Newsletter | June 18, 2025

06.18.25 -- Decoding Recent MHRA & EMA mRNA Regulatory Guidance

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Delivery remains RNA therapeutics' biggest hurdle—especially beyond the liver. In this Advancing RNA Live, Anna Rose Welch is joined by experts exploring nonviral, non-LNP delivery solutions pushing the boundaries of coding and noncoding RNA. Hear what makes these novel vehicles promising and learn how companies are tackling the scientific and operational challenges that stand in the way. Don’t miss this deep dive into the future of RNA drug delivery innovation.

FEATURED EDITORIAL

Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions

Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem. 

Designing Our Way Toward Circular RNA Medicines With AI

The closed-loop structure of circular RNA can offer sustained, durable expression. We caught up with Sail Biomedicines' Kerry Benenato and Rajesh Ramaswamy to chat about ways to leverage AI for design/engineering.

Understanding The Impact Of New Regulatory Guidance

In this Advancing RNA Live discussion, editorial and community director Anna Rose Welch sat down with CureVac’s Ulrike Jägle and Eliquent Life Science’s Tiffany Lucas to take a closer look at the latest mRNA regulatory guidance. They identified the biggest challenges the industry faced in navigating these guidances and explored the overarching learnings and best practices mRNA developers could apply across their programs, regardless of therapeutic approach.

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RNA Leaders USA Congress

The RNA Leaders series explores scientific, clinical, and commercial advancements in RNA medicines, including RNAi, antisense, and mRNA therapies. This September, the 4th USA edition returns to the East Coast, welcoming 350+ attendees across oligos, mRNA and next-gen RNA streams. Join biotech leaders, discovery innovators, delivery developers, manufacturers, pharma, and investors at this exclusive forum for senior RNA experts advancing RNA-based therapies.

INDUSTRY INSIGHTS

A New Centre For Continuous mRNA Manufacturing

See how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.

Ophthalmic Drug Delivery

Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.

Antisense Oligonucleotide Extraction Optimization Reveals Differences

Our findings provide critical insights into refining ASO extraction protocols, which can enhance the accuracy of downstream analyses and support further research into ASO-based therapeutics.

Understanding mRNA Technology As A Platform For Biopharma

Learn about the advantages of mRNA technology, the process steps of large-scale mRNA production, and the effect of common contaminants on mRNA manufacturing.

IVT mRNA Encapsulation Efficiency Assessment

Discover how an analyzer system enhances encapsulation efficiency and critical quality attributes in in vitro transcribed (IVT) mRNA workflows.

FAQs On The siRNA Therapeutics

Stay ahead in the rapidly evolving field of siRNA therapeutics by exploring the latest clinical trends, breakthrough delivery technologies, combination strategies, and global regulatory pathways.

Drug Discovery And Screening, A Digital Era For RNA-LNP Therapeutics

Learn about the key stages of drug discovery and screening as well as how to overcome bottlenecks in screening mRNA-LNPs to rapidly develop genomic medicines.

Manufacturing Strategies For mRNA Vaccines And Therapeutics

mRNA has emerged as a promising modality offering a great deal of versatility for a wide range of therapeutics and vaccines with its use of non-viral delivery systems.