2nd International China BioPharmaceutical Symposium (ICBPS II) 7 - 11 December 2008,
Beijing, China
The Chinese Pharmaceutical Association (CPA) and Battelle Memorial Institute, as Hosts and Sponsors, take pleasure in announcing this second ICBPS.
Beijing, China. This ICBPS II will bring the international pharmaceutical, biopharmaceutical and regulatory communities together to further dialog and cooperation. Goals and objectives include learning each others capabilities for product development and manufacturing; learning the technical, scientific, medical and legal aspects of research and development, drug discovery, 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 in China and the West for Chinese and non-Chinese 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 ICBPS 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
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: The primary theme for ICBPS II is Vaccines to include therapeutic proteins; and, sub topic areas across the spectrum of related areas.
This is a science and industry meeting for professionals to exchange ideas for developing, testing, and manufacturing vaccines and biotherapeutics in both China and Western countries. This exchange will be between government, industry, science, medical, legal and business professionals. This should include considerations in standardizing materials, production and testing procedures, regulations and registration requirements.
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 GLP/GMP standards. For industry - how do we ramp-up in an emergency, how do we keep the pipelines full? What pre-planning is required? How do we establish a presence to any level in China – now. The ICBPS offers the opportunity to meet fellow professionals from China and other countries and to have them understand your concerns and requirements and for them to be able to do the same with you. The one on one personal contact really works in the ICBPS relaxed, shirt sleeved, professional environment.
Major Topic Areas
Vaccines and Therapeutic Proteins
Therapeutic vaccines for HIV, TB, diabetes, allergies, serious infectious and non-infectious bacterial and viral diseases; pandemic preparedness for emerging infections such as H5N1 and the possibilities of therapeutics for radiation poisoning treatment, example “Hollis-Eden’s drug candidate NEUMUNE (HE2100)” and others coming on line
Regulations and Regulatory Standardization for therapeutic as well as regular vaccines; and, Registration such as WHO requirements and WHO certification
New type vaccines, current R&D, preventatives; liability issues
Biopharmaceuticals, including vaccines, antibodies and broad spectrum immunomodulators as therapeutic agents. The focus is on new approaches/treatments for old/emerging diseases.
Transitioning from science to products; worldwide R&D, test, and evaluation; new product licensing and compliance, registration and regulation and standardization between countries and between organizations.
Bioresponsibility as a consideration when vaccine development and/or testing, requires work with live agent. This includes: Biosecurity, Biocontainement (even if virulence is not known), Bioethics, QC/QA, and appropriate SOP’s to improve pathogen handling and identification of BSL requirements
Sub Topic Areas
Therapeutic vaccines – are there acceptable animal models?
Regulatory standards – Should they be the same for therapeutic products as for prophylactic vaccines?
What advanced technology may be needed for manufacturers to ramp up more quickly in the event of pandemic disease?
H5N1 Pandemic – Where do we stand as regards improved vaccines and manufacturing methods and new drugs for prevention and treatment?
Equipment: Adoption of new technologies and guidelines; Disposable equipment required, available or in development; equipment manufacturers and their concepts on how new equipment might be used?
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.
How to navigate and understand the regulatory environments -- in different countries.
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. For "non-listed" areas, the author should show how the subject fits within 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:
20 May: Pre-registration begins. Includes Abstract title and brief outline of subject - as soon as possible. (see para E)
Note for all: On all message traffic, please use term “ICBPS” in Subject line.
E. Pre-registration and information:
Please forward at the earliest time to ASA/ICBPS, your pre-registration information to include name; organization, tel/fax and e-mail numbers, proposed Abstract title. The data requested are also on the ICBPS registration form.
Abstracts in above Topic Areas are to be 250 words or less and submitted in
text only format via e-mail to ASA for the Science Review Committee:
Title (all caps)
Presenting author and organization, address, telephone, fax, and e-mail
first. Other authors and organizations after. Only the family name of the presenting author is all caps or upper case.
Body of Abstract: No tables, figures or references are to be used in abstract
File must be named with the family name of the presenting author and must end in NAME_abst.txt. For the example below the file name is:
Price_abst.txt
Abstract submissions are due no later than 17 October 2008 and completed papers are due no later than 14 November 2008.
For all prospective participants who would like update information on this ICBPS meeting, please forward your preferred e-mail address for entry into the ICBPS Update network. Send your e-mail address to: cbmts@asanltr.com. To expedite messages, please put “ICBPS” in subject line.
K. Registration, Hotel and Accompanied Person Fees: in US $
Note: Individuals may send their registration payment by 07 October 2008 to ASA/ICBPS. Payment may be by Visa, Master Card, American Express or check or electronic transfer. The special ASA-ICBPS bank account numbers for bank transfer will be supplied upon request.
Registration Fees: Before 18 October = US $975.00;
After 17 October = US $1075.00
•• Registration fee includes local transportation, most meals including lunches on each day of the Technical Symposium (8,9,10 December); Welcome reception, Symposium dinner and special events as arranged by the Hosts, all coffee breaks, conference materials, tour with industry and Great Wall tour.
Hotel Fees: Hotel Crowne Plaza: Single (S); Double (D)
Superior Room (most are Twin beds) – RMB 1250.00
Delux Room (most are King bed) – RMB 1450.00
Executive Superior Room – RMB 1630.00
Executive Deluxe room – RMB 1750.00
Business suite –to be supplied soon
Rates include 15% hotel service charge and breakfasts for 1 or 2 persons. There are no added charges for the second person (accompanied person) in a room. The US Dollar converts to about 7 RMB Chinese.
Hotels require one night booking fee. This can be held by credit card to ASA/ICBPS who will then guarantee Hotel Booking Fee to the Travel Agency selected by the Chinese ICBPS Organizing Committee to assist with all travel arrangements within China for this meeting.
Registration forms are to be completed and returned by not later than 07 October. From 08 October a late registration fee will be charged. Payment is as listed in K1 above. Forms may be sent by Fax or E-mail.
M. Sponsors:
Sponsors are permitted to exhibit and conduct business while at the Symposium. Sponsors are listed in three categories: Major Sponsors, Sponsors and Co-Sponsors
Major Sponsors may have a double booth exhibit space provided at the Symposium venue, a one page advert provided in the Program/Proceedings and ASA Newsletter. Major sponsors will have up to four registrations paid.
Sponsors will have a single booth exhibit space provided and a one page advert in the Program and ASA Newsletter and up to 3 registrations paid.
Co-Sponsors: A single booth space provided and a one half page advert in the Program, Proceedings and ASA Newsletter and will have up to two registrations paid.
For information on Sponsor payment and sponsor benefits for each of the three sponsor levels – please contact ASA/ICBPS at cbmts@asanltr.com/