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Suggested Citation:"Appendix B AGENDA." National Research Council. 2010. 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. doi: 10.17226/12899.
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Suggested Citation:"Appendix B AGENDA." National Research Council. 2010. 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. doi: 10.17226/12899.
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Page 18

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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

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

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A major goal of the US Department of Defense (DOD) Transformational Medical Technologies Initiative (TMTI) is to develop countermeasures that will protect military personnel against bioweapons, including specific infectious-disease agents and toxins. An explicit TMTI objective is to respond quickly to such threats by producing an appropriate amount of an effective countermeasure--currently defined as enough material to treat or vaccinate 3 million personnel--within 12 months of identification of a specific threat. DOD officials call for TMTI programs to be up and running by 2014.

The National Academies hosted a workshop which brought together scientists from academe, government, and the biotechnology industry to identify and discuss challenges and ideas related to the TMTI's vision of developing countermeasures within a few months after an agent is identified. The workshop focused on manufacturing processes and specifically on the development of "manufacturing platforms"--repeatable components of manufacturing that reduce both development time and risk. An underlying assumption was that demonstrating that integrated platforms can reliably produce safe and efficacious countermeasures might shorten the regulatory approval process. The workshop is summarized in this book.

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