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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 TMTIâs 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 âRules of Thumbâ for Monoclonal Antibody Platforms? How Can These be Applied to TMTI Approaches? Discussion (led by Peter Patriarca) ï· TMTI ï· Jonathan Coffman, Ph.D.; Wyeth BioPharma ï· Phil Gomez, Ph.D., Principal, PRTM ï· 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
2:30 What are General Guidelines or âRules of Thumbâ for Manufacturing Using Yeast Platforms? How Can These be Applied to TMTI Approaches? Discussion (led by Peter Patriarca) ï· TMTI ï· Jonathan Coffman, Ph.D.; Wyeth BioPharma ï· Phil Gomez, Ph.D., Principal, PRTM ï· Pascal Longchamp, Ph.D., MBA; VP of Business Development, Evolva ï· 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 Summaryâs of Todayâs Themes Peter Patriarca 5:30 Adjourn 18