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Biosimilars 2008 is a two day conference to "air the issues" and "raise the questions" associated with the legislation for, and applications and use of, biotech medicines currently under consideration in the United States Congress to provide the authority to the FDA to regulate Biosimilars (also called follow-on biologics or generic biologicals).
The global development of biosimilars is now recognized to be a critical part of the future of biotechnology, as the pharma, legal and payor/patient communities consider the legal, scientific, technical, financial and economic impacts.
Participants will hear from, and interact with, leading professionals from government, non-govermental organizations and the private sector over the two-day Biosimilars2008 Conference.
Scherago International
525 Washington Blvd, Ste 3310, Jersey City, NJ 07310
Phone: 1-201-653-4777 x20
Fax: 1-201-653-5705
E-mail: biosimilarstoday@scherago.com
Scherago International is the conference organizer for Biosimilars 2008.
For industry participants the fee will be:
Cancellation Policy:
Cancellations received on or before September 12, 2008 will be refunded less a $100 processing fee.
After September 12 no refunds will be issued.
Rinis Travel is the official travel agent for the Biosimilars 2008 meeting.
Rinis Travel
9517 Georgia Avenue
Silver Spring, MD 20910
Phone: 301-587-1021
Fax: 301-587-3418
Email: rts.travel@verizon.net
Contacts: Babette or Mike
8:00 am - 8:45 am - Registration & Continental Breakfast
8:45 am - Opening Welcome - Rachelle S. Heller, Ph.D. - The George Washington University
Session 1 - Legislative & Policy
Chairperson - David Schmickel, Ph.D., HELP/US Senate
9:00 am - Hon. Henry Waxman, US House of Representatives
9:20 am - Senator Orrin Hatch (Invited)
9:40 am - Hon. Anna Eshoo, US House of Representatives (Invited)
10:00 am - Bill Yauzin, PhRMA (Invited)
10:20 am - Networking Refreshment Break - Sponsored by Arnold & Porter LLP
10:50 am - TBA
11:10 am - TBA
11:30 am - Panel Discussion
12:00 pm - 2:00 pm - Lunch & Networking
Session 2 - Legal/Patent
Chairperson - Daniel Kracov, Arnold & Porter LLP
2:00 pm - David Martin, M-CAM, Inc.
2:30 pm - TBA
2:50 pm - TBA
3:10 pm - TBA
3:50 pm - Networking Refreshment Break - Sponsored by Engel & Novitt LLP
4:20 pm - Panel Discussion
5:00 pm - 6:00 pm - Conference Reception
Tuesday, September 23, 2008
8:30am - 9:00am - Registration & Continental Breakfast
Session 3 - Economics & Financial
Chairperson - Geoffrey Allan, Ph.D., Insmed, Inc
9:00 am - Pamela Jones Harbour, FTC Commissioner
9:30 am - Ben Flock, Microsoft
9:50 am - Geoffrey Allan, Ph.D., Insmed, Inc
10:10 am - Jim Reddoch, FBR (Invited)
10:30 am - Networking Refreshment Break
11:00 am - Darin Hinderman, Caterpillar (Invited)
11:20 am - Panel Discussion
12:00 pm Noon - 2:00 pm - Lunch & Networking
Session 4 - Regulatory & Technical (Sesion Theme - Product Attributes)
Chairpersons - James Green, Ph.D, Biogen Idec & Emily Shacter, Ph.D, FDA
2:00 pm - Lincoln Tsang, Ph.D - Arnold & Porter LLP