RNA Clinical Trials Articles

  1. 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?

  2. Top 5 mRNA/RNA Developments of 2024 (Part 1) 12/23/2024

    In the past few weeks, I’ve shared two articles outlining several RNA executives’ thoughts on advancements from 2024, as well as the challenges facing us in 2025. But why stop there? Below in the first of this two-part article, I share the first two of my five overarching observations from 2024.

  3. "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.

  4. "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.

  5. Developing Bespoke Antisense Oligonucleotides To Treat Rare Diseases 11/26/2024

    EveryONE Medicines CEO, Kent Rogers, explains the company’s mission to address a major unmet need in children with rare neurodegenerative diseases, one patient at a time.

  6. 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.

  7. 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.

  8. 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.

  9. A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies 10/2/2024

    This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. 

  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.