CLINICAL TRIALS ARTICLES

  • The In Vivo CAR-T Playbook: Differentiating Your mRNA Candidates

    Fortunately, as my conversation with ParcelBio CEO David Weinberg emphasized, there’s still a lot of room to grow in terms of what our RNA-based products can be and how they can perform. Here in part 2 of this two-part article, Weinberg walks me through how ParcelBio is approaching this market and helping define what a competitive mRNA product will look like in the in vivo CAR-T space. 

  • Inside the In Vivo CAR-T Boom: Where Does mRNA Fit In?

    I had the chance to sit down with ParcelBio’s CEO David Weinberg to learn more about the emerging market dynamics in the in vivo CAR-T space, with a particular focus on the challenges facing RNA biotechs looking to navigate this up-and-coming therapeutic class.

  • What Baby KJ Taught Us About Patient & Physician Communication

    Over the past few weeks, I’ve been sharing my takeaways from the overall event, as well as from a specific panel featuring JHU’s Jeff Coller, CHOP’s Rebecca Ahrens-Nicklas, and Plowshare Therapies’ Kevin Strauss. Together, these three discussed the biggest learnings and takeaways from the miraculous Baby KJ experience that we very much hope to replicate in the future. As you can likely imagine, patient and physician communication played a large role in the discussion at hand. 

  • What Baby KJ Taught Us About mRNA COGS

    Here, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”

  • What Baby KJ Taught Us About Sustainable mRNA Development

    Of course, these conversations are rarely simple, and the learnings are multifaceted. In the following three-part series, I’ll share my 3 biggest takeaways from the discussion between Coller, Ahrens-Nicklas, and Strauss. Here in part 1, I’ll start by parsing out the learnings about drug development we can take away from the overall heroic efforts to dose Baby KJ. 

  • From Baby KJ To Global Access: The 3 Pillars Of Next-Gen mRNA Expansion

    Obviously, the transition from RNA vaccines to therapeutics is an “expansion” all on its own; but to do this successfully, we need to expand our science, our products’ deliverability, and our patient access. In the following article, I highlight a few of the best practices and/or innovations that came up in conversation during this event that will play a significant role in helping us expand mRNA’s reach, both scientifically and therapeutically.

CLINICAL TRIALS VIDEOS

Discover how the clinical research bridge between China and the US supports accelerated clinical development from early to late phase trials while ensuring the inclusion of MRCT data packages in future regulatory applications.

Explore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.

How many mRNAs are too many in a multivalent therapy? In this clip, Eliquent Life Science’s Tiffany Lucas and CureVac’s Ulrike Jägle delve into this question, emphasizing the factors that are essential for regulatory success and patient benefit.

Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 1, Welch draws a few connections between the magical world of Harry Potter and the challenging scientific work mRNA companies are doing today to explore and/or broaden mRNA's therapeutic potential in a variety of indications.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS