Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop (2019)
Chapter: Appendix A: Workshop Agenda
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Appendix A
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Suggested Citation:
"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25340.
Appendix A
Workshop Agenda
JULY 30, 2018
| 8:30 a.m. | Registration |
| 8:55 a.m. | Welcome |
| Elizabeth Boyle, The National Academies of Sciences, Engineering, and Medicine | |
| 9:00 a.m. | Promise of Continuous Manufacturing |
| Kelvin Lee, University of Delaware | |
| 9:40 a.m. | Continuous Manufacturing: Now and What the Future Might Hold at Biomedical Advanced Research and Development (BARDA) |
| Rick Bright, BARDA | |
| 10:20 a.m. | Break |
| 10:30 a.m. | Session 1: Business Case for Continuous Manufacturing |
| Art Hewig, Amgen | |
| Mauricio Futran, Janssen | |
| Franqui Jimenez, Sanofi | |
| Panel Discussion: All Session Speakers | |
| Moderated by: Gintaras V. Reklaitis, Chair, Purdue University | |
| 12:00 p.m. | Lunch |
| 1:00 p.m. | Session 2: Upstream Processing |
| Daisie Ogawa, Boehringer Ingelheim | |
| Shawn Barrett, Sanofi | |
| Eva Gefroh, Just Biotherapeutics | |
| Panel Discussion: All Session Speakers | |
| Moderated by: Ken Lee, MedImmune |
Suggested Citation:
"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25340.
| 2:30 p.m. | Break |
| 2:45 p.m. | Session 3: Downstream Processing |
| Lindsay Arnold, MedImmune | |
| Andrew Zydney, The Pennsylvania State University | |
| Mark Brower, Merck | |
| Panel Discussion: All Session Speakers | |
| Moderated by: Eva Gefroh, Just Biotherapuetics | |
| 4:15 p.m. | Breakout Sessions |
| Business Case | |
| Upstream Processing | |
| Downstream Processing | |
| 5:15 p.m. | Adjourn |
JULY 31, 2018
| 8:30 a.m. | Goals for the Workshop from the U.S. Food and Drug Administration (FDA) |
| Janet Woodcock, FDA | |
| 9:10 a.m. | Session 4: Product Manufacturing |
| Satoshi Ohtake, Pfizer Inc. | |
| William Whitford, GE Healthcare | |
| Tarit Mukhopadhyay, University College London | |
| Panel Discussion: All Session Speakers | |
| Moderated by: Michael Ladisch, Purdue University | |
| 10:40 a.m. | Break |
| 10:50 a.m. | Session 5: Integration |
| Chris Love, Massachusetts Institute of Technology (MIT) | |
| Richard Braatz, MIT | |
| Doug Richardson, Merck | |
| Panel Discussion: All Session Speakers | |
| Moderated by: Charles Cooney, MIT | |
| 12:20 p.m. | Lunch |
Suggested Citation:
"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25340.
| 1:00 p.m. | Session 6: Regulatory and Quality Aspects of Continuous Manufacturing |
| Moheb Nasr, Consultant | |
| Lisa Connell-Crowley, Just Biotherapeutics | |
| Veena Warikoo, Roche | |
| Panel Discussion: All Session Speakers | |
| Moderated by: Keith Roper, University of Arkansas | |
| 2:30 p.m. | Break |
| 2:40 p.m. | Breakout Sessions |
| Product Manufacturing | |
| Integration | |
| Regulatory and Quality Aspects of Continuous Manufacturing | |
| 3:40 p.m. | Report Back from Breakouts and Moderated Audience Discussion |
| Moderated by: Gintaras V. Reklaitis, Chair, Purdue University | |
| 5:00 p.m. | Adjourn |
Suggested Citation:
"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25340.
Suggested Citation:
"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25340.
Suggested Citation:
"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop. Washington, DC: The National Academies Press.
doi: 10.17226/25340.
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