Biosimilars 2007
September 24-25, 2007
George Washington University - Jack Morton Auditorium - Washington, DC
Index
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Biosimilars 2008 will return to GW University - September 22-23, 2008
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 200-250.
Biosimilars 2007 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).
2007 is the 25th anniversary of the first genetically engineered drug approved by the FDA - Lilly's recombinant insulin - Humulin. 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 Biosimilars2007 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 2007.
Cancellation Policy:
Cancellations received on or before September 14, 2007 will be refunded less a $100 processing fee.
After September 14 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 2007 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:
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
- Rudy Potenzone, Ph.D. - Microsoft, USA
- Lincoln Tsang, Ph.D - Arnold & Porter LLP, UK
- Gillian Woollett, MA, DPhil - Engel & Novitt LLP, USA
Draft Program
Monday, September 24, 2007
7:45 am - 8:45 am - Registration & Continental Breakfast
Session 1 - Legislative in the US, EU and Japan
Chairperson - David Schmickel, Ph.D. - HELP/US Senate
8:45 am - Rachelle S. Heller, Ph.D. - The George Washington University
"Conference Opening"
9:00 am - Hon. Henry Waxman
"Establishing a Pathway for Generic Biotech Drugs in the US"
9:20 am - Patricia Knight - Chief of Staff to Senator Hatch
9:40 am - Lincoln Tsang, Ph.D. - Arnold & Porter LLP
"European Regulation and Policy for Biosimilar Products"
10:00 am - Andrea Rappagliosi - EuropaBio
"European Biosimilar Legislation: EuropaBio’s Perspective"
10:20 am - Networking Refreshment Break - Sponsored by Arnold & Porter LLP
10:50 am - Brent Del Monte - BIO
"Legislative Outlook for Follow-On Biologics in the 110th Congress"
11:10 am - Takao Hayakawa, Ph.D. - PMDA
"Evaluation of Subsequent-entry Protein Products - A View from Japan"
11:30 am - Panel Discussion
12:00 pm - 1:40 pm - Lunch & Networking
Session 2 - Policy
Chairperson - Steve Heller, Ph.D. - NIST
1:40 pm - Steve Kozlowski, M.D. - FDA
"FDA Considerations on Follow on Biologics"
2:00 pm - Scott Gottlieb, M.D. - AEI
2:20 pm - Gillian Woollett, MA, DPhil - Engel & Novitt LLP
"BioSames, BioDifferents, BioSimilars -- Designing The BioFuture"
2:40 pm - Ajaz Hussain, Ph.D. - Sandoz, Inc.
"Creating a Regulatory Path for FOB's in US: Points to Consider"
3:00 pm - Kay Holcombe - Genzyme
"The Biosimilars Discussion - Some Basics"
3:20 pm - Panel Discussion
3:50 pm - Networking Refreshment Break - Sponsored by Engel & Novitt LLP
Session 3 - Legal/Patent
Chairperson - Daniel Kracov - Arnold & Porter LLP
4:20 pm - Brand Perspectivies:
Jeffrey Kushan - Sidley Austin Brown & Wood LLP
"Assessing Patent Issues in Follow-On Biologics Legislation"
Meredith Manning - Hogan & Hartson LLP
"Legal Issues Surrounding Biosimilars: Innovators' Perspectives"
Jeffrey B. Chasnow - Pfizer
Biosimilars 2007: An Innovators' Perspective"
4:50 pm - Biosimilar Perspectivies:
John Engel - Engel and Novitt LLP
"Achieving A Middle Ground On Biosimilars Legislation -- Balancing A Robust Scientific Pathway And Respect For IP Rights"
William Schultz - Zuckerman Spaeder
"Basic Principles For Effective Biosimilars Legislation"
5:20 pm - Panel Discussion - Speakers plus representative
5:45 pm - 7:00 pm - Conference Reception
Tuesday, September 25, 2007
8:00am - 9:00am - Registration & Continental Breakfast
Session 4 - Economic and Financial
Chairperson - Richard Manning, Ph.D. - Pfizer
9:00 am - Ronny Gal, Ph.D. - Sanford Bernstein LLP
"Is Profitability Still Beyond The Horizon?"
9:20 am - Richard Fitzgerald - Nucleonics, Inc.
Emerging Biotech Perspective
9:40 am - Steve Miller, M.D. - Express-Scripts
"Can We Afford Biologic Drugs? The Payers Prospective"
10:00 am - Cheryl Matheis - AARP
10:20 am - Networking Refreshment Break
10:50 am - Edward (Ted) Buckley - BIO
"The Economics of Follow-On Biologics"
11:10 am - Gary Heimberg - GPhA
"We Can't Afford To Say No To Biogenerics"
11:30 am - Panel Discussion
12:00 pm Noon - 1:40 pm - Lunch & Networking
Session 5 - Regulatory/Scientific & Technical
Chairperson - James Green, Ph.D - Biogen Idec
1:40 pm - Robin Thorpe, Ph.D. - NIBSC
"Immunogenicity Issues for Biosimilars"
2:00 pm - Tina Morris, Ph.D. - USP
"Follow-On Biologics: USP Perspective"
2:20 pm - Curtis Meuse, Ph.D. - NIST
"National Institute of Standards and Technologies' Measurments for Protein Products"
2:40 pm - Ganesh Venkataraman, Ph.D. - Momenta Pharmaceuticals
"Characterization and Equivalence of Complex Products"
3:00 pm - Networking Refreshment Break
3:30 pm - Keith Webber, Ph.D. - CDER/FDA
"On the Road to Biosimilars: Are We There Yet?"
3:50 pm - Panel Discussion: Speakers plus representatives of Innovator Industry
Amgen - Andrew Fox
Genentech - Rob Garnick
J&J - Tony Lubiniecki
FDA - Emily Shacter
5:00 pm - Conference ends
5:30pm - 7:30pm - Brief overview of Biosimilars in Latin America
Juana Hughes, Pharmaceutical Affairs - Merck Serono Latin America
Alejandro Torrendell - Legal Counsel & Government Relations - Merck Serono Latin America
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