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 |
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 |
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 |