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Day One, Friday, March 19, 2010

7:30-8:30 Check-In & Registration

8:30 Welcoming Remarks

8:40-10:00 Presentation/Q&A Session
"IP Issues for Pioneers and Generics in Drugs, Devices, and Biologics"
Samuel E. Webb Partner Stoel Rives LLP, Seattle

10:00-10:30 Networking Break (refreshments will be provided)

10:30-12:00Presentation/Q&A Session
"Immunologic Identity and Biosimilars: How Close is Close Enough?"
Kirsten L. Vadheim, Ph.D., RAC BioCompliance Consulting, Inc.

12:00-1:30 Lunch (on your own or host a group)

1:30-3:00 Presentation/Q&A Session
"Regulatory Considerations for Biosimilars: Attitudes of the FDA"
Andrew Fox Director of Regulatory Affairs Amgen, Inc. Thousand Oaks, CA

3:00-3:15 Networking & Break (refreshments will be provided)

3:15-4:45 Presentation/Q&A Session
"What is happening where biosimilars are currently available? –The case of Latin America"
Rafael Alfonso, MD, MSc Research Associate, School of Pharmacy Pharmaceutical Outcomes Research & Policy Program University of Washington

Day Two, Saturday, March 20, 2010

7:30-8:30Check-in & registration

8:30-10:00 Presentation/Q&A
"Economic Considerations for Biosimilars: Theory and Examples"
Kyle Ross, PhD UW-Lilly Senior Post-Doctoral Research Fellow Pharmaceutical Outcomes Research and Policy Program University of Washington.

10:00-10:30 Networking Break (refreshments will be provided)

10:30-12:00 Presentation/Q&A Session
"Biosimilars and Clinical Trials: What are the Issues?"
Royce Morrison, MD, CPI Director of Clinical Strategy Charles River

12:00-1:30 Lunch & Poster Presentations (Lunch provided at UW Tower)

1:30-3:00 Presentation/Q&A Session
"Biochemical and Biophysical Characterization of Proteins"
Carlos Enrique Catalano, Pharm.D., Ph.D. Professor, Department of Medicinal Chemistry School of Pharmacy University of Washington

3:00-3:30 Conference Summary and Take-away Points
Thomas A Baillie, Dean, School of Pharmacy

4:00 Conference Concludes