ARTICLES BY ANNA ROSE WELCH

• Bluebird Bio FDA AdCom: 3 Key Takeaways For The Cell & Gene Therapy Industry

  7/6/2022

  Below, I’ve boiled down the 15 dizzyingly technical hours comprising bluebird bio's two FDA AdCom meetings into three high-level takeaways that speak to the opportunities and limitations facing CGTs and their all-important CMC frameworks.  

• From Manufacturing Floor To C-Suite: “Scaling Up” Cell & Gene Therapy Communication

  6/20/2022

  Though "communicate often" is a commonly offered best practice in the CGT space, what is rarely discussed is what this can and should look like, especially when it comes to elevating information from the manufacturing floor/team up to the C-suite. Mark Gergen, CEO of Poseida Therapeutics, gives us a great idea of what this can look like for growing CGT companies.

• The “Renaissance” Approach To Cell & Gene Therapy Manufacturing

  6/13/2022

  We’re all familiar with the concept of the “Renaissance Man/Woman". In the context of the CGT space, however, can there be such a thing as a “Renaissance Company”? My conversation with Poseida Therapeutics' CEO Mark Gergen proves that there can be and establishes why a generalist mindset is necessary to bring the CGT manufacturing paradigm to maturity.

• ARW’s C&G (+RNA!) Manufacturing Must-Reads (Dracula Edition!)

  6/3/2022

  Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, 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. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

• Can USP, NIST, & NIIMBL Conquer The Biggest AAV Quality Challenge?

  5/18/2022

  As the CGT industry continues struggling to sufficiently characterize its AAV, USP's Fouad Atouf and I unpacked the ins-and-outs of this ongoing USP, NIST, and NIIMBL AAV quality initiative — as well as the CGT industry’s greatest needs from such a collaboration.

• ARW’s C&G Manufacturing Must-Reads (The Simpsons Edition!)

  5/9/2022

  Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, 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. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

• ARW’s Cell & Gene Manufacturing Must-Reads (Classic Literature Edition!)

  4/25/2022

   Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format and send them out via email. For this April 21 edition, I decided to play with the “Thank You For Libraries Day” theme. Below, each section of articles includes a quote and several not-so-subtle references to classic works of literature you’d likely find in any of the world's most glorious libraries.

• Time Well-Spent: Embracing Opportunity Costs In Gene Therapy Manufacturing

  4/11/2022

  It goes without saying that “taking time” to get a solid process in place is a best practice. But what I particularly appreciated about my conversation with Tenaya CTO's Kee-Hong Kim was how his own experiences and perspectives helped define what exactly “time well spent” means in the CGT development process. 

• ARW’s C&G Manufacturing Must-Reads (GIANT RODENT! Edition)

  4/8/2022

  Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, 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. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

• Show Me The Money! A Closer Look At COGS In Gene Therapy Manufacturing

  4/6/2022

  It’s almost inevitable that any conversation about manufacturing will be filled with references to “Time” and “Money,” and my conversation with Tenaya CTO, Kee-Hong Kim was no exception. But while these words can be dangerously vague, Kim’s experience added some valuable context into how he approaches these two resources in his role — starting first with “money.”

• Your C&G Manufacturing Must-Reads (Philly Cheesesteak Edition!)

  3/25/2022

  Here’s a “permanent” copy of my C&G Manufacturing Must-Reads newsletter that was delivered on March 24, which just happened to be National Cheesesteak Day. Ergo, this is the “Philly Cheesesteak edition” of your manufacturing must-reads, in honor of our many friends in “Cellicon Valley”/Philadelphia.

• Your C&G Manufacturing Must-Reads (Super Mario Edition!)

  3/11/2022

  This is a “permanent” copy of my C&G Manufacturing Must-Reads newsletter that was delivered on March 10. As March 10 is also known as Super Mario Day (Mar10), this Manufacturing Must-Reads has a Super Mario theme. 

• From “Wild West” To “Rainforest”: Cell & Gene Manufacturing Ecosystem Embraces Symbiosis

  2/28/2022

  We often affectionately refer to the CGT manufacturing sector as “The Wild West.” However, I’m also starting to see a subtle reformation happening — one that takes us beyond the barren desert full of dueling cowboys and heat-crazed goldminers to that of a lush, productive, and symbiotic rainforest.

• Your C&G Manufacturing Must-Reads (Mixologist Edition!)

  2/25/2022

  Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, 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. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

• Lightning-Fast CMC Meets Incremental Innovation in Cell & Gene Therapy Manufacturing

  2/24/2022

  I’ve heard it said that cell and gene therapy companies shouldn’t “let the perfect be the enemy of the good.” My conversation with Wugen’s VP of CMC, Ken Chrobak, was a fantastic example of how such a best practice can be translated into an actual CGT manufacturing program.