Featured Editorial

  1. What Do We (Really) Know About DNA Quality For In Vitro Transcription? 2/19/2025

    Gene therapies and nucleic acid medicines are dependent upon a starting DNA template that defines the protein or antigen. The sequence of this template DNA being correct is critical.

  2. FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

  3. 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. 

  4. FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program 2/10/2025

    The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

  5. 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.

  6. 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.

  7. 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.

  8. mRNA Empowering Engineered In Vivo Cell Therapies 1/21/2025

    Recent advances in non-viral delivery technologies have enabled a first generation of genetically modified immune cells in vivo. Deploying these new approaches can address challenges with traditional ex vivo CAR-T cell therapy.

  9. 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?

  10. 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.