Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies Proceedings of a Workshop (2017) / Chapter Skim
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Appendix A: Workshop Agenda
Appendix A: Workshop Agenda
Pages 81-88
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From page 81... ...
Siegel, Forum Co-Chair Chief Biotechnology Officer Head, Scientific Strategy and Policy Johnson & Johnson 8:35 a.m. Charge to Workshop Speakers and Participants Claudia Zylberberg, Workshop Co-Chair Founder and Chief Executive Officer Akron Biotech Steven Oh, Workshop Co-Chair Acting Deputy Director, Division of Cellular and Gene Therapies Office of Tissues and Advanced Therapies Center for Biologics Evaluation and Research U.S.
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From page 82... ...
Moderator: Krishanu Saha, Assistant Professor, University of Wisconsin–Madison 9:10–9:55 a.m. Speakers: Bruce Levine Barbara and Edward Netter Professor in Cancer Gene Therapy University of Pennsylvania Perelman School of Medicine Laura Niklason Professor of Anesthesiology and Biomedical Engineering Yale University Bob Preti President and Chief Executive Officer PCT Cell Therapy Services, LLC
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From page 83... ...
Speakers: Anne Plant Chief of the Biosystems and Biomaterials Division National Institute of Standards and Technology Linda Kelley Director, Cell Therapies Processing Facility Moffitt Cancer Center Robert Deans Chief Technology Officer BlueRock Therapeutics 11:30 a.m.–noon Discussion with Workshop Participants Noon–1:00 p.m.
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From page 84... ...
Speakers: Isabelle Rivière Director, Cell Therapy and Cell Engineering Facility Memorial Sloan Kettering Cancer Center Rodney Rietze Lead, cGMP Process Automation for Cell and Gene Therapies Novartis Philip Vanek General Manager, Cell Therapy Technologies GE Healthcare 1:45–2:15 p.m. Discussion with Workshop Participants
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From page 85... ...
Food and Drug Administration Katherine Tsokas Senior Director, Global Regulatory Affairs Johnson & Johnson 3:00–3:35 p.m. Discussion with Workshop Participants 3:35–3:50 p.m.
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From page 86... ...
Closing Keynote: Dean Kamen Advanced Regenerative Manufacturing Institute DEKA Research & Development Corporation 4:10–4:30 p.m. Panelist Reflections Bob Preti President and Chief Executive Officer PCT Cell Therapy Services, LLC Anne Plant Chief of the Biosystems and Biomaterials Division National Institute of Standards and Technology Philip Vanek General Manager, Cell Therapy Technologies GE Healthcare Robert Mcburney President and Chief Executive Officer Accelerated Cures Project for Multiple Sclerosis Co-Principal Investigator iConquerMS Patient-Powered Research Network 4:30–5:00 p.m.
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From page 87... ...
Food and Drug Administration 5:15 p.m. Adjourn
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