AIChE's website is experiencing issues with Login, online registration, join, renew and other transactions. We are working to resolve the problem and apologize for the inconvenience.
Conference Program
...
Monday, February 29 | |
| 5:00 - 7:00 PM | Registration Opens |
| 6:00 - 8:00 PM | Welcome Reception |
Tuesday, March 1 | |
| 7:30 -5:00 PM | Registration |
| 7:30 - 8:30 AM | Continental Breakfast |
| 8:30 - 8:50 AM | Chairman's Introduction |
| 8:50 - 12:00 PM | Session I: Continuous Manufacturing of Pharmaceuticals - Why and Why Now? |
| 8:50 - 9:30 AM | Talk 1: Continuous Manufacturing: Achieving the Vision of Modernizing Pharmaceutical Manufacturing Speaker: Rapti Madurawe, FDA |
| 9:30 - 10:10 AM | Talk 2: Approaches to Regulatory Engagement and Filing for Continuous Manufacturing Speaker: Mark Buswell, GlaxoSmithKline |
| 10:10 -10:40 AM | Coffee Break |
| 10:40 - 11:20 AM | Talk 3: Powders to Tablets in Minutes: Implementation of a Portable, Continuous, Miniature, and Modular (PCMM) Factory in a Warehouse Speaker: Mike O’Brien, Pfizer |
| 11:20 - 12:00 PM | Talk 4: Design and Implementation of a Small Footprint Continuous API facility for Portfolio Commercialization Speaker: Eoin McManus, Eli Lilly and Company-Ireland |
| 12:00 - 1:15 PM | Lunch |
| 1:15 - 4:15 PM | Session II: Top Challenges Faced in Industry based Focus Groups |
| 1:15 - 2:45 PM | 3 Groups in Parallel Reviewing Topic 1: Perceived Challenges with FDA/EU/Other Regulatory Review Questions, as well as PAIs Topic 1: Group#1 Moderators: Sharmistha Chaterjee, FDA and Ahmad Almaya, Eli Lilly and Company Topic 1: Group #2 Moderators: Celia Cruz, FDA and Joe Hannon, Scale-up Systems Topic 1: Group #3 Moderators: Rapti Madurawe, FDA and John Lepore, Merck |
| 2:45 - 4:15 PM | Topic 2: Applicability of Continuous Manufacturing to a Diverse Pharmaceutical Portfolio Moderators: Scott May, Eli Lilly and Company and Kirk VanDer Kamp, Eli Lilly and Company |
| 2:45 - 4:15 PM | Topic 3: Experience and Technical Capability of Staff to Implement Continuous Manufacturing Moderator: Mark Buswell, GSK |
| 2:15 - 4:15 PM | Topic 4: Needed Equipment and Associated Facility Cost Moderators: Dan Blackwood, Pfizer and Derek Berglund, Eli Lilly and Company |
| 4:15 - 4:35 PM | Coffee Break |
| 4:35 - 5:00 PM | Session III: Summary of Day 1 |
| 6:30 - 8:30 PM | Workshop Reception |
Wednesday, March 2 | |
| 7:30 AM -12:00 PM | Registration |
| 7:30 - 8:30 AM | Continental Breakfast |
| 8:30 - 8:40 AM | Chairman's Summary of Previous Day's Discussion |
| 8:40 - 10:10 AM | Session IV: Focus Group Recap and Discussion |
| 8:40 - 9:10 AM | Report out on Topic 1: Perceived challenges with FDA/EU/other Regulatory review questions as well as PAIs |
| 9:10 - 9:30 AM | Report out on Topic 2: Applicability of Continuous Manufacturing to a Diverse Pharmaceutical Portfolio |
| 9:30 - 9:50 AM | Report out on Topic 3: Experience and Technical Capability of Staff to Implement Continuous Manufacturing |
| 9:50 - 10:10 AM | Report out on Topic 4: Needed Equipment and Associated Facility Cost |
| 10:10 - 10:30 AM | Coffee Break |
| 10:30 - 12:30 PM | Session V: Part 1: Continuous Processing and Enhanced Process Control: The Realization of QbD |
| 10:30 - 11:00 AM | Talk 1: How Process Models can Facilitate Quality Risk Management for Emerging Technologies Speaker: Tom O’Connor, FDA |
| 11:00 - 11:30 AM | Talk 2: Strategies to Accelerate Process Control Adoption in the Pharmaceutical Industry Speaker: Richard Braatz, MIT |
| 11:30 - 12:00 PM | Talk 3: An Integrated Multi-Layer Approach to Control Strategy for Continuous Drug Product Manufacture Speaker: Ahmad Almaya, Eli Lilly and Company |
| 12:00 - 12:30 PM | Talk 4: Control Strategy, Residence Time Distribution Testing, and Real Time Release Implementation for Continuous Drug Product Manufacturing Speaker: Sarah Nielsen, Johnson & Johnson/Janssen |
| 12:30 - 1:35 PM | Lunch |
| 1:35 - 2:35 PM | Session V: Part 2: Continuous Processing and Enhanced Process Control: The Realization of QbD |
| 1:35 - 2:05 PM | Talk 5: A Decade’s Experience Delivering Clinical Supplies using Fully Continuous Hot Melt Extrusion Speaker: Robert Meyer, Merck |
| 2:05 - 2:35 PM | Talk 6: Control Strategy and Real Time Release Testing - Implementation and Considerations for Continuous Manufacturing Speaker: Kelly Swinney, Vertex |
| 2:35 - 3:35 PM | Session VI: Panel Discussion & Recap of Workshop |
| 2:35 - 3:35 PM | Panel Discussion on Continuous Processing and Enhanced Process Control Panelists Include:
|
| 3:35 - 3:50 PM | Coffee Break |
| 3:50 - 4:25 PM | Session VII: Workshop Recap and Next Steps Session Moderator: Paul Collins, Eli Lilly and Company |