[Biojava-l] Immunogenicity Symposium including FDA Participation at IBC's Well Characterized Biologicals

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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: inq at ibcusa.com


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.
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