READ: ARW ON RNA

1. "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.

2. 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?

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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. 

10. FDA's Platform Guidance Raises Long-Term Questions For mRNA Makers 9/5/2024

    As I read through the FDA's draft platform designation guidance and listened to various panel discussions the past few months, a handful of additional observations and considerations came to mind that are important to reiterate for the RNA space, particularly as we advance into therapeutics development.