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 Regulatory Gaps in Manufacturing of Cancer Vaccines in Clinical Phases: Aligning Process Development & CMC to Achieve GMP Certification & Tech Transfer Readiness
Synopsis
- Adapting regulatory regulatory frameworks for platform technologies to support the demands of cancer vaccine production in clinical phases, including managing variability and ensuring compliance across small batch processes
- What are the best practices for developing a robust control strategy and managing process change control in early-phase manufacturing to reduce regulatory risk and facilitate smoother tech transfer
- How to proactively engage with local and regulatory agencies to gain manufacturing licence as well as GMP readiness and clarify dossier expectations, overcome challenges in product pathways, and align on tech transfer timelines to avoid delays in clinical progression
NEW COMPANY
NOVEL MRNA MODALITY
9:30 am Designing the Ideal mRNA Platform: How to Align with CEPI’s Vision for Rapid Outbreak Response
Synopsis
- Engineering platform technologies that meet CEPI’s 21-characteristic framework for speed, scalability, and global readiness
- Balancing modularity and manufacturability to enable rapid pivoting in response to new pathogens
- Embedding regulatory flexibility, platform comparison, and equitable access into platform design from day one
NEW COMPANY
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 Harnessing Modifications to Enhance Drug Product Stability & Reduce Cold Chain Burden
Manasa Chilara, Researcher - Todd Przybycien Lab, Rensselaer Polytechnic Institute
Track 2: IND Enabling & Clinical Scale
12:30 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 Reimagining RNA Delivery: Breaking the LNP Barrier with Peptide-Based Vectors
Gilles Divita, Chief Executive Officer, Divincell
2:30 pm Exploring Non-Lipid-Based Nanoparticles to Expand Delivery and Storage Options to Improve Patient Accessibility
Kinkini Roy, Associate Director, Drug Product Development, Aviceda Therapeutics
Track 2: IND Enabling & Clinical Scale
3:00 pm Afternoon Break
Executing Commercial Manufacturing with Robust Supply & Regulatory Frameworks to Increase Market Penetration & Global Reach
3:30 pm Roundtable: Building Globally Resilient Supply Chains to Support mRNA Vaccine & Therapeutic Commercialization
Synopsis
- Securing scalable access to key raw materials, such as lipids, enzymes, and nucleotide reagents, to avoid shortages and de-risk global manufacturing scale-up
- Building regionally distributed cold chain logistics and fill–finish capabilities to support rapid, large-volume deployment in response to global health needs
- Coordinating international CDMOs, regulatory alignment, and digital infrastructure to enable cross-border supply continuity and emergency responsiveness
NEW COMPANY
4:00 pm Leading the Way in Self-Amplifying RNA: Commercialization of saRNA Vaccine Manufacturing
Synopsis
- Navigating the regulatory approval pathway for saRNA vaccines by leveraging process design parameters to accelerate clinical-to-commercial timelines in other regions
- Building and validating domestic saRNA manufacturing capacity to improve regional supply security and enable rapid commercial deployment
- Incorporating collaborative model across industry, government, and academia to support innovation and global leadership in next-generation mRNA platforms
NOVEL MRNA MODALITY