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 |