Technical Program
Thursday, November 21st
| 7:30 AM - 12:00 PM | Registration |
| 8:00 AM - 8:30 AM | Morning Coffee |
| 8:30 AM - 8:45 AM | Opening Remarks - Carla Luciani, Eli Lilly & Co |
| 8:45 AM - 11:00 AM | Session 1: Plenary Session – The Future of Pharmaceutical Manufacturing |
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Thought leaders will discuss how pharmaceutical industry, academia, and regulatory bodies are positioned to adapt to the future of pharmaceutical manufacturing and share their views on: what is the impact of new modalities and personalized medicines? What are the major barriers for technology adoption? Why do regulatory agencies pursue modernization? What are the major technological opportunities? Session Chair: Raymond Knox, Lyndra Therapeutics |
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| 8:45 AM - 9:30 AM |
Advanced Manufacturing for Small Molecule and Biotechnology Drug Products: Improved Quality for the Sake of Patients Michael Kopcha, FDA |
| 9:30 AM - 10:15 AM |
A Tale of Two Pharma – Which One will we Choose? Paul Collins, Eli Lilly & Co |
| 10:15 AM - 11:00 AM |
Accelerating Pharmaceutical Development and Manufacturing through AI and PI Klavs Jensen, MIT |
| 11:00 AM - 12:15 PM | Lunch |
| 12:15 PM - 2:35 PM | Session 2: Regulatory considerations for QbD of the future |
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In addition to the typical innovation inhibitors including scientific gaps and financial constraints, organizations tend to favor less innovative investments due to the perception that regulatory bodies may not be receptive to novel approaches. In this session, invited speakers will challenge that perception and share their vision for QbD of the future. Session Chair: Ahmed Zidan, FDA |
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| 12:15 PM - 12:45 PM |
Emerging Technology Program 2.0 Continuing to Support Innovation Tom O'Connor, FDA |
| 12:45 PM - 1:15 PM |
Opportunities for Harmonization (Quality) – An Industry Perspective Tim Watson, Pfizer |
| 1:15 PM - 1:45 PM | James Coburn, FDA |
| 1:45 PM - 2:15 PM | Coffee Break/Networking |
| 2:15 PM - 4:45 PM | Session 3: Industry 4.0 |
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The so-called new industrial revolution is rooted in digitization and automation. Integration and connectivity are expected to create new levels of transparency and speed for pharmaceutical development and manufacturing. Speakers will discuss readiness, maturity, vulnerabilities, and opportunities for the implementation of IoT, digital twins, cloud computing and A.I. Session Chair: Steven Ferguson, University College Dublin |
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| 2:15 PM - 2:45 PM |
Digital Design of Pharmaceutical Products and Their Manufacturing Processes through Science-Based Digital Twins: Enabling QbD through Digitalization and Systems-Based Methodologies David Slade, Process Systems Enterprise |
| 2:45 PM - 3:15 PM |
Towards Industry 4.0 Enabled PAT Process Monitoring Jon Dieringer, Eli Lilly & Co |
| 3:15 PM - 3:45 PM |
Connecting the Bots: Grassroots Digital Transformation Jake Albrecht, Bristol-Myers Squibb |
| 3:45 PM - 4:15 PM |
Time-Accurate Simulation of Bioreactors: Application to Virtual Reality-Based Design John Thomas, M-Star |
| 4:15 PM - 4:45 PM | Coffee Break/Networking |
| 4:45 PM - 5:15 PM | Round table (Digitalization/Industry 4.0/Regulatory) |
| Moderator: Jake Albrecht, Bristol-Myers Squibb | |
| 5:15 PM - 5:45 PM | Q&A |
| 5:45 PM - 7:15 PM | Poster, Exhibitor Session and Reception |
Friday, November 22nd
| 7:30 AM - 12:00 PM | Registration |
| 8:00 AM - 8:45 AM | Morning Coffee |
| 8:45 AM - 9:00 AM |
Report-Out Session - Joe Hannon, Scale-up Systems |
| 9:00 AM - 12:00 PM | Session 4: Emerging Technologies |
| In this session, speakers will describe emerging technologies that propel flexibility, efficiency, and speed. A discussion of the advances in continuous manufacturing for small, medium, and large molecules, new technologies/platforms/devices, modeling and simulation, and the future of pharmaceutical processing adapting to a rapidly-changing environment. Session Chair: Robert Meyer, Merck & Co. |
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| 9:00 AM - 9:30 AM |
Continuous Processing for the Manufacture of Active Pharmaceutical Ingredients Marty Johnson, Eli Lilly & Co. |
| 9:30 AM - 10:00 AM |
Devices and Advanced Manufacturing for Personalized Combination Therapies Martin McLoughlin, Bristol-Myers Squibb |
| 10:00 AM - 10:30 AM |
CMC Manufacturing, Future Considerations Ken Ford, Novartis |
| 10:30 AM - 11:00 AM | Rich Osifchin, Merck & Co. |
| 11:00 AM - 11:30 AM |
Accelerating process development for biologics on a small-scale, integrated, multi-product manufacturing platform Laura Crowell, MIT |
| 11:30 AM - 12:00 PM |
The Evolution of Digital Data and Modeling in Pharmaceutical Development Jose Tabora, Bristol-Myers Squibb |
| 12:00 PM - 1:15 PM | Lunch |
| 1:15 PM - 3:15 PM | Session 5: Overcoming the Fear of Advanced Process Control |
| Speakers will focus on implementation of advanced process control (APC) strategies to meet patient and/or business needs. In the era of continuous manufacturing, it is puzzling that pharmaceutical industry hasn’t embraced APC yet. Themes will include successes and failures trying to develop, implement or maintain APC, current and future states, barriers and opportunities. Session Chair: Joe Hannon, Scale-up Systems |
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| 1:15 PM - 1:45 PM | Salvador Garcia, Eli Lilly & Co |
| 1:45 PM - 2:15 PM |
Role of Advanced Process Control in Product Quality Assurance Nima YazdanPanah, FDA |
| 2:15 PM - 2:45 PM |
Barriers and Opportunities in Implementing APC in Pharmaceutical Manufacturing: Academic Perspective Gintaras (Rex) Reklaitis, Purdue University |
| 2:45 PM - 3:15 PM | Coffee Break/Networking |
| 3:15 PM - 5:15 PM | Session 6: Innovation - Foster and Fund |
| Speakers will discuss innovation engines and outcomes as it applied to the future of pharmaceutical manufacturing highlighting investment, innovation process and implementation. Areas of interest include novel technologies, funding opportunities, milestones, IP protection, etc. Session Chair: Connor Coley, MIT |
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| 3:15 PM - 3:45 PM |
Robotic manufacturing of personalized drug delivery systems – from scientific discovery to industrial scale Fred Parietti, Multiply Labs |
| 3:45 PM - 4:15 PM |
Continuous Revolutions- Disrupting the Pharmaceutical Supply Chain Luke Rogers, On Demand Pharmaceuticals |
| 4:15 PM - 4:45 PM |
The RAPID Manufacturing Institute: Transforming the Process Industries through Modular Chemical Process Intensification William Grieco, RAPID |
| 4:45 PM - 5:15 PM | Open discussion, concluding remarks and next steps |
