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IBC Life Sciences presents the 6th International Conference on Well Characterized Biologicals Demonstrating Biocomparability to Expedite Process Approval and Changes When: May 8-9, 2003 Where: Bethesda, MD, USA http://www.LifeSciencesInfo.com/WCB?source=2854btq IBC's 6th Well Characterized Biologicals conference continues to serve as a leading resource for industry representatives seeking updates on current analytical technologies and regulatory policies surrounding highly characterized biological therapeutics. Presentations and case studies describe techniques to characterize therapeutics and support product stability, demonstrating the relationship between analytical data and efficacy, safety and comparability of biologics. Experts explain strategies that can eliminate the need to repeat costly clinical trials. Find out what your company should know about predicting unwanted immunogenicity in the special Pre-Conference Symposium: Immunogenicity -- Resolving Regulatory and Scientific Issues in Unwanted Immunogenicity. Featured speakers include Anthony Mire-Sluis, Ph.D., Head, Analytical Science and Standards, Office of the Center Director OTRR, CBER, US FDA; Steven J. Swanson, Ph.D., Director of Clinical Immunology, Amgen, Inc.; Steve Indelicate, Ph.D., Associate Director, Biotechnology Development, Schering-Plough Pharmaceuticals; Fredric G. Bader, Ph.D., Vice President, Process Sciences, Worldwide Biotech Supply Chain, Centocor; and Melissa Jezuit, Scientist and Manager, Immunochemical Research Technologies, Wyeth Research. Attendees will be among the first to get updates on changes in regulatory policy taking place at the FDA. Presentations from Janet Woodcock, M.D., Director, CDER and CBER representatives will deliver insight into regulatory perspectives on the evaluation of biologics. Additional sessions will cover thinking on international perspectives on comparability. Hear reports from leading companies including Johnson & Johnson, Epicyte Pharmaceuticals, MedImmune, GTC Biotherapeutics, Pharmacia, Abgenix, Biogen, ILEX Products and Chiron on analytical technologies, manufacturing process improvements and product characterization. Other conference highlights include a case study from Biogen on the 8 years of characterization and comparability studies on Avonex(TM) and a case study from ILEX Products on process improvements and new comparability data on their recently approved therapeutic CAMPATH. Also, Christopher Holloway, Ph.D. of ERA Consulting will discuss how comparability studies can be used in risk assessment and management. Learn how these studies should be designed, as well as details on their scope and limitations. Characterization of transgenic proteins continues to be a hot area in the biologics space. This conference will review new data on the characterization of transgenic proteins produced in plants and animals. An interactive panel discussion provides a unique opportunity to have your specific questions answered at the conclusion of the symposium. IBC's 6th Well Characterized Biologicals conference is conveniently scheduled just after IBC's highly respected 5th Intensive Symposium on Biological Assay Development and Validation (http://www.LifeSciencesInfo.com/2853) . This conference is a unique opportunity for attendees. To promote an interactive environment, space at this conference has been limited. Please review the program right away and register now to ensure your place. To review detailed abstracts and to register online, please visit: http://www.LifeSciencesInfo.com/WCB?source=2854btq Phone: (508) 616-5550 * Fax: (508) 616-5522 * E-Mail: [EMAIL PROTECTED] About IBC Life Sciences IBC Life Sciences is an independent organizer that is in business to provide an unbiased forum for the evaluation of current research, market trends, technological developments and applications. IBC Life Sciences is part of The Informa Life Sciences Group, the leading provider of scientific, technological and business information. The Informa Group has been a publisher and event organizer in the life sciences industry for over 20 years. ******************************************************** This segmented email list tends to serve the people who are interested in news and product info in Proteomics sector. To unsubscribe, simply reply to this email. To distribute your releases to this list, contact [EMAIL PROTECTED] To order market report "Cancer Immunotherapy Beyond Monoclonals" from Biotaq.com at: http://www.biotaq.com/onsale/biotaqreports.htm BIOTAQ.COM's email Newswire service is focused exclusively on biotech industry. Edit or change your interest category selections at: https://www.biotaq.com/interests.htm ************************************************************************** ** _______________________________________________ Biojava-l mailing list - [EMAIL PROTECTED] http://biojava.org/mailman/listinfo/biojava-l