Biosimilars 2008
September 22-23, 2008
George Washington University - Jack Morton Auditorium - Washington, DC

Index

Adobe Acrobat software is required to view and print some of the documents
listed above. If you do not have this software, you can download it for free by
clicking on the Adobe Acrobat Reader button below.

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 200.

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.

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

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

Scherago International is the conference organizer for Biosimilars 2008.

Registration Fees:

Pre-registration deadline is September 1, 2008.

$600 advance registration, postmarked or submitted by 1 Sept 2008
$800 late advance and on-site registration, postmarked or submitted after 1 Sept 2008
For industry participants the fee will be:
$1,600 advance registration, postmarked or submitted by 1 Sept 2008
$1,800 late advance and on-site registration, postmarked or submitted after 1 Sept 2008

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.

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

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 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

Contact Darrin Scherago for details at darrins@scherago.com

Sponsors:

Arnold & Porter LLP
Engel & Novitt LLP

Organizing Committee

James Green, Ph.D - Biogen Idec, USA
Takao Hayakawa, Ph.D. - Pharmaceuticals and Medical Devices Agency, Japan
Rachelle Heller, Ph.D. - George Washington University, USA
Steven Kozlowski, M.D.- FDA, USA
Curtis Meuse, Ph.D. - NIST, USA
Rudy Potenzone, Ph.D - Microsoft, USA
Emily Shacter, Ph.D. - FDA, USA
Lincoln Tsang, Ph.D. - Arnold & Porter LLP, UK
Gillian Woollett, MA, DPhil - Engel & Novitt LLP, USA

Draft Program

Monday, September 22, 2008

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

David Dorsey, US Senate/HELP(Invited)

Kathleen Jaeger, GPHA (Invited)

Elizabeth Dickinson, FDA (Invited)

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

Steve Miller, M.D., Express Scripts (Panel Chair/Invited)

Diane Edquist Dorman, National Organization for Rare Disorders (NORD)

Mark Merritt, Pharmaceutical Care Management Association

Amy Melnick, Arthritis Foundations (Invited)

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

"International Nonproprietary Names (INN) Policy for Biosimilars Products"
2:30 pm - TBA
2:50 pm - TBA
3:10 pm - TBA
3:50 pm - Networking Refreshment Break
4:20 pm - Panel Discussion
5:00 pm - Conference ends