RNA Formulation Articles

1. Is The mRNA Payload The Real MVP of Targeted Delivery? 3/24/2025

   As one delightfully colorful quote from a panel discussion at the AMM Ascent meeting last fall reminds us, there’s a lot more to be explored, discussed, and understood as it relates to the mRNA cargo’s role in targeted delivery. 

2. Learning From Oligos: Delivery & Clinical Strategies For mRNA Therapeutics 3/17/2025

   Those of us who attended the Alliance for mRNA Medicines’ inaugural Ascent conference last fall had the opportunity to hear from Zdravka Medarova of TransCode Therapeutics on her experiences working in the oligo sector. Here, I summarize some of her learnings and/or suggestions for the encoding RNA field as we set out to develop mRNA therapeutics for oncology.

3. Courtroom Clash: Inside The High-Stakes World Of mRNA Patent Litigation 2/28/2025

   Here, Shores provides the “who’s who” and “what’s what” behind some of the hottest legal cases to hit the headlines in the mRNA space to-date, as well as why these cases are or could be significant to companies commercializing mRNA products in the future.

4. IP Considerations For Early-Stage mRNA Therapeutics Development 2/7/2025

   Fortunately, navigating the patent landscape is hardly a “doomsday” scenario. But it is a challenge biotechs need to tackle early so they don’t end up too far down the path toward the clinic or in the clinic mired with delays and expensive litigation. Here, Rothwell Figg partner Dan Shores shares several strategies companies may choose to employ when facing a legal gray area to protect their products from patent litigation upon commercialization.

5. A Primer On The RNA Patent Landscape 1/31/2025

   In the first- of this three-part article, Shores gives us an important primer on the RNA legal landscape as it stands today. As many of us are working on crafting the next generation of mRNA/RNA products and LNPs, I wanted to get his sense of how our continued scientific advancement is likely to impact the IP landscape in the long-term.

6. Tune Therapeutics' 2025 Epigenome Editing Outlook 1/10/2025

   Chief Scientific Officer Derek Jantz talks about recent key innovations in gene therapy and RNA technology while considering what milestones we might see in 2025.

7. Top 5 mRNA/RNA Advancements of 2024 (Part 2) 12/30/2024

   As I took stock of the year behind us, there were five overarching ways in which I saw our industry taking steps forward and finding itself on sturdier scientific and clinical footing. Here, in the second of this two-part article, I continue down this list with my last three takeaways.

8. "The Ghost Of mRNA's Future": 2025 Outlook From RNA Leaders 12/17/2024

   As the Charles Dickens fans among us already know, there is still one pretty important “ghost” that has yet to be channeled on this “hallowed” page, and that’s the “Ghost of mRNA/RNA Innovations Yet To Come.” (Yes. That’s a thing.) Here, I share several future-facing “visions” from the conversations I had with five RNA leaders.

9. FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics 12/11/2024

   FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.

10. Commercializing mRNA: 3 "Action Items" To Turn Promising Science Into Real-World Impact 11/26/2024

    The recent Alliance for mRNA Medicines’ inaugural Ascent conference provided us with a lot of great updates on the mRNA industry’s progress. But throughout each of these specific conversations, there was a shared underlying question: How can we become a less esoteric industry?