ARTICLES BY ANNA ROSE WELCH

• GMP Principles: The True Star Of Cell & Gene FDA Interactions

  4/3/2023

  Though many topics caught my attention during the FDA’s recent cell and gene therapy town halls, I was struck by the sheer number of questions related to defining, demonstrating, and documenting the quality of our raw materials.

• Beyond Moderna’s Regulatory Legacy: (Re)defining The mRNA Regulatory “Norm”

  3/22/2023

  It’s unlikely we will need to burn nearly as much “midnight oil” as Moderna and the regulatory bodies did during the pandemic. However, I share Moderna's unique experiences because they’re a great reminder that the mRNA therapeutics industry is set to face a much different regulatory challenge moving forward.

• Moderna’s Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance

  3/22/2023

  We may no longer be living in the fast-and-furious days of Emergency Use Authorization, nor are we all working strictly on mRNA vaccines. But after listening to Moderna’s Director of Regulatory CMC Chris Kelly share his whirlwind regulatory experiences, there were still several broad takeaways for companies navigating this nascent space.

• Cell & Gene Therapy COGS: Words Of Wisdom To ‘Keep The End In Mind’

  3/7/2023

  As a delightfully diverse space, it goes without saying that understanding a product’s process and COGS drivers will be a highly individualized and complex undertaking. However, there were a few valuable points that came up in my conversation with Dark Horse Consulting's Katy Spink that were worthy of sharing as we step back and consider what "keeping the end in mind" will look like for our development paradigm and its COGS.

• Cell & Gene Therapy COGS: Progress & Pitfalls In Our Quest For Affordability

  2/28/2023

  We regularly talk about “getting to know” our products. This can mean a lot of different things depending on the functional area in which we work. But as conversations about affordability and commercial sustainability increase pressure on manufacturing teams, I wanted to get Spink’s thoughts on how we can understand our products from a COGS standpoint and how this will continue to challenge us in the years ahead.

• 4 “Hot Takes” On Cell & Gene Therapy Manufacturing From Advanced Therapies Week 2023

  1/24/2023

  There is truly no article more difficult to write than a takeaway article from a conference. But as I recently spent the past week attending various panels and hearing different perspectives at Phacilitate’s Advanced Therapies Week, I wanted to attempt to do “the impossible” (for me): Share four of the burning manufacturing takeaways that jumped out at me most during the week.

• Defining The RNA Therapeutics Industry In 2023

  1/3/2023

  Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

• "Lean On Me": Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships

  11/1/2022

  While I cannot define precisely what (or which) shape(s) risk-sharing will take for the multitude of unique CGT products in the works, I’ve been privy to several conversations that go a long way toward defining the current state of these evolving ATMP outsourcing partnerships and business models.

• “Risky Business:” How Cell & Gene Therapies Are Upending Partnership Models

  10/25/2022

  This article is the final installment of a three-part series examining how advanced therapy scientific and quality expectations are impacting outsourcing business practices/models today and, hopefully, creating a foundation for greater risk-sharing in the future.

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

  8/1/2022

  There is a broad philosophical question of identity that companies manufacturing CGTs are facing today: Should you be approaching establishing your CGT manufacturing platform as a specialist or as a generalist?

• 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.

• Scott Gottlieb: The Future Of The CGT Regulatory Paradigm

  2/1/2022

  Though Dr. Gottlieb has become one of the most trusted voices through the COVID pandemic, I wanted to hear how his thoughts on the advanced therapies development paradigm have evolved in the past few years, and how he sees the world of CGT CMC changing in the future.

• How Will The CGT Manufacturing Paradigm Mature In 2022?

  1/4/2022

  As these four cell and gene execs shared their expectations for 2022 and beyond, what emerged was a benchmark for what the CGT manufacturing paradigm could realistically look like in 2022 and which in-the-works innovations will help the industry slowly but surely mature.

• Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?

  1/20/2021

  In this fourth installment of the Editorial Board 2021 Outlook, it's clear that stakeholders are relying more heavily on biosimilars and that it’s more important than ever for biosimilar companies to keep carrying the torch for more competition, cost-savings, value, and responsible pricing.