2nd International China BioPharmaceutical Symposium (ICBPS II)
18-21 November 2008,
Shanghai, China

A preliminary announcement

The China Pharmaceutical Association (CPA) and Battelle Memorial Institute, as Hosts and Sponsors, take pleasure in announcing this second ICBPS.

          Beijing, China. Mr. Liu Chunguang, International Affairs Department, CPA, has notified Battelle Memorial Institute's Dr. David Robinson and Dr. Mason Soule that preparations are proceeding rapidly for this second CPA/Battelle ICBPS meeting. This ICBPS is to bring all professionals in the international pharmaceutical and biopharmaceutical as well as regulatory communities together to further dialog and coordination/cooperation in these critical areas. Goals and objectives will include to learn each others capabilities and capacities for product development and manufacturing; to learn the technical, scientific, medical and legal aspects of the processes associated with research and development, drug discovery, and developing and bringing biopharmaceuticals and pharmaceuticals to market in China and the West. These areas include standards and trade practices, case studies and regulation, as well as distribution and networking, market development internal to and external from China for Chinese and non-Chinese product, bulk product and an exploration of the benefits of having stable supplies of Active Pharmaceutical Ingredient (API).

          This ICBPS II effort follows the very successful ICBPS I which was held in Beijing in December 2006. As one member of the Western diplomatic community noted about ICBPS I "A World Class event". Some of the papers at CBMTS I included:

• Partnerships from applied science to commercialization
  
• Anti-body based biopharmaceuticals in China
  
• Conjugate vaccine development in China
  
• The third revision of the Chinese patent law
  
• Licensing of medical products requires using alternate approaches on efficacy demonstration when traditional human clinical trials are not possible
  
• The clinical trial for a new drug in China
  
• A novel polyepitope Malaria vaccine randomly constructed with epitope shuffling
  
• Correlation of disulfide bond conformation to hormonal activity of oxytocin
  
• The biopharmaceutical market in Brazil
  
• An overview of the drug sector within the Saudi Food and Drug Authority with emphasis on biologicals
  
• Key factors in the growing European biotechnology sector

A. Who Should Attend ICBPS II?

• Industry, government and academic professionals in science, medicine, law and policy.
  
• Specialists in intellectual property rights, marketing professionals, and government specialists in the requirements area of their FDA type organizations.
  
• Medical, veterinary, public health and research professionals; industry scientists/engineers with an interest in either introducing product into China, helping to develop specialized product within China or exporting product such as API from China.

B. Call for papers/topic and theme areas:

          This is a science and industry meeting to exchange ideas and approaches for manufacturing and testing biotherapeutics in both China and Western countries. This exchange will be between industry and science, medical, legal and business professionals. Chinese and Western industries have much to gain from each other beyond scientific exchange: China has capabilities and capacities to produce both intermediates and final drug chemicals and biologicals and Western companies have knowledge and ability to test and produce drugs and biologicals according to the GLP/GMP standards. For industry - how do we keep the pipelines full.

Major Topic Area

1. Biopharmaceuticals/therapeutics, including vaccines, antibodies and immunomodulation therapeutics. The focus is on new approaches/treatments for old/emerging diseases.
   
2. Transitioning from science to products; drug discovery to clinical testing. The road is neither smooth nor straightforward. What are acceptable paths?
   
3. Pre-clinical testing and clinical trials. What makes testing and trials successful? Can trials in China and other countries be acceptable to each other without duplication?
   
4. Production, importance of requirements and procedures for GMP, especially for bulk active pharmaceutical ingredients (APIs). Stability, storage and purity of APIs. How to design a biopharmaceutical plant to meet GMP requirements and why they are important.
   
5. How to navigate and understand the regulatory environment -- in different countries.
   
6. The role of IP protection and rights in the drug and biotherapeutics industry.

Note 1: Papers should cover any one or a combination of the listed topic areas as well as areas not listed.Ê For Ônon-listedÕ areas, the author could show how the subject does fit with the theme of the Symposium.
Note 2: Because of the importance of the subject area to all countries, the ICBPS will consider applicants who wish to attend without a paper.

Some individual areas within the baskets of topics above that are already mentioned include:

• Therapeutic vaccines
  
• Emergent diseases and treatment. Emergency response.
  
• Collaboration in research & biopharmaceutical production
  
• Safety and evaluation of biopharmaceutical product
  
• Diagnostic procedures and the contribution of biopharmaceuticals as reagents for diagnostic procedures
  
• Biosafety and biosecurity
  
• Methicillin-resistant Staphylococcus aureus (MRSA) and other drug resistance. What can be done?

C. Important Dates:

• 14 May: Pre-registration begins. Includes Abstract title and brief outline of subject - as soon as possible. (see para E)
  
• 21 May: Registration begins (see para L)
  
• 18 September: Last date for Abstracts (see para F)
  
• 24 September: Registration & increased fees (para K)
  
• 18 October: Program is finalized and sent to the Printer for Publication.
  
• 03 November: Completed Papers are due.
  
• 18 November: ICBPS II Registration/Welcome Party at the Symposium venue, the Hua Ting Hotel in Shanghai.

Complete information to include Registration and Hotel Fees will be provided, updated and located at:

www.icbps.com/GenInfo.html or visit www.asanltr.com and click on ICBPS II. This site will be available by 20 May '08. To be placed on ICBPS Update network, please send your e-mail address to: cbmts@asanltr.com subject: ICBPS II

For the Professional in Government and Industry with an interest in Nuclear, Biological and Chemical Defense, Disarmament and Verification; Emergency and Disaster Medical Planning; Industrial Health and Safety; and Environmental Protection