Explore the Agenda
7:30 am Morning Check In & Coffee
Next Generation mRNA Delivery Day
8:00 am Chair’s Opening Remarks: Pushing the Envelope of Innovation in mRNA Delivery to Unlock the Full Potential of mRNA Therapeutics
Innovating Non-Viral mRNA Delivery to Expedite Clinical Readiness & Overcome Challenges with Conventional LNP (Part 1)
8:30 am Showcasing Key Updates to the saRNA/LION-TM Platform for Improved Safety & Efficacy
9:00 am Session Reserved For Mercury Bio
9:30 am MEVs (Microalgae Extracellular Vesicles) – A Universal Delivery System for RNA Therapeutics, Vaccines & Gene Therapies
10:00 am Transforming RNA-based Therapeutics With Structural Nanomedicine
10:30 am Morning Networking Break
Innovating Non-Viral mRNA Delivery to Expedite Clinical Readiness & Overcome Challenges with Conventional LNP (Part 2)
11:15 am Selective Extrahepatic Delivery of mRNA by Passive Targeting
11:45 am Session Reserved For Kindeva
12:15 pm Panel Discussion: Bio-Derived or Synthetic? Looking into the Future of mRNA delivery Carriers in LNP & Beyond
1:00 pm Networking Lunch Break
Converging Material Science, Biology & Artificial Intelligence to Inform Design of mRNA Carriers with Improved Efficacy & Tolerability
2:00 pm Utilizing Machine Learning to Improve LNP Safety & Toxicity Profile
2:30 pm Investigating RNA Nanocarriers & Their Toxicities
3:00 pm Panel Discussion: Exploring Materials Science-Biology Interface to Inform Next Generation Gene Carrier Design
3:45 pm Chair’s Closing Remarks
4:00 pm End of Pre-Conference Day
Workshop Day
8:30 am Workshop A Building an Innovative & Investable mRNA Platform From Discovery R&D Towards Clinical Readiness
Being able to design and develop an mRNA drug from concept into an effective drug product can be a challenge, with new emerging technologies and that require validation and regulatory approval. However, without this, there is limited progress to expand mRNA potential.
This workshop will explore the latest innovations on the horizon, bringing together key thought-leaders to share their insights and experience on the future directions and potential of mRNA by setting a roadmap from discovery to market and ensuring better outcomes for patients.
This workshop will address:
- Where are the current gaps in RNA innovation that can be filled?
- What roadmap and endpoints are required to transition your platform from discovery to market?
- What funding opportunities are there for new innovations and to ensure they can be clinically validated?
Case Studies Include:
- Pioneering Selectively Activated, Precise In Vivo mRNA Therapeutics
- Engineering Novel Circular RNA Therapeutics
- Developing Broadly-Protective Vaccines on PopVax’s mRNA-LNP Platform Using Machine Learning-Enabled Computational Immunogen Design
10:30 am Morning Networking Break
11:15 am Workshop B mRNA Regulatory Planning Workshop – Outlining Key Regulatory Compliance Data to Secure IND Filing & Speed to Clinic
The regulatory landscape for mRNA is changing and becoming increasingly complex with new products now entering clinical phase trials from novel cancer vaccines to unique protein replacement therapeutics. Drug developers remain without clarity on how their pipeline will make it, without a clear regulatory consensus or guidelines.
This workshop will feature experienced regulatory submission tried-and-tested strategies for maximizing your speed to clinic.
This workshop will address:
- How does regulatory strategy differ for a vaccine versus therapeutics?
- How much data and quality of data is required to secure approval for different modalities and indications?
- Is there a strategy for gaining accelerated approval once you’re in the clinic leveraging your platform?
Case studies include:
- From Pandemic Urgency to Inter-Pandemic Normalcy: How the Regulatory Landscape has Evolved for mRNA Products
1:00 pm Networking Lunch Break
2:00 pm Workshop C Sourcing & Supplier Workshop – Finding the Right Partnership to Build a Robust & Trusting Relationship to Accelerate mRNA Development to Commercial Markets
The mRNA community thrives on strategic alliances, which allow for cross-functional sharing of knowledge, skills, and experience across different disciplines to truly advance mRNA technologies to accelerate drug development to patients faster.
This workshop will feature experts sharing strategies to ensure you build the right partnerships from supplier to manufacturer to help you towards commercial viability alongside patient accessibility.
This workshop will address:
- How to overcome the complexities of decision-making and cultural boundaries for developing, acquiring, licensing and advancing innovative approaches
- Where are the gaps and costs when using mRNA approaches that the service provider, biotechnology and academic sector can fill?
- Developing successful expertise in house vs external sourcing and supply management vs asset acquisition partnering strategies