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Biosimilars 2011 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 Biosimilars 2011 Conference.
All administrative questions should be addressed to Darrin Scherago at:
Scherago International
For industry participants the fee will be:
Cancellation Policy:
Rinis Travel is the official travel agent for the Biosimilars 2011 meeting.
Rinis Travel
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
Registration Fees:
Pre-registration deadline is February 18, 2011.
For university, non-profit and Government participants the fee will be:
Cancellations received on or before March 1, 2011 will be refunded less a $100 processing fee.
After March 1 no refunds will be issued.
Location:
George Washingtion University - Jack Morton Auditorium
Media and Public Affiars Bldg.
805 21st Street, NW
Washington, DC 20052
Website: www.gwu.edu/~mpaevent/venuempa.html
Internet Access (Complimentary):
Complimentary Wireless internet will be available throughtout the Jack Morton Auditorium. It is called "Event Wireless"
and requires a username and password which will be provided at the registration desk.
Hotel Information:
Hotel Lombardy
2019 Pennsylvania Avenue, N.W.
Washington D.C. 20006
Tel: 202-828-2600
Fax: 800-424-5486
Website: www.hotellombardy.com
9517 Georgia Avenue
Silver Spring, MD 20910
Phone: 301-587-1021
Fax: 301-587-3418
Email: rts.travel@verizon.net
Contacts: Babette or Mike
Organizing Committee:
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 - Regulatory & Policy
Chairperson - Elizabeth Jex, FTC
9:00am - TBD
9:30am - Mark McCamish, Sandoz
10:00am - Coffee Break
11:00am - Lincoln Tsang, Arnold & Porter
11:30am - TBD
12:00 - Roundtable Discussion/Q & A
12:30 pm - 1:30 pm - Lunch & Networking
Session 2 - Legal/Patent
Chairperson - Dan Kracov, Arnold & Porter
1:30 pm - Dan Kracov, Arnold & Porter
2:00 pm - Sandra Dennis, Biotechnology Industry Organization
2:30 pm - Brian Malkin, Frommer Lawrence & Haug LLP
3:00 pm - Coffee Break
4:00 pm - John Engel, Engel & Novitt
4:30 pm - Roundtable Discussion/Q & A
Tuesday, March 15, 2011
8:00 am - 9:00 am - Registration & Continental Breakfast
Session 3 - Economics & Financial
Chairperson - Ronny Gal, Sanford Bernstein
9:00 am - Richard Dicicco, Harvest Moon Pharma
9:30 am - TBD
10:00 am - Coffee Break
11:00 am - TBD
11:30 am - TBD
12:00 pm - Roundtable Discussion/Q & A
12:30 pm - 1:30 pm - Lunch & Networking
Session 4 - Technical
Chairperson - Gillian Woollett, Engel & Novitt
1:30 pm - Emily Shacter, FDA
2:00 pm - Mike Tarlov, NIST
2:30 pm - Tina S. Morris, United States Pharmacopeial Convention
3:00 pm - Coffee Break
4:00 pm - Roundtable Discussion/Q & A