Applying Systems Thinking to Regenerative Medicine Proceedings of a Workshop (2021) / Chapter Skim
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Appendix A: Workshop Agenda
Appendix A: Workshop Agenda
Pages 127-136
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From page 127... ...
ET DAY 1: October 22, 2020 11:00 a.m. ET Welcome from the Forum Co-Chairs Tim Coetzee, Forum Co-Chair Chief Advocacy, Services, and Research Officer National Multiple Sclerosis Society Kathy Tsokas, Forum Co-Chair Regulatory Head of Regenerative Medicine & Advanced Therapy Johnson & Johnson 127
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From page 128... ...
Milton Chair Professor Director, Engineering Research Center for Cell Manufacturing Technologies National Science Foundation Engineering Research Center for Cell Manufacturing Technologies Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Wallace H Coulter Department of Biomedical Engineering Georgia Institute of Technology and Emory University SESSION I: INTRODUCTION TO SYSTEMS THINKING CONCEPTS Moderator: Claudia Zylberberg, Akron Biotech Session Objectives: • Provide important background and an introduction to systems thinking approaches and related terminology.
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From page 129... ...
Break SESSION II: THE CHALLENGE OF CRITICAL QUALITY ATTRIBUTES: THE ROLE OF SYSTEMS THINKING Moderator: Anne Plant, National Institute of Standards and Technology Session Objective: • Understand the challenges associated with identifying critical quality attributes in the discovery, regulation, and manufactur ing of regenerative medicine products and how systems thinking approaches may be applied.
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From page 130... ...
Douglas Olson President and Chief Executive Officer, BUHLMANN Diagnostics Corp. Scientific Advisory Board Member, Cell Manufacturing Technologies Sally Temple Scientific Director, Principal Investigator, and Co-Founder Neural Stem Cell Institute 2:15 p.m.
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From page 131... ...
Milton Chair Professor Director, Engineering Research Center for Cell Manufacturing Technologies National Science Foundation Engineering Research Center for Cell Manufacturing Technologies Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Wallace H Coulter Department of Biomedical Engineering Georgia Institute of Technology and Emory University 4:00 p.m.
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From page 132... ...
Coulter Department of Biomedical Engineering Georgia Institute of Technology and Emory University SESSION IV: CHALLENGES AND OPPORTUNITIES ASSOCIATED WITH SYSTEMS-LEVEL ANALYSIS AND MODELING Moderator: Malcolm Moos, Food and Drug Administration Session Objectives: • Discuss the current state of the art of systems thinking approaches and how these approaches are being used to inform identification of important variables to measure. • Illuminate current gaps in knowledge and areas for further study.
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From page 133... ...
Modeling the Manufacturing Process in Regenerative Medicine Theresa Kotanchek Chief Executive Officer Evolved Analytics, LLC 12:15 p.m. Supply Chain and Cost Modeling Ben Wang Gwaltney Chair in Manufacturing Systems Professor and Executive Director Georgia Tech Manufacturing Institute 12:30 p.m.
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From page 134... ...
Anne Plant, Workshop Planning Committee Co-Chair Fellow, National Institute of Standards and Technology
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From page 135... ...
Coulter Department of Biomedical Engineering Georgia Institute of Technology and Emory University 2:00 p.m. Adjourn Workshop Day 2
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