Explore the Agenda

Focus Day

Monday, July 29

Day One

Tuesday, July 30

Day Two

Wednesday, July 31

8:00 am Morning Check In & Coffee

Next Generation mRNA Delivery Day

8:50 am Chair’s Opening Remarks

Advancing Novel Lipid Discovery to Improve Nanoparticle Composition for Safe Systemic Delivery of LNP-mRNA

9:00 am Overcoming Anti-PEG Antibody Responses to Increase Potency & Decrease Adverse Side Effects of mRNA-LNP Formulations

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9:30 am Phospholipids in Vaccines

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10:00 am AI-Assisted Design of IV-Administered Organ-Targeting LNPs for Effective Nucleic Acid Delivery to Extrahepatic Organs

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Innovating Nanoparticles Beyond LNPs to Access Specific Organs & Supercharge Your mRNA Delivery Chair: Annette Bak, Head of Drug Delivery, AstraZeneca

11:00 am Crafting a Multi-Layered Nano Formulation Approach to mRNA Stabilization & Cell-Specific Delivery Using a Novel Nucleic Acid Delivery Platform

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11:30 am yEVs Enabling the High-Efficiency Introduction of Diverse Cargos, Including mRNA, Functional Antibodies, & Enzymes, to a Broad Range of Cell & Tissue Types

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12:00 pm Engineering Futuristic & Next Generation Nanoplatforms for Delivery of mRNA Therapeutics: Academia-to-Industry Innovation Mind Shift

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Optimizing System Design to Increase Delivery Efficiency & Unlock Novel Therapeutic Applications of mRNA

1:30 pm Panel Discussion: Delving into the Latest Innovations in LNPs & Beyond for Effective Delivery of mRNA Therapeutics

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2:00 pm Moving Beyond the Needle: mRNA Vaccine Delivery via Dermal, Pulmonary, & Nasal Pathways

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2:30 pm Designing Lipid Nanoparticles for mRNA Delivery to Study & Treat Diseases in Pregnancy

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Regulatory Affairs Strategy Day

8:50 am Chair’s Opening Remarks

Tackling mRNA CMC Challenges Through Regulatory Engagement & Platform Strategies for Faster Manufacturing

9:00 am Anticipating & Planning for CMC-Related Regulatory Hurdles to Advance the Manufacturing of Next Generation mRNA Vaccines

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9:30 am Roundtable Discussion: Aligning Quality Control & Regulatory Submissions for Personalized Cancer Vaccines tGet Life-Saving Drugs to Patients Faster

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10:00 am Discussing How to Engage with the EMA to Expedite mRNA Medicines to Patients Faster

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Building Pre-Clinical, Process, Analytical & Comparability Strategies to Create a Holistic Regulatory Package for Your mRNA Platform

11:00 am Creating an mRNA Process & Analytical Toolbox to Meet Platform Requirements in a Regulatory Context

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11:30 am Comparability – Regulatory Strategy Considerations for mRNA Product CMC Changes

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12:00 pm Planning for Success: Creating a Regulatory Strategy for the Successful Development of a Novel mRNA Platform

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Engaging with the Regulatory Nuances for Different Disease Areas to Create Effective mRNA Drugs Against All Indications for All Patients

1:30 pm Evolving the Regulatory Landscape to Unlock the Potential of mRNA Platforms for Rare Diseases

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2:00 pm Disease-Specific & Personal: mRNA Therapy Immunogenicity Risk for Rare Diseases

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2:30 pm Addressing the Differences in Regulatory Strategy for Various Batch Sizes of Personalized Cancer Vaccines

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3:00 pm Afternoon Networking Break

3:45 pm Breakthrough Innovations Workshop Save millions of lives, trillions of dollars, and enable real global equity

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6:45 pm Drinks Reception hosted by Wellcome Leap

Day One
Day Two
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