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Appendix B AGENDA Considerations For Assuring Safety And Efficacy Of Vaccines And Therapeutic Proteins Manufactured Using Platform Approaches September 15, 2008 National Academies Keck Center, Washington, DC 8:00 a.m. Introduction to Workshop Objectives and Organizational Strategy Peter A. Patriarca, M.D. Senior Clinical Consultant; Biologics Consulting Group, Inc. 8:15 TMTI’s Grand Vision/Premise for Developing Platforms to Manufacture and Develop Vaccines and Therapeutic Proteins Brian Reinhardt, TMTI Discovery Deputy 9:00 Platforms for Rapid, Large-Scale Monoclonal Antibody Development & Production Brian Kelley. Ph.D. Senior Director, Bioprocess Development, Genentech 9:30 Questions for Brian Kelley 10:00 Break 10:15 Platform Technologies for the Development and Production of Monoclonal Antibody Biopharmaceuticals Dane Zabriskie, Ph.D. Vice President, Global Process Development, Amgen Inc. 10:45 Questions for Dane Zabriskie 11:15 What are General Guidelines or “Rules of Thumb” for Monoclonal Antibody Platforms? How Can These be Applied to TMTI Approaches? Discussion (led by Peter Patriarca) TMTI Jonathan Coffman, Ph.D.; Wyeth BioPharma Phil Gomez, Ph.D., Principal, PRTM Mark A. Schenerman, Ph.D.; Vice President, Analytical Biochemistry, MedImmune 12:45 Lunch 1:30 Process Of Using Platform Approach To Facilitate FDA Approval: Insight From Merck Yeast Platform Products David K. Robinson, Ph.D. VP BioProcess R&D, Merck & Co., West Point, PA. 2:00 Questions for David K. Robinson 17
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2:30 What are General Guidelines or “Rules of Thumb” for Manufacturing Using Yeast Platforms? How Can These be Applied to TMTI Approaches? Discussion (led by Peter Patriarca) TMTI Jonathan Coffman, Ph.D.; Wyeth BioPharma Phil Gomez, Ph.D., Principal, PRTM Pascal Longchamp, Ph.D., MBA; VP of Business Development, Evolva Mark A. Schenerman, Ph.D.; Vice President, Analytical Biochemistry, MedImmune 3:15 Discussion of Questions Prepared by Committee Peter Patriarca 4:00 Break 4:15 Continued Discussion of Questions Prepared by Committee 5:15 Summary’s of Today’s Themes Peter Patriarca 5:30 Adjourn 18