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.  Continue Reading..
Cell & Gene Comparability: FDA’s Recommendations For Coping With Change
I wouldn’t say the FDA’s recent C&G CMC town halls provided us a clearer blueprint from which we can proceed in answering our biggest comparability questions. However, we did receive some helpful high-level reminders and/or clarifications during these town halls, several of which I’ve summarized below.   Continue Reading..
Overcoming CGT Potency Assay Woes: 4 Best Practices
Here, I share a few of the actionable takeaways I walked away with from the ARM/ASGCT potency assay working session in the hopes they will be a complementary exploration of the analytical challenge impacting every ATMP company.  Continue Reading..
CGT Potency Assays: When Will We Wake Up From The Nightmare?
Here, I offer my biggest takeaways from a recent ARM/ASGCT workshop on one of the most popular topics to gossip about both in and outside the analytical labs: Potency assays. In part one of this two-part article, I start by unpacking what I see as the most prominent knowledge gaps and questions underpinning the industry’s potency assay challenge.  Continue Reading..
mRNA & RNA Therapeutics In 2023: Where Do We Go From Here?
To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.  Continue Reading..
"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.  Continue Reading..
“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.  Continue Reading..
Beyond “The Building Phase”: Evolving The Cell & Gene Outsourcing Paradigm
This article is part two 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.  Continue Reading..
“Science Over Steel:” Exploring The Foundations Of A Hybrid CGT Outsourcing Strategy
This article is part one of a three-part series examining how advanced therapy scientific and quality-related challenges are impacting outsourcing models. We start first by unpacking the considerations ATMP innovators are faced with as they evaluate the increasingly popular hybrid outsourcing model.  Continue Reading..
Bluebird Bio FDA AdCom: 3 Key Takeaways For The Cell & Gene Therapy Industry
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.    Continue Reading..
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.