Advances in Biopharmaceutical Technology in China
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Chapter 1:   Introduction: A China Biopharmaceuticals Strategy

Scott M. Wheelwright, Ph.D.
President and CEO
Strategic Manufacturing Worldwide
info@smwbiotech.com
www.smwbiotech.com
408 420 5352

About the Author:
Scott M. Wheelwright, Ph.D., is founder and principal of the consulting firm Strategic Manufacturing Worldwide, Inc. Dr. Wheelwright has over twenty years experience in bringing novel products to market, including new drug applications (BLAs and NDAs) in the US and Japan, numerous investigational applications (INDs) and commercial product launches. His work experience encompasses pharmaceutical firms and both large and small biotech companies, including Abbott, Chiron, Scios, Calydon, DURECT and Genitope. Dr. Wheelwright received his Ph.D. in chemical engineering from the University of California at Berkeley and continued post-doctoral studies at the Max Planck Institute for Biophysics in Frankfurt, Germany. He is the author of a book on protein purification and has published numerous articles on manufacturing and process development. His focus is on long-term strategic and near-term planning for development (CMC issues including process development, analytical testing and characterization), manufacturing and facilities. Dr. Wheelwright is skilled in setting up and managing complex project plans covering all aspects of development and manufacturing. He is also well versed in the selection, negotiation and supervision of outsourcing contracts. Dr. Wheelwright, who speaks Japanese, has led project teams that have conducted technology transfer within the US and overseas, supervised scale-up at CMOs and managed complex projects involving multiple outsource vendors.

Abstract:
China has one of the fastest growing economies in the world today and its participation on the world economic and political stage is rapidly changing. China's economy is doubling about every 9 years, and the biopharmaceutical industry in China is also expanding rapidly. With a total population of 1.3 billion and a middle class rivaling the population of the United States, the market for pharmaceuticals in China is expected by many observers to continue to expand rapidly over the next few years. There are 400 research and development laboratories (including government institutes, universities, private enterprises, and state-owned enterprises) and 228 biotechnology enterprises registered in China. This collection of information represents the most comprehensive assembly of data ever put together on this subject. The authors of the various chapters include finance specialists, legal experts, academic scientists and industry observers from China, Japan, the US and Europe. The biopharmaceutical industry in China faces many challenges. While the pharmaceutical industry has filed 246 drug master files (DMF) with the US Food and Drug Administration in support of API manufacture, the infrastructure in China to support biopharmaceuticals is weak with respect to meeting international standards for Good Manufacturing Practice (GMP). Perhaps because of these challenges, many opportunities exist for collaboration with organizations in China. From research through product and clinical development to marketing and commercialization, alternatives abound for government, private enterprise, and academic partnering from throughout the world with counterparts in China. Every organization has a China strategy, though for many of us it is simply "ignore it." A great opportunity exists in working with China and implementing an effective company strategy. However, winning in Asia in the new millennium will require fundamental changes in partnerships between western and Asian companies. Every company faces the question "What should our China strategy be?" But to neglect China is to forego opportunities to gain efficiency in most of the things we are trying to do. China provides opportunities that allow us to do different things and not just do things differently. This volume provides an overview of the biopharmaceutical industry, and the state of technology. It will help the reader understand general business practice in China, analyze business opportunities and in identifying potential partners for working in China. It provides a ready reference for all aspects of the world of biopharmaceuticals in China, including general understanding, detailed technical and business descriptions, and detailed information on all types of organizations involved in biopharmaceuticals in China, whether they be companies (state owned or privately owned), universities, or government institutions.

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Eric Langer
BioPlan Associates, Inc.
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