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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.
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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.
×
Page 45
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.
×
Page 46
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.
×
Page 47
Next: Appendix B: Biographies of Planning Committee Members, Speakers, and National Academies of Sciences, Engineering, and Medicine Staff »
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On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

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