READ: ARW ON RNA

  1. "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.

  2. "Ghosts Of mRNA Past & Present": 6 RNA/LNP Execs Revisit 2024 12/10/2024

    But much like Dicken's “A Christmas Carol” with its emphasis on how the past and present inform the future, I was struck by six RNA executive’s appreciation for where we have been and currently are as an industry, and how these moments in time are already informing mRNA/RNA’s bright future.

  3. 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?

  4. RNA Therapeutics: Navigating The "Holy Trinity" Of Structure, Process, & Biology 11/19/2024

    During our hour-long conversation, Sagaert and I covered a lot of ground on the current state of the industry. But given his background in quality, it shouldn’t come as a surprise that our conversation ultimately gravitated back to some of the biggest questions we currently have and need to answer about our product’s structure and function — and how to adequately demonstrate this critical knowledge to regulators.

  5. Lessons From The Past: How mRNA Can Thrive In The Evolving ATMP Market 11/4/2024

    Fortunately, as multiple presenters during the AGC CDMO Summit explained, there have been a few historical case studies of how the industries preceding us did (or didn’t quite) do the due-diligence they should have to trigger meaningful societal change. Not only do these case studies provide a few tactical pointers for those of us in the mRNA/RNA therapeutics space, I also think they can be particularly instructive in helping us craft/finetune mRNA’s value proposition.

  6. A Tale of Two Futures: Financial Trends Shaping The Advanced Therapies Space 10/25/2024

    In the first of this two-part article, I’ll share a few of the commercial nuances informing what the path forward may look like for all of us in the ATMP financial sector.

  7. A "Flight Plan" For Achieving These 3 mRNA Development Milestones 10/18/2024

    Here, in the final installment of this three-part series, I’ll share the panelists’ greatest learning experiences and regulatory advice (so far) on what we should be looking out for as we strive to achieve three big milestones: Entering the clinic; implementing advanced manufacturing technologies into our processes; and standardizing our manufacturing platforms.

  8. Are We Actually Living In An mRNA Regulatory "Desert?" 10/11/2024

    Fortunately for us, the panel shared a few important reminders for us all as we continue to navigate mRNA in a variety of different therapeutic applications and, perhaps, as we explore the implementation of advanced manufacturing technologies in our mRNA-LNP manufacturing processes. In the second of this three-part article series, I walk through one big takeaway I had from this panel’s conversation about the current state of mRNA regulatory affairs.

  9. Shifting Sands Scales: Manufacturing Considerations For Small-Scale mRNA Production 9/30/2024

    Though mRNA may, in theory, be the “perfect technology” for scaling up/out and down, several industry experts from a panel during Cytiva’s recent RNA-LNP Summit explained that the successful transition from large to small-scale, high-quality mRNA production demands specific manufacturing capability improvements/advancements. In the first of this two-part article, I outline a few of these important manufacturing and outsourcing considerations that must accompany our shift to smaller scales.

  10. One Unspoken Issue With The FDA's Platform Designation 9/19/2024

    Subjectivity and hearsay will no doubt play a big role in how we approach the FDA's Platform Designation guidance moving forward, and I daresay these hard to mitigate factors will complicate our relationship with this designation in the future.