewer for ten years in Sichuan Drug Administration. She is very familiar with the history and the procedures of drug development in China.
AbstractSince the end of 1993, Shanghai government has decided to make biotechnology and pharmaceutical industry the most important direction of its development. Nowadays, under the guidance of the government's policy and energetic engagement with enterprises and research institutes, Shanghai has made great progress in the study of theories, technological applications, exploration and industrialization of small scale research. In addition, the industry scale, the product pipeline, the quality of operation and the total layout of the industry itself are changing for the better. In the next five years, Shanghai government will determine that biotechnology and the pharmaceutical industry are new strategic targets. Shanghai will create new drug development framework and mainly develop biotechnology and natural drug products with emphasis on the drug market. We warmly welcome investments from both domestic and overseas and continue to promote the pharmaceutical industry that will benefit all parties involved.
BiographyMr. Wang Jianping graduated from Shanghai Jiao Tong University. He is currently a Senior Engineer and Director of the Department of Science & Technology Commission of Shanghai Municipality. He is also Assistant Director in the Biotechnology & Pharmaceutical Industry Office of Shanghai Municipality. He has been engaged for a long time in the management of both science and technology research and development. His responsibilities include routine management of affairs, drafting medium and industry in Shanghai, formulating policies to promote priority of projects and the coordination of programs in the development of biological medical projects.
AbstractThe Chinese pharmaceutical market, its main drivers, various sectors and the regulatory environment are discussed. Huge regional and urban-rural disparities in drug expenditure and lifestyles characterize the market, which is driven by a combination of factors such as greater utilization of drugs, increase in urban population, rapidly aging population and changing disease profile and healthcare reforms. The market is and in the near future will be dominated by the hospital sector although the over-the-counter (OTC) drugs poise to carve an increasing share of the market. The market dominance by generic products and the shift towards locally produced drugs are set to continue in the foreseeable future as a result of government policies in healthcare reforms and price control. The recent development and future prospect of government’s healthcare reform program are discussed as is its impacts upon the medical industry. The domestic pharmaceutical industry has been struggling to pull itself out of the inflexibility and restraints under the planned economy and is undergoing painful structural changes. These changes are vital for its continued survival as China’s WTO accession draws closer. SOE reforms in the industry, foreign investments, the problems with intellectual property rights and the convoluted distribution system are discussed along with the issues facing the government’s drive to develop the industry in the western regions of China. Within the industry, three sectors are identified as future high growth areas: 1) Biotech sector, 2) OTC sector, 3) Traditional Chinese Medicine (TCM). Each of these sectors is examined in details with regard to its market structure, growth areas/products and the its main problems. The pros and cons of their development plans are also discussed. BiographyDr. Qi Bao, Senior Consultant, Manager of Pharmaceuticals Group. Qi is the pharmaceuticals sector specialist at China Concept. He resides in London but divides his time among China Concept’s London, Beijing and Hong Kong Offices. He graduated from Shandong Medical University in China and obtained his Ph.D. in medicine at the Royal Postgraduate Medical School in London. Following several years in pharmaceutical research project management, he undertook and completed a MBA study at Cranfield School of Management in England. After his Ph.D., Qi worked as a clinical researcher and then project leader at Hammersmith Hospital and the National Institute for Medical Research in London for 7 years. During the period, he led a number of high-profile international clinical projects involving project teams from France, Germany, Denmark, USA, China and the UK and had many publications in peer-reviewed journals. Following his MBA, Qi joined China Concept Consulting where he leads the pharmaceuticals group and all projects in the sector. Working closely with the regulatory authorities in both China and Europe, and the industry, he has led a number of market research and public affairs projects at China Concept for clients in the pharmaceutical industry and investment-banking sector. He was a main editor/translator of China Pharmaceuticals Guide, a joint publication by The Information Center of SDA, China Concept Consulting and Informa Pharmaceuticals in London. Qi is also the Editor-in-Chief of www.ChinaPharmaNews.com, a joint-venture online news service in English provided by China Concept in association with SDA on latest developments in the Chinese pharmaceutical market. Qi serves as the Secretary General of Chinese Medical Society UK. SAPA-NE 2000-2001 Outstanding Contribution AwardDr. Huimin Chen: SAPA-NE Director of Membership, Genetics Institute Accomplishments: Dr. Chen took great efforts to reorganize the SAPA-NE membership database which ensured the timely renewal of all old memberships and facilitated the communication between the executive committee and SAPA members. He organized and chaired the SAPA-NE March 24 Intellectual Property Symposium. He also re-established the SAPA-NE coordinator team and helped to hold a couple of coordinator meetings. Dr. Chen published a general gene therapy paper as well as reporting a few SAPA events for the SAPA newsletter.
Accomplishments: Dr. Xian collected information to facilitate the use of our organization as a platform to help our members in their career development. He also organized and chaired SAPA-NE Nov’00 career workshop which attracted over 100 members including 16 company recruiters from Genzyme, Biogen, Genetics Institute, Millennium, etc., to post job listings and meet our members. He also collected and updated job listing information from other companies on our website which helped our members to obtain job offers. He was also in charge of the trade exhibition and job clearing house sessions in several of our other symposia, especially at the annual meeting.
Accomplishments: For the past 3 years, Mr. Shen has been a great supporter and advisor to SAPA-NE's various IT initiatives including the design of the membership database, establishment and development of SAPA-NE's website, and the implementation of online registration, forum, job posting service, etc. By providing many technological insights and expertise to the SAPA-NE chapter, he dedicated much of his time and personal contributions to facilitate and maintain the website as well as communication between the SAPA-NE executive committee and its members. His dedication and commitment in this effort has been appreciated by many SAPA members.
Accomplishments: Dr. Hong is one of our most active members. He was a speaker at one of the SAPA drug discovery symposia and helped to organize several SAPA-NE symposia by inviting speakers to the meetings or acting as a host. He also provided valuable consultation for our organizational development in moving SAPA to the US mainstream and contributed greatly towards our fund-raising efforts.
Accomplishments: Ms. Quern has assisted greatly in the preparation of the 4th SAPA-NE Annual Conference and put forth tremendous efforts in its mailer design and conference promotion. She also initiated and implemented the on-line registration set-up combined with the ArQule website as well as playing a key role between SAPA-NE executive committee and the lead sponsor company, ArQule, Inc..
Ms. Jean DuffyAccomplishments: Ms. Duffy participated in several SAPA-NE career service sessions. She displayed many career opportunities in her organization and communicated directly with our members in a personal manner that was highly appreciated with our members. Jean was a good example in demonstrating communication between biotech/pharmaceutical employers and SAPA members. Corporate Award: ArQule Inc., the lead sponsor of SAPA-NE 4th Annual Conference. SAPA-New England Events (1999-2001) 08/07/1999 Rutgers University SAPA 7th Annual Conference 08/28/1999 MIT SAPA-NE 1st Election Party 09/10/1999 Sichuan Garden SAPA-NE EC Meeting 09/26/1999 Boston City Hall Celebration of 50th Anniversary of PRC 10/02/1999 Blue Hill Reservation SAPA-NE 1st Coordinator Outing 11/06/1999 MIT SAPA-NE Biopharmaceutical Forum 11/06/1999 MIT SAPA-NE EC Meeting 11/14/1999 King School Passport Renewal 12/17/1999 Yangtze River Restaurant SAPA-NE EC Meeting 01/22/2000 MIT SAPA-NE 2nd Celebration of Chinese New Year 02/13/2000 Royal East Meeting with William Au (Guangzhou International Bioisland) 02/27/2000 MIT SAPA-NE EC Meeting 03/11/2000 MIT SAPA-NE 2nd Business Development Symposium 04/11/2000 Biogen Dalian Delegation 05/06/2000 Yangtze River Restaurant SAPA-NE EC Meeting 05/11/2000 Beijing International Biotechnology Conference 06/24/2000 MIT SAPA-NE 3rd Annual Conference 08/05/2000 Rutgers University SAPA 8th Annual Conference 09/15/2000 SAPA NE Election/Member Reunion Party 09/22/2000 MIT SAPA-NE EC Meeting 10/14/2000 Blue Hill Reservation SAPA-NE 2nd Coordinator Outing 11/03/2000 YumYum Restaurant SAPA-NE EC Meeting 11/11/2000 MIT SAPA-NE Career Workshop 01/28/2001 MIT SAPA-NE 3rd Celebration of Chinese New Year 02/24/2001 International Buffet SAPA-NE EC Meeting 03/17/2001 Royal Dynasty Restaurant SAPA-NE EC Meeting 03/24/2001 MIT SAPA-NE Intellectual Property Symposium 04/22/2001 Harvard Business School SAPA-NE EC Meeting 05/18/2001 MIT Whitehead Institute SAPA-NE EC Meeting 06/08-9/2001 Harvard Business School SAPA-NE 4th Annual Conference Rhodia ChiRex, A Corporate Sponsor of SAPA-NE T   he mission:
to commercialize new drugs The method: our chemistry services Rhodia ChiRex is a leading company in the field of pharmaceutical active ingredient outsourcing, offering a combination of proprietary chiral and non-chiral process chemistry technologies, contract process research, development services, and commercial-scale contract manufacturing. Our sustainable competitive advantage is based on: Experienced and highly competent people Customer intimacy and responsiveness Reliability through tight control of our commitments Breadth and competitiveness of our technologies and processes Full range of capabilities from laboratory to commercial scale Rhodia ChiRex Inc. 56 Roland Street Boston, MA 02129 1-617-628-5246 hr@rhodiachirex.com www.rhodiachirex.com 
The Drug Substance Company
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