Biosimilars 2008
September 22-23, 2008
George Washington University - Jack Morton Auditorium - Washington, DC
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 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.
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
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 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:
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 - The Hon Orrin Hatch, United States Senate
"Now is the Time to Act: The Urgent Need to Pass S. 1695 in the 110th Congress"
9:20 am - The Hon Henry Waxman, United States House of Representatives
"Getting to Consensus on Generic Biologics"
9:40 am - Patrick Vink, Mylan Pharmaceuticals
"Bio-similars; A global marketplace?"
10:00 am - Thomas Bols, Amgen
"An Innovator Company's Perspective on Biosimilars"
10:20 am - Networking Refreshment Break - Sponsored by Arnold & Porter LLP
10:50 am - John Engel, Engel & Novitt LLP
"The Global Outlook For Biosimilars In The Absence Of Consensus & Congressional Action: WHO Will Fill The Void & How Might EU-Wide Tenders Shape The Global Marketplace?”
11:10 am - Panel Discussion
David Schmickel, Ph.D., HELP/US Senate (Panel Chair)
Bruce Artim, Eli Lilly
Elizabeth Dickinson, FDA
David Dorsey, US Senate/HELP
John Engel, Engel & Novitt LLP
Lisa Layman, GPhA
Patrick Vink, Mylan Pharmaceuticals
Brent Del Monte, BIO
Richard Kingham, Covington & Burling
12:15 pm - 2:00 pm - Lunch & Networking
Session 2 - Legal/Patent
Chairperson - Daniel Kracov, Arnold & Porter LLP
2:00 pm - Daniel Kracov, Arnold & Porter LLP
"The Current Legal Framework: How Did We Get Here?"
Perspectives on Biosimilars Legal Challenges:
William Schultz, Partner, Zuckerman Spaeder LLP
Sandra Dennis, Biotechnology Industry Organization (BIO)
Jeffrey Kushan, Partner, Sidley Austin LLP
3:30 pm - Networking Refreshment Break - Sponsored by Engel & Novitt LLP
3:50 pm - David Martin, M-CAM, Inc.
"Patently Obvious: Innovation that Kills - Innovation the Cures"
4:10 pm - Panel Discussion
Daniel Kracov, Arnold & Porter LLP (Panel Chair)
David Martin, M-CAM, Inc.
Sandra Dennis, BIO
Jeffrey Kushan, Sidley Austin LLP
William Schultz, Zuckerman Spaeder LLP
5:00 pm - 6:00 pm - Conference Reception
Tuesday, September 23, 2008
8:00am - 8:45 am - Registration & Continental Breakfast
Keynote Speaker
8:45 am - The Hon Anna Eshoo, United States House of Representatives
"Pathway for Biosimilars Act - Protecting Patients and Innovation"
Session 3 - Economics & Financial
Chairperson - Geoffrey Allan, Ph.D., Insmed, Inc
9:15 am - Pamela Jones Harbour, FTC Commissioner
“The Federal Trade Commission’s Perspective on Biosimilars: Current Initiatives and Long-Term Goals”
9:35 am - Les Jordan, Microsoft
"Driving Innovation in BioPharma"
9:55 am - Geoffrey Allan, Ph.D., Insmed, Inc
"The Path to Follow-On Biologics - Progress and Prospects"
10:15 am - Networking Refreshment Break
10:45 am - Michael King, Rodman & Renshaw
"Biosimilars: View from Wall Street"
11:05 am - Panel Discussion
Brian Seiz, Pharm.D, Express Scripts (Panel Chair)
Diane Edquist Dorman, National Organization for Rare Disorders (NORD)
Missy Jenkins, Pharmaceutical Care Management Association
Jim Furniss, Bridgehead International Limited
Les Jordan, Microsoft
Anna Schwamlein Howard, AARP
Geoffrey Allan, Ph.D., Insmed, Inc
Michael King, Rodman & Renshaw
Alexis Ahlstrom, Avalere Health
12:00 pm Noon - 1:30 pm - Lunch & Networking
Session 4 - Regulatory & Technical (Session Theme - Relationship between Product Quality Attributes and Clinical Outcomes)
Chairpersons - James Green, Ph.D, Biogen Idec & Emily Shacter, Ph.D, FDA
1:30 pm - Ingrid Schwarzenberger, Sandoz Biopharmaceuticals Development
"Case Studies in Follow-on Biologics - a Global Perspective from the Biopharma Industry Pioneer"
2:15 pm - Milt Axley, Ph.D., MedImmune
"Critical Product Attributes - "Past, Present and Future"
3:00 pm - Networking Refreshment Break
3:30 pm - Falk Ehmann, M.D./Ph.D., EMEA, UK
"Biosimilars in the European Union - Experienced gained and Latest Perspectives"
4:15 pm - Susan Kirshner, Ph.D., FDA
"Clinical Outcomes for Manufacturing Changes - Case Studies and FDA Perspectives"
5:00 pm - Conference ends
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