Newsletter | April 22, 2026

04.22.26 -- How Informal FDA Feedback Is Driving RNA Capital Allocation

SPONSOR

5th Circular & Self‑Amplifying RNA Therapeutics Summit

This May, the 5th Circular & Self‑Amplifying RNA Therapeutics Summit is returning to Boston. This is the only meeting dedicated exclusively to circular and self‑amplifying RNA, bringing together senior biotech and pharma leaders working on next‑generation RNA therapeutics. As an Advancing RNA subscriber, you get 10% off! Just use code AdvancingRNA10 at checkout to enjoy a discount on all tickets.

FEATURED EDITORIAL

The "Middle Ground" Advantage: Why Alnylam Is Betting Big On Chemoenzymatic Ligation

As Alynlam’s CTO and Chief Quality Officer Tim Maines argues, embarking into the “middle ground” of enzymatic ligation is essential for garnering the step-by-step learnings needed to help us unlock even bigger manufacturing wins in the future. 

Novel Lipid Chemistries And Their Impact On Passive LNP Delivery

In this Advancing RNA Live clip, NanoVation’s Dominik Witzigmann and Stealth Co’s John Zuris break down the scientific advancements we’re seeing for each of an LNP’s components (i.e., the ionizable lipid, helper lipid, and PEG), albeit with the caveat that, with these advancements, Freedom to Operate (FTO) continues to grow increasingly complicated.

How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation

Subtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.

Inside The mRNA–LNP Patent Wars: A Q&A With Goodwin On Litigation, Strategy, And What Comes Next

Patent disputes around mRNA constructs and LNP delivery are intensifying. Goodwin’s Natasha Daughtrey and Bill Christiansen unpack litigation trends, IP strategy, and what RNA developers should expect next.

INDUSTRY INSIGHTS

Refinement Strategies For mRNA Stability And Delivery

RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.

How Do You Navigate Through The Jungle Of Columns?

Whether prioritizing mass spectrometry compatibility or loading capacity, understanding the specific trade-offs between IP-RP, AEX, and SEC methodologies is essential for successful characterization.

The Current And Future Value Of mRNA Vaccines And Therapeutics

Decades of research have positioned mRNA at the center of modern medicine. Examine the technological milestones driving drug development and the future potential of gene-based therapies.

Optimizing Contamination Control: Strategy Planning And Execution

A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

Overcoming Operational Hurdles In RNA Drug Development

RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.

A Critical Selection: Reducing Double Stranded RNA Formation

T7 polymerase generates substantial dsRNA in IVT reactions. Non-T7 alternatives tell a different story, and the data makes a compelling case for reconsidering your enzyme selection.

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With 1900+ attendees, TIDES USA, May 11-14, 2026, at Boston's Hynes Convention Center, is North America's leading forum for advancing oligonucleotide, peptide, mRNA, genome editing, and delivery innovations. This event bridges research to reality, fostering collaboration, and breakthrough solutions. Explore cutting-edge workshops, tracks, and exhibits while connecting with global pioneers like Robert Langer and Kiran Musunuru. Register early for any early bird savings and save an additional 10% with VIP code ADVRNA10 at checkout!

SOLUTIONS

A Small But Mighty Vector Platform

Vaccinia Capping System For mRNA Therapeutics