READ: ARW ON RNA

  1. “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.

  2. 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.

  3. 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. 

  4. 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. 

  5. 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.

  6. Beyond Moderna's Regulatory Legacy: (Re)defining The mRNA Regulatory “Norm” 3/22/2023

    It’s unlikely we will need to burn nearly as much “midnight oil” as Moderna and the regulatory bodies did during the pandemic. However, I share Moderna's unique experiences because they’re a great reminder that the mRNA therapeutics industry is set to face a much different regulatory challenge moving forward.

  7. Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance 3/22/2023

    We may no longer be living in the fast-and-furious days of Emergency Use Authorization, nor are we all working strictly on mRNA vaccines. But after listening to Moderna’s Director of Regulatory CMC Chris Kelly share his whirlwind regulatory experiences, there were still several broad takeaways for companies navigating this nascent space.

  8. Metaphorical mRNA: An Argument For (More) Creativity In RNA Therapeutics 1/25/2023

    In putting together my mRNA outlook presentation for November's 2022 AGC CDMO Summit, I realized there is one opportunity that should be top of mind for the RNA therapeutics industry in the years to come. We all, regardless of our functional area in the industry (i.e., manufacturing, quality, R&D, commercial), need to figure out how we can make this important science more accessible to populations around the world. 

  9. Defining The RNA Therapeutics Industry In 2023 1/16/2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

  10. Overcoming CGT Potency Assay Woes: 4 Best Practices 12/21/2022

    Here, I share a few of the actionable takeaways I walked away with from the ARM/ASGCT potency assay working session in the hopes they will be a complementary exploration of the analytical challenge impacting every ATMP company.