Biosimilars 2011
March 14-15, 2011
George Washington University - Jack Morton Auditorium - Washington, DC

__________________________________________________________________
Due to the lack of information coming from the FDA and no immediate
plans to move forward the Biosimilars 2011 meeting has been postponed.

At this time no other information is available. If you have any questions,
send an email to biosimilarstoday@scherago.com
__________________________________________________________________

Index

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Introduction

This draft plan will be updated on an regular basis. As the program details are finalized there will be minor changes. Attendance is projected to be 100-150.

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.

Who should Attend

Pharma/Biotech Industry from the USA, Europe, Japan, India, Singapore, China, Israel, and other countries with biotech and generic biotech organizations:
  • Legal Affairs
  • Corporate Strategy
  • Regulatory Affairs
  • Intellectual Property
  • Patent Attorneys
  • Regulatory Compliance
  • New Product Development
  • Business Development
  • Business Operations
  • Project Management
  • Laboratory Heads/Chiefs
  • Scientific Affairs
  • Principal Scientists
  • Chief Scientific Officer
  • Industry and lobbying organizations involved in the Pharma and biotech areas
  • Consumer groups, Health Insurers/Payees, and State government staff concerned about health care costs.
  • FDA, NIH, US Patent Office staff, and their EU and Japanese equivalent staffs involved in biotech activities
  • University scientists and others involved in the scientific, economic, legal, and regulatory issues of biotech medicines
  • Contract labs and organizations that provide scientific testing and analysis of biotech products
  • Financial analysts who cover the Pharma and health care industries
  • Print and electronic media who write and report on the health care industry.

Administration

Scherago International is the conference organizer for Biosimilars 2011.

All administrative questions should be addressed to Darrin Scherago at:

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

Registration Fees:

Pre-registration deadline is February 18, 2011.
    For university, non-profit and Government participants the fee will be:
  • $700 advance registration, postmarked or submitted by 18 February 2011
  • $900 late advance and on-site registration, postmarked or submitted after 18 February 2011

    For industry participants the fee will be:

  • $1,700 advance registration, postmarked or submitted by 18 February 2011
  • $1,900 late advance and on-site registration, postmarked or submitted after 18 February 2011

Cancellation Policy:
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

Rinis Travel is the official travel agent for the Biosimilars 2011 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

  • Contact Darrin Scherago for details at darrins@scherago.com

    Organizing Committee:

    • Dan Kracov, Arnold & Porter, USA
    • Gillian Wollett, Engel & Novitt, USA
    • John Engel, Engel & Novitt, USA
    • Ronny Gal, Sanford Bernstein, USA
    • Elizabeth Jex, FTC, USA
    • Mark McCamish, Sandoz International, USA

    • Draft Program

    Monday, March 14, 2011

    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

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