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PAPERBACK price:$15.00 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources Display this book on your site! Related Titles Monoclonal Antibody Production Priorities for the National Vaccine Plan Other Related Titles Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches: Summary of a Workshop (2010) Board on Life Sciences (BLS) Citation Manager Export the bibliographic data for this book in your chosen format Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Citation Manager . "Appendix B AGENDA." Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches: Summary of a Workshop. Washington, DC: The National Academies Press, 2010. Please select a format: Page 17   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore Page 17 Front Matter (R1-R12) INTRODUCTION/PLATFORMS FOR LARGE-SCALE MONOCLONAL ANTIBODY PRODUCTION/PLATFORMS FOR VACCINE PRODUCTION/SUMMARY OF KEY POINTS (1-15) Appendix A Statement of Task (16-16) Appendix B AGENDA (17-18) Appendix C Biographies (19-26)

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OCR for page 17
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

OCR for page 18
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