SUNDAY, March 2

4:00 PM - Welcome by the Honorable Senator Ted Kennedy (D-MA)
Chairman of the Senate Health Education,
Labor and Pensions Committee

5:30 PM - Reception to follow

MONDAY, March 3

7:00 AM - 8:00 AM - Continental Breakfast

8:00 AM - 9:00 AM - Plenary Lecture: Randall Lutter
Deputy Commisioner for Policy
US FDA

9:15 AM - 12:45 PM - BIOANALYTICAL
Presentations and panel discussion
Chair: Barry L. Karger, Director, Barnett Institute and James L. Waters Chair, Northeastern University.
Charles DiLiberti, Vice President of Scientific Affairs, Barr Laboratories, Inc.
Reed Harris, Director of Analytical Development, Genentech, Inc.
Ram Sasisekharan, Professor of Biological Engineering, MIT.
Emily Shacter, Chief, Lab. Biochem., Div. Therapeutic Proteins, CDER, US FDA

12:45 PM - 2:00 PM - Luncheon

2:00 PM - 5:00 PM - IMMUNOGENICITY
Presentations and panel discussion
Chair: James D. Green, Sr. Vice President of Preclinical and Clinical Development Sciences, Biogen Idec Inc.
Amy Rosenberg, Director, Division of Therapeutic Proteins, FDA
Huub Schellekens, Professor, Director of the Central Lab Animal Institute, Utrecht University.
Meena Subramanyam, Senior Director, Clinical Science & Technology, Biogen Idec Inc
Steve Swanson, Director of Clinical Immunology, Amgen Inc

5:00 PM - 6:30 PM - Reception

TUESDAY, March 4

7:00 AM - 8:00 AM - Continental Breakfast

8:00 AM - 9:00 AM - Plenary Lecture: Jean-Hugues Trouvin
Chair of Biologics Working Party,
European Medicines Agency (EMEA)

9:15 AM - 12:15 PM - BIOMANUFACTURING
Presentations and panel discussion
Chair: Tony Lubiniecki, Vice President of Technology Transfer & Project Planning, Centocor, Inc
Stuart Builder, Consultant, Strategic Biodevelopment, Belmont, CA
William S. Hancock, Professor of Chemistry and Bradstreet Chair, Barnett Institute, Northeastern University
Ganesh Venkataraman, Senior Vice President, Momenta Pharmaceuticals.

12:15 PM - 1:30 PM - Luncheon

1:30 PM - 5:00 PM- REGULATORY
Presentations and panel discussion
Chair: Stephen G. Dilly, Chief Executive Officer, APT Pharmaceuticals Inc.
Robert Garnick, Senior Vice President of Regulatory, Quality and Compliance, Genentech, Inc
Takao Hayakawa, Senior Advisor, Pharmaceutical and Medical Devices Agency, Japan (invited)
Mathias Hukkelhoven, Senior Vice President, Global Head of Drug Regulatory Affairs, Novartis
Alison Lawton, Senior Vice President, Regulatory Affairs and Quality Systems, Genzyme Corporation
Mary Alice Hefford, Centre for Biologics Research, Biologics and Genetic Therapies Directorate, Health Canada

Close of Conference