ARTICLES BY ANNA ROSE WELCH

• Britney Spears' Take On Building Platform Analytics for mRNA Therapeutics

  4/2/2025

  As many of the presentations throughout the two-day USP quality forum revealed, we’re doing what we must to understand the benefits and the limitations of our methods. Yes, this is painstaking and expensive work. But understanding our methods is also one of the critical steps toward a future in which we can rely upon platform analytical procedures and — channeling our inner Britney Spears — say “[Ooo], I did it again!” to the regulatory agencies for each of the subsequent molecules in our pipelines.  

• 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. 

• 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.

• The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?"

  3/5/2025

  During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. However, as each of the AMM panelists pointed out, there are short- and long-term technological innovations in the works that will be essential in advancing the manufacturing infrastructure for mRNA therapeutics in all their shapes, forms, and scales. 

• 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.

• Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions

  2/13/2025

  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. 

• 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.

• 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.

• From Promise To Precision: Defining The Therapeutic Niche for mRNA

  1/21/2025

  CureVac CEO Alexander Zehnder shares his thoughts/visions on how mRNA neoantigen vaccines could become even more revolutionary for patient populations in the future. Though it may be early days, this conversation is a great case study for how RNA companies are striving to keep both scientific and commercial market opportunities top of mind from the earliest days of development.

• The Marriage of Science & Strategy: Identifying mRNA Therapeutics' Value Propositions

  1/13/2025

  Though it’s not a question we can answer fully yet, in the first of this two-part article, CureVac CEO Alexander Zehnder starts us down the path of answering a critical question about our RNA therapies: In what ways can and should our mRNA products add value to our patients’ lives?