7:30 am Morning Coffee & Registration
8:20 am Chairs Opening Remarks
Aligning Regulatory Expectations with Process Development & CMC Requirements to Accelerate mRNA Platform Advancement
8:30 am Fireside Chat: Bridging Gaps in Manufacturing of Cancer Vaccines : Best practices for Process Development & CMC
9:30 am Microfluidic Biochips-Based Manufacturing of Personalized mRNA Cancer Therapeutics
Synopsis
- Automated Precision Manufacturing and on-line in-process testing with NMU-SymphonyTM
- End-to-end workflow: from RNA design to drug product in 3 weeks
- Single-use, closed-system flow path including biochips to minimize cross-contamination risks
10:00 am Morning Break
Track 1: Research Scale
Enhancing mRNA Stability to Extend Shelf Life, Improve Translation, & Support Global Distribution
11:00 am Leveraging Identity Assays to Enhance Drug Substance Stability to Preserve Integrity & Extend Usability Across Development Stages
Christine Tkaczyk, director, AstraZeneca
11:30 am Achieving Thermostability Through Lyophilization to Extend Shelf Life & Improve Storage Flexibility
Brian Luk, Senior Scientist II, Arcturus Therapeutics
12:00 pm Parker PureTain Single Use Technology
Rob Blackman, Sales Manager, Product, Parker Hannifin
Track 2: IND Enabling & Clinical Scale
12:10 pm Lunch Break
Track 1: Research Scale
Evolving Formulation Strategies to Improve Stability, Delivery Precision & Modality Compatibility for Increased Patient Use
1:30 pm Engineering Next-Generation LNP Design to Maximise Payload, Encapsulation Efficiency & Mechanistic Understanding
Daryl Drummond, Chief Scientific Officer, Akagera Medicines
2:00 pm Exploring Non-Lipid-Based Nanoparticles to Expand Delivery and Storage Options to Improve Patient Accessibility
Kinkini Roy, PhD, Associate Director, Drug Product Development, Aviceda Therapeutics
2:30 pm Reimagining RNA Delivery: Breaking the LNP Barrier with Peptide-Based Vectors
Gilles Divita, Chief Executive Officer, Divincell
Track 2: IND Enabling & Clinical Scale