• Defining A Competitive Next-Gen RNA Therapeutic In 2024

    To start singling-out where the opportunities exist to craft the next generation of RNA therapeutics, Anna Rose Welch sat down with four RNA executives.

  • Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships

    In part 1 of this two-part article, Jason C. Foster, CEO and executive director of Ori Biotech, and Abe Maingi, VP of business development and co-founder of Inceptor Bio, share their perspectives on how partnerships must evolve to mitigate the unique scientific and financial risks facing autologous cell therapies. 

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

    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”

    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

    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’

    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

    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

    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

    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

    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

    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

    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!)

    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?

    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

    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.

Anna Rose Welch Headshot

Anna Rose Welch

Anna Rose Welch is the director of Cell & Gene Collaborative. In this role, she is forging close relationships with the leading voices and organizations in the cell and gene therapy manufacturing sphere. This includes establishing a peer group comprising Cell & Gene company manufacturing SMEs, conducting interviews and hosting interactive roundtables on the evolving manufacturing paradigm, and authoring thought leadership articles and blog posts via the Cell & Gene Collaborative blog.

Prior to launching Cell & Gene Collaborative, Anna Rose spent five years building an extensive network and editorial following as the Chief Editor of Biosimilar Development. In addition to penning thought leadership on biosimilar regulatory affairs, government policy, and commercialization advances, she was also an active participant in the biosimilar conferences circuit. She was appointed chair or served as a speaker and panel moderator at international conferences, including the World Biosimilar Congress USA, The Biotech Pharma Summit (EU), the CBI Biosimilars Summit, DIA Biosimilars Conference, and the Biosimilar Medicines Group Conference (EU). In 2018, she was invited to Brazil where she addressed members of the Brazilian Ministry of Health, ANVISA, and local biologics and biosimilar manufacturers on establishing national biologics and biosimilar policies. She also represented the publication on a media tour of Bangkok, Thailand in 2017, during which she reported on the country’s efforts to bolster its life sciences industry. In addition to writing for Biosimilar Development, she penned the introductory chapter to the book, Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (Springer, 2018).

In 2018, her first book of poetry, We, The Almighty Fires, was published by Alice James Books.