READ: ARW ON RNA

  1. Why Nike's "Just Do It!" Is The Wrong Slogan For The RNA Industry 1/10/2024

    As Becraft and I discuss, it’s not just the public we need to educate about the possibilities and limitations of mRNA therapeutics. Members of the biopharmaceutical industry at large and the investors supporting emerging and established RNA therapeutics companies could also use a post-pandemic “refresher” about mRNA’s potential use cases beyond vaccines and the (often under-emphasized) truths of what it will take to successfully achieve these use cases.

  2. A Meditation on mRNA's Reputation & Regulatory Complexities 12/21/2023

    I see our modality’s capability to be used in the vaccine and ATMP spaces posing some unique challenges for the RNA space moving forward — particularly as we strive to accomplish two key goals as a space: fleshing out the mRNA regulatory paradigm and confronting misinformation in the years ahead. 

  3. How To Break RNA's “4-Minute Mile” 12/20/2023

    Four CEOs provide their take on some of the hot topics of discussion in the RNA therapeutics space. Whether they be homing in on platform development, much-needed scientific advancements, or commercialization considerations, each of these experts’ quotes speaks to the important “training efforts” we should be building into our “workout” regimens to condition our companies and our products to achieve (and surpass!) RNA’s own “four-minute mile(s).”

  4. Defining A Competitive Next-Gen RNA Therapeutic In 2024 12/11/2023

    To start singling-out where the opportunities exist to craft the next generation of RNA therapeutics, I sat down with four RNA executives who helped me piece together where we and our RNA therapeutics are today and which scientific advancements and mindsets will be essential to craft a “next generation” RNA therapeutic.

  5. Peter Marks: An Early Preview of mRNA, Gene Therapy Platforms 11/28/2023

    Though Marks emphasized that this concept/designation at the regulatory level is still somewhat of a “we’ll-know-it-when-we-see-it” phenomenon, his remarks this summer — as well as a few additional discussions that have occurred throughout 2023 — add a bit more clarity to our understanding of what a gene therapy platform can be.

  6. “Alice In [mRNA] Wonderland:” 3 Realities Facing The mRNA Industry 8/7/2023

    The mRNA industry is an exciting place to be, and I have no doubt we will celebrate some significant triumphs in the future. But there are three critical realities (or perhaps difficult truths) I was reminded of during the mRNA Therapeutics Summit worth reiterating to keep us grounded through all our uninhibited dreaming.

  7. Where Fly-Fishing Meets mRNA: The Art Of mRNA Immunogenicity 5/22/2023

    In the final installment of this two-part series comparing fly-fishing and mRNA immunogenicity, I summarize some of the basic immunology-centric underpinnings of our mRNA development efforts and the enduring immunogenicity questions and concerns shaping and re-shaping these efforts today.

  8. What Fly-Fishing Can Teach Us About mRNA Immunogenicity 5/17/2023

    In part one of this two-part article, I spell out some of the decisions fly-fishermen must make to “trick” a fish, and how these decisions are akin to those of the mRNA industry as we strive to successfully navigate “the enigmatic beast” that is the human immune system. 

  9. Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned 3/29/2023

    One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain. 

  10. Moderna's Global mRNA Manufacturing Strategy: A Closer Look 3/27/2023

    In part 2 of this 3-part series, I argue Moderna’s strategy for scaling its mRNA vaccine manufacturing paradigm globally is one of the best examples the ATMP space has today of what it means to begin with and keep the end in mind.