READ: ARW ON RNA
-
From “Barbieland” To ATW 2024: Evolving Beyond “Stereotypical” Advanced Therapies
1/26/2024
What I was met with this year at Phacilitate's Advanced Therapies Week was an industry that knows its worth, but which is facing similar issues as Barbie around what its long-term identity can be and how it can transcend beyond being just a promising idea. Here, I’ve come up with a few snippets of “identity-chiseling” wisdom for the ATMP space.
-
ARW’s ATMP Manufacturing Must-Reads (2024 NEW YEAR’S RESOLUTIONS EDITION!)
1/12/2024
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.
-
Why Nike’s “Just Do It!” Is The Wrong Slogan For The RNA Industry
1/10/2024
As Becraft and I discuss, it’s not just the public we need to educate about the possibilities and limitations of mRNA therapeutics. Members of the biopharmaceutical industry at large and the investors supporting emerging and established RNA therapeutics companies could also use a post-pandemic “refresher” about mRNA’s potential use cases beyond vaccines and the (often under-emphasized) truths of what it will take to successfully achieve these use cases.
-
A Meditation on mRNA’s Reputation & Regulatory Complexities
12/21/2023
I see our modality’s capability to be used in the vaccine and ATMP spaces posing some unique challenges for the RNA space moving forward — particularly as we strive to accomplish two key goals as a space: fleshing out the mRNA regulatory paradigm and confronting misinformation in the years ahead.
-
How To Break RNA’s “4-Minute Mile”
12/20/2023
Four CEOs provide their take on some of the hot topics of discussion in the RNA therapeutics space. Whether they be homing in on platform development, much-needed scientific advancements, or commercialization considerations, each of these experts’ quotes speaks to the important “training efforts” we should be building into our “workout” regimens to condition our companies and our products to achieve (and surpass!) RNA’s own “four-minute mile(s).”
-
Defining A Competitive Next-Gen RNA Therapeutic In 2024
12/11/2023
To start singling-out where the opportunities exist to craft the next generation of RNA therapeutics, I sat down with four RNA executives who helped me piece together where we and our RNA therapeutics are today and which scientific advancements and mindsets will be essential to craft a “next generation” RNA therapeutic.
-
Peter Marks: An Early Preview of mRNA, Gene Therapy Platforms
11/28/2023
Though Marks emphasized that this concept/designation at the regulatory level is still somewhat of a “we’ll-know-it-when-we-see-it” phenomenon, his remarks this summer — as well as a few additional discussions that have occurred throughout 2023 — add a bit more clarity to our understanding of what a gene therapy platform can be.
-
“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.
-
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.
-
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.