SOURCE: IBC Life Sciences

October 31, 2007 09:00 ET

Experts From US FDA and Sandoz, Inc. to Keynote at IBC's Global Follow-On Biologics Conference

Conference Will Take Place December 10-11, 2007 in Reston, VA

WESTBOROUGH, MA--(Marketwire - October 31, 2007) - IBC Life Sciences' 5th Annual Global Follow-On Biologics conference, to take place December 10-11, 2007 at the Hyatt Regency Reston in Reston, VA, will include keynote presentations from the US Food and Drug Administration and Sandoz, Inc.

The keynote presentations will kick off the first day of Global Follow-On Biologics. Keynote topics will cover the most up-to-date regulatory and scientific business strategies necessary to bring biosimilars, biosames, and biobetters to market.

9:00 am, December 10, 2007:
Scientific Considerations of Follow-On Proteins
Steven Kozlowski, Ph.D., Director, Office of Biotechnology Products, OPS,
CDER, US FDA

9:45 am, December 10, 2007:
Immunogenicity Considerations for Comparability and Interchangeability
Assessments
Amy Rosenberg, M.D., Director, Division of Therapeutic Proteins, CDER, US
FDA

11:00 am, December 10, 2007:
Follow-On Biologics Pathways: Current Status and Impact on the
Biopharmaceutical Industry
Ajaz S.Hussain, Ph.D., Vice President & Global Head of Biopharmaceutical
Development, Sandoz, Inc.

"For the first time, interchangeability or substitutability will be directly debated in these lectures," said Ellen C. King, Head, Bioprocessing Series, IBC Life Sciences. "With several biosimilar EPOs now approved in Europe, the biosimilar field is moving ahead very quickly. Absent clear authority, will the regulators in the US have any say in interchangeability decisions for biologics, or will those decisions be rendered on a case-by-case basis for those who develop formularies and health plans, including CMS?"

For questions about this conference, contact IBC at 800.390.4078 or visit the website at www.IBCLifeSciences.com/FOB.

Writers and editors are encouraged to attend. To request a press pass please contact Keri Dostie at kdostie@ibcusa.com.

About IBC Life Sciences

IBC Life Sciences is the worldwide leader in scientific, technological and business conferences and courses for the life science industry. To develop its programs IBC actively researches the advancements, technologies and trends impacting and driving the race for new drugs and therapies. No other organization can make claim to the breadth and quality that IBC Life Sciences delivers in each event giving the company recognition around the globe for quality, service and value. For more information, visit www.IBCLifeSciences.com.

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