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Peter Marks: An Early Preview of mRNA, Gene Therapy Platforms
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.  Continue Reading..
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“With This MSA, I Thee Contract:” The “Make-or-Breaks” In CGT Outsourcing Negotiations
To help us all feel a bit stronger in the face of a negotiation, Haskett and Graskemper did not shy away from providing their go-to contracting best practices and tips for tackling an MSA and Quality Technical Agreement (QTA). While our discussion was far from exhaustive, they singled out several potentially showstopping areas that demand greater prescriptiveness in our MSAs for the sake of much stronger and long-term outsourcing partnerships.&nb...  Continue Reading..
What’s Mine Is (Maybe) Yours: Risk-Sharing In CGT Outsourcing
Here, Haskett and Graskemper walk me through the different nuances of risk-sharing in the current CGT outsourcing space and how they identify the best partner, platform, and intellectual property (IP) strategy when reviewing and (re)negotiating an MSA.  Continue Reading..
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“Once Upon A Platform”: A Realistic Look At “Plug & Play” CGT Development
We can’t just talk broadly about our need for more advanced capabilities from our outsourcing partners without closely examining the current maturity of CDMOs' AAV-based gene therapy and LVV-based cell therapy platforms. Lucky for us, Haskett and Graskemper shared their top tips and tricks for evaluating the seaworthiness of current CGT platform offerings.   Continue Reading..
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From Capacity To Comparability: The Shifting Onus In Cell & Gene Therapy Outsourcing
As we continue progressing beyond the COVID (i.e., the seller’s) economy, both Haskett and Graskemper agree we’re steadily seeing biotechs taking on a much more empowered role in negotiating with and securing CDMO partners. But they also see several shifts in the CGT development landscape that could impact both biotechs and their outsourcing partners equally — for the better, or if we’re not careful, for the worse.  Continue Reading..
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Sarepta’s FDA Adcom: Manufacturing Comparability In The Real World
There are a few must-know details about the why & how of Sarepta’s comparability exercise, which I’ll outline for you here. But it wasn’t the facts and figures underpinning the comparability assessment itself that I found the most noteworthy; rather, this adcom served as an important reminder about the overall role comparability can and likely will play in the regulation of our advanced therapies moving forward.  Continue Reading..
FDA To Sarepta’s Gene Therapy: “Express Yourself…Maybe?”
Though we cling to — and simultaneously despair over — the fact that regulatory experiences are product-specific, the hurdles/debates Sarepta faced remind us of the scientific and clinical complexities our future CGT products will no doubt be faced with during their own BLA reviews.  Continue Reading..
“Alice In [mRNA] Wonderland:” 3 Realities Facing The mRNA Industry
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.  Continue Reading..
A Meditation On Change In The CGT Manufacturing Space
A few weeks ago, I published an article recapping my biggest takeaways from the PDA ATMP conference. Throughout the many technical discussions of the two-day event, I was predominantly struck by how often the conversation circled back to the importance of humility and self-improvement in our CMC. Since publishing that article, I’ve continued to read and hear more about the importance of “growing up” in CMC.   Continue Reading..
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A “Portrait” of Risk In Cell & Gene Manufacturing
The eventual shape of our industry became increasingly top-of-mind as I listened to the final expert panel at the PDA ATMP conference, during which several experts shared the industry challenges currently keeping them up at night. Not surprisingly, many of these experts’ concerns revealed the tenuous relationship we as an industry have with our (often vastly different) assessments of risk in the CGT manufacturing paradigm.   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.